Implementing oral (event-driven and daily) and long-acting pre-exposure prophylaxis in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)

Implementing oral (event-driven and daily) and long-acting pre-exposure prophylaxis in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN) | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Implementing oral (event-driven and daily) and long-acting pre-exposure prophylaxis in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN) Sylvia Kusemererwa, Bernadette Nayiga, Limakatso Lebina, Linda Gail Bekker, and 10 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5704553/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 10 Nov, 2025 Read the published version in Trials → Version 1 posted 6 You are reading this latest preprint version Abstract Background : Men who are mobile for work are a key population at high risk of acquiring HIV. Flexible pre-exposure prophylaxis (PrEP) options, including event-driven (ED) oral PrEP and long-acting injectable cabotegravir (CAB-LA), may offer increased access and acceptability for these men. However, limited data exist on the effectiveness and implementation of CAB-LA and ED PrEP among mobile men in Africa. Our study aims to assess the effectiveness and implementation of CAB-LA and oral Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (both daily and ED) through comparison of uptake, retention in care, coital coverage, and participant choice. Methods : We will conduct a mixed method, phase 3b, open-label, hybrid type 2 implementation and effectiveness randomized controlled trial (RCT). The trial will be carried out in 400 HIV negative men aged 18 years or older in South Africa and Uganda. Men will be randomized 1:1 to either Group A: oral TDF/FTC PrEP (ED or daily) or Group B: CAB-LA over 9-months. After 9 months, participants from both groups will be offered a choice of PrEP (oral TDF/FTC or CAB-LA) for a further 9 months, with the ability to change their choice as required. Various strategies to support PrEP adoption, initiation, and persistence will be implemented, monitored, and reported on using a RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) implementation science framework. Discussion : This study will provide critical data to inform scalable delivery models for both oral and injectable PrEP among mobile men at high risk for HIV acquisition. Findings will also highlight the potential of PrEP choice delivery and its benefits, offering evidence for governments to consider in the roll out of injectable PrEP in public health systems. Trial registration : NCT06133686, registered 14 November 2023. PACTR202409632006463, registered on 2 September 2024 HIV PrEP long-acting cabotegravir mobile populations sub-Saharan Africa men Figures Figure 1 Administrative information Title {1} Implementing oral (event-driven and daily) and long-acting Pre-Exposure Prophylaxis in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN) Trial registration {2a and 2b} NCT06133686; PACTR202409632006463 Protocol version {3} 3.0 Funding {4} European Union (EU) Horizon/ European and Developing Countries Clinical Trials Partnership (EDCTP) Global health call for vulnerable adults (Project number: 101103140). Author details {5a} 1 Medical Research Council/ Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda 2 Africa Research Health Institute, Durban, South Africa 3 Desmond Tutu HIV Foundation, Cape Town, South Africa 4 University College London, London, United Kingdom 5 South African Medical Research Council, Cape Town, South Africa 6 University of the Witwatersrand, Johannesburg, South Africa 7 London School of Hygiene and Tropical Medicine, London, United Kingdom 8 King’s College London, London, United Kingdom Name and contact information for the trial sponsor {5b} Eugene Ruzagira MRC/UVRI and LSHTM Uganda Research Unit, Plot 51-59 Nakiwogo Road, P.O. Box 49 Entebbe, Uganda Email: [email protected] Role of sponsor {5c} This is an investigator-initiated trial. The sponsor takes responsibility for the design of the study, the collection, analysis, and interpretation of the data, and the writing of the manuscript. The design, management, analysis and reporting of the study are independent of the funding source. Introduction Background and rationale {6a} Whilst daily HIV prevention pre-exposure prophylaxis (PrEP) has been extensively evaluated in men who have sex with men and adolescent girls and young women (AGYW) [1], there have been few evaluations of injectable and event-driven (ED) PrEP in men who mainly have sex with women in sub-Saharan Africa. ED PrEP is a regimen that involves taking two pills 2–24 hours before sex, and then one pill every 24 hours until 48 hours after the last sexual encounter [2]. Research to fill this gap is required to improve PrEP guidelines and facilitate successful PrEP roll out, a key focus of the Sustainable Development Goal target to end AIDS by 2030 [3]. ED PrEP for men, regardless of sexual orientation or sexual modality, has been recommended by WHO since 2019 [4], but this approach has not been endorsed in South Africa and only recently endorsed in Uganda [5] despite evidence of high acceptability demonstrated in feasibility studies [6]. Compared to daily oral PrEP, ED PrEP may require fewer tablets, which will lead to lower costs and fewer side effects. More recently, injectable PrEP has been shown to be more effective than daily oral PrEP, [7] mainly because of better adherence, and as a result, long-acting cabotegravir (CAB-LA) has been recommended for use since 2022 [8]. To support roll out of CAB-LA where the HIV burden is greatest, there is a need for studies to include men from sub-Saharan Africa. Acceptability studies have indicated that men show a preference for CAB-LA over oral PrEP, however, this is yet to be trialed [8-12]. Furthermore, there is a need to develop affordable and accessible HIV testing strategies for CAB-LA monitoring so that it can be delivered safely in primary care settings. Although the WHO recommends the use of national HIV testing algorithms for those on CAB-LA, this approach is more likely to miss early infection than nucleic acid-based tests, particularly at CAB-LA initiation [13]. Conversely, HIV viral load testing in CAB-LA is problematic as such tests lack regulatory approval as HIV diagnostic tests are expensive and require laboratories. Furthermore, clinical trials of CAB-LA have found positive tests very difficult to interpret [14,15]. HIV self-tests have not been used in CAB-LA provision so far and their use to increase the frequency of HIV testing may increase detection of early HIV infection. An important factor in successfully enabling people to protect themselves is choice. Oral and injectable PrEP offer different benefits. The short-acting oral agents offer the ability to discontinue PrEP rapidly when desired. While long-acting PrEP removes the need for tablets and potentially improves adherence, it increases the number of clinic visits and the need for a trained health care worker to give the injection [16]. With the introduction of CAB-LA, a concern amongst providers is that it could lead to the re-medicalization of PrEP, hindering the migration of PrEP services into community venues (outside of clinic facilities) and the administration of PrEP by lay health workers [4, 17]. The delivery of injectable PrEP in community settings and for mobile groups is essential for widespread roll out. Little is known about the most effective way to implement PrEP choice for men in Uganda and South Africa. Engaging men and retaining them in HIV prevention and treatment programmes has been met with challenges in sub-Saharan Africa [18].Men consistently fare worse than women in levels of HIV testing and ART initiation [18, 19]. Indeed, the failure of some Treatment As Prevention (TASP) trials to show effect was mainly due to the inability to test and treat young men [20]. Providing PrEP for men therefore represents a large unaddressed gap in HIV services in Africa [21]. In South Africa and Uganda, other than voluntary medical male circumcision , and condom promotion, there have been few prevention options for heterosexual men. Men have had limited access to oral PrEP in part due to poor access to primary health care services, due to stigma, inconvenient opening times and long waiting times, and due to a lack of knowledge of HIV prevention options [21-23]. Men who are mobile due to work or looking for work are a key population at high risk of acquiring HIV [21]. High HIV prevalence remains disproportionately high in this population in sub-Saharan Africa. Estimates range from 0.95% to 54% among truck drivers [24], and 39.5% to 42% among farm workers [25], 26% among unemployed men in South Africa [26], and 40% among men in fishing communities in Uganda [27]. As Africa's large youth bulge moves into young adulthood, the search for work and associated mobility will further increase. Despite this, PrEP intervention studies have not included these populations [28] and, as such, a real-world delivery model for HIV prevention in mobile men has not been developed. One specific concern is that those who are mobile for work may require more flexible PrEP delivery systems to allow for extended periods away from home [4]. Political decisions regarding rollout and delivery models need to take into account implementation needs and cost effectiveness. Recent economic analyses comparing CAB-LA to oral PrEP have shown mixed results. Seven studies modelled data and scenarios specific to South Africa [29-35], but with the exception of two [31, 35, 36],none was based on trial or implementation study data. Additionally, one study assessed costs for men who have sex with men and transgender women in the United States [37]. Economic analyses comparing CAB-LA to oral PrEP based on data from implementation and countries other than South Africa are therefore needed. The Mobile Men study will provide data on the cost and outcomes of ED PrEP and HIV antibody test monitoring of CAB-LA to be used for such economic analyses. We also, for the first time, will provide cost data for Uganda for oral PrEP and CAB-LA PrEP. For this, we will use the HIV Synthesis model, an individual based model that includes both oral and long-acting injectable PrEP, while accounting for drug resistance [36,38]. This is particularly important for CAB-LA, given its tail dosing and the potential for cross-resistance between cabotegravir and dolutegravir, the cornerstone drug of first-line HIV treatment globally. To improve uptake, persistence, and effective use of all forms of PrEP in men, there is a need for simplified and differentiated delivery of PrEP that is person- and community-centred. Effective use requires that all potentially high-risk sex acts be covered by an effective preventive intervention such as PrEP. Given the importance of flexibility due to travel in this group, our hypothesis is that both oral PrEP (in particular, ED PrEP) and CAB-LA PrEP will be highly acceptable to men in two high-burden, resource limited, African countries, with high levels of effective use including persistence and coital coverage. Policy makers will need evidence not only around effective use but also the reach, adoption and choice, implementation and maintenance of PrEP in different settings and with different high-risk mobile men to inform generalisability and scalability of PrEP for heterosexual men. The Mobile Men study is the first PrEP study implementing both ED oral PrEP and CAB-LA targeting mobile men in sub-Saharan Africa (South Africa and Uganda). The study will provide the evidence for effectiveness, implementation and cost-effectiveness, which are critical to decision making by African governments and donors on how to prioritise prevention resources and inform guidelines. Objectives {7} The overall objective of the Mobile Men study is to assess effectiveness and implementation of CAB-LA and oral TDF/FTC (both daily and ED) amongst men who are mobile for work in South Africa and Uganda, through comparison of uptake, retention in care, coital coverage, and participant choice. The primary user effectiveness objective is to compare short term (9 months) and longer term (18 months) PrEP persistence patterns across different PrEP modalities (oral and injectable) amongst men who are mobile for work in South Africa and Uganda. The primary implementation objective is to compare adoption (uptake and choice) across the different PrEP modalities (oral and injectable) amongst men who are mobile for work in South Africa and Uganda. The secondary clinical objectives are: To compare the effective coital coverage of oral daily/ED TDF/FTC versus CAB-LA To describe the safety, tolerability and acceptance of all methods, as determined by self-reported side effects, adverse events (AEs) and reasons for PrEP pause or discontinuation The secondary implementation objectives are: To understand the Reach of PrEP for mobile men and understand the barriers to, and facilitators of, uptake amongst those at risk who do and do not accept oral or injectable PrEP. To describe Adoption: To identify characteristics of men who adopt oral PrEP versus CAB-LA To describe patterns of use of daily, ED, and long-acting PrEP amongst different groups of mobile men. To understand the Implementation of ED and long-acting PrEP for mobile men amongst service providers to inform scale-up. To understand the feasibility and fidelity of delivering ED and long-acting PrEP in different settings. To describe how ED and long-acting PrEP are delivered in practice. To describe the service-level needs to implement ED and long-acting PrEP. To evaluate acceptability and implementation of antibody-based HIV status monitoring for CAB-LA. To assess the total and average cost of oral PrEP and CAB-LA in South Africa and Uganda under study conditions from the provider perspective (Maintenance). The exploratory objectives are: To describe HIV incidence across the two PrEP modality arms To describe any evidence of HIV drug resistance mutations in participants who acquire HIV infection whilst using PrEP across the two PrEP modality arms. To describe persistence in care of those diagnosed with HIV at screening To describe body mass index (BMI) and blood pressure across both arms. Trial design {8} The Mobile Men study is a phase 3b, open-label, hybrid effectiveness-implementation type 2 trial to evaluate the initial implementation (scale-up) phase of CAB-LA as a PrEP option in men who are mobile for work in South Africa and Uganda with a high burden of HIV. The trial is a phase 3b, open label, hybrid type 2 study with co-primary aims of effective use and implementation. The implementation of PrEP choice in mobile men is further investigated using a mixture of social science and health economics methods to understand reach, adoption, implementation and maintenance. These include repeat rapid ethnographic assessments [39], qualitative interviews with users and providers, process evaluation, modelling and cost-effectiveness analysis. A schematic representation of the trial design is shown in Figure 1. Participants will be screened for HIV at enrolment. Those testing negative will be randomised to receive either oral or injectable PrEP for an initial 9-month period. Then, throughout the 9 to 18 months period following randomisation, participants will be offered a choice of oral or injectable PrEP. Participants determined as living with HIV at screening will be linked to care and followed up as a separate cohort alongside randomised trial participants. An embedded social science component provides data on the process of trial implementation as well as detailed information on study sites, local communities and perspectives on both trial and trial products by participants. This component of the study is divided into three parts: a rapid ethnographic assessment conducted at three time points during the trial period (before, during and at the end), qualitative data collection with trial and non-trial participants and trial staff throughout the trial, using in-depth interviews, group discussion, observations and structured debriefings, and a health economics component addressing costs and cost-effectiveness. Methods: Participants, interventions and outcomes of the trial Study setting {9} The study will take place at three sites: two in South Africa [KwaZulu-Natal and Buffalo City Metro (BCM) Municipality, Eastern Cape]and one in Uganda (Masaka city, Masaka district). In South Africa, the study will be conducted by the Africa Health Research Institute in KwaZulu-Natal, and the Desmond Tutu Health Foundation in East London. In Uganda, the study will be conducted by the Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit. Eligibility criteria for the trial {10} The inclusion criteria are as follows: Ability and willingness to provide informed consent Age 18 years or older Willingness to undergo HIV testing Assigned male at birth History of work-related travel in the past six months, including spending at least one night away from home for work purposes, and being at risk of HIV infection Willingness to use PrEP The exclusion criteria are as follows: Confirmed HIV infection Reasons at the discretion of site investigator for unsuitability for study inclusion Body weight less than 35kg Use of contraindicated medications including: Medication for tuberculosis (e.g., rifampin, rifapentine), anticonvulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin) Known allergy to any of the study products Who will take informed consent? {26a} Informed consent will be obtained by trained study staff delegated by the Principal Investigator. At the screening visit, participants will have the opportunity to ask questions and have a full discussion of the information provided in writing and/or visually and verbally. This will include the following key messages: That there is a 1 in 2 chance that the participant will be assigned to CAB-LA and a 1 in 2 chance that they will be assigned to oral PrEP. That condoms and PrEP are known to reduce the risk of acquiring HIV when used or taken consistently. Participants will be shown images of the PrEP pills and the CAB-LA vials. They will be asked if they discussed their intention to participate in the study with anyone and if any problems arose because of this. If they wish to proceed, they will be given an informed consent form to read and sign prior to any study procedures. The informed consent form will be dated and countersigned by the investigator or delegated person, who administers the informed consent process. If the participant is unable to read and write, they will be asked to place their thumbprint on the informed consent form in the presence of an independent witness who will have been present during the discussion. The witness cannot be a member of the site study staff. The right of the participant to refuse to participate without giving reasons will be respected. A copy of the consent form will be provided to the participant and one copy kept securely in the study file according to local procedures. For the qualitative component of the study, the Participant Information Sheet for the in-depth interviews and group discussions will be used to provide information to study participants in one-on-one conversations. Written informed consent will be obtained prior to conducting interviews by staff trained in interview techniques. Additional consent provisions for collection and use of participant data and biological specimens {26b} Additional consent will be obtained to collect and store blood samples from people who acquire HIV during the study. Interventions Explanation for the choice of comparators {6b} Daily oral PrEP is effective, but a substantial proportion of people offered this approach either fail to initiate it, discontinue relatively soon after starting, or do not use it effectively [18]. While the WHO endorses ED PrEP for men, regardless of sexual orientation or sexual modality, this regimen has not been taken up in South Africa and has only recently been introduced in Uganda [5]. To date, no efficacy studies have been carried out using ED PrEP for heterosexual men in Africa. Research carried out by our consortium recently showed that ED PrEP is the oral prevention method of choice among young men in South Africa, Uganda, and Zimbabwe [6]. The advantage of oral ED PrEP over daily PrEP means that potentially fewer tablets are required which lowers the cost, minimizes side effects, and potentially lowers the risk of stigma due to reduced visibility of PrEP use particularly when travelling for work. CAB-LA is a strand transfer integrase inhibitor that is delivered as a suspension via a gluteal intramuscular injection every two months. Two double-blind, double-placebo studies, HPTN 083 and HPTN 084, have shown CAB-LA is superior to daily oral TDF/FTC, with significantly lower HIV incidence observed in the CAB-LA arms across both male and female populations [7,13]. HPTN 083 was conducted amongst cis-gender men and transgender women who have sex with men in the US, Latin America, Asia, and Africa. Participants in the CAB-LA arm had a 66% lower risk of HIV infection compared to their counterparts in the TDF/FTC arm [13]. HPTN 084 was conducted amongst cis-gender women across seven sub-Saharan African countries. Participants in the CAB-LA arm had an 88% lower risk of HIV infection compared to those in TDF/FTC arm [7]. Intervention description {11a} Eligible participants (men testing HIV negative at screening) will be randomized in a 1:1 ratio to either Group A: oral TDF/FTC PrEP (ED or daily) or Group B: CAB-LA over 9-months. After 9-months, participants from both groups will be offered a choice of PrEP (oral TDF/FTC or CAB-LA) for a further 9 months, with the ability to change their choice as required. Criteria for discontinuing or modifying allocated interventions {11b} There are no planned modifications to oral TDF/FTC or CAB-LA PrEP dose. PrEP must be interrupted if a participant suffers a serious adverse event (SAE) that could be a drug reaction. Participants who have a positive Hepatitis B virus test will be recalled if they are using CAB-LA PrEP and invited to switch to oral PrEP at the end of month 1 or counselled on alternative HIV prevention products. If an individual chooses to stop PrEP, they may remain in the study, and the reason for stopping documented. The study investigator can also discontinue an individual from their allocated intervention for the following reasons: Confirmed HIV infection Unacceptable toxicity that precludes the continuation of PrEP Intercurrent illness that prevents the safe use of PrEP Early termination of study Participants who enrol on the study and/or have received at least one CAB-LA injection or one PrEP tablet will be asked to remain in follow-up. However, participants may withdraw their consent for further visits at any point during the trial. Data that are already collected from participants who stop follow-up early may still be analysed, provided they have given consent. Strategies to improve adherence to interventions {11c} Participants will be offered counselling to enhance PrEP adherence and attend scheduled study appointments. At enrolment, participants will be asked for a primary and secondary phone number, if they have one, as well as their home address. They will also be asked whether they consent to home visits by the study team in case of missed study visits. Additionally, a clinical hotline will be provided to enable participants to directly contact the study team for assistance. Oral PrEP: All participants will receive detailed information on how to correctly use PrEP. Adherence to oral PrEP will be assessed using self-reported data, pill counts of dispensed medication, and drug concentration levels measured in dried blood spots (DBS). Injectable PrEP: All injections will be administered by site staff and recorded in the relevant case report form (CRF). If an injection is not given within the ideal window, the deviation and reason for it will be recorded in the CRF. Relevant concomitant care permitted or prohibited during the trial {11d} No concomitant medications are prohibited for TDF/FTC. Concomitant medications that are prohibited for CAB-LA are Rifampicin, Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital, and Rifapentine. Provisions for post-trial care {30} All participants exiting the trial will be signposted and linked to HIV prevention services that provide PrEP. It may be that locally available CAB-LA is not yet in place, and this will be discussed with participants wanting to access it. Outcomes {12} The trial will have two co-primary outcomes: User effectiveness co-primary outcome: This will assess persistent use of PrEP during the randomised period and throughout the full follow-up period. Persistent use of PrEP during the randomised period will be defined as a binary outcome. Participants randomised to the CAB-LA arm who receive all injections as per schedule (initial injection at month 0, followed by injections at months 1, 3, 5 and 7, with an acceptable window of +/- 7 days for each injection), will be considered “persistent on PrEP”. Participants who do not receive all injections as scheduled will be classified as “non-persistent on PrEP”, regardless of the frequency or timing of self-reported condomless sex. Participants randomised to the oral PrEP arm will be considered “persistent on PrEP” if they attend scheduled three-monthly visits, receive sufficient PrEP to maintain supply until the next visit, and have detectable TFV-DP levels in DBS. During the full follow-up period (18 months), persistence will be assessed as a multinomial outcome with the following categories: single modality, consistent use; multiple modalities, consistent use; single or multiple modality, inconsistent use; never started PrEP. Implementation co-primary outcome : This will compare the adoption (uptake when offered and choice preference of the different modalities). Uptake is defined as the proportion of participants who are offered and subsequently take PrEP (oral PrEP arm versus CAB-LA arm) during the 9-month randomised period. Choice preference will be measured as the proportion of participants who choose and use each modality (daily or ED oral PrEP or CAB-LA), captured at the start and the end of the subsequent 9-month choice period. Secondary outcomes include: Short term flexible PrEP persistence: a binary outcome that is analogous to the user effectiveness co-primary outcome but with more flexibility allowed on visit windows, specifically an acceptable window of -7 to +28 days for scheduled injections at months 3, 5 and 7 in the CAB-LA arm, and for scheduled visits at months 4 and 7 in the oral PrEP arm. Effective peri-coital coverage of PrEP: A binary outcome measuring whether, at the time of last condomless sex, the participant was “covered” by PrEP. Safety, tolerability and acceptance: Assessed based on self-reported AEs and the reasons for PrEP pause or discontinuation. Reach: Evaluated qualitatively through three serial rapid ethnographic assessments capturing information on awareness and reach of PrEP amongst mobile men. Adoption: This will be evaluated by (i) comparing the characteristics of men who uptake oral PrEP with those who uptake CAB-LA when offered at month 0, (ii) comparing the characteristics of men who choose oral PrEP with those who uptake CAB-LA when given the choice at month 9, (iii) describing patterns of use of daily, ED, and long-acting PrEP during months 9-18 of the trial, and the transitions between these modalities. Implementation: Evaluated using qualitative data collected from service providers, with a focus on fidelity and feasibility. Maintenance: Evaluated through calculation of total and average cost of oral PrEP and CAB-LA in South Africa and Uganda under study conditions, from the provider perspective. Participant timeline {13} The participant timeline is shown in Table 1. Table 1: Mobile Men study schedule of enrolment, interventions, and assessments. 1 Visit schedule for choice phase is dependent on choice of PrEP made at month 9 and at each subsequent visit; 2 Done at visits corresponding to the intervention received by the participant;CAB-LA, Long-acting injectable cabotegravir; PrEP, pre-expsoure prophylaxis; CRF, Case report form; IDIs, In-depth interviews; FGDs, Focus group discussions; HIV, Human immunodeficiency virus; STI, sexually transmitted infection; DBS, Dried blood spot; BMI, Body mass index; CrCl, creatinine clearance; HepBsAg, Hepatitis B surface antigen Sample size {14} The planned enrolment sample size of 400 participants (randomised), will allow 80% power to detect an absolute difference of 11% in persistence between trial arms, assuming 80% persistence in the lower persistence arm (and 91% persistence in the higher persistence arm), and allowing for 20% lack of ascertainment of persistence, for example, due to medical ineligibility to receive the randomised intervention, or death. If the persistence in the lower persistence arm is lower, at 60%, then we will have 80% power to detect an absolute difference of 15% (i.e. 60% versus 75% persistence). Recruitment {15} Preparatory work: Preliminary work in the communities is being carried out including a rapid ethnographic assessment study to inform and facilitate study implementation. Demand creation for PrEP will be achieved through a community engagement campaign and peer and sex worker outreach activities prior and during the study start. These efforts will expose men in the communities to PrEP educational materials and encourage them to visit community and public health sites to access sexual health services, including PrEP. Potential participants will be provided with educational information about each of the PrEP products both during the enrolment visit and as part of the broader community-wide demand creation campaign preceding the study. Masaka, Uganda: Recruitment efforts will mainly focus on landing sites around the shores of Lake Victoria in Masaka district. These fishing communities have a high HIV burden that is attributed to several factors, including high mobility, sex work, relatively young populations with disposable daily income, and inadequate health services. People in these communities frequently move between different landing sites and islands, with up to 47% of men and 25% of women reporting being away from home for at least two days each month. This mobility is mainly driven by the seasonal fish catch. Previous studies have highlighted that such high mobility can limit access to health services, increase HIV infection risk, and underscore the need for tailored HIV prevention interventions that account for these mobility patterns [40]. The Mobile Men study has been designed to address these challenges. The study team will work with local leaders and members of Village Health Teams and via community HIV testing services to identify potential participants from places of entertainment (such as lodges/guest houses, bars) and from their homes. Detailed locator information, including addresses, telephone contacts, and next-of-kin details, will be collected to facilitate effective phone and/or physical tracing during the follow-up phase of the study. Buffalo City Metro (BCM) municipality, Eastern Cape, South Africa: The Eastern Cape Province is a historically under-resourced and under-researched province. Since 1990, Eastern Cape has ranked last among South Africa’s nine provinces in its Human Development Index score [41, 42]. In 2022, the estimated HIV prevalence in the province was 19.4% among individuals aged 15-49 years. That same year, an estimated 92.6% of individuals living with HIV in Eastern Cape knew their status, 74.9% were on ART, but only 62.6% were virally suppressed (Viral load <1000 copies/mL) [43, 44]. Given that South African men are less likely to know their HIV status, initiate ART, or be virally suppressed compared to women, we expect these indicators will be worse for men in the province [45]. Within BCM, men will be recruited from Duncan Village (urban) and Mdantsane (peri-urban) townships. These predominantly black, Xhosa-speaking, communities have some of the highest HIV prevalence rates in South Africa. Both Duncan Village and Mdantsane are densely populated, with many residents living in informal housing. Mdantsane, in particular, is one of the largest townships in the country. Mobile men from these communities return home on a regular basis to visit their extended families. Recruitment will target men who sit by the roadside waiting for offers of casual labour. Previous studies have reported an HIV prevalence of 16.6% in this population [46]. Additionally, construction workers and migrant workers (men who leave their partners and families to work) will be recruited. Truck drivers will also be targeted through nurse-led primary healthcare services at a fixed roadside Wellness Centre located near East London’s shipping port and airport. The centre serves an extremely busy route for the long-distance goods transport. KwaZulu-Natal, South Africa : Recruitment will focus on mobile young men from a busy urban and peri-urban taxi rank and market area in Mtubatuba town, in uMkhanyakude where the main N2 highway intersects with the R618 route to St. Lucia, and surrounding areas. This primarily rural area faces significant economic challenges compared to other regions in South Africa, with high levels of unemployment. For example, over 85% of young people aged 20-24 are unemployed. The uMkhanyakude district also has a very high HIV prevalence of 30% [47]. Healthcare infrastructure is limited, with only one public hospital and 13 fixed-location primary healthcare clinics, all of which face resource constraints in delivering HIV prevention and health promotion [48]. Men looking for work, or on their way to find work in larger urban setting of Durban and Johannesburg, the Richards Bay shipping port, the coalmines and sugar plantations of uMkhanyakude will mostly transition through the taxi rank and market area of Mtubatuba. It is also a hub where men who move for work spend their earnings, on food, sex work/transactional sex, other recreational activities and alcohol. Stakeholder engagement, key informant interviews and rapid ethnographic assessments prior to the study suggested that mobile clinics based in Mtubatuba taxi rank that provide hypertension and diabetes screening, and supported by peer and sex worker outreach, would reach men who are mobile for work. Assignment of interventions: allocation Sequence generation {16a} The allocation sequence will be generated using computer-generated random numbers. Randomisation will be done in a 1:1 ratio, stratified by setting (three groups) and using randomly permuted block size. Concealment mechanism {16b} The allocation sequence will be embedded within the data collection system (REDCap). At the time of enrolment, each participant will be given a unique randomisation identifier in the temporal order in which they are randomised within their setting. The trial arm allocation for this unique identifier will then be accessed in REDCap. The trial arm allocation will be hidden until the participant has received their unique randomisation identifier. Implementation {16c} The allocation sequence will be implemented in a STATA program written by the trial statistician, and with the random seed chosen by a statistician who is otherwise uninvolved with the study. Participants will be enrolled by clinicians. After determining a participant’s eligibility, the clinician will log onto REDCap using their personal access credentials. REDCap will then prompt the clinician to confirm eligibility and the site and that they want to randomise a new participant with the next randomisation ID for that site to the trial. Once confirmed, the participant is randomised by the clinician and assigned to a randomisation arm according to the next unique identifier on the allocation list. The randomisation allocation assigned will now be read-only and cannot be edited after this. Assignment of interventions: Blinding Who will be blinded {17a} Due to the nature of the trial, it is not possible to blind participants, study staff involved with participant care, or outcome assessors. Procedure for unblinding if needed {17b} Not applicable. This is an open-label study. Data collection and management Plans for assessment and collection of outcomes {18a} Collection of clinical, socio-demographic and behavioral data Participants’ weight, height, and blood pressure will be measured at screening and at specified follow-up visits (Table 1), as injectable PrEP is potentially associated with weight gain and hypertension. Socio-demographic, behavioural, risk and mobility information will be collected through surveys at baseline and specified follow-up visits (Table 1). PrEP-related data, including, details of the PrEP provided to and used by the participant, will be documented at each visit. During the “choice period” (9 to 18 months), participants will be asked at each visit to indicate their preferred PrEP intervention. For participants who choose to switch PrEP options, their reasons will be captured on a PrEP switch CRF. To evaluate PrEP adherence and ensure consistent counseling, a PrEP adherence CRF will be administered by a study team member at every visit. The PrEP adherence questionnaire will focus on: Self-reported PrEP use, including whether participants are currently taking PrEP, the number of days since their last PrEP tablet, and adherence surrounding condomless sex (e.g., the number of tablets taken the day before and after the sex act). Any adverse clinical or social effects experienced as a result of PrEP use. Reasons for pausing or discontinuing PrEP. Collection of laboratory data The following laboratory tests will be performed at screening and specified time points (Table 1) to confirm participant eligibility and the safety of product use. HIV testing: HIV will be confirmed at each in-person visit using the national HIV testing algorithm. Participants who test positive during the trial will be counselled and referred to local clinical centres for HIV care and treatment. Hepatitis B viral (HBV) testing: a blood sample will be collected at screening to test for Hepatitis B infection, the site’s routine test for Hepatitis B surface antigen. Creatinine clearance: Serum creatinine levels will be measured at screening for men aged 30 years and older. Subsequent testing will be conducted if clinically indicated. DBS: These samples will be collected and stored for later retrospective analysis of drug levels of drug levels and possibly viral load testing. Sexually transmitted infections (STIs): Testing for STIs, including gonorrhoea, chlamydia and syphilis, will be performed based on local guidelines. Collection of social and economic science implementation data To answer the secondary implementation objectives of Reach, Adoption, Implementation and Maintenance using the RE-AIM implementation science framework (Table 2), a mixed-methods data collection approach will be adopted. Table 2: The proposed RE-AIM evaluation Domain Definition Implementation outcome Data source R each Client (user) level : Extent to which mobile men at risk of HIV acquisition effectively take up PrEP measured as the patterns of uptake and persistence per arms and community experience. Rapid ethnographic assessments of each community, the surveys and process of engagement with services E ffectiveness Client (user) level: Increased effective use (adopt and adhere) of PrEP amongst mobile men. Measured as proportion who are retained on PrEP and participant choice Pragmatic randomized controlled trial (RCT) A doption Client (user) level : Acceptability (uptake when offered), attitudes towards, preferences/choices and patterns of use amongst different groups of mobile men. Pragmatic RCT, the surveys, qualitative interviews with service users & process of engagement with services, exit interviews. I mplementation Provider (service) level : Appropriateness, feasibility, practicability, and fidelity of CAB-LA in the three stages or initiation, continuation, and safe stopping with national HIV testing algorithms” Qualitative data from service providers, time motion studies and HIV self-testing study. M aintenance Provider and Health Systems level : Affordability and resources needed for scalability Time motion studies, costing and modelling Data collection methods will include the following: Rapid ethnographic assessments: These assessments will be conducted at baseline, after 9 months and at end line to provide implementation data on reach of the intervention. The assessments will use a rapid ethnographic assessment (REA) methodology, a structured approach that combines a variety of qualitative methods in a sequential format, designed to move from broad contextual understanding to a more specific focus on the study topic. This approach allows for the collection of focused data that addresses both the whole community context as a whole and the specific behaviours and HIV-prevention choices of mobile men. The REA methodology comprises of a set of structured activities such as community entry, spiral walks, observations, individual conversations/interviews, natural group discussions, and focus group discussions. This is aimed at gathering a comprehensive perspective on the area of study and the communities living there. The rapid ethnographic assessment approach is conducted within a defined 15-day period [49]. Community entry is conducted a few months prior to the commencement of data collection. The research teams engage with the Community Advisory Boards (CABs) overseeing the chosen research sites for guidance on appropriate community entry specific to the sites concerned [50, 51]. This is followed by seeking the relevant permissions from the local leadership, including traditional, political or community leaders, depending on the area [52]. The data collection methodology is standardized across study areas, ensuring consistency and rigor in the process [39, 53]. In-depth qualitative interviews with service users: One-on-one interviews will be conducted with up to 10% of participants across the sites, based on the visit schedule. These participants will be purposively selected to represent the emerging patterns of risk and adherence behaviours identified from the quantitative data. These interviews will provide insights into the experience, motivations and barriers that facilitate or obstruct adoption of each PrEP modality during the randomised phase and the rationale for adoption of each modality during the choice phase. In addition to exploring individual behaviour changes, the interviews will capture changes in the communities/places the participants stay, to inform the trial about context-specific factors which may affect trial outcomes (e.g., loss of employment options in a location and changes in health care provision) and how participants move between PrEP choices. Exit interviews (choices, trial participation) : Exit interviews will be conducted with all participants as they exit the trial, to capture their experiences and reflections on the study. These interviews will focus on their reasons for trial participation, their PrEP choices, and their overall experiences with the intervention. Participants who seroconvert at any time during follow-up will also be invited to take part in an in-depth interview as described above. These interviews will explore key factors contributing to seroconversion, including details about condom less sex or PrEP adherence since their last negative result, as well as the number and characteristics of new sexual partners during the follow-up period. Group discussions: These will be conducted with a subset of participants, typically comprising approximately eight participants per group. Group discussions will be led by staff trained in qualitative research methods, who are independent of the clinic team, to ensure objectivity and minimise potential biases. Participants will be purposefully selected based on specific criteria, while others will be invited on an ad hoc basis to ensure diverse perspectives. These group discussions will aim to explore participants’ experiences, perceptions, and insights on the trial, including their motivations, challenges, and changes in behavior related to PrEP use. Interviews with service providers: Structured debriefs and one-on-one interviews with community and counselling staffwill be conducted by a social scientist during the study. Typically, these interviews will capture conversations observed or initiated by staff with and between participants, non-participants, clinic staff and community workers. The notes will be anonymous and documented using a standardised template. Special attention will be given to understanding how participants transition between ED and daily PrEP, through conversations with a range of service providers, including mobilisers/recruiters. To support reflection and inform ongoing training and supervsion, peer-navigators and clinical staff will be trained to keep very brief notes of their daily activities. These notes will be used during debriefing sessions to discuss key observations and challenge. These interviews will take place once recruitment is closed, additional, `endline’ interviews scheduled with service providers, stakeholders, and community members. Peer navigators will be interviewed and natural group discussions will be facilitated with various stakeholder groups, such as community leaders, Community Advisory Board members, and local healthcare providers, to gather perspectives on the study's implementation and impact. Collaborative problem-solving meetings: Meetings will be held with healthcare workers from all sites to allow for collaborative problem solving. Implementation of the study will be discussed, and modifications made for improvement will be documented to inform the implementation analysis (implementation and adoption domains of the RE-AIM framework). Quantitative survey: The survey will collect data on demographics (age, relationship status, education, income, location), mobility patterns, mental health, social economic factors [food security, social cohesion (network of friends), and support systems]. Surveys at months 9 and 18 will additionally explore participants’ PrEP choices and rating of their experiences with PrEP using a Likert scale. Health economics: Cost data will be collected using bottom-up and top-down costing, drawing on expenditure reports, resource use from CRFs, from the provider perspective. We will combine these with relevant, up-to-date information on public sector prices and salaries in either country. At mid-point of implementation, data collectors will conduct a time-and-motion study with study staff involved in implementation at each site to estimate staff time and resources used on key activities. Trial resource use will be adapted to represent potential rollout in routine care. Plans to promote participant retention and complete follow-up {18b} Measures to support PrEP persistence will include pre-dose counselling at each visit and standard retention efforts if the participant fails to report for a subsequent visit. All participants with a missed visit will be followed up in the following way: At day 7 post a missed visit, the participant will be called using the telephone number provided at the most recent visit. After three unsuccessful attempts on subsequent days, at different times, the study team will carry out a home visit. Participants will be strongly encouraged to come in irrespective of whether or not they need PrEP. For CAB-LA participants who fail to return within 7 days, a home visit will be conducted (if permission has been given and it is safe to do so). Once contacted, a study visit will be rescheduled as soon as possible. However, due to the risk associated with stopping CAB-LA without coverage for the tail period, participants in the CAB-LA arm will be followed up with further phone calls and a home visit (if permitted) following the 7-day period. If the participant indicates that they wish to withdraw from the study, then the withdrawal will be documented, with the reason for withdrawal noted if provided. If the participant is in the CAB-LA arm, the participant will be encouraged to take oral PrEP to cover the tail period and provided counselling on safe sex. Participants will not be considered lost to follow-up until the trial has ended, unless they have left the country with no plans to return, and with no means to ascertain HIV status. The date of loss to follow-up will be the date of their last study visit. Data management {19} Wherever possible, study data collected during clinic visits will be recorded directly into an electronic data capture system (REDCap). The data capture system will be programmed with quality control measures including range checks for quantitative variables. When direct data entry is not practical or is not available, the data will be recorded in a source document and will be transcribed into the electronic data capture system using double data entry within a reasonable timeframe. All electronic and non-electronic documents and forms will be kept securely. Full details of data management procedures are provided in the study Data Management Plan. Confidentiality {27} All data will be encrypted and stored on password-protected servers, which have Multi-Factor Authentication activated to ensure secure access control. Each participant will be assigned a unique project identity number (ID) for capturing and storing their data. Personal identifiers will not be stored in the study data set and all computers will be equipped with antivirus software and security passwords. Participant contact information will be kept separately from project documentation. While the study is in progress, study-related forms will be maintained in locked cabinets with access restricted to authorised personnel only. Upon study conclusion, these documents will be digitized, indexed, and stored indefinitely on the central server. The original paper documents will be destroyed. Plans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} At each visit, DBS will be taken and stored for future analysis of drug levels and HIV viral load. Furthermore, for individuals who acquire HIV during the study, blood will be taken for analysis including HIV viral load, resistance testing, drug levels and storage for future use. Statistical methods Statistical methods for primary and secondary outcomes {20a} The demographic, behavioural, and clinical characteristics of the two enrolled groups at baseline will be summarised, both overall and stratified by setting. All analyses will be done by intention-to-treat. For the primary user effectiveness outcome (persistence on PrEP during the randomised period), the odds ratio for persistence on PrEP comparing the two trial arms and a corresponding 95% confidence interval (CI), and p-value will be generated using logistic regression, adjusting for setting (as randomisation is stratified by setting). The same approach will be used for binary secondary outcomes. For persistence during the full follow-up period, which is a multinomial outcome, multinomial logistic regression will be used, adjusted for setting. For primary implementation outcomes, the odds ratio for uptake of PrEP comparing the two trial arms and a corresponding 95% CI, and p-value will be generated using logistic regression, adjusting for setting (as randomisation is stratified by setting). Similarly, an odds ratio for the proportion who choose injectable compared to oral PrEP and a corresponding 95% CI, and p-value will be generated using logistic regression, adjusting for setting. A full statistical analysis plan will be finalised before database lock and will include sensitivity analyses to assess the impact of each element of the primary effectiveness outcome (which is a composite outcome) on study findings, and to investigate a more flexible visit window for PrEP persistence. Interim analyses {21b} No formal interim analyses are planned. Interim data on protocol adherence and safety will be reviewed by an independent data monitoring committee (IDMC) but no formal stopping guidelines are planned. Methods for additional analyses (e.g. subgroup analyses) {20b} Subgroup analyses by study setting will be done to determine whether differences between trial arms are consistent across settings. These will be assessed by stratifying analyses by setting and testing for interaction. Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} The primary analysis population will be all randomized participants, regardless of protocol adherence or use of PrEP, with the exception that participants who are discontinued from receiving their allocated PrEP for medical reasons will not be included in the primary user effectiveness outcome analyses. No per-protocol analyses are planned. Participants who are lost to follow-up will be included in primary user effectiveness outcome analyses, as they will be considered as non-persistent on PrEP. If the proportion of participants with missing data is >10% then multiple imputation will be investigated, otherwise complete case analysis only will be used. Qualitative data analysis Data analysis for the rapid ethnographic assessments will be done manually using the framework analysis approach [54]. Manual analysis enables the three site teams to manage a range of data which consists of notes from observations, sketch maps, interview and discussion group transcripts. Themes will be shared and discussed across the sites to arrive at a shared coding framework. Following the identification of themes, indexing (coding) and charting (cutting and pasting data according to thematic areas) will be done simultaneously at each site. Mapping (visual display of data) allows researchers to identify patterns, associations, and concepts, allowing descriptive and analytical memos to then be produced from these charts. We will produce a short report to provide an overview for the wider study team on each community and we will also aim to write a short feedback flyer to share with the communities based on the same short report. Once an initial report has been completed and summary findings shared with the participating communities , we will conduct a finer analysis of the data from the rapid ethnographic assessment, using a thematic content analysis – the approach we will also use for the qualitative data collected during the trial from interviews and group discussions. For the qualitative data collected during the conduct of the trial from the IDIs and group discussions, we will again develop a shared coding framework, drawing from both the topic guides, learning from the rapid ethnographic assessments and new themes, which may come from the data collected. Analysis will be conducted by the site-specific research teams, and regular (electronic) meetings across the Ugandan and South African teams will support data interpretation. This will provide a more comprehensive understanding of men’s mobility and PrEP use across the trial groups and in the different settings/countries, as well as the acceptability and feasibility of the intervention. Where required to support the analysis, data sharing between sites will only involve the sharing of anonymised data through a secure data enclave. Health economics analysis Cost analysis: We will analyse the incremental financial and economic costs of implementing either intervention over routine care for these populations from the perspective of the provider, the South African or Ugandan government. Standard of care approaches to retaining people in care will be identified from routine government services for HIV in each recruiting country. Total and average cost per person retained at 3 and 6 months will be estimated from the perspective of the provider, and the public healthcare system in each country. Additionally, we will estimate PrEP coverage during periods of sexual activity. We will calculate annualized capital and recurrent costs at facility and any other relevant implementation level. Non-annualized annual economic costs will be used to inform the budget impact for each country and inform governments and other relevant funders of the intervention’s affordability. Cost-effectiveness analysis: We will combine results regarding the incremental cost from above and HIV Synthesis model outputs regarding the incremental number of infections averted, life-years saved and disability-adjusted life-years (DALYs) averted by each strategy (oral or injectable PrEP) over baseline (no scale up of PrEP) to calculate the incremental cost-effectiveness of each intervention, as well as the strategy of offering either intervention. The HIV Synthesis model will be fitted to epidemiological data to represent the current HIV epidemics in South Africa and Uganda and be parameterised and structured to account for important behavioural heterogeneity, including how behaviours and PrEP choices vary among cohort participants and within persons over time. The Synthesis model will be used to calculate costs over the long term, as well as life-years lost and DALYs, with costs and effectiveness calculated over a sufficiently long period to represent the difference in the main impacts between strategies, but at least over 20 years. Plans to give access to the full protocol, participant level-data and statistical code {31c} The full protocol, participant-level dataset, and statistical code will all be available upon request. Additionally, a metadata-only record will be created to catalogue the resources, including qualitative and quantitative data, codebooks, data dictionaries, algorithms, scripts, and research instruments such as questionnaires and interview guides. These resources will be archived in the LSHTM Data Compass ( https://datacompass.lshtm.ac.uk ), a curated digital repository designed to host materials that support the verification and reproduction of research findings. The study protocol is registered on ClinicalTrials.gov (NCT06133686) and the Pan-African Clinical Trials Registry (PACTR202409632006463). Oversight and monitoring Composition of the coordinating centre and trial steering committee {5d} The trial management group (TMG) The trial management group (TMG) comprises the chief Investigator, coordinating investigator, all investigators, representatives of ViiV Healthcare (Investigational Product providers), key trial site staff, and members of the MRC/UVRI and LSHTM Uganda Research Unit Trial Coordinating Centre. The TMG is responsible for the day-to-day running and management of the trial. The trial management team (TMT) The trial management team (TMT) comprises the chief Investigator, coordinating investigator, trial statistician, other investigators (clinical and non-clinical) with operational coordination operational responsibilities, and members of the MRC/UVRI and LSHTM Uganda Research Unit Trial Coordinating Centre. The TMT is responsible for the overall management and coordination of the trial, including: protocol development, data management, laboratory coordination, regulatory and ethical compliance, procurement and supplies, maintaining the Trial Master File (TMF) and ensuring compliance with Good Clinical Practice (GCP), development of the Statistical Analytical Plan (SAP), and preparing reports for the IDMC. The trial safety group (TSG) The Trial Safety Group (TSG) comprises medically qualified members of the TMT who are not directly involved in the clinical management of trial participants. The TSG is responsible for: ensuring participant safety throughout the trial, evaluating all SAE reports and providing expert advice on further investigation and management, offering guidance on the clinical management of events affecting trial participants, reviewing updated safety data, including changes to the Summary of Product Characteristics (SmPC) for PrEP, and emergent safety reports from product providers, and determining the implications of new safety information on the trial. The trial steering committee (TSC) The TSC comprises key study investigators, including representatives from each participating trial site, as well as independent researchers with expertise in HIV prevention and PrEP in sub-Saharan Africa. The TSC acts as an oversight body delegated by the sponsor, providing strategic guidance and ensuring the trial’s conduct aligns with its objectives. It provides advice through its independent chair to the Trial Management Team (TMT) and Trial Management Group (TMG) on all aspects of the trial. Members formally register their agreement to join the committee. The independent data monitoring committee (IDMC) {21a} The IDMC is composed of experts in HIV prevention both internationally and in Africa. The main responsibility of the IDMC is to safeguard the interests of the trial participants and monitor safety and overall trial conduct. The committee will review accumulating trial data and make recommendations to the TSC and the sponsor regarding trial modification, continuation, or termination. The IDMC members will formally sign an assent to join the IDMC and declare any competing interests. Further information regarding IDMC-specific responsibilities, terms of reference, meetings, and communication is detailed in the IDMC charter. Adverse event reporting and harms {22} Information on AEs will be collected through an open question about health at study visits. Study staff will record the diagnosis or the symptoms if a diagnosis is not apparent, the date of onset and the date of resolution if appropriate. If the event is ongoing, it may be appropriate to conduct a symptom directed examination. Events will be graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric AEs version 2.1, July 2017 [55]. The relationship to CAB-LA or oral PrEP will be determined by the investigator. All this information will be recorded on the appropriate CRF. If the participant is unable to attend a safety follow-up visit for personal reasons, the interview may be conducted on the telephone or at a home visit if the participant is agreeable. Study staff will make every effort to follow AEs to resolution or stabilisation. After the trial has closed and the database has been locked, additional information regarding SAEs that comes to the attention of the study staff will be reported by email to the Chief Investigator and study Sponsor. Frequency and plans for auditing trial conduct {23} Risk based monitoring will be implemented and conducted by the study sponsor designated monitors. Both onsite monitoring that involves an in-person evaluation of study conduct at the site and remote monitoring that involves relying on the site to provide the required information while using digital platforms will be undertaken. Site visits will occur starting with a Site Qualification Visit conducted prior to the study Site Initiation Visit (SIV). The SIV will be conducted prior to study start after all requisite ethical and regulatory approvals have been obtained. At each site, six interim monitoring visits will take place at 3-6 monthly intervals, with a combination of onsite and remote interim monitoring visits in keeping with the monitoring plan. Monitoring will also be based on the site risk review, upon which a remote or site visit may be conducted (triggered site monitoring visit). A close out monitoring visit will occur after the last participant’s last visit, data cleaning and investigational medicinal product inventory have been completed. Sites will be subject to audits should these be required by the Sponsor. Ethics and regulatory authority inspections will also be permitted. Appropriate consent for monitoring, audits and inspections will be obtained from the study participants. Plans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25} Any changes to the protocol will be submitted to relevant ethics committees and regulatory authorities for review and approval. Where applicable, changes will be shared with trial participants through one-on-one interactions with trial staff during follow up visits. Amendments that result in changes to consent documents will require the re-consenting of trial participants. Relevant updates will be made to the trial registry in case of protocol amendments. Dissemination plans {31a} A whole or part of this trial’s results will be communicated, orally presented, and/or published in appropriate scientific journals and at both local and international academic conferences. Full anonymity of participants’ details will be maintained throughout. Participants can request a copy of the journal article that contains the results of the trial from the investigators once it has been published. Results will be disseminated to the participants in the study during a formal dissemination event that accommodates a question-and-answer session to support full understanding of the study results by the participants. Discussion This multi-country, mixed-methods study seeks to evaluate the effectiveness and acceptability of PrEP among men who are mobile for work in sub-Saharan Africa, a group at heightened risk for HIV acquisition. Through a hybrid implementation-effectiveness RCT, we will assess both ED oral PrEP and CAB-LA as flexible prevention options designed specifically to meet the needs of mobile men. The findings from this RCT, complemented by qualitative data, will help inform future PrEP delivery strategies tailored to this high-risk population. The study will gather critical insights through IDIs, group discussions, and qualitative surveys to understand how mobile men approach PrEP use. These qualitative methods will uncover practical challenges, preferences, and barriers, helping to shape PrEP interventions that align with the unique lifestyles and mobility patterns of men engaged in work-related travel. In South Africa, the trial will be conducted through mobile clinics, made possible by a paperless study system. A rapid ethnographic assessment provided key insights into each participating community, allowing the research team to anticipate and address potential operational challenges. This proactive planning ensured a smooth trial launch. The use of the RE-AIM framework in this trial provides a structured, comprehensive approach to evaluating the real-world implementation of both oral and injectable PrEP for mobile men in sub-Saharan Africa. By extending beyond clinical efficacy, the RE-AIM framework enables a real-world assessment of PrEP's performance, identifying facilitators and barriers to access within mobile clinic settings. These insights will inform targeted adjustments in PrEP messaging, education, and delivery, ensuring they are tailored to the unique needs of mobile men. The RE-AIM framework enhances the study’s capacity to inform scalable and impactful HIV prevention strategies for this high-risk group. Trial status Recruitment commenced on 20 August 2024, at the Desmond Tutu HIV Foundation (DTHF) and on 10 September 2024 at the Africa Health Research Institute (AHRI) in South Africa. In Uganda, recruitment commenced on 16 October 2024. Recruitment in both countries concluded on 8 November 2024.The manuscript was submitted shortly after completion of trial recruitment; it was not submitted earlier due to the trial team focusing efforts on ensuring that the necessary ethical and regulatory approvals were in place to enable rapid trial initiation and participant enrolment. Participant follow-up and data collection is ongoing and expected to conclude by April 2026. The trial is being conducted under protocol version 3.0, dated 9 April 2024. Abbreviations AGYW Adolescent girls and young women KCL King’s College London AHRI Africa Health Research Institute LSHTM London School of Hygiene & Tropical Medicine AIDS Acquired immunodeficiency syndrome MRC Medical Research Council ART Antiretroviral therapy RCT Randomised controlled trial BCM Buffalo City Metro SA South Africa BMI Body mass index SAE Serious Adverse Event BREC Biomedical Research Ethics Committee SAP Statistical Analysis Plan CAB-LA Cabotegravir long-acting SAPHRA South Africa Health Products Regulatory Authority CI Confidence interval SIV Site Initiation Visit CRF Case report form SMS Short message service DAIDS Division of AIDS SQV Site Qualification Visit DBS Dry blood spot STD Sexually Transmitted Disease DTHF Desmond Tutu Health Foundation TASP Treatment as prevention ED Event-driven TB Tuberculosis EDCTP European and Developing Countries Clinical Trials Partnership TDF Tenofovir disoproxil fumarate EU European Union TFV Tenofovir FTC Emtricitabine TMF Trial master file GCP Good clinical practice TMG Trial management group HBV Hepatitis B virus TMT Trial management team HIV Human immunodeficiency virus TSC Trial steering committee HPTN HIV Prevention Trials Network UNAIDS Joint United Nations Programme on HIV/AIDS HREC Human Research Ethics Committee USA United States of America IDMC Independent Data Monitoring Committee UVRI Uganda Virus Research Institute IMP Investigational medicinal product WHO World Health Organisation Declarations Acknowledgements We would like to acknowledge the following: Desmond Tutu Health Foundation DTHF, South Africa: Linda-Gail Bekker, Andrew Medina-Marino, Riaan Beukes, Annelize Louw, Keitumetse Lebelo, Yamkela Sapepa, Phezukonko Mndebele, Joanne Batting, Sipesihle (Mylo) Pitsha, Mbasa Njomane, Nsika Buxeka, Yamkela Mangwane, Sandisiwe Mema, Anathi Mkamfu, Uviwe Maglgas, Lwazi Ndzwayiba, Olwethu Sogoni, Ntombozuko Ngetu, Mzuvukile Mlunguzi, Neliswa Swartbooi, Valmy Craffert, Viwe Mpaka, Ngcobo Seluleko. E, Mkamfu Anathi, Malgas Uviwe, Mema Sandisiwe, Ndzwayiba Lwazi African Health Research Institute AHRI, South Africa: Limakatso Lebina, Maryam Shahmanesh, Nonhlanhla Okesola, Anne Derache, Jaco Dreyer, Zizile Sikhosana, Lucky Mtolo, Nkosinathi Ngcobo, Thandeka Danisa, Carina Herbst, Nompilo Buthelezi, Mncedidi Ngubane, Thembeka Mtshali, Merab Lusweti, Thabang Manyaapelo, Xolani Ngwenya, Mpilonhle Nzuza, Zama Nxumalo, MRC/UVRI and LSHTM Uganda Research Unit, Uganda: Eugene Ruzagira, Bernadette Nayiga Kalanzi, Cissy Lillian Nalubega, Sylvia Kusemererwa, Martin Onyango, Shamim Ssendagire, Ayoub Kakande, Shamim Nabukenya, Paddy Kafeero L, Namirembe Aeron, Naphtali Erima, Sophia Nakkazi Kakyama, Sylvia Masawi, Vincent Basajja, Joseph Kitumba, Florence Nambazira, Dora Jocelyn Mulondo, Joyce Nabunnya, Ayebazibwe Gloria Kakoba, John Vianney Kagaba, Elizabeth Mbabazi Atuhuura, Margaret Nambooze, Grace Muyingo, Philip Kibuuka, Ivan Kisubika, Doreen Asio, Angel Nansere, Henry Ssemaganda, Solomon Wasswa , Penelope Akankunda, Wilson Kakeeto, Mugagga Kyeyune, Phiona Nabaggala, Dorothy Abigaba, Sarah Nakamanya, Martin Mbonye, Teddy Maria Ndagire, Richard Muhumuza, Esther Awino, Charles Ogwang, Samuel J Bengo and Geofrey Kimbugwe. Authors’ contributions {31b} JF is the programme lead, ER the Chief Investigator, EW trial statistician, JS lead social scientist, MS lead implementation scientist, GMR lead health economist, LBM lead modeller. SK and BNK lead the drafting of the manuscript. SK, LGB and LL are site principal investigators. All authors read and approved the final manuscript. Funding {3} This project is funded by the European Union through the Horizon/EDCTP Global Health call for vulnerable adults (Project 101103140). Oral PrEP drugs for the trial were supplied by the Ministry of Health PrEP programs in South Africa and Uganda, while injectable CAB-LA was provided by ViiV Healthcare, which also contributed funding for trial insurance. The funders were not involved in the study design, data collection, analysis, interpretation, or manuscript preparation. Availability of data and materials {29} The original dataset will only be available to researchers directly involved in the study, and will be kept on secure, access-restricted servers. Anonymised data will, upon publication of the study, be made available upon reasonable request to the principal investigator. Ethics approval and consent to participate {24} The protocol, informed consent forms, and other relevant documents were approved by the Uganda Virus Research Institute Research Ethics Committee (Reference number: GC/127/1002), Uganda National Council for Science and Technology (Reference number: HS4366ES), London School of Hygiene and Tropical Medicine Research Ethics Committee (Reference number: 31223) and National Drug Authority (Reference number: CTC 0276/2024) in Uganda, and the University of Cape Town Human Research Ethics Committee (Reference number: 803/2023), the University of KwaZulu-Natal Biomedical Research Ethics Committee (Reference number: BREC/000006454/2023) and South Africa Health Products Regulatory Authority (Reference number: 20231108) in South Africa. The Investigator will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the original approved documents. This study will be conducted only in compliance with the most recent approved protocol and the ICH-GCP guidelines. Informed consent will be obtained prior to conducting any study procedures. Consent for publication {32} Not applicable. Competing interests {28} The authors declare that they have no competing interests References Fonner VA, Dalglish SL, Kennedy CE, Baggaley R, O’reilly KR, Koechlin FM, et al. Effectiveness and safety of oral HIV preexposure prophylaxis for all populations. Aids. 2016;30(12):1973-83. What’s the 2+1+1? Event-driven oral pre-exposure prophylaxis to prevent HIV for men who have sex with men: Update to WHO’s recommendation on oral PrEP, (2019). UNAIDS. The AIDS response in the 2030 agenda for sustainable development: joint work, shared gains | UNAIDS UNAIDS.org2024 [cited 2024 6 December ]. Available from:https://www.unaids.org/en/site-search#?cludoquery=the%20aids%20response%20in%20the%202030%20agenda%20for%20sustainable%2 0development%3A%20joint%20work%20shared%20gains&cludopage=1&cludorefurl=https%3A %2F%2Fwww.unaids.org%2Fen%2FAIDS_SDGs&cludorefpt=The%20AIDS%20response%20in %20the%202030%20agenda%20for%20sustainable%20development%3A%20joint%20work%2C %20shared%20gains%20%7C%20UNAIDS&cludoinputtype=standard. World Health Organization. Differentiated and simplified pre-exposure prophylaxis for HIV prevention: update to WHO implementation guidance: technical brief. 2022. Technical Guidance on Pre-Exposure Prophylaxis (PrEP) for Persons at Substantial Risk of HIV Infection in Uganda, (2022). Dietrich JJ, Ahmed N, Webb EL, Tshabalala G, Hornschuh S, Mulaudzi M, et al. A multi‐country cross‐sectional study to assess predictors of daily versus on‐demand oral pre‐exposure prophylaxis in youth from South Africa, Uganda and Zimbabwe. 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Bazzi AR, Valasek CJ, Streuli SA, Vera CF, Harvey-Vera A, Philbin MM, et al. Long-acting injectable human immunodeficiency virus pre-exposure prophylaxis preferred over other modalities among people who inject drugs: Findings from a qualitative study in California. AIDS patient care and STDs. 2022;36(7):254-62. Gill K, Johnson L, Dietrich J, Myer L, Marcus R, Wallace M, et al. Acceptability, safety, and patterns of use of oral tenofovir disoproxil fumarate and emtricitabine for HIV pre-exposure prophylaxis in South African adolescents: an open-label single-arm phase 2 trial. The lancet child & adolescent health. 2020;4(12):875-83. Landovitz RJ, Donnell D, Clement ME, Hanscom B, Cottle L, Coelho L, et al. Cabotegravir for HIV prevention in cisgender men and transgender women. New England Journal of Medicine. 2021;385(7):595-608. Schmidt HMA, Rodolph M, Schaefer R, Baggaley R, Doherty M. 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Male engagement in HIV testing, treatment and prevention in Eastern and Southern Africa. 2021. Iwuji CC, Orne-Gliemann J, Larmarange J, Balestre E, Thiebaut R, Tanser F, et al. Universal test and treat and the HIV epidemic in rural South Africa: a phase 4, open-label, community cluster randomised trial. The lancet HIV. 2018;5(3):e116-e25. Giguère K, Eaton JW, Marsh K, Johnson LF, Johnson CC, Ehui E, et al. Trends in knowledge of HIV status and efficiency of HIV testing services in sub-Saharan Africa, 2000–20: a modelling study using survey and HIV testing programme data. The Lancet HIV. 2021;8(5):e284-e93. Mhlongo S, Dietrich J, Otwombe KN, Robertson G, Coates TJ, Gray G. Factors associated with not testing for HIV and consistent condom use among men in Soweto, South Africa. PLoS One. 2013;8(5):e62637. Otwombe K, Dietrich J, Laher F, Hornschuh S, Nkala B, Chimoyi L, et al. Health-seeking behaviours by gender among adolescents in Soweto, South Africa. Global health action. 2015;8(1):25670. Mutie C, Otieno B, Mwangi E, Kithuci K, Mutisya A, Gachohi J, et al. Global burden of HIV among long-distance truck drivers: a systematic review and meta-analysis. BMJ open. 2024;14(8):e085058. Mlangeni N, Adetokunboh O, Lembani M, Malotle M, Ngah V, Nyasulu PS. Provision of HIV prevention and care services to farmworkers in sub‐Saharan African countries. Tropical Medicine & International Health. 2023;28(9):710-9. Delany-Moretlwe S, Bello B, Kinross P, Oliff M, Chersich M, Kleinschmidt I, et al. HIV prevalence and risk in long-distance truck drivers in South Africa: a national cross-sectional survey. International journal of STD & AIDS. 2014;25(6):428-38. Uganda AIDS Commission. The HIV and AIDS Uganda country progress report 2014. 2015 15 June 2014. Musumari PM, Techasrivichien T, Srithanaviboonchai K, Wanyenze RK, Matovu JK, Poudyal H, et al. HIV epidemic in fishing communities in Uganda: A scoping review. PloS one. 2021;16(4):e0249465. Glaubius RL, Hood G, Penrose KJ, Parikh UM, Mellors JW, Bendavid E, et al. Cost-effectiveness of injectable preexposure prophylaxis for HIV prevention in South Africa. Reviews of Infectious Diseases. 2016;63(4):539-47. Quaife M, Eakle R, Cabrera Escobar MA, Vickerman P, Kilbourne-Brook M, Mvundura M, et al. Divergent preferences for HIV prevention: a discrete choice experiment for multipurpose HIV prevention products in South Africa. Medical Decision Making. 2018;38(1):120-33. Smith JA, Garnett GP, Hallett TB. The potential impact of long-acting cabotegravir for HIV prevention in South Africa: a mathematical modeling study. The Journal of infectious diseases. 2021;224(7):1179-86. van Vliet MM, Hendrickson C, Nichols BE, Boucher CA, Peters RP, van de Vijver DA. Epidemiological impact and cost‐effectiveness of providing long‐acting pre‐exposure prophylaxis to injectable contraceptive users for HIV prevention in South Africa: a modelling study. African Journal of Reproduction and Gynaecological Endoscopy. 2019;22(12). Vogelzang M, Terris-Prestholt F, Vickerman P, Delany-Moretlwe S, Travill D, Quaife M. Cost-effectiveness of HIV pre-exposure prophylaxis among heterosexual men in South Africa: a cost-utility modeling analysis. JAIDS Journal of Acquired Immune Deficiency Syndromes. 2020;84(2):173-81. Walensky RP, Jacobsen MM, Bekker L-G, Parker RA, Wood R, Resch SC, et al. Potential clinical and economic value of long-acting preexposure prophylaxis for South African women at high-risk for HIV infection. The Journal of infectious diseases. 2016;213(10):1523-31. Jamieson L, Johnson LF, Nichols BE, Delany-Moretlwe S, Hosseinipour MC, Russell C, et al. Relative cost-effectiveness of long-acting injectable cabotegravir versus oral pre-exposure prophylaxis in South Africa based on the HPTN 083 and HPTN 084 trials: a modelled economic evaluation and threshold analysis. The lancet HIV. 2022;9(12):e857-e67. Smith J, Bansi-Matharu L, Cambiano V, Dimitrov D, Bershteyn A, van de Vijver D, et al. Predicted effects of the introduction of long-acting injectable cabotegravir pre-exposure prophylaxis in sub-Saharan Africa: a modelling study. The Lancet HIV. 2023;10(4):e254-e65. Neilan AM, Landovitz RJ, Le MH, Grinsztejn B, Freedberg KA, McCauley M, et al. Cost-effectiveness of long-acting injectable HIV preexposure prophylaxis in the United States: a cost-effectiveness analysis. Annals of internal medicine. 2022;175(4):479-89. Phillips AN, Bershteyn A, Revill P, Bansi-Matharu L, Kripke K, Boily M-C, et al. Cost-effectiveness of easy-access, risk-informed oral pre-exposure prophylaxis in HIV epidemics in sub-Saharan Africa: a modelling study. The Lancet HIV. 2022;9(5):e353-e62. Bond V, Ngwenya F, Murray E, Ngwenya N, Viljoen L, Gumede D, et al. Value and limitations of broad brush surveys used in community-randomized trials in Southern Africa. Qualitative health research. 2019;29(5):700-18. Kwena Z, Nakamanya S, Nanyonjo G, Okello E, Fast P, Ssetaala A, et al. Understanding mobility and sexual risk behaviour among women in fishing communities of Lake Victoria in East Africa: a qualitative study. BMC public health. 2020;20:1-10. Global Data Lab. Subnational Human Development Index - South Africa [cited 2023 1 July]. Available from: https://globaldatalab.org/shdi/table/shdi/ZAF/. Smits J, Permanyer I. The subnational human development database. Scientific data. 2019;6(1):1-15. Johnson LF, Dorrington RE, Moolla H. Progress towards the 2020 targets for HIV diagnosis and antiretroviral treatment in South Africa. Southern African journal of HIV medicine. 2017;18(1):1-8. Thembisa version 4.6: National and Provincial Model Outputs. Thembisa. 2023 [Internet]. 2023 [cited 4 July 2023]. Available from: https://thembisa.org/content/downloadPage/ProvOutput4_6. Simbayi L, Zuma K, Zungu N, Moyo S, Marinda E, Jooste S, et al. South African national HIV prevalence, incidence, behaviour and communication survey, 2017: towards achieving the UNAIDS 90-90-90 targets. 2019. Nglazi MD, van Schaik N, Kranzer K, Lawn SD, Wood R, Bekker L-G. An incentivized HIV counseling and testing program targeting hard-to-reach unemployed men in Cape Town, South Africa. Journal of acquired immune deficiency syndromes (1999). 2012;59(3):e28. Baisley K, Seeley J, Siedner M, Koole K, Matthews P, Tanser F, et al. Findings from home‐based HIV testing and facilitated linkage after scale‐up of test and treat in rural South Africa: young people still missing. HIV medicine. 2019;20(10):704-8. Gareta D, Baisley K, Mngomezulu T, Smit T, Khoza T, Nxumalo S, et al. Cohort profile update: Africa Centre Demographic Information System (ACDIS) and population-based HIV survey. International journal of epidemiology. 2021;50(1):33-4. Bond V, Nel M, Simuyaba M, Chirwa T, Viljoen L, Chiti B, et al. The Broad-Brush Survey Approach. A set of methods for rapid qualitative community assessment. 2023. Reddy P, Buchanan D, Sifunda S, James S, Naidoo N. The role of community advisory boards in health research: Divergent views in the South African experience. Sahara-J: Journal of social aspects of HIV/AIDS. 2010;7(3). Stewart MK, Boateng B, Joosten Y, Burshell D, Broughton H, Calhoun K, et al. Community advisory boards: experiences and common practices of clinical and translational science award programs. Journal of Clinical and Translational Science. 2019;3(5):218-26. Diallo DA, Doumbo OK, Plowe CV, Wellems TE, Emanuel EJ, Hurst SA. Community permission for medical research in developing countries. Clinical infectious diseases. 2005;41(2):255-9. Bond V, Chiti B, Hoddinott G, Reynolds L, Schaap A, Simuyaba M, et al. “The difference that makes a difference”: highlighting the role of variable contexts within an HIV Prevention Community Randomised Trial (HPTN 071/PopART) in 21 study communities in Zambia and South Africa. AIDS care. 2016;28(sup3):99-107. Gale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC medical research methodology. 2013;13:1-8. Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, (2017). Cite Share Download PDF Status: Published Journal Publication published 10 Nov, 2025 Read the published version in Trials → Version 1 posted Editorial decision: Minor revision 29 Aug, 2025 Reviewers agreed at journal 16 Aug, 2025 Reviewers invited by journal 16 Aug, 2025 Editor invited by journal 04 Mar, 2025 Editor assigned by journal 02 Mar, 2025 First submitted to journal 26 Feb, 2025 You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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\u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 44.9251%;\"\u003e\n \u003cp\u003eTitle {1}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 55.0749%;\"\u003e\n \u003cp\u003eImplementing oral (event-driven and daily) and long-acting Pre-Exposure Prophylaxis in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 44.9251%;\"\u003e\n \u003cp\u003eTrial registration {2a and 2b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 55.0749%;\"\u003e\n \u003cp\u003eNCT06133686;\u003c/p\u003e\n \u003cp\u003ePACTR202409632006463\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 44.9251%;\"\u003e\n \u003cp\u003eProtocol version {3}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 55.0749%;\"\u003e\n \u003cp\u003e3.0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 44.9251%;\"\u003e\n \u003cp\u003eFunding {4}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 55.0749%;\"\u003e\n \u003cp\u003eEuropean Union (EU) Horizon/\u0026nbsp;European and Developing Countries Clinical Trials Partnership\u0026nbsp;(EDCTP) Global health call for vulnerable adults (Project number: 101103140).\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 44.9251%;\"\u003e\n \u003cp\u003eAuthor details {5a}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 55.0749%;\"\u003e\n \u003cp\u003e\u003csup\u003e1\u003c/sup\u003eMedical Research Council/ Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit, Entebbe, Uganda\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e2\u003c/sup\u003eAfrica Research Health Institute, Durban, South Africa\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e3\u003c/sup\u003eDesmond Tutu HIV Foundation, Cape Town, South Africa\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e4\u003c/sup\u003eUniversity College London, London, United Kingdom\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e5\u003c/sup\u003eSouth African Medical Research Council, Cape Town, South Africa\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e6\u003c/sup\u003eUniversity of the Witwatersrand, Johannesburg, South Africa\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e7\u003c/sup\u003eLondon School of Hygiene and Tropical Medicine, London, United Kingdom\u003c/p\u003e\n \u003cp\u003e\u003csup\u003e8\u003c/sup\u003eKing\u0026rsquo;s College London, London, United Kingdom\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 44.9251%;\"\u003e\n \u003cp\u003eName and contact information for the trial sponsor {5b}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 55.0749%;\"\u003e\n \u003cp\u003eEugene Ruzagira\u003c/p\u003e\n \u003cp\u003eMRC/UVRI and LSHTM Uganda Research Unit, Plot 51-59 Nakiwogo Road, P.O. Box 49 Entebbe, Uganda\u003c/p\u003e\n \u003cp\u003eEmail: [email protected]\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 44.9251%;\"\u003e\n \u003cp\u003eRole of sponsor {5c}\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 55.0749%;\"\u003e\n \u003cp\u003eThis is an investigator-initiated trial. The sponsor takes responsibility for the design of the study, the collection, analysis, and interpretation of the data, and the writing of the manuscript.\u003c/p\u003e\n \u003cp\u003eThe design, management, analysis and reporting of the study are independent of the funding source.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Introduction","content":"\u003cp\u003e\u003cstrong\u003eBackground and rationale {6a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWhilst daily HIV prevention pre-exposure prophylaxis (PrEP) has been extensively evaluated in men who have sex with men and adolescent girls and young women (AGYW) [1], there have been few evaluations of injectable and event-driven (ED) PrEP in men who mainly have sex with women in sub-Saharan Africa. ED PrEP is a regimen that involves taking two pills 2\u0026ndash;24 hours before sex, and then one pill every 24 hours until 48 hours after the last sexual encounter [2]. Research to fill this gap is required to improve PrEP guidelines and facilitate successful PrEP roll out, a key focus of the Sustainable Development Goal target to end AIDS by 2030 [3].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eED PrEP for men, regardless of sexual orientation or sexual modality, has been recommended by WHO since 2019 [4], but this approach has not been endorsed in South Africa and only recently endorsed in Uganda [5] despite evidence of high acceptability demonstrated in feasibility studies [6]. Compared to daily oral PrEP, ED PrEP may require fewer tablets, which will lead to lower costs and fewer side effects. \u0026nbsp;More recently, injectable PrEP has been shown to be more effective than daily oral PrEP, [7] mainly because of better adherence, and as a result, long-acting cabotegravir (CAB-LA) has been recommended for use since 2022 [8].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTo support roll out of CAB-LA where the HIV burden is greatest, there is a need for studies to include men from sub-Saharan Africa. Acceptability studies have indicated that men show a preference for CAB-LA over oral PrEP, however, this is yet to be trialed [8-12]. Furthermore, there is a need to develop affordable and accessible HIV testing strategies for CAB-LA monitoring so that it can be delivered safely in primary care settings. \u0026nbsp;Although the WHO recommends the use of national HIV testing algorithms for those on CAB-LA, this approach is more likely to miss early infection than nucleic acid-based tests, particularly at CAB-LA initiation [13]. Conversely, HIV viral load testing in CAB-LA is problematic as such tests lack regulatory approval as HIV diagnostic tests are expensive and require laboratories. Furthermore, clinical trials of CAB-LA have found positive tests very difficult to interpret [14,15]. HIV self-tests have not been used in CAB-LA provision so far and their use to increase the frequency of HIV testing may increase detection of early HIV infection.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAn important factor in successfully enabling people to protect themselves is choice. Oral and injectable PrEP offer different benefits. The short-acting oral agents offer the ability to discontinue PrEP rapidly when desired. While long-acting PrEP removes the need for tablets and potentially improves adherence, it increases the number of clinic visits and the need for a trained health care worker to give the injection [16]. With the introduction of CAB-LA, a concern amongst providers is that it could lead to the re-medicalization of PrEP, hindering the migration of PrEP services into community venues (outside of clinic facilities) and the administration of PrEP by lay health workers [4, 17]. The delivery of injectable PrEP in community settings and for mobile groups is essential for widespread roll out.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLittle is known about the most effective way to implement PrEP choice for men in Uganda and South Africa. Engaging men and retaining them in HIV prevention and treatment programmes has been met with challenges in sub-Saharan Africa [18].Men consistently fare worse than women in levels of HIV testing and ART initiation [18, 19]. Indeed, the failure of some Treatment As Prevention (TASP) trials to show effect was mainly due to the inability to test and treat young men [20]. Providing PrEP for men therefore represents a large unaddressed gap in HIV services in Africa [21]. In South Africa and Uganda, other than \u003cem\u003evoluntary medical male circumcision\u003c/em\u003e, and condom promotion, there have been few prevention options for heterosexual men. \u0026nbsp;Men have had limited access to oral PrEP in part due to poor access to primary health care services, due to stigma, inconvenient opening times and long waiting times, and due to a lack of knowledge of HIV prevention options [21-23].\u003c/p\u003e\n\u003cp\u003eMen who are mobile due to work or looking for work are a key population at high risk of acquiring HIV [21]. High HIV prevalence remains disproportionately high in this population in sub-Saharan Africa. Estimates range from 0.95% to 54% among truck drivers [24], and 39.5% to 42% among farm workers [25], 26% among unemployed men in South Africa [26], and 40% among men in fishing communities in Uganda [27]. As Africa\u0026apos;s large youth bulge moves into young adulthood, the search for work and associated mobility will further increase. Despite this, PrEP intervention studies have not included these populations [28] and, as such, a real-world delivery model for HIV prevention in mobile men has not been developed. One specific concern is that those who are mobile for work may require more flexible PrEP delivery systems to allow for extended periods away from home [4].\u0026nbsp;\u003c/p\u003e\n\u003cp\u003ePolitical decisions regarding rollout and delivery models need to take into account implementation needs and cost effectiveness. Recent economic analyses comparing CAB-LA to oral PrEP have shown mixed results. Seven studies modelled data and scenarios specific to South Africa [29-35], but with the exception of two [31, 35, 36],none was based on trial or implementation study data. Additionally, one study assessed costs for\u0026nbsp;men who have sex with men\u0026nbsp;and transgender women in the United States [37]. Economic analyses comparing CAB-LA to oral PrEP based on data from implementation and countries other than South Africa are therefore needed. The Mobile Men study will provide data on the cost and outcomes of ED PrEP and HIV antibody test monitoring of CAB-LA to be used for such economic analyses. We also, for the first time, will provide cost data for Uganda for oral PrEP and CAB-LA PrEP. For this, we will use the HIV Synthesis model, an individual based model that includes both oral and long-acting injectable PrEP, while accounting for drug resistance [36,38].\u0026nbsp;This is particularly important for CAB-LA, given its tail dosing and the potential for cross-resistance between cabotegravir and dolutegravir, the cornerstone drug of first-line HIV treatment globally.\u003c/p\u003e\n\u003cp\u003eTo improve uptake, persistence, and effective use of all forms of PrEP in men, there is a need for simplified and differentiated delivery of PrEP that is person- and community-centred. Effective use requires that all potentially high-risk sex acts be covered by an effective preventive intervention such as PrEP. Given the importance of flexibility due to travel in this group, our hypothesis is that both oral PrEP (in particular, ED PrEP) and CAB-LA PrEP will be highly acceptable to men in two high-burden, resource limited, African countries, with high levels of effective use including persistence and coital coverage. Policy makers will need evidence not only around effective use but also the reach, adoption and choice, implementation and maintenance of PrEP in different settings and with different high-risk mobile men to inform generalisability and scalability of PrEP for heterosexual men. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe Mobile Men study is the first PrEP study implementing both ED oral PrEP and CAB-LA targeting mobile men in sub-Saharan Africa (South Africa and Uganda). The study will provide the evidence for effectiveness, implementation and cost-effectiveness, which are critical to decision making by African governments and donors on how to prioritise prevention resources and inform guidelines.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eObjectives {7}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe overall objective of the Mobile Men study is to assess effectiveness and implementation of CAB-LA and oral TDF/FTC (both daily and ED) amongst men who are mobile for work in South Africa and Uganda, through comparison of uptake, retention in care, coital coverage, and participant choice.\u003c/p\u003e\n\u003cp\u003eThe primary user effectiveness objective is to compare short term (9 months) and longer term (18 months) PrEP persistence patterns across different PrEP modalities (oral and injectable) amongst men who are mobile for work in South Africa and Uganda.\u003c/p\u003e\n\u003cp\u003eThe primary implementation objective is to compare adoption (uptake and choice) across the different PrEP modalities (oral and injectable) amongst men who are mobile for work in South Africa and Uganda.\u003c/p\u003e\n\u003cp\u003eThe secondary clinical objectives are:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eTo compare the effective coital coverage of oral daily/ED TDF/FTC versus CAB-LA\u003c/li\u003e\n \u003cli\u003eTo describe the safety, tolerability and acceptance of all methods, as determined by self-reported side effects, adverse events (AEs) and reasons for PrEP pause or discontinuation\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eThe secondary implementation objectives are:\u0026nbsp;\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eTo understand the Reach of PrEP for mobile men and understand the barriers to, and facilitators of, uptake amongst those at risk who do and do not accept oral or injectable PrEP. \u0026nbsp;\u003c/li\u003e\n \u003cli\u003eTo describe Adoption: \u0026nbsp;\u0026nbsp;\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eTo identify characteristics of men who adopt oral PrEP versus CAB-LA \u0026nbsp;\u003c/li\u003e\n \u003cli\u003eTo describe patterns of use of daily, ED, and long-acting PrEP amongst different groups of mobile men.\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n \u003cli\u003eTo understand the Implementation of ED and long-acting PrEP for mobile men amongst service providers to inform scale-up.\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eTo understand the feasibility and fidelity of delivering ED and long-acting PrEP in different settings.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eTo describe how ED and long-acting PrEP are delivered in practice.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eTo describe the service-level needs to implement ED and long-acting PrEP.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eTo evaluate acceptability and implementation of antibody-based HIV status monitoring for CAB-LA.\u0026nbsp;\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n \u003cli\u003eTo assess the total and average cost of oral PrEP and CAB-LA in South Africa and Uganda under study conditions from the provider perspective (Maintenance).\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003eThe exploratory objectives are:\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eTo describe HIV incidence across the two PrEP modality arms\u003c/li\u003e\n \u003cli\u003eTo describe any evidence of HIV drug resistance mutations in participants who acquire HIV infection whilst using PrEP across the two PrEP modality arms.\u003c/li\u003e\n \u003cli\u003eTo describe persistence in care of those diagnosed with HIV at screening\u003c/li\u003e\n \u003cli\u003eTo describe body mass index (BMI) and blood pressure across both arms.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eTrial design {8}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Mobile Men study is a phase 3b, open-label, hybrid effectiveness-implementation type 2 trial to evaluate the initial implementation (scale-up) phase of CAB-LA as a PrEP option in men who are mobile for work in South Africa and Uganda with a high burden of HIV. The trial is a phase 3b, open label, hybrid type 2 study with co-primary aims of effective use and implementation. \u0026nbsp;The implementation of PrEP choice in mobile men is further investigated using a mixture of social science and health economics methods to understand reach, adoption, implementation and maintenance. These include repeat rapid ethnographic assessments [39], qualitative interviews with users and providers, process evaluation, modelling and cost-effectiveness analysis.\u003c/p\u003e\n\u003cp\u003eA schematic representation of the trial design is shown in Figure 1. Participants will be screened for HIV at enrolment. Those testing negative will be randomised to receive either oral or injectable PrEP for an initial 9-month period. Then, throughout the 9 to 18 months period following randomisation, participants will be offered a choice of oral or injectable PrEP. Participants determined as living with HIV at screening will be linked to care and followed up as a separate cohort alongside randomised trial participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAn embedded social science component provides data on the process of trial implementation as well as detailed information on study sites, local communities and perspectives on both trial and trial products by participants. This component of the study is divided into three parts: a rapid ethnographic assessment conducted at three time points during the trial period (before, during and at the end), qualitative data collection with trial and non-trial participants and trial staff throughout the trial, using in-depth interviews, group discussion, observations and structured debriefings, and a health economics component addressing costs and cost-effectiveness.\u003c/p\u003e"},{"header":"Methods: Participants, interventions and outcomes of the trial ","content":"\u003cp\u003e\u003cstrong\u003eStudy setting {9}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study will take place at three sites: two in South Africa [KwaZulu-Natal and Buffalo City Metro (BCM) Municipality, Eastern Cape]and one in Uganda (Masaka city, Masaka district). In South Africa, the study will be conducted by the Africa Health Research Institute in KwaZulu-Natal, and the Desmond Tutu Health Foundation in East London. In Uganda, the study will be conducted by the Medical Research Council/Uganda Virus Research Institute and London School of Hygiene and Tropical Medicine Uganda Research Unit.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEligibility criteria for the trial {10}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe inclusion criteria are as follows:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eAbility and willingness to provide informed consent\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAge 18 years or older\u003c/li\u003e\n \u003cli\u003eWillingness to undergo HIV testing\u003c/li\u003e\n \u003cli\u003eAssigned male at birth\u003c/li\u003e\n \u003cli\u003eHistory of work-related travel in the past six months, including spending at least one night away from home for work purposes, and being at risk of HIV infection\u003c/li\u003e\n \u003cli\u003eWillingness to use PrEP\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eThe exclusion criteria are as follows:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eConfirmed HIV infection\u003c/li\u003e\n \u003cli\u003eReasons at the discretion of site investigator for unsuitability for study inclusion\u003c/li\u003e\n \u003cli\u003eBody weight less than 35kg\u003c/li\u003e\n \u003cli\u003eUse of contraindicated medications including: Medication for tuberculosis (e.g., rifampin, rifapentine), anticonvulsants (e.g., carbamazepine, oxcarbazepine, phenobarbital, phenytoin)\u003c/li\u003e\n \u003cli\u003eKnown allergy to any of the study products\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eWho will take informed consent? {26a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformed consent will be obtained by trained study staff delegated by the Principal Investigator. At the screening visit, participants will have the opportunity to ask questions and have a full discussion of the information provided in writing and/or visually and verbally. This will include the following key messages:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eThat there is a 1 in 2 chance that the participant will be assigned to CAB-LA and a 1 in 2 chance that they will be assigned to oral PrEP.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eThat condoms and PrEP are known to reduce the risk of acquiring HIV when used or taken consistently.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eParticipants will be shown images of the PrEP pills and the CAB-LA vials. They will be asked if they discussed their intention to participate in the study with anyone and if any problems arose because of this. If they wish to proceed, they will be given an informed consent form to read and sign prior to any study procedures. The informed consent form will be dated and countersigned by the investigator or delegated person, who administers the informed consent process. If the participant is unable to read and write, they will be asked to place their thumbprint on the informed consent form in the presence of an independent witness who will have been present during the discussion. The witness cannot be a member of the site study staff. The right of the participant to refuse to participate without giving reasons will be respected.\u003c/p\u003e\n\u003cp\u003eA copy of the consent form will be provided to the participant and one copy kept securely in the study file according to local procedures. For the qualitative component of the study, the Participant Information Sheet for the in-depth interviews and group discussions will be used to provide information to study participants in one-on-one conversations. Written informed consent will be obtained prior to conducting interviews by staff trained in interview techniques.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdditional consent provisions for collection and use of participant data and biological specimens {26b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAdditional consent will be obtained to collect and store blood samples from people who acquire HIV during the study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterventions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExplanation for the choice of comparators {6b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDaily oral PrEP is effective, but a substantial proportion of people offered this approach either fail to initiate it, discontinue relatively soon after starting, or do not use it effectively [18]. While the WHO endorses ED PrEP for men, regardless of sexual orientation or sexual modality, this regimen has not been taken up in South Africa and has only recently been introduced in Uganda [5]. To date, no efficacy studies have been carried out using ED PrEP for heterosexual men in Africa. Research carried out by our consortium recently showed that ED PrEP is the oral prevention method of choice among young men in South Africa, Uganda, and Zimbabwe\u0026nbsp;[6]. The advantage of oral ED PrEP over daily PrEP means that potentially fewer tablets are required which lowers the cost, minimizes side effects, and potentially lowers the risk of stigma due to reduced visibility of PrEP use particularly when travelling for work.\u003c/p\u003e\n\u003cp\u003eCAB-LA is a strand transfer integrase inhibitor that is delivered as a suspension via a gluteal intramuscular injection every two months. Two double-blind, double-placebo studies, HPTN 083 and HPTN 084, have shown CAB-LA is superior to daily oral TDF/FTC, with significantly lower HIV incidence observed in the CAB-LA arms across both male and female populations [7,13]. HPTN 083 was conducted amongst cis-gender men and transgender women who have sex with men in the US, Latin America, Asia, and Africa. Participants in the CAB-LA arm had a 66% lower risk of HIV infection compared to their counterparts in the TDF/FTC arm [13]. HPTN 084 was conducted amongst cis-gender women across seven sub-Saharan African countries. Participants in the CAB-LA arm had an 88% lower risk of HIV infection compared to those in TDF/FTC arm [7].\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIntervention description {11a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEligible participants (men testing HIV negative at screening) will be randomized in a 1:1 ratio to either Group A: oral TDF/FTC PrEP (ED or daily) or Group B: CAB-LA over 9-months. After 9-months, participants from both groups will be offered a choice of PrEP (oral TDF/FTC or CAB-LA) for a further 9 months, with the ability to change their choice as required.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCriteria for discontinuing or modifying allocated interventions {11b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThere are no planned modifications to oral TDF/FTC or\u0026nbsp;CAB-LA PrEP dose. PrEP must be interrupted if a participant suffers a serious adverse event (SAE) that could be a drug reaction. Participants who have a positive Hepatitis B virus test will be recalled if they are using CAB-LA PrEP and invited to switch to oral PrEP at the end of month 1 or counselled on alternative HIV prevention products.\u003c/p\u003e\n\u003cp\u003eIf an individual chooses to stop PrEP, they may remain in the study, and the reason for stopping documented.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe study investigator can also discontinue an individual from their allocated intervention for the following reasons:\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eConfirmed HIV infection\u003c/li\u003e\n \u003cli\u003eUnacceptable toxicity that precludes the continuation of PrEP\u003c/li\u003e\n \u003cli\u003eIntercurrent illness that prevents the safe use of PrEP\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eEarly termination of study\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eParticipants who enrol on the study and/or have received at least one CAB-LA injection or one PrEP tablet will be asked to remain in follow-up. However, participants may withdraw their consent for further visits at any point during the trial. Data that are already collected from participants who stop follow-up early may still be analysed, provided they have given consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStrategies to improve adherence to interventions {11c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants will be offered counselling to enhance PrEP adherence and attend scheduled study appointments. At enrolment, participants will be asked for a primary and secondary phone number, if they have one, as well as their home address. They will also be asked whether they consent to home visits by the study team in case of missed study visits. \u0026nbsp;Additionally, a clinical hotline will be provided to enable participants to directly contact the study team for assistance.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOral PrEP:\u003c/strong\u003e All participants will receive detailed information on how to correctly use PrEP. Adherence to oral PrEP will be assessed using self-reported data, pill counts of dispensed medication, and drug concentration levels measured in dried blood spots (DBS).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInjectable PrEP:\u003c/strong\u003e All injections will be administered by site staff and recorded in the relevant case report form (CRF). If an injection is not given within the ideal window, the deviation and reason for it will be recorded in the CRF.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRelevant concomitant care permitted or prohibited during the trial {11d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo concomitant medications are prohibited for TDF/FTC. Concomitant medications that are prohibited for CAB-LA are Rifampicin, Carbamazepine, Oxcarbazepine, Phenytoin, Phenobarbital, and Rifapentine.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProvisions for post-trial care {30}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll participants exiting the trial will be signposted and linked to HIV prevention services that provide PrEP. \u0026nbsp;It may be that locally available CAB-LA is not yet in place, and this will be discussed with participants wanting to access it.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOutcomes {12}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial will have two co-primary outcomes:\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003e\u003cstrong\u003eUser effectiveness co-primary outcome:\u003c/strong\u003e This will assess persistent use of PrEP during the randomised period and throughout the full follow-up period. Persistent use of PrEP during the randomised period will be defined as a binary outcome. Participants randomised to the CAB-LA arm who receive all injections as per schedule (initial injection at month 0, followed by injections at months 1, 3, 5 and 7, with an acceptable window of +/- 7 days for each injection),\u0026nbsp;will be considered \u0026ldquo;persistent on PrEP\u0026rdquo;. Participants who do not receive all injections as scheduled will be classified as \u0026ldquo;non-persistent on PrEP\u0026rdquo;, regardless of the frequency or timing of self-reported condomless sex. Participants randomised to the oral PrEP arm will be considered \u0026ldquo;persistent on PrEP\u0026rdquo; if they attend scheduled three-monthly visits, receive sufficient PrEP\u0026nbsp;to maintain supply until the next visit, and have detectable TFV-DP levels in DBS.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eDuring the full follow-up period (18 months), persistence will be assessed as a multinomial outcome with the following categories: single modality, consistent use; multiple modalities, consistent use; single or multiple modality, inconsistent use; never started PrEP.\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003e\u003cstrong\u003eImplementation co-primary outcome\u003c/strong\u003e: This will compare the adoption (uptake when offered and choice preference of the different modalities). Uptake is defined as the proportion of participants who are offered and subsequently take PrEP (oral PrEP arm versus CAB-LA arm) during the 9-month randomised period. Choice preference will be measured as the proportion of participants who choose and use each modality (daily or ED oral PrEP or CAB-LA), captured at the start and the end of the subsequent 9-month choice period.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eSecondary outcomes include:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eShort term flexible PrEP persistence: a binary outcome that is analogous to the user effectiveness co-primary outcome but with more flexibility allowed on visit windows, specifically an acceptable window of -7 to +28 days for scheduled injections at months 3, 5 and 7 in the CAB-LA arm, and for scheduled visits at months 4 and 7 in the oral PrEP arm.\u003c/li\u003e\n \u003cli\u003eEffective peri-coital coverage of PrEP: A binary outcome measuring whether, at the time of last condomless sex, the participant was \u0026ldquo;covered\u0026rdquo; by PrEP.\u003c/li\u003e\n \u003cli\u003eSafety, tolerability and acceptance: Assessed based on self-reported AEs and the reasons for PrEP pause or discontinuation.\u003c/li\u003e\n \u003cli\u003eReach: Evaluated qualitatively through three serial rapid ethnographic assessments capturing information on awareness and reach of PrEP amongst mobile men.\u003c/li\u003e\n \u003cli\u003eAdoption: This will be evaluated by (i) comparing the characteristics of men who uptake oral PrEP with those who uptake CAB-LA when offered at month 0, (ii)\u0026nbsp;comparing the characteristics of men who choose oral PrEP with those who uptake CAB-LA when given the choice at month 9, (iii) describing patterns of use of daily, ED, and long-acting PrEP during months 9-18 of the trial, and the transitions between these modalities.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eImplementation:\u0026nbsp;Evaluated using qualitative data collected from service providers, with a focus on fidelity and feasibility.\u003c/li\u003e\n \u003cli\u003eMaintenance:\u0026nbsp;Evaluated through calculation of total and average cost of oral PrEP and CAB-LA in South Africa and Uganda under study conditions, from the provider perspective.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eParticipant timeline {13}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe participant timeline is shown in Table 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1: Mobile Men study schedule of enrolment, interventions, and assessments.\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cimg 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\" width=\"641\" height=\"708\"\u003e\u003c/p\u003e\n\u003cp\u003e\u003csup\u003e1\u003c/sup\u003eVisit schedule for choice phase is dependent on choice of PrEP made at month 9 and at each subsequent visit; \u003csup\u003e2\u003c/sup\u003eDone at visits corresponding to the intervention received by the participant;CAB-LA, Long-acting injectable cabotegravir; PrEP, pre-expsoure prophylaxis; CRF, Case report form; IDIs, In-depth interviews; FGDs, Focus group discussions; HIV, Human immunodeficiency virus; STI, sexually transmitted infection; DBS, Dried blood spot; BMI, Body mass index; CrCl, creatinine clearance; HepBsAg, Hepatitis B surface antigen\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSample size {14}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe planned enrolment sample size of 400 participants (randomised), will allow 80% power to detect an absolute difference of 11% in persistence between trial arms, assuming 80% persistence in the lower persistence arm (and 91% persistence in the higher persistence arm), and allowing for 20% lack of ascertainment of persistence, for example, due to medical ineligibility to receive the randomised intervention, or death. If the persistence in the lower persistence arm is lower, at 60%, then we will have 80% power to detect an absolute difference of 15% (i.e. 60% versus 75% persistence).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment {15}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePreparatory work:\u003c/strong\u003e Preliminary work in the communities is being carried out including a rapid ethnographic assessment study to inform and facilitate study implementation. \u0026nbsp;Demand creation for PrEP will be achieved through a community engagement campaign and peer and sex worker outreach activities prior and during the study start. These efforts will expose men in the communities to PrEP educational materials and encourage them to visit community and public health sites to access sexual health services, including PrEP. Potential participants will be provided with educational information about each of the PrEP products both during the enrolment visit and as part of the broader community-wide demand creation campaign preceding the study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMasaka, Uganda:\u0026nbsp;\u003c/strong\u003eRecruitment efforts will mainly focus on landing sites around the shores of Lake Victoria in Masaka district. These fishing communities have a high HIV burden that is attributed to several factors, including high mobility, sex work, relatively young populations with disposable daily income, and inadequate health services. People in these communities frequently move between different landing sites and islands, with up to 47% of men and 25% of women reporting being away from home for at least two days each month. This mobility is mainly driven by the seasonal fish catch. Previous studies have highlighted that such high mobility can limit access to health services, increase HIV infection risk, and underscore the need for tailored HIV prevention interventions that account for these mobility patterns [40]. The Mobile Men study has been designed to address these challenges.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe study team will work with local leaders and members of Village Health Teams and via community HIV testing services to identify potential participants from places of entertainment (such as lodges/guest houses, bars) and from their homes. Detailed locator information, including addresses, telephone contacts, and next-of-kin details, will be collected to facilitate effective phone and/or physical tracing during the follow-up phase of the study. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBuffalo City Metro (BCM) municipality, Eastern Cape, South Africa:\u003c/strong\u003e The Eastern Cape Province is a historically under-resourced and under-researched province. Since 1990, Eastern Cape has ranked last among South Africa\u0026rsquo;s nine provinces in its Human Development Index score [41, 42]. In 2022, the estimated HIV prevalence in the province was 19.4% among individuals aged 15-49 years. That same year, an estimated 92.6% of individuals living with HIV in Eastern Cape knew their status, 74.9% were on ART, but only 62.6% were virally suppressed (Viral load \u0026lt;1000 copies/mL) [43, 44]. Given that South African men are less likely to know their HIV status, initiate ART, or be virally suppressed compared to women, we expect these indicators will be worse for men in the province [45].\u003c/p\u003e\n\u003cp\u003eWithin BCM, men will be recruited from Duncan Village (urban) and Mdantsane (peri-urban) townships. These predominantly black, Xhosa-speaking, communities have some of the highest HIV prevalence rates in South Africa. Both Duncan Village and Mdantsane are densely populated, with many residents living in informal housing. Mdantsane, in particular, is one of the largest townships in the country. Mobile men from these communities return home on a regular basis to visit their extended families.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRecruitment will target men who sit by the roadside waiting for offers of casual labour. Previous studies have reported an HIV prevalence of 16.6% in this population [46]. \u0026nbsp;Additionally, construction workers and migrant workers (men who leave their partners and families to work) will be recruited. Truck drivers will also be targeted through nurse-led primary healthcare services at a fixed roadside Wellness Centre located near East London\u0026rsquo;s shipping port and airport. The centre serves an extremely busy route for the long-distance goods transport.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eKwaZulu-Natal, South Africa\u003c/strong\u003e: Recruitment will focus on mobile young men from a busy urban and peri-urban taxi rank and market area in Mtubatuba town, in uMkhanyakude where the main N2 highway intersects with the R618 route to St. Lucia, and surrounding areas. \u0026nbsp;This primarily rural area faces significant economic challenges compared to other regions in South Africa, with high levels of unemployment. For example, over 85% of young people aged 20-24 are unemployed. The uMkhanyakude district also has a very high HIV prevalence of 30% [47]. Healthcare infrastructure is limited, with only one public hospital and 13 fixed-location primary healthcare clinics, all of which face resource constraints in delivering HIV prevention and health promotion [48]. Men looking for work, or on their way to find work in larger urban setting of Durban and Johannesburg, the Richards Bay shipping port, the coalmines and sugar plantations of uMkhanyakude will mostly transition through the taxi rank and market area of Mtubatuba. It is also a hub where men who move for work spend their earnings, on food, sex work/transactional sex, other recreational activities and alcohol. \u0026nbsp;Stakeholder engagement, key informant interviews and rapid ethnographic assessments prior to the study suggested that mobile clinics based in Mtubatuba taxi rank that provide hypertension and diabetes screening, and supported by peer and sex worker outreach, would reach men who are mobile for work. \u0026nbsp; \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: allocation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSequence generation {16a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe allocation sequence will be generated using computer-generated random numbers. Randomisation will be done in a 1:1 ratio, stratified by setting (three groups) and using randomly permuted block size.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConcealment mechanism {16b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe allocation sequence will be embedded within the data collection system (REDCap). At the time of enrolment, each participant will be given a unique randomisation identifier in the temporal order in which they are randomised within their setting. The trial arm allocation for this unique identifier will then be accessed in REDCap. The trial arm allocation will be hidden until the participant has received their unique randomisation identifier.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eImplementation {16c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe allocation sequence will be implemented in a STATA program written by the trial statistician, and with the random seed chosen by a statistician who is otherwise uninvolved with the study. Participants will be enrolled by clinicians. After determining a participant\u0026rsquo;s eligibility, the clinician will log onto REDCap using their personal access credentials. REDCap will then prompt the clinician to confirm eligibility and the site and that they want to randomise a new participant with the next randomisation ID for that site to the trial. Once confirmed, the participant is randomised by the clinician and assigned to a randomisation arm according to the next unique identifier on the allocation list. The randomisation allocation assigned will now be read-only and cannot be edited after this.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAssignment of interventions: Blinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eWho will be blinded {17a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDue to the nature of the trial, it is not possible to blind participants, study staff involved with participant care, or outcome assessors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eProcedure for unblinding if needed {17b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. This is an open-label study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection and management\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for assessment and collection of outcomes {18a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCollection of clinical, socio-demographic and behavioral data\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants\u0026rsquo; weight, height, and blood pressure will be measured at screening and at specified follow-up visits (Table 1), as injectable PrEP is potentially associated with weight gain and hypertension. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSocio-demographic, behavioural, risk and mobility information will be collected through surveys at baseline and specified follow-up visits (Table 1). PrEP-related data, including, details of the PrEP provided to and used by the participant, will be documented at each visit. During the \u0026ldquo;choice period\u0026rdquo; (9 to 18 months), participants will be asked at each visit to indicate their preferred PrEP intervention. For participants who choose to switch PrEP options, their reasons will be captured on a PrEP switch CRF. To evaluate PrEP adherence and ensure consistent counseling, a PrEP adherence CRF will be administered by a study team member at every visit. The PrEP adherence questionnaire will focus on:\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eSelf-reported PrEP use, including whether participants are currently taking PrEP, the number of days since their last PrEP tablet, and adherence surrounding condomless sex (e.g., the number of tablets taken the day before and after the sex act).\u003c/li\u003e\n \u003cli\u003eAny adverse clinical or social effects experienced as a result of PrEP use.\u003c/li\u003e\n \u003cli\u003eReasons for pausing or discontinuing PrEP.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eCollection of laboratory data\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe following laboratory tests will be performed at screening and specified time points (Table 1) to confirm participant eligibility and the safety of product use.\u0026nbsp;\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eHIV testing: HIV will be confirmed at each in-person visit using the national HIV testing algorithm. Participants who test positive during the trial will be counselled and referred to local clinical centres for HIV care and treatment.\u003c/li\u003e\n \u003cli\u003eHepatitis B viral (HBV) testing: a blood sample will be collected at screening to test for Hepatitis B infection, the site\u0026rsquo;s routine test for Hepatitis B surface antigen.\u003c/li\u003e\n \u003cli\u003eCreatinine clearance: Serum creatinine levels will be measured at screening for men aged 30 years and older. Subsequent testing will be conducted if clinically indicated.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eDBS: These samples will be collected and stored for later retrospective analysis of drug levels of drug levels and possibly viral load testing.\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eSexually transmitted infections (STIs): Testing for STIs, including gonorrhoea, chlamydia and syphilis, will be performed based on local guidelines.\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003e\u003cstrong\u003eCollection of social and economic science implementation data\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTo answer the secondary implementation objectives of Reach, Adoption, Implementation and Maintenance using the RE-AIM implementation science framework (Table 2), a mixed-methods data collection approach will be adopted.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2: The proposed RE-AIM evaluation\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"659\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eDomain\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eDefinition\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eImplementation outcome\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003eData source\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cu\u003eR\u003c/u\u003e\u003c/strong\u003e\u003cstrong\u003eeach\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cu\u003eClient (user) level\u003c/u\u003e: \u0026nbsp; \u0026nbsp; Extent to which mobile men at risk of HIV acquisition effectively take up PrEP measured as the patterns of uptake and persistence per arms and community experience. \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eRapid ethnographic assessments of each community, the surveys and process of engagement with services \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cu\u003eE\u003c/u\u003e\u003c/strong\u003e\u003cstrong\u003effectiveness\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cu\u003eClient (user) level:\u003c/u\u003e Increased effective use (adopt and adhere) of PrEP amongst mobile men. \u0026nbsp; \u0026nbsp; Measured as proportion who are retained on PrEP and participant choice\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePragmatic randomized controlled trial (RCT)\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cu\u003eA\u003c/u\u003e\u003c/strong\u003e\u003cstrong\u003edoption\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cu\u003eClient (user) level\u003c/u\u003e: \u0026nbsp; \u0026nbsp; Acceptability (uptake when offered), attitudes towards, preferences/choices and patterns of use amongst different groups of mobile men.\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003ePragmatic RCT, the surveys, qualitative interviews with service users \u0026amp; process of engagement with services, exit interviews. \u0026nbsp; \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cu\u003eI\u003c/u\u003e\u003c/strong\u003e\u003cstrong\u003emplementation\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cu\u003eProvider (service) level\u003c/u\u003e: Appropriateness, feasibility, practicability, and fidelity of CAB-LA in the three stages or initiation, continuation, and safe stopping with\u0026nbsp;national HIV testing algorithms\u0026rdquo;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eQualitative data from service providers, time motion studies and HIV self-testing study. \u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cu\u003eM\u003c/u\u003e\u003c/strong\u003e\u003cstrong\u003eaintenance\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003e\u003cu\u003eProvider and Health Systems level\u003c/u\u003e: Affordability and resources needed for scalability\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\"\u003e\n \u003cp\u003eTime motion studies, costing and modelling\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eData collection methods will include the following:\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRapid ethnographic assessments:\u0026nbsp;\u003c/strong\u003eThese assessments will be conducted at baseline, after 9 months and at end line to provide implementation data on reach of the intervention. The assessments will use a rapid ethnographic assessment (REA) methodology, a structured approach that combines a variety of qualitative methods in a sequential format, designed to move from broad contextual understanding to a more specific focus on the study topic. This approach allows for the collection of focused data that addresses both the whole community context as a whole and the specific behaviours and HIV-prevention choices of mobile men.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe REA methodology comprises of a set of structured activities such as community entry, spiral walks, observations, individual conversations/interviews, natural group discussions, and focus group discussions. \u0026nbsp; This is aimed at gathering a comprehensive perspective on the area of study and the communities living there. The rapid ethnographic assessment approach is conducted within a defined 15-day period\u0026nbsp;[49]. Community entry is conducted a few months prior to the commencement of data collection. The research teams engage with the Community Advisory Boards (CABs) overseeing the chosen research sites for guidance on appropriate community entry specific to the sites concerned [50, 51]. This is followed by seeking the relevant permissions from the local leadership, including traditional, political or community leaders, depending on the area [52]. \u0026nbsp;The data collection methodology is standardized across study areas, ensuring consistency and rigor in the process [39, 53]. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eIn-depth qualitative interviews\u003c/strong\u003e\u003cstrong\u003e\u0026nbsp;with service users:\u0026nbsp;\u003c/strong\u003eOne-on-one interviews will be conducted with up to 10% of participants across the sites, based on the visit schedule. These participants will be\u0026nbsp;purposively selected to represent the emerging patterns of risk and adherence behaviours identified from the quantitative data. These interviews will provide insights into the experience, motivations and barriers that facilitate or obstruct adoption of each PrEP modality during the randomised phase and the \u0026nbsp;rationale for adoption of each modality during the choice phase. In addition to exploring individual behaviour changes, the interviews will capture changes in the communities/places the participants stay, to inform the trial about context-specific factors which may affect trial outcomes (e.g., loss of employment options in a location and changes in health care provision) and how participants move between PrEP choices.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eExit interviews (choices, trial participation)\u003c/strong\u003e: Exit interviews will be conducted with all participants as they exit the trial, to capture their experiences and reflections on the study. \u0026nbsp;These interviews will focus on their reasons for trial participation, their PrEP choices, and their overall experiences with the intervention.\u0026nbsp;Participants who seroconvert at any time during follow-up will also be invited to take part in an in-depth interview as described above. These interviews will explore key factors contributing to seroconversion, including details about condom less sex or PrEP adherence since their last negative result, as well as the number and characteristics of new sexual partners during the follow-up period.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eGroup discussions:\u0026nbsp;\u003c/strong\u003eThese will be conducted with a subset of participants, typically comprising approximately eight participants per group. Group discussions will be led by staff trained in qualitative research methods, who are independent of the clinic team, to ensure objectivity and minimise potential biases. Participants will be purposefully selected based on specific criteria, while others will be invited on an ad hoc basis to ensure diverse perspectives. These group discussions will aim to explore participants\u0026rsquo; experiences, perceptions, and insights on the trial, including their motivations, challenges, and changes in behavior related to PrEP use.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterviews with service providers:\u0026nbsp;\u003c/strong\u003eStructured debriefs and one-on-one interviews with community and counselling staffwill be conducted by a social scientist during the study. Typically, these interviews will capture conversations observed or initiated by staff with and between participants, non-participants, clinic staff and community workers. The notes will be anonymous and documented using a standardised template. Special attention will be given to understanding how participants transition between ED and daily PrEP, through conversations with a range of service providers, including mobilisers/recruiters. To support reflection and inform ongoing training and supervsion, peer-navigators and clinical staff will be trained to keep very brief notes of their daily activities. These notes will be used during debriefing sessions\u0026nbsp;to discuss key observations and challenge. \u0026nbsp;These interviews will take place once recruitment is closed,\u0026nbsp;additional, `endline\u0026rsquo; interviews scheduled with service providers, stakeholders, and community members. Peer navigators will be interviewed and natural group discussions will be facilitated with various stakeholder groups, such as community leaders, Community Advisory Board members, and local healthcare providers, to gather perspectives on the study\u0026apos;s implementation and impact.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCollaborative problem-solving meetings:\u003c/strong\u003e Meetings will be held with healthcare workers from all sites to allow for collaborative problem solving. Implementation of the study will be discussed, and modifications made for improvement will be documented to inform the implementation analysis (implementation and adoption domains of the RE-AIM framework).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQuantitative survey:\u0026nbsp;\u003c/strong\u003eThe survey will collect data on demographics (age, relationship status, education, income, location), mobility patterns, mental health, social economic factors [food security, social cohesion (network of friends), and support systems]. Surveys at months 9 and 18 will additionally explore participants\u0026rsquo; PrEP choices and rating of their experiences with PrEP using a Likert scale.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHealth economics:\u0026nbsp;\u003c/strong\u003eCost data will be collected using bottom-up and top-down costing, drawing on expenditure reports, resource use from CRFs, from the provider perspective. We will combine these with relevant, up-to-date information on public sector prices and salaries in either country. At mid-point of implementation, data collectors will conduct a time-and-motion study with study staff involved in implementation at each site to estimate staff time and resources used on key activities. Trial resource use will be adapted to represent potential rollout in routine care.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to promote participant retention and complete follow-up {18b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eMeasures to support PrEP persistence will include pre-dose counselling at each visit and standard retention efforts if the participant fails to report for a subsequent visit. \u0026nbsp;All participants with a missed visit will be followed up in the following way:\u003c/p\u003e\n\u003cul\u003e\n \u003cli\u003eAt day 7 post a missed visit, the participant will be called using the telephone number provided at the most recent visit. After three unsuccessful attempts on subsequent days, at different times, the study team will carry out a home visit. \u0026nbsp;\u003c/li\u003e\n \u003cli\u003eParticipants will be strongly encouraged to come in irrespective of whether or not they need PrEP.\u003c/li\u003e\n \u003cli\u003eFor CAB-LA participants who fail to return within 7 days, a home visit will be conducted (if permission has been given and it is safe to do so). Once contacted, a study visit will be rescheduled as soon as possible. However, due to the risk associated with stopping CAB-LA without coverage for the tail period, participants in the CAB-LA arm will be followed up with further phone calls and a home visit (if permitted) following the 7-day period. If the participant indicates that they wish to withdraw from the study, then the withdrawal will be documented, with the reason for withdrawal noted if provided. If the participant is in the CAB-LA arm, the participant will be encouraged to take oral PrEP to cover the tail period and provided counselling on safe sex.\u0026nbsp;\u003c/li\u003e\n\u003c/ul\u003e\n\u003cp\u003eParticipants will not be considered lost to follow-up until the trial has ended, unless they have left the country with no plans to return, and with no means to ascertain HIV status. The date of loss to follow-up will be the date of their last study visit.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData management {19}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWherever possible, study data collected during clinic visits will be recorded directly into an electronic data capture system (REDCap). The data capture system will be programmed with quality control measures including range checks for quantitative variables. When direct data entry is not practical or is not available, the data will be recorded in a source document and will be transcribed into the electronic data capture system using double data entry within a reasonable timeframe. All electronic and non-electronic documents and forms will be kept securely. Full details of data management procedures are provided in the study Data Management Plan.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConfidentiality {27}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll data will be encrypted and stored on password-protected servers, which have Multi-Factor Authentication activated to ensure secure access control. Each participant will be assigned a unique project identity number (ID) for capturing and storing their data. Personal identifiers will not be stored in the study data set and all computers will be equipped with antivirus software and security passwords. Participant contact information will be kept separately from project documentation. While the study is in progress, study-related forms will be maintained in locked cabinets with access restricted to authorised personnel only. Upon study conclusion, these documents will be digitized, indexed, and stored indefinitely on the central server. The original paper documents will be destroyed.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for collection, laboratory evaluation and storage of biological specimens for genetic or molecular analysis in this trial/future use {33}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAt each visit, DBS will be taken and stored for future analysis of drug levels and HIV viral load. Furthermore, for individuals who acquire HIV during the study, blood will be taken for analysis including HIV viral load, resistance testing, drug levels and storage for future use.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical methods for primary and secondary outcomes {20a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe demographic, behavioural, and clinical characteristics of the two enrolled groups at baseline will be summarised, both overall and stratified by setting. All analyses will be done by intention-to-treat.\u003c/p\u003e\n\u003cp\u003eFor the primary user effectiveness outcome (persistence on PrEP during the randomised period), the odds ratio for persistence on PrEP comparing the two trial arms and a corresponding 95% confidence interval (CI), and p-value will be generated using logistic regression, adjusting for setting (as randomisation is stratified by setting). The same approach will be used for binary secondary outcomes. For persistence during the full follow-up period, which is a multinomial outcome, multinomial logistic regression will be used, adjusted for setting.\u003c/p\u003e\n\u003cp\u003eFor primary implementation outcomes, the odds ratio for uptake of PrEP comparing the two trial arms and a corresponding 95% CI, and p-value will be generated using logistic regression, adjusting for setting (as randomisation is stratified by setting). \u0026nbsp;Similarly, an odds ratio for the proportion who choose injectable compared to oral PrEP and a corresponding 95% CI, and p-value will be generated using logistic regression, adjusting for setting. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA full statistical analysis plan will be finalised before database lock and will include sensitivity analyses to assess the impact of each element of the primary effectiveness outcome (which is a composite outcome) on study findings, and to investigate a more flexible visit window for PrEP persistence.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eInterim analyses {21b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo formal interim analyses are planned. Interim data on protocol adherence and safety will be reviewed by an\u0026nbsp;independent data monitoring committee (IDMC) but no formal stopping guidelines are planned.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods for additional analyses (e.g. subgroup analyses) {20b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSubgroup analyses by study setting will be done to determine whether differences between trial arms are consistent across settings. These will be assessed by stratifying analyses by setting and testing for interaction.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary analysis population will be all randomized participants, regardless of protocol adherence or use of PrEP, with the exception that participants who are discontinued from receiving their allocated PrEP for medical reasons will not be included in the primary user effectiveness outcome analyses. No per-protocol analyses are planned. Participants who are lost to follow-up will be included in primary user effectiveness outcome analyses, as they will be considered as non-persistent on PrEP. If the proportion of participants with missing data is \u0026gt;10% then multiple imputation will be investigated, otherwise complete case analysis only will be used.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eQualitative data analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData analysis for the rapid ethnographic assessments will be done manually using the framework analysis approach [54]. Manual analysis enables the three site teams to manage a range of data which consists of notes from observations, sketch maps, interview and discussion group transcripts. \u0026nbsp;Themes will be shared and discussed across the sites to arrive at a shared coding framework. \u0026nbsp;Following the identification of themes, indexing (coding) and charting (cutting and pasting data according to thematic areas) will be done simultaneously at each site. Mapping (visual display of data) allows researchers to identify patterns, associations, and concepts, allowing descriptive and analytical memos to then be produced from these charts.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe will produce a short report to provide an overview for the wider study team on each community and we will also aim to write a short feedback flyer to share with the communities based on the same short report. \u0026nbsp;Once an initial report has been completed and summary findings shared with the participating communities\u003cstrong\u003e,\u003c/strong\u003e we will conduct a finer analysis of the data from the rapid ethnographic assessment, using a thematic content analysis \u0026ndash; the approach we will also use for the qualitative data collected during the trial from interviews and group discussions.\u003c/p\u003e\n\u003cp\u003eFor the qualitative data collected during the conduct of the trial from the IDIs and group discussions, we will again develop a shared coding framework, drawing from both the topic guides, learning from the rapid ethnographic assessments and new themes, which may come from the data collected. Analysis will be conducted by the site-specific research teams, and regular (electronic) meetings across the Ugandan and South African teams will support data interpretation. This will provide a more comprehensive understanding of men\u0026rsquo;s mobility and PrEP use across the trial groups and in the different settings/countries, as well as the acceptability and feasibility of the intervention. \u0026nbsp;Where required to support the analysis, data sharing between sites will only involve the sharing of anonymised data through a secure data enclave.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eHealth economics analysis\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCost analysis:\u003c/strong\u003e We will analyse the incremental financial and economic costs of implementing either intervention over routine care for these populations from the perspective of the provider, the South African or Ugandan government. Standard of care approaches to retaining people in care will be identified from routine government services for HIV in each recruiting country. Total and average cost per person retained at 3 and 6 months will be estimated from the perspective of the provider, and the public healthcare system in each country. Additionally, we will estimate PrEP coverage during periods of sexual activity. \u0026nbsp;We will calculate annualized capital and recurrent costs at facility and any other relevant implementation level. Non-annualized annual economic costs will be used to inform the budget impact for each country and inform governments and other relevant funders of the intervention\u0026rsquo;s affordability.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCost-effectiveness analysis:\u003c/strong\u003e We will combine results regarding the incremental cost from above and HIV Synthesis model outputs regarding the incremental number of infections averted, life-years saved and disability-adjusted life-years (DALYs) averted by each strategy (oral or injectable PrEP) over baseline (no scale up of PrEP) to calculate the incremental cost-effectiveness of each intervention, as well as the strategy of offering either intervention. The HIV Synthesis model will be fitted to epidemiological data to represent the current HIV epidemics in South Africa and Uganda and be parameterised and structured to account for important behavioural heterogeneity, including how behaviours and PrEP choices vary among cohort participants and within persons over time. The Synthesis model will be used to calculate costs over the long term, as well as life-years lost and DALYs, with costs and effectiveness calculated over a sufficiently long period to represent the difference in the main impacts between strategies, but at least over 20 years.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans to give access to the full protocol, participant level-data and statistical code {31c}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe full protocol, participant-level dataset, and statistical code will all be available upon request. Additionally, a metadata-only record will be created to catalogue the resources, including qualitative and quantitative data, codebooks, data dictionaries, algorithms, scripts, and research instruments such as questionnaires and interview guides. These resources will be archived in the LSHTM Data Compass (\u003ca href=\"https://datacompass.lshtm.ac.uk\" target=\"_new\"\u003ehttps://datacompass.lshtm.ac.uk\u003c/a\u003e), a curated digital repository designed to host materials that support the verification and reproduction of research findings. The study protocol is registered on ClinicalTrials.gov (NCT06133686) and the Pan-African Clinical Trials Registry (PACTR202409632006463).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eOversight and monitoring\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eComposition of the coordinating centre and trial steering committee {5d}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe trial management group (TMG)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial management group (TMG) comprises the chief Investigator, coordinating investigator, all investigators, representatives of ViiV Healthcare (Investigational Product providers), key trial site staff, and members of the MRC/UVRI and LSHTM Uganda Research Unit Trial Coordinating Centre. The TMG is responsible for the day-to-day running and management of the trial.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe trial management team (TMT)\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe trial management team (TMT) comprises the chief Investigator, coordinating investigator, trial statistician, other investigators (clinical and non-clinical) with operational coordination operational responsibilities, and members of the MRC/UVRI and LSHTM Uganda Research Unit Trial Coordinating Centre. The TMT is responsible for the overall management and coordination of the trial, including: protocol development, data management, laboratory coordination, regulatory and ethical compliance, procurement and supplies, maintaining the Trial Master File (TMF) and ensuring compliance with Good Clinical Practice (GCP), development of the Statistical Analytical Plan (SAP), and preparing reports for the IDMC.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe trial safety group (TSG)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe Trial Safety Group (TSG) comprises medically qualified members of the TMT who are not directly involved in the clinical management of trial participants. The TSG is responsible for: ensuring participant safety throughout the trial, evaluating all SAE reports and providing expert advice on further investigation and management, offering guidance on the clinical management of events affecting trial participants, reviewing updated safety data, including changes to the Summary of Product Characteristics (SmPC) for PrEP, and emergent safety reports from product providers, and determining the implications of new safety information on the trial.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe trial steering committee (TSC)\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe TSC comprises key study investigators, including representatives from each participating trial site, as well as independent researchers with expertise in HIV prevention and PrEP in sub-Saharan Africa. The TSC acts as an oversight body delegated by the sponsor, providing strategic guidance and ensuring the trial\u0026rsquo;s conduct aligns with its objectives. It provides advice through its independent chair to the Trial Management Team (TMT) and Trial Management Group (TMG) on all aspects of the trial. Members formally register their agreement to join the committee.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eThe independent data monitoring committee (IDMC) {21a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe IDMC is composed of experts in HIV prevention both internationally and in Africa. The main responsibility of the IDMC is to safeguard the interests of the trial participants and monitor safety and overall trial conduct. \u0026nbsp;The committee will review accumulating trial data and make recommendations to the TSC and the sponsor regarding trial modification, continuation, or termination. The IDMC members will formally sign an assent to join the IDMC and declare any competing interests. Further information regarding IDMC-specific responsibilities, terms of reference, meetings, and communication is detailed in the IDMC charter.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdverse event reporting and harms {22}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eInformation on AEs will be collected through an open question about health at study visits. Study staff will record the diagnosis or the symptoms if a diagnosis is not apparent, the date of onset and the date of resolution if appropriate. If the event is ongoing, it may be appropriate to conduct a symptom directed examination. Events will be graded according to the Division of AIDS (DAIDS) Table for Grading the Severity of Adult and Paediatric AEs version 2.1, July 2017 [55]. The relationship to CAB-LA or oral PrEP will be determined by the investigator. All this information will be recorded on the appropriate CRF. If the participant is unable to attend a safety follow-up visit for personal reasons, the interview may be conducted on the telephone or at a home visit if the participant is agreeable. Study staff will make every effort to follow AEs to resolution or stabilisation.\u0026nbsp;After the trial has closed and the database has been locked, additional information regarding SAEs that comes to the attention of the study staff will be reported by email to the Chief Investigator and study Sponsor.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFrequency and plans for auditing trial conduct {23}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRisk based monitoring will be implemented and conducted by the study sponsor designated monitors. Both onsite monitoring that involves an in-person evaluation of study conduct at the site and remote monitoring that involves relying on the site to provide the required information while using digital platforms will be undertaken. Site visits will occur starting with a Site Qualification Visit conducted prior to the study Site Initiation Visit (SIV). The SIV will be conducted prior to study start after all requisite ethical and regulatory approvals have been obtained. At each site, six interim monitoring visits will take place at 3-6 monthly intervals, with a combination of onsite and remote interim monitoring visits in keeping with the monitoring plan. Monitoring will also be based on the site risk review, upon which a remote or site visit may be conducted (triggered site monitoring visit). A close out monitoring visit will occur after the last participant\u0026rsquo;s last visit, data cleaning and investigational medicinal product inventory have been completed. Sites will be subject to audits should these be required by the Sponsor. Ethics and regulatory authority inspections will also be permitted. Appropriate consent for monitoring, audits and inspections will be obtained from the study participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePlans for communicating important protocol amendments to relevant parties (e.g. trial participants, ethical committees) {25}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAny changes to the protocol will be submitted to relevant ethics committees and regulatory authorities for review and approval. Where applicable, changes will be shared with trial participants through one-on-one interactions with trial staff during follow up visits. Amendments that result in changes to consent documents will require the re-consenting of trial participants. Relevant updates will be made to the trial registry in case of protocol amendments.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDissemination plans {31a}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA whole or part of this trial\u0026rsquo;s results will be communicated, orally presented, and/or published in appropriate scientific journals and at both local and international academic conferences. Full anonymity of participants\u0026rsquo; details will be maintained throughout. Participants can request a copy of the journal article that contains the results of the trial from the investigators once it has been published. Results will be disseminated to the participants in the study during a formal dissemination event that accommodates a question-and-answer session to support full understanding of the study results by the participants.\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eThis multi-country, mixed-methods study seeks to evaluate the effectiveness and acceptability of PrEP among men who are mobile for work in sub-Saharan Africa, a group at heightened risk for HIV acquisition. Through a hybrid implementation-effectiveness RCT, we will assess both ED oral PrEP and CAB-LA as flexible prevention options designed specifically to meet the needs of mobile men. The findings from this RCT, complemented by qualitative data, will help inform future PrEP delivery strategies tailored to this high-risk population.\u003c/p\u003e\n\u003cp\u003eThe study will gather critical insights through IDIs, group discussions, and qualitative surveys to understand how mobile men approach PrEP use. These qualitative methods will uncover practical challenges, preferences, and barriers, helping to shape PrEP interventions that align with the unique lifestyles and mobility patterns of men engaged in work-related travel.\u003c/p\u003e\n\u003cp\u003eIn South Africa, the trial will be conducted through mobile clinics, made possible by a paperless study system. A rapid ethnographic assessment provided key insights into each participating community, allowing the research team to anticipate and address potential operational challenges. This proactive planning ensured a smooth trial launch.\u003c/p\u003e\n\u003cp\u003eThe use of the RE-AIM framework in this trial provides a structured, comprehensive approach to evaluating the real-world implementation of both oral and injectable PrEP for mobile men in sub-Saharan Africa. By extending beyond clinical efficacy, the RE-AIM framework enables a real-world assessment of PrEP\u0026apos;s performance, identifying facilitators and barriers to access within mobile clinic settings. These insights will inform targeted adjustments in PrEP messaging, education, and delivery, ensuring they are tailored to the unique needs of mobile men. The RE-AIM framework enhances the study\u0026rsquo;s capacity to inform scalable and impactful HIV prevention strategies for this high-risk group.\u003c/p\u003e"},{"header":"Trial status","content":"\u003cp\u003eRecruitment commenced on 20 August 2024, at the Desmond Tutu HIV Foundation (DTHF) and on 10 September 2024 at the Africa Health Research Institute (AHRI) in South Africa. In Uganda, recruitment commenced on 16 October 2024. Recruitment in both countries concluded on 8 November 2024.The manuscript was submitted shortly after completion of trial recruitment; it was not submitted earlier due to the trial team focusing efforts on ensuring that the necessary ethical and regulatory approvals were in place to enable rapid trial initiation and participant enrolment. Participant follow-up and data collection is ongoing and expected to conclude by April 2026. The trial is being conducted under protocol version 3.0, dated 9 April 2024.\u0026nbsp;\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eAGYW\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eAdolescent girls and young women\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eKCL\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eKing\u0026rsquo;s College London\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eAHRI\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eAfrica Health Research Institute\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eLSHTM\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eLondon School of Hygiene \u0026amp; Tropical Medicine\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eAIDS\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eAcquired immunodeficiency syndrome\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eMRC\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eMedical Research Council\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eART\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eAntiretroviral therapy\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eRCT\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eRandomised controlled trial\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eBCM\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eBuffalo City Metro\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eSA\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eSouth Africa\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eBMI\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eBody mass index\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eSAE\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eSerious Adverse Event\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eBREC\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eBiomedical Research Ethics Committee\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eSAP\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eStatistical Analysis Plan\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eCAB-LA\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eCabotegravir \u0026nbsp; \u0026nbsp; long-acting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eSAPHRA\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eSouth Africa Health Products Regulatory Authority\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eCI\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eConfidence interval\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eSIV\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eSite Initiation Visit\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eCRF\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eCase report form\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eSMS\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eShort message service\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eDAIDS\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eDivision of AIDS\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eSQV\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eSite Qualification Visit\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eDBS\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eDry blood spot\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eSTD\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eSexually Transmitted Disease\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eDTHF\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eDesmond Tutu Health Foundation\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eTASP\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eTreatment as prevention\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eED\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eEvent-driven\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eTB\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eTuberculosis\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eEDCTP\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eEuropean and Developing Countries Clinical Trials Partnership\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eTDF\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eTenofovir disoproxil fumarate\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eEU\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eEuropean Union\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eTFV\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eTenofovir\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eFTC\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eEmtricitabine\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eTMF\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eTrial master file\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eGCP\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eGood clinical practice\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eTMG\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eTrial management group\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eHBV\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eHepatitis B virus\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eTMT\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eTrial management team\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eHIV\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eHuman immunodeficiency virus\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eTSC\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eTrial steering committee\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eHPTN\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003e\u003cem\u003eHIV Prevention Trials Network\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eUNAIDS\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eJoint United Nations Programme on HIV/AIDS\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eHREC\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eHuman Research Ethics Committee\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eUSA\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eUnited States of America\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eIDMC\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eIndependent Data Monitoring Committee\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eUVRI\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eUganda Virus Research Institute\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eIMP\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003eInvestigational medicinal product\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003eWHO\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003eWorld Health Organisation\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 254px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 70px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 233px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe would like to acknowledge the following:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDesmond Tutu Health Foundation DTHF, South Africa:\u0026nbsp;\u003c/strong\u003eLinda-Gail Bekker, Andrew Medina-Marino, Riaan Beukes, Annelize Louw, Keitumetse Lebelo, Yamkela Sapepa, Phezukonko Mndebele, Joanne Batting, Sipesihle (Mylo) Pitsha, Mbasa Njomane, Nsika Buxeka, Yamkela Mangwane, Sandisiwe Mema, Anathi Mkamfu, Uviwe Maglgas, Lwazi Ndzwayiba, Olwethu Sogoni, Ntombozuko Ngetu, Mzuvukile Mlunguzi, Neliswa Swartbooi, Valmy Craffert, Viwe Mpaka, Ngcobo Seluleko. E, Mkamfu Anathi, Malgas Uviwe, Mema Sandisiwe, Ndzwayiba Lwazi\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAfrican Health Research Institute AHRI, South Africa:\u0026nbsp;\u003c/strong\u003eLimakatso Lebina, Maryam Shahmanesh, Nonhlanhla Okesola, Anne Derache, Jaco Dreyer, Zizile Sikhosana, Lucky Mtolo, Nkosinathi Ngcobo, Thandeka Danisa, Carina Herbst, Nompilo Buthelezi, Mncedidi Ngubane, Thembeka Mtshali, Merab Lusweti, Thabang Manyaapelo, Xolani Ngwenya, Mpilonhle Nzuza, Zama Nxumalo,\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMRC/UVRI and LSHTM Uganda Research Unit, Uganda:\u0026nbsp;\u003c/strong\u003eEugene \u0026nbsp;Ruzagira, Bernadette Nayiga Kalanzi, Cissy Lillian Nalubega, Sylvia Kusemererwa, Martin Onyango, Shamim Ssendagire, Ayoub Kakande, Shamim Nabukenya, Paddy Kafeero L, \u0026nbsp; Namirembe Aeron, Naphtali Erima, Sophia Nakkazi Kakyama, Sylvia Masawi, Vincent Basajja, Joseph Kitumba, Florence Nambazira, Dora Jocelyn Mulondo, Joyce Nabunnya, Ayebazibwe Gloria Kakoba, \u0026nbsp; John Vianney Kagaba, Elizabeth Mbabazi Atuhuura, Margaret Nambooze, Grace Muyingo, Philip Kibuuka, Ivan Kisubika, Doreen Asio, Angel Nansere, \u0026nbsp;Henry Ssemaganda, Solomon Wasswa , Penelope Akankunda, Wilson Kakeeto, Mugagga Kyeyune, Phiona Nabaggala, \u0026nbsp;Dorothy Abigaba, Sarah Nakamanya, Martin Mbonye, Teddy Maria Ndagire, Richard Muhumuza, Esther Awino, Charles Ogwang, Samuel J Bengo and Geofrey Kimbugwe.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors’ contributions {31b}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eJF is the programme lead, ER the Chief Investigator, EW trial statistician, JS lead social scientist, MS lead implementation scientist, GMR lead health economist, LBM lead modeller. SK and BNK lead the drafting of the manuscript. SK, LGB and LL are site principal investigators. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding {3}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis project is funded by the European Union through the Horizon/EDCTP Global Health call for vulnerable adults (Project 101103140). Oral PrEP drugs for the trial were supplied by the Ministry of Health PrEP programs in South Africa and Uganda, while injectable CAB-LA was provided by ViiV Healthcare, which also contributed funding for trial insurance. The funders were not involved in the study design, data collection, analysis, interpretation, or manuscript preparation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials {29}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe original dataset will only be available to researchers directly involved in the study, and will be kept on secure, access-restricted servers. Anonymised data will, upon publication of the study, be made available upon reasonable request to the principal investigator.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate {24}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe protocol, informed consent forms, and other relevant documents were approved by the Uganda Virus Research Institute Research Ethics Committee (Reference number: GC/127/1002), Uganda National Council for Science and Technology (Reference number: HS4366ES), London School of Hygiene and Tropical Medicine Research Ethics Committee (Reference number: 31223) and National Drug Authority (Reference number: CTC 0276/2024) in Uganda, and the University of Cape Town Human Research Ethics Committee (Reference number: 803/2023), the University of KwaZulu-Natal Biomedical Research Ethics Committee (Reference number: BREC/000006454/2023) and South Africa Health Products Regulatory Authority (Reference number: 20231108) in South Africa. The Investigator will submit and, where necessary, obtain approval from the above parties for all substantial amendments to the original approved documents. This study will be conducted only in compliance with the most recent approved protocol and the ICH-GCP guidelines. \u0026nbsp;Informed consent will be obtained prior to conducting any study procedures.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication {32}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests {28}\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eFonner VA, Dalglish SL, Kennedy CE, Baggaley R, O\u0026rsquo;reilly KR, Koechlin FM, et al. Effectiveness and safety of oral HIV preexposure prophylaxis for all populations. Aids. 2016;30(12):1973-83.\u003c/li\u003e\n\u003cli\u003eWhat\u0026rsquo;s the 2+1+1? Event-driven oral pre-exposure prophylaxis to prevent HIV for men who have sex with men: Update to WHO\u0026rsquo;s recommendation on oral PrEP, (2019).\u003c/li\u003e\n\u003cli\u003eUNAIDS. The AIDS response in the 2030 agenda for sustainable development: joint work, shared gains | UNAIDS UNAIDS.org2024 [cited 2024 6 December ]. Available from:https://www.unaids.org/en/site-search#?cludoquery=the%20aids%20response%20in%20the%202030%20agenda%20for%20sustainable%2\u003cbr\u003e0development%3A%20joint%20work%20shared%20gains\u0026amp;cludopage=1\u0026amp;cludorefurl=https%3A\u003cbr\u003e%2F%2Fwww.unaids.org%2Fen%2FAIDS_SDGs\u0026amp;cludorefpt=The%20AIDS%20response%20in\u003cbr\u003e%20the%202030%20agenda%20for%20sustainable%20development%3A%20joint%20work%2C\u003cbr\u003e%20shared%20gains%20%7C%20UNAIDS\u0026amp;cludoinputtype=standard.\u003c/li\u003e\n\u003cli\u003eWorld Health Organization. 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Guidelines on long-acting injectable cabotegravir for HIV prevention. Geneva: World Health Organization; 2022.\u003c/li\u003e\n\u003cli\u003ePhilbin MM, Parish C, Kinnard EN, Reed SE, Kerrigan D, Alcaide ML, et al. Interest in long-acting injectable pre-exposure prophylaxis (LAI PrEP) among women in the women\u0026rsquo;s interagency HIV study (WIHS): a qualitative study across six cities in the United States. AIDS and Behavior. 2021;25:667-78.\u003c/li\u003e\n\u003cli\u003eSued O, Nardi N, Spadaccini L. Key population perceptions and opinions about long-acting antiretrovirals for prevention and treatment: a scoping review. Current Opinion in HIV and AIDS. 2022;17(3):145-61.\u003c/li\u003e\n\u003cli\u003eBazzi AR, Valasek CJ, Streuli SA, Vera CF, Harvey-Vera A, Philbin MM, et al. Long-acting injectable human immunodeficiency virus pre-exposure prophylaxis preferred over other modalities among people who inject drugs: Findings from a qualitative study in California. 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Predicted effects of the introduction of long-acting injectable cabotegravir pre-exposure prophylaxis in sub-Saharan Africa: a modelling study. The Lancet HIV. 2023;10(4):e254-e65.\u003c/li\u003e\n\u003cli\u003eNeilan AM, Landovitz RJ, Le MH, Grinsztejn B, Freedberg KA, McCauley M, et al. Cost-effectiveness of long-acting injectable HIV preexposure prophylaxis in the United States: a cost-effectiveness analysis. Annals of internal medicine. 2022;175(4):479-89.\u003c/li\u003e\n\u003cli\u003ePhillips AN, Bershteyn A, Revill P, Bansi-Matharu L, Kripke K, Boily M-C, et al. Cost-effectiveness of easy-access, risk-informed oral pre-exposure prophylaxis in HIV epidemics in sub-Saharan Africa: a modelling study. The Lancet HIV. 2022;9(5):e353-e62.\u003c/li\u003e\n\u003cli\u003eBond V, Ngwenya F, Murray E, Ngwenya N, Viljoen L, Gumede D, et al. Value and limitations of broad brush surveys used in community-randomized trials in Southern Africa. Qualitative health research. 2019;29(5):700-18.\u003c/li\u003e\n\u003cli\u003eKwena Z, Nakamanya S, Nanyonjo G, Okello E, Fast P, Ssetaala A, et al. Understanding mobility and sexual risk behaviour among women in fishing communities of Lake Victoria in East Africa: a qualitative study. BMC public health. 2020;20:1-10.\u003c/li\u003e\n\u003cli\u003eGlobal Data Lab. Subnational Human Development Index - South Africa [cited 2023 1 July]. Available from: https://globaldatalab.org/shdi/table/shdi/ZAF/.\u003c/li\u003e\n\u003cli\u003eSmits J, Permanyer I. The subnational human development database. Scientific data. 2019;6(1):1-15.\u003c/li\u003e\n\u003cli\u003eJohnson LF, Dorrington RE, Moolla H. Progress towards the 2020 targets for HIV diagnosis and antiretroviral treatment in South Africa. Southern African journal of HIV medicine. 2017;18(1):1-8.\u003c/li\u003e\n\u003cli\u003eThembisa version 4.6: National and Provincial Model Outputs. Thembisa. 2023 [Internet]. 2023 [cited 4 July 2023]. Available from: https://thembisa.org/content/downloadPage/ProvOutput4_6.\u003c/li\u003e\n\u003cli\u003eSimbayi L, Zuma K, Zungu N, Moyo S, Marinda E, Jooste S, et al. South African national HIV prevalence, incidence, behaviour and communication survey, 2017: towards achieving the UNAIDS 90-90-90 targets. 2019.\u003c/li\u003e\n\u003cli\u003eNglazi MD, van Schaik N, Kranzer K, Lawn SD, Wood R, Bekker L-G. An incentivized HIV counseling and testing program targeting hard-to-reach unemployed men in Cape Town, South Africa. Journal of acquired immune deficiency syndromes (1999). 2012;59(3):e28.\u003c/li\u003e\n\u003cli\u003eBaisley K, Seeley J, Siedner M, Koole K, Matthews P, Tanser F, et al. Findings from home‐based HIV testing and facilitated linkage after scale‐up of test and treat in rural South Africa: young people still missing. HIV medicine. 2019;20(10):704-8.\u003c/li\u003e\n\u003cli\u003eGareta D, Baisley K, Mngomezulu T, Smit T, Khoza T, Nxumalo S, et al. Cohort profile update: Africa Centre Demographic Information System (ACDIS) and population-based HIV survey. International journal of epidemiology. 2021;50(1):33-4.\u003c/li\u003e\n\u003cli\u003eBond V, Nel M, Simuyaba M, Chirwa T, Viljoen L, Chiti B, et al. The Broad-Brush Survey Approach. A set of methods for rapid qualitative community assessment. 2023.\u003c/li\u003e\n\u003cli\u003eReddy P, Buchanan D, Sifunda S, James S, Naidoo N. The role of community advisory boards in health research: Divergent views in the South African experience. Sahara-J: Journal of social aspects of HIV/AIDS. 2010;7(3).\u003c/li\u003e\n\u003cli\u003eStewart MK, Boateng B, Joosten Y, Burshell D, Broughton H, Calhoun K, et al. Community advisory boards: experiences and common practices of clinical and translational science award programs. Journal of Clinical and Translational Science. 2019;3(5):218-26.\u003c/li\u003e\n\u003cli\u003eDiallo DA, Doumbo OK, Plowe CV, Wellems TE, Emanuel EJ, Hurst SA. Community permission for medical research in developing countries. Clinical infectious diseases. 2005;41(2):255-9.\u003c/li\u003e\n\u003cli\u003eBond V, Chiti B, Hoddinott G, Reynolds L, Schaap A, Simuyaba M, et al. \u0026ldquo;The difference that makes a difference\u0026rdquo;: highlighting the role of variable contexts within an HIV Prevention Community Randomised Trial (HPTN 071/PopART) in 21 study communities in Zambia and South Africa. AIDS care. 2016;28(sup3):99-107.\u003c/li\u003e\n\u003cli\u003eGale NK, Heath G, Cameron E, Rashid S, Redwood S. Using the framework method for the analysis of qualitative data in multi-disciplinary health research. BMC medical research methodology. 2013;13:1-8.\u003c/li\u003e\n\u003cli\u003eDivision of AIDS (DAIDS) Table for Grading the Severity of Adult and Pediatric Adverse Events, (2017).\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":true,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"HIV, PrEP, long-acting cabotegravir, mobile populations, sub-Saharan Africa, men","lastPublishedDoi":"10.21203/rs.3.rs-5704553/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5704553/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Men who are mobile for work are a key population at high risk of acquiring HIV. Flexible pre-exposure prophylaxis (PrEP) options, including event-driven (ED) oral PrEP and long-acting injectable cabotegravir (CAB-LA), may offer increased access and acceptability for these men. However, limited data exist on the effectiveness and implementation of CAB-LA and ED PrEP among mobile men in Africa. Our study aims to assess the effectiveness and implementation of CAB-LA and oral Tenofovir disoproxil fumarate/emtricitabine (TDF/FTC) (both daily and ED) through comparison of uptake, retention in care, coital coverage, and participant choice.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e: We will conduct a mixed method, phase 3b, open-label, hybrid type 2 implementation and effectiveness randomized controlled trial (RCT). The trial will be carried out in 400 HIV negative men aged 18 years or older in South Africa and Uganda. Men will be randomized 1:1 to either Group A: oral TDF/FTC PrEP (ED or daily) or Group B: CAB-LA over 9-months. After 9 months, participants from both groups will be offered a choice of PrEP (oral TDF/FTC or CAB-LA) for a further 9 months, with the ability to change their choice as required. Various strategies to support PrEP adoption, initiation, and persistence will be implemented, monitored, and reported on using a RE-AIM (Reach, Effectiveness, Adoption, Implementation, and Maintenance) implementation science framework.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e: This study will provide critical data to inform scalable delivery models for both oral and injectable PrEP among mobile men at high risk for HIV acquisition. Findings will also highlight the potential of PrEP choice delivery and its benefits, offering evidence for governments to consider in the roll out of injectable PrEP in public health systems.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTrial registration\u003c/strong\u003e: NCT06133686, registered 14 November 2023.\u003c/p\u003e\n\u003cp\u003ePACTR202409632006463, registered on 2 September 2024\u003c/p\u003e","manuscriptTitle":"Implementing oral (event-driven and daily) and long-acting pre-exposure prophylaxis in mobile men in Sub-Saharan Africa: a phase 3b, open-label, hybrid type 2 implementation and effectiveness trial (MOBILE MEN)","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-08-27 06:15:31","doi":"10.21203/rs.3.rs-5704553/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"decision","content":"Minor revision","date":"2025-08-29T17:35:44+00:00","index":"","fulltext":""},{"type":"reviewerAgreed","content":"","date":"2025-08-17T00:18:10+00:00","index":0,"fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-16T18:42:00+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"Trials","date":"2025-03-04T11:09:56+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-03-02T07:41:45+00:00","index":"","fulltext":""},{"type":"submitted","content":"Trials","date":"2025-02-27T03:57:16+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"trials","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"trls","sideBox":"Learn more about [Trials](http://trialsjournal.biomedcentral.com/)","snPcode":"13063","submissionUrl":"https://www.editorialmanager.com/trls","title":"Trials","twitterHandle":"MedicalEvidence","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"em","reportingPortfolio":"BMC/SO AJ","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"3bba539a-4e05-400b-8bec-be78d2e24904","owner":[],"postedDate":"August 27th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[],"tags":[],"updatedAt":"2025-11-17T16:01:57+00:00","versionOfRecord":{"articleIdentity":"rs-5704553","link":"https://doi.org/10.1186/s13063-025-09138-5","journal":{"identity":"trials","isVorOnly":false,"title":"Trials"},"publishedOn":"2025-11-10 15:58:00","publishedOnDateReadable":"November 10th, 2025"},"versionCreatedAt":"2025-08-27 06:15:31","video":"","vorDoi":"10.1186/s13063-025-09138-5","vorDoiUrl":"https://doi.org/10.1186/s13063-025-09138-5","workflowStages":[]},"version":"v1","identity":"rs-5704553","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5704553","identity":"rs-5704553","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}