Impact of integrated community-based HIV and sexual and reproductive health services for youth aged 16-24 years on population-level HIV outcomes in Zimbabwe: the CHIEDZA cluster randomized trial

Impact of integrated community-based HIV and sexual and reproductive health services for youth aged 16-24 years on population-level HIV outcomes in Zimbabwe: the CHIEDZA cluster randomized trial | 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 Article Impact of integrated community-based HIV and sexual and reproductive health services for youth aged 16-24 years on population-level HIV outcomes in Zimbabwe: the CHIEDZA cluster randomized trial Rashida Ferrand, Ethel Dauya, Chido Dziva Chikwari, Tsitsi Bandason This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-5594349/v1 This work is licensed under a CC BY 4.0 License Status: Published Journal Publication published 24 Jun, 2025 Read the published version in Nature Medicine → Version 1 posted You are reading this latest preprint version Abstract We conducted a cluster randomized trial of community-based services incorporating HIV testing, treatment and adherence support integrated with sexual and reproductive health services for youth (16-24years) in Zimbabwe . 24 clusters were randomized 1:1 to intervention or control (existing services only). Primary outcome was virological suppression (VS=viral load<1000copies/ml) among youth living with HIV (YLWH), ascertained through a population-level outcome survey of 17,682 youth (18-24years). Secondary outcomes corresponded to UNAIDS 90-90-90 targets. There was no difference by arm in primary outcome (mean cluster prevalence:41.3% (intervention) vs 38.3% (control); RR:1.07 (95%CI:0.88-1.30)), or in proportion of YLWH who were diagnosed. In the intervention arm, a lower proportion of diagnosed YLWH were taking treatment (RR=0.91 (95%CI:0.83-0.99)), but a higher proportion of those taking treatment had VS (RR=1.18 (95%CI:1.02-1.37)). The intervention did not impact proportion of youth with undiagnosed HIV, which explains the effect on primary outcome. Among those taking ART, the intervention improved VS. Health sciences/Medical research/Epidemiology Scientific community and society/Developing world Figures Figure 1 Figure 2 Introduction The general global decline in new HIV infections has been much less marked in youth. In 2019, 30% of HIV infections in eastern and southern Africa occurred among women aged 15–24 years. 1 Compared to other age-groups, youth living with HIV are less likely to be diagnosed and those diagnosed have lower rates of HIV viral suppression once they start antiretroviral therapy (ART). 2 HIV testing is a prerequisite for accessing care or prevention services. Population-based surveys from sub-Saharan Africa, where two-thirds of the world’s population with HIV lives, show a substantial burden of undiagnosed HIV infection among youth. Only 52%, 48% and 45% of those aged 15–24 years in Zimbabwe, Malawi and Zambia respectively reported ever having an HIV test in Population HIV Impact Assessments (PHIAs) conducted between 2015–2017. 3 – 5 In these countries, it was estimated that only 40–50% of 15–24-year-olds living with HIV were aware of their HIV status compared with 66–73% of those aged > 24 years. Similarly, HIV viral load suppression among youth taking ART was significantly lower than among older people. Youth are therefore a priority group to achieve HIV control. 6 , 7 Viral non-suppression is associated not only with morbidity but with increased risk of onward HIV transmission. Youth face personal, social, legal, and structural barriers to access HIV services. 8 Stigma remains much more pronounced for youth because HIV is often associated with taboo behaviours and promiscuity. 9 There remain legal constraints with a requirement for consent from guardians to access HIV services, with a varying age threshold for this requirement that can be as high as 18 years in some countries for independent consent. 10 , 11 Existing HIV services are mostly verticalized and facility-based, and often not geared to address the particular needs of youth. For example, there remains a large unmet need and demand for sexual and reproductive health (SRH) services among youth, including those who are living with HIV, 12 but provision of these alongside HIV prevention and/or care programmes remains the exception rather than the rule. 9 , 13 In addition, judgemental provider attitudes result in poor engagement. 9 , 12 Achieving improved HIV outcomes requires that both supply and demand side barriers be addressed. As HIV services are often not a priority for youth, we hypothesized that integrating the provision of SRH services and HIV services would act as a ‘hook’ and increase uptake. In addition, such a service model, particularly if configured to be youth-friendly could facilitate engagement, be more acceptable, and potentially lead to improved programmatic efficiency. 14 We conducted a trial (CHIEDZA) in Zimbabwe to investigate the impact on population-level HIV outcomes of community-based HIV testing, treatment and adherence support integrated with comprehensive SRH services and general health counselling for youth aged 16–24 years. Our rationale was that services situated within communities may be more accessible for youth, 15 and addressing the whole HIV cascade including HIV testing, linkage to care and support to maintain viral suppression may minimise the risk of attrition at each step. Results The deployment of the intervention across the provinces was staggered, with implementation starting in April 2019 in Harare, July 2019 in Bulawayo and October 2019 in Mashonaland East. The uptake of the different CHIEDZA service components including HIV testing, and HIV virological suppression (VS) among CHIEDZA attendees who were living with HIV, are reported separately. 16 17 Briefly, 36991 youths accessed the CHIEDZA intervention over the 30-month period. Overall, 84.1% of those eligible had at least one HIV test, resulting in 38,603 HIV tests by 29,826 youth, of which 377 were positive (prevalence of newly diagnosed HIV 1.3%). In addition, 1162 youth accessing CHIEDZA services self-reported being HIV positive. 17 Outcome survey participant characteristics The outcome survey was conducted between October 2021 and June 2022. In total, 18721 youth aged 18-24 years resident in households in the randomly selected road segments were enumerated of whom 17682 (94.5%) were eligible, gave consent and were enrolled (Figure 1). Males and older individuals were less likely to be enrolled (Supplementary Table 1). Of those enrolled, 130 (0.7%) were excluded from analysis of the primary outcome due to missing data leaving 17552 (Figure 1). Overall, 60.8% of participants were female and the median age was 20 (IQR 19-22) years. The two arms were balanced with respect to socio-demographic characteristics (Table 1). In total, 1200 participants had a positive HIV test result on their DBS and an additional 26 participants were categorised as HIV-positive based on their self-report although their DBS test result was negative (20), indeterminate (4) or missing (2). A higher proportion in the intervention than control arm reported having ever had an HIV test (71.1% vs 66.1%, p=0.016) and knowing their HIV status (68.5% vs 63.1%, p=0.057). The difference by arm was more pronounced for those who had tested for HIV in the past 12 months (44.4% (intervention) vs 34.7% (control), p<0.001). The HIV prevalence was 6.2% and 7.8% in intervention and control arms respectively, giving a much larger sample size of YLWH than the expected 21 per cluster based on an anticipated HIV prevalence of 3%. Participants were defined as having an HIV diagnosis if they self-reported as HIV positive (N=435), or if ART drugs were detected in their sample (N=211). Youth living with HIV (YLWH) with an HIV diagnosis were defined as on ART if they self-reported as such (N=386) or if ART drugs were detected N=211) (Figure 2). Notably, of 1226 YLWH overall, 576 (47.0%) were undiagnosed. Out of 791 YLWH who self-reported as negative or of unknown status, 215 (27.2%) had ARVs detected in their blood sample while 294 were not tested for ARVs due to high viral load. Trial outcomes There was no difference by arm in the primary outcome i.e. the proportion of YLWH who had VS (41.3% vs 38.3%, RR 1.07 (95% CI 0.88-1.30). There was also no difference by am in the proportion of YLWH who had an HIV diagnosis (51.6% vs 51.5%, RR 0.99 (95% CI 0.76-1.28) (Table 2). In the intervention arm a lower proportion of diagnosed YLWH were taking ART (87.3% vs 96.3%, RR=0.91 (95%CI 0.83-0.99) but a higher proportion of those taking ART were virally suppressed (62.7% vs 52.6%, RR=1.19 (95% CI 1.02-1.39). When stratified by age and sex, there were no differences by arm in the primary outcome (Table 3). There was also no significant interaction between study arm and age or sex for any of the secondary outcomes (Table 3). Three participants had indeterminate HIV test result and did not self-report as HIV positive. In a sensitivity analysis in which they were coded as HIV positive and virally suppressed, results were similar to the primary analysis. Among a sub-group of participants who resided less than the median distance from the community centers from which CHIEDZA services were or would be delivered and who had lived in the clusters for more than two years, the risk ratio for the primary outcome in the intervention vs the control arm was higher, but did not reach statistical significance (Supplementary Table 2). Intervention coverage Based on the estimated population of youth aged 18-24 years in intervention clusters (as estimated from the enumeration in the prevalence survey) and the number of clients who accessed the intervention and would have been the right age for the survey, the intervention coverage would have been approximately 75% of eligible cluster residents (Supplementary Table 2). However, actual reported intervention coverage (proportion of outcome survey participants who reported accessing the intervention in the intervention clusters) was only 23.5% (Supplementary Table 3). Intervention effects among those who accessed the intervention In a Complier Average Causal Effect (CACE) analysis, corresponding to the primary analysis, there was no difference between arms in the primary outcome or in the proportion of YLWH who had an HIV diagnosis (Supplementary Table 4). A model of the proportion of diagnosed YLWH taking ART failed to converge. Among those taking ART, there was evidence of a higher prevalence of viral suppression in the intervention than in the control arm RR=3.85 (95% CI 1.56, 9.54)). There was little difference between results using the models that used two compliance predictor variables and models that used six (Supplementary Table 4). Discussion Delivery of community-based HIV services covering the whole HIV care cascade including HIV testing and treatment and adherence support, integrated with comprehensive SRH services for youth, had no impact on population-level HIV viral suppression among youth living with HIV, the primary outcome. The starting point for the trial was that existing strategies have not been sufficient to address the disproportionately worse HIV outcomes in youth compared to other age-groups. Achieving viral suppression requires an individual to access HIV testing, link to HIV care services and initiate and maintain adherence to ART. The CHIEDZA intervention addressed each of these steps (often termed the HIV care cascade), and the combined effect across all these steps was assessed by the primary outcome (proportion of youth with HIV who were virally suppressed). The individual effects on each step of the HIV care cascade were assessed in the secondary outcomes, reflecting the UNAIDS 90-90-90 targets. 18 CHIEDZA achieved high levels of HIV testing among those who attended CHIEDZA with 84% having at least one HIV test. 19 This translated into a population-level impact on HIV testing (ever tested and testing in the past 12 months) and knowledge of HIV status. This is consistent with findings of the Yathu Yathu trial in Zambia which also offered HIV testing together with SRH services in community hubs to youth and reported substantially increased uptake of HIV testing particularly among adolescent boys aged 15-19 years. 20 While HIV testing is a critical first step to accessing HIV treatment, it is also an entry point to HIV prevention services. 8 In addition, engaging with HIV testing once may help overcome anxiety and fear and potentially promote more regular subsequent HIV testing. However, there was no observed difference by arm in the proportion of YLWH who were diagnosed (the first step of the HIV care cascade and one of the secondary outcomes), which likely explains the lack of effect of the intervention on the primary outcome. There are a number of likely reasons for this. Firstly, over the past decade there has been a scale-up of a range of HIV testing approaches, including the large-scale HIV Self-testing Africa Initiative (STAR) first launched in Zimbabwe, Malawi and Zambia, 21,22 and this may have diluted any difference between intervention and control clusters. Secondly, the effect of the intervention on outcomes was critically dependent not only the intervention itself but also on coverage, given that outcomes were measured at population-level. We have also shown that both knowledge and utilisation of CHIEDZA services correlated strongly with distance from community centres. 23 Also, intervention coverage may have been compromised by high in- and out- migration among youth. One in four survey participants had been resident in their study community for less than 12 months, and therefore had limited exposure to the intervention. We observed a substantial difference between the proportion of participants in the intervention arm who reported accessing the intervention and the estimated coverage based on the number of attendees as a proportion of the estimated population of youth in the intervention communities (based on estimates obtained through enumeration). It is therefore possible that while the intervention achieved higher coverage than the 23.5% reported, many individuals who had attended the intervention had subsequently migrated out from the intervention communities. Furthermore, it is possible that individuals who were temporarily or not resident in the clusters, for example those who resided in neighbouring areas may have accessed the intervention. While attendees were asked about their age and address, we relied on attendees’ self-report to confirm eligibility. Such attendees were not necessarily from the control clusters which were separated by significant geographical boundaries (such as rivers, major roads) and with sufficient distance between them to avoid contamination. 24 Indeed, contamination (i.e. individuals resident in control clusters accessing CHIEDZA services) was found to be very low (approximately 3%), when ascertained by comparing the proportion of fingerprint matches of survey participants from the control clusters with those of intervention attendees. 23 Overall, this meant that the participants in the outcome survey were not necessarily representative of individuals who had been exposed to the intervention. In the exploratory subgroup analysis among those who had lived longer in the clusters (longer exposure to intervention) and lived closer to the community centres, a stronger effect of the intervention on the primary outcome was observed, although the effect was not statistically significant. Thirdly, despite the intervention being configured to address the well-recognised demand and supply barriers to HIV testing in youth, it is likely that those at highest risk of being HIV-positive were not reached either because they did not access the CHIEDZA services or did not take up HIV testing if they attended. Consistent with Wasserheit and Aral’s theory of phase specific dynamics of transmission of sexually transmitted infections, as the HIV incidence declines and preventive interventions are established, the sexual and social networks that drive the epidemic become increasingly located within subpopulations that are characterised by higher risk behaviours and less contact with health care services. 25 The proportion of YLWH who were on ART (coverage of ART) was high in both trial arms, suggesting that current ART services are performing well for youth who know their HIV-positive status and link to care. ART coverage in our population-based survey was higher than that reported in the 2020 Population-based Impact Assessment which could reflect overall improved access to ART over time. 26 The proportion of YLWH (aware of their HIV status) accessing ART in the intervention arm was lower than that in the control arm. The CHIEDZA intervention provided not just testing but also registration into the ART programme, initiation of ART and follow-up care including adherence support for the duration of the intervention. However, the service was available only once-weekly and therefore not at the same frequency as clinic-based services (5-6 days/week). Also, despite counselling, some youth were not yet ready to start ART, which the providers respected. 16 Providers were trained in provision of youth-friendly services with autonomy and choice being a key aspect. Mobility may also have adversely affected linkage to care. However, this highlights one of many challenges of provision of HIV treatment to youth. 27,28 The proportion virologically suppressed fell far short of the UNAIDS 90-90-90 targets in both arms. The challenges of adherence among young people are well-recognised, 29 and the PHIAs in the region shown much lower levels of VS among youth compared to other age-groups. 3-5 Notably, among those YLWH taking ART, the proportion who were virally suppressed was higher in the intervention than in the control arm. In a CACE analysis in which outcomes were compared among those who accessed the intervention, the risk of VS among YLWH on ART was more than 3.5 times higher in the intervention than in the control arm, suggesting that the intervention may have been effective in supporting adherence to ART. This was likely due to the multi-modal approach used to support adherence including follow-up by providers of those who did not attend for ART refills, specialist counselling and a peer support group. A community-based service model such as CHIEDZA could be an effective approach to complement existing HIV treatment services, providing support for adherence and even support transition to adult-centred care, while providing holistic health services. While the principal objectives were centred around impact on HIV outcomes, the CHIEDZA trial provides strong evidence of the feasibility of delivering integrated HIV and SRH services to all youth, a group that is often under-served by existing health services. The CHIEDZA service model facilitated uptake of essential services beyond HIV by youth, and addressed an important programmatic gap. 17 Co-designed and co-delivered with youth, it was highly effective in engaging youth- a group that has hitherto been hard to engage. 30 Results from an embedded process evaluation (reported separately) showed that the uptake of other services was very high and the service model was highly acceptable to youth. 31 The model therefore provides a practical template for provision of youth-friendly services. The model complemented, not duplicated, existing facility-based services, was responsive to context, and promote a holistic approach to service delivery, which while being acceptable to users may also be programmatically more efficient. Notably, CHIEDZA services were considered “critical” and were selectively endorsed by health authorities to remain open during the COVID-19 pandemic lockdown periods, with operational modifications. An ongoing cost analysis will inform scalability. Such a model offers the potential of incorporating other services such as mental health disorders and substance use, which are not only major causes of morbidity among youth but are also associated with increased risk of HIV infection and worse HIV treatment outcomes. 32,33 The strengths of the study were the use of an objective biological primary outcome that captured the combined effect across every step of the HIV care cascade including testing and linkage to and adherence to treatment, with secondary outcomes assessing individual steps. The outcome was assessed at population level and has strong public health relevance, both in terms of impact on individual health outcomes and potentially on HIV transmission given the overwhelming body of evidence that those who are virally suppressed cannot sexually transmit HIV (Undetectable=Untransmittable or “U=U”). 34 The study was well-powered, and high participation rates were achieved in the outcome survey. Studies relying solely on self-report may underestimate the proportion of YLWH who know their status. It is notable that ARVS were detected in 215 YLWH who reported that they were HIV negative or did not know their status, suggesting that they did in fact know their HIV positive status and were on treatment. ARV levels were incorporated into our diagnostic algorithm alongside self-report to obtain a more objective measure of knowledge of HIV status. We acknowledge several limitations. The trial was conducted in urban and peri-urban settings only as population densities in rural areas are low, making a trial of this magnitude unfeasible. Knowledge of HIV status relied partly on self-report which is subject to social desirability bias, and may have resulted in an over-estimate of the proportion of undiagnosed HIV among YLWH. We did undertake testing of samples for ART levels in those with a viral load of <10,000copies/ml who did not self-report as being HIV-positive. It is however possible that a proportion of those with higher viral loads who did not self-report being HIV-positive knew their status and were taking ART. There was a 60:40 female to male ratio in the outcome survey. While we note that the rate of participation by males was lower than for females, data from the enumeration carried out by the Zimbabwe PHIA in similar areas suggests that this proportion reflects the distribution of females to males in these communities. 26 This was complemented by findings from focus group discussions conducted with study communities reporting that there are fewer men due to outmigration for employment from urban centres either to neighbouring countries or to agricultural or mining areas. 35 Implementation of the intervention coincided with the COVID-19 pandemic which resulted in shutdown of the intervention for two months This as well as the subsequent modification of the intervention likely adversely affected engagement and intervention uptake, particularly among young men. 36 In addition, out-migration may have increased due to the adverse socio-economic consequences of the pandemic. In summary, there was no effect of the trial intervention on viral suppression among YLWH at population level, but among those that were diagnosed and accessing ART, the intervention significantly improved viral load suppression. Nearly 50% of YLWH remained undiagnosed and were not reached even by services that aimed to address many of the well-known demand and supply barriers to accessing health services. This group needs to be characterised to identify more nuanced strategies for reaching and engaging them, including in HIV care once diagnosed. Innovative and flexible approaches will need to be explored for example use of electronic technologies to provide health-related services and information or ART pick-up points, for youth who are mobile. While community-based settings may overcome some of the demand-side barriers to service provision, mapping and situating services in non-traditional settings that youth frequent such as educational institutions and settings where youth socialise may be needed to improve access. This will need to be coupled with ongoing efforts to address community-level stigma and configuring services to be youth-friendly. Declarations Funding The study was funded by the Wellcome Trust through a Senior Fellowship in Clinical Science to RAF (Grant no 206316/Z/17/Z). Funding to support the menstrual hygiene aspects was provided by the Swiss Development Corporation. Delivery of SMS messaging was supported by the Charlize Theron Africa Outreach Project. Contributors RAF and RJH conceptualised the study. CM, CDC, ED, MT, SB, KK, and RAF developed the intervention with input from OM. CMY, CM, MT, and SB conducted the process evaluation of the intervention. RAF, ED, and CDC coordinated the trial. TB and VS were responsible for data management. VS analysed the data with input from KK, RJH, CDC, and RAF. OM advised on intervention deployment and implementation and facilitated modifications during COVID-19 lockdowns. All authors contributed to writing the report and have seen and approved the final draft. Data Availability Data presented in this manuscript will be made available via LSHTM Data Compass at the time of publication. Requests for data should be sent to the corresponding author. Acknowledgments We thank all participants, the CHIEDZA intervention providers and Trial Steering Committee members. We thank Tino Mavimba for designing the intervention materials and for leading the community engagement initiatives. Methods Study design and setting CHIEDZA was a parallel open-label two-arm cluster randomized trial (CRT) conducted across three provinces in Zimbabwe (Harare, Bulawayo, and Mashonaland East). Zimbabwe has experienced an early-onset, sustained generalised HIV epidemic with an HIV prevalence of 11.8% in 2020 among adults aged 15-49 years. 26 Harare is the capital and largest city in Zimbabwe and the population is predominantly of Shona ethnicity; Bulawayo, the second largest city in the country, is situated 440kms from Harare, and is predominantly Ndebele. Mashonaland East province borders Harare and peri-urban settings in this province were selected. In combination, these provinces represented the country’s two main ethnic groups. A cluster design was used as the intervention was a service which could not be assessed at the level of the individual. A cluster was defined as a geographically demarcated area with an estimated population of approximately 2000–4000 youth aged 16–24 years (based on Zimbabwe 2012 Census estimates 37 ) that contained a multi-purpose community centre from which the intervention could be delivered. A cluster had to be serviced by a defined primary care clinic that was not serving another study cluster and was situated within the cluster to ensure integration and collaboration with public-sector services. Where possible, natural boundaries were used to form the edge of the cluster to minimise contamination. Individuals aged between 16–24 years and who lived within the boundaries of an intervention cluster were eligible to access the intervention. Those who were ineligible i.e. self-reported being outside the eligible age-range or living outside the cluster boundaries were advised to access services at the nearest health facility. Randomization and masking A total of 24 clusters, stratified by province, were randomized in a 1:1 allocation ratio to either the control arm or the intervention arm, so that each province had four intervention and four control clusters. A public randomization ceremony was performed in each province, with representatives of the community, the Ministry of Health and Child Care (MoHCC) and respective City Health or town council health departments, to ensure transparency and buy-in from stakeholders. Within each province, coloured balls were drawn from a bag to allocate each cluster to a trial arm. Given the nature of the intervention, it was not possible to mask either investigators or study communities. Intervention design and implementation The intervention was co-designed with relevant stakeholders including youth and community members (who often serve as gatekeepers to young people accessing services), service providers and policy makers. 30 A key feature of the intervention design process (reported separately) was to centre youth: participatory workshops were held with youth to achieve consensus on the intervention’s content and configuration including the types of services, location of service delivery, types of service providers and the “branding” of the service. 30 The trial intervention and the logic model showing how the intervention was intended to achieve its intended effects are described in detail in the published trial protocol. 24 In brief a package of integrated HIV and SRH services was delivered in each intervention cluster. Services included HIV testing - either provider-delivered using a blood-based test or self-testing on site using an oral mucosal test. Those who tested HIV-positive or had previously tested HIV-positive but were not linked to care were offered a choice of receiving HIV care from the CHIEDZA service including ART initiation and drug refills, adherence counselling, viral load monitoring and membership of a peer support group, or linkage to HIV care at the nearest health facility. Youth who were already in HIV care elsewhere could also opt to receive any of these services from CHIEDZA. Other services included advice and information on menstrual health and provision of analgesics and reusable menstrual products, pregnancy testing, family planning information, counselling, a choice of short and long-acting contraceptives and emergency contraception, termination of pregnancy, syndromic management of sexually transmitted infections following national guidelines, expedited referral for voluntary male medical circumcision, condoms and HIV risk reduction counselling, and general health counselling with onward referral to other health service providers for relevant care where appropriate e.g. mental health issues or intimate partner violence. Information, education, and counselling materials about SRH, HIV and general health issues were available in the form of video clips, a health manual available at the centres and online, and a series of short evidence-based SMS messages. 38 All CHIEDZA resources can be found at https://www.chiedza.co.zw/resources. All services were voluntary (clients could choose whichever services they wanted from a menu card) and free-of-cost. Tents were pitched within the community centre, each of which served as a private consultation area. Confidentiality was a key aspect of the intervention and therefore only age, sex and the service component(s) taken up were recorded for each client who accessed the intervention. Clients were registered using a fingerprint which was converted into a Global Unique Identification number using SIPMRINTS software (SIMPRINTS, Cambridge, UK). Fingerprints were used to record every attendance and track service uptake. The intervention was configured to be “youth friendly” i.e. able to effectively attract youth, meet their needs responsively and retain them in care. Social activities incorporating music, drama, dance, sport and games were held at community centres to increase their engagement with the intervention. A key barrier to youth accessing services is healthcare provider attitudes and therefore ongoing training, supervision and mentorship of providers was an integral component of the intervention, as was community engagement. This included sensitisation and peer outreach at locations frequented by youth including secondary schools. Activities included flyer distribution, information dissemination, and in-field live demonstrations of CHIEDZA products (e.g. reusable pads, menstrual cups, and condoms) to educate, generate support and strengthen community engagement. Services were provided once weekly on the same day every week in each cluster, except for public holidays by a multi-disciplinary team that included two nurses, four community health workers (CHWs), one counsellor and two youth workers. Youth workers provided group education including product demonstrations, information about menstrual products etc, registered the clients, organised social activities and were available for informal conversations with clients. CHWs and nurses undertook consultations and nurses also performed clinical examinations and dispensed ART and contraception. A doctor was available on the phone to provide specialist advice where required. The intervention teams underwent a two-week a structured training programme. Additional training to manage LGBQTI+ youth or youth with disabilities was also provided. Debrief meetings were held every 1-2 months whereby challenging consultations and situations were discussed and refresher training was provided. During the implementation period, the intervention was stopped from April to June 2020 in response to the Coronavirus Disease 2019 (COVID-19) pandemic. When service delivery restarted, the intervention was modified as follows: face masks and handwashing were mandatory and the number of individuals present at the community centre at any time point was restricted, opening hours were shortened and all social activities, group health information sessions and community mobilisation activities were stopped. The effects of these adaptations have been reported previously. 36,39 Originally, a 24-month intervention period was anticipated to achieve optimal coverage within a cluster. An extension of six months was added to mitigate against the effects of the COVID-19-related national control measures including physical distancing, orders to stay home where possible, and restrictions on public gatherings. The start date of the intervention was staggered across provinces by three months with Harare province starting first, followed by Bulawayo, followed by Mashonaland East. Other than mapping existing health services (largely facility-based) before trial implementation, the study team delivered no services in the control arm. Trial outcomes Trial outcomes were measured at population level. The primary outcome was the proportion of youth living with HIV (YLWH) who were virally suppressed (defined as having an HIV viral load <1000 copies/ml). The secondary outcomes, reflecting the UNAIDS 90-90-90 targets, were proportion of YLWH who knew their HIV status, proportion of YLWH who knew their HIV status who were taking ART, and proportion of YLWH taking ART who were virally suppressed, and enabled assessment of the intervention on each step of the HIV care cascade. YLWH were defined as knowing their status if they self-reported as HIV positive or if ARVs were detected. YLWH were defined as taking ART if they self-reported as taking it or if ARVs were detected (see ascertainment of trial outcomes). YLWH were defined as virally suppressed if their viral load was <1000 copies/ml, and those who did not have a viral load result were excluded from this outcome. Ascertainment of trial outcomes Outcomes were ascertained through a population-based cross-sectional survey conducted among 18–24-year-olds living in the study clusters at the end of the 30-months intervention period. This age-group was chosen to ensure maximal exposure to the intervention. Surveys were conducted in the eight trial clusters in each province over a three-month period, and the start date of the survey in each province was staggered, reflecting the staggered start date of the intervention. 24 The sampling methodology for the outcome survey combined remote selection methodologies incorporating satellite imagery and traditional random street selection. All streets within a cluster were manually split into 100—300 metre segments within GIS software (ArcGIS version 10.5), which were then randomly selected. Following community sensitisation, all households (defined as a person or group of related or unrelated persons who live together in the same dwelling or unit(s) of a dwelling, who acknowledge one male or female as head of the household, who share the same housekeeping arrangements, and who are considered a single unit) in each dwelling in the selected street segments were enumerated. All individuals aged 18–24 years residing in the enumerated households were eligible to participate. If a potentially eligible individual was not available at the time of enumeration, up to three repeat visits were made to enrol the individual. A fingerprint was collected from each participant (as for the intervention). An interviewer-administered questionnaire was used to record sociodemographic data, duration of residence and exposure to the intervention. Participants were asked about knowledge of HIV status, history of HIV testing and care. A DBS sample was collected for anonymised HIV antibody testing and HIV viral load testing (for those who were HIV antibody positive) and for ARV testing (in selected samples). Dried blood spot (DBS) samples from all YLWH who did not self-report as living with HIV and who had a viral load less than 10,000 copies/ml were tested using LC-MS/MS quantification for the presence of antiretroviral drugs (ARVs): efavirenz, atazanavir, ritonavir, nevirapine, abacavir, lamivudine, zidovudine and dolutegravir. Due to resource constraints, a pragmatic cut-off of 10,000copies/ml was used to indicate testing for ARVs and higher viral loads were assumed to indicate no treatment being taken. Participants were defined as ‘ARVs detected’ if at least one ARV was detected, with the exception of lamivudine and efavirenz. If only efavirenz (N=70) or lamivudine (N=4) were detected, the participants were not defined as ‘ARVs detected’. Efavirenz has been known to be used as a street drug, and the presence of lamivudine alone could not be explained. 40 Sample size considerations The anticipated sample size was 700 youth per cluster (16 800 total). Assuming a conservative estimate of 3% HIV prevalence among 18–24-year-olds and that the proportion of YLWH who were virally suppressed was 43% in the control arm (60% diagnosed × 84% on ART × 85% virally suppressed, based on ZIMPHIA estimates), with a coefficient of variation of 0.25, the study would have 80% power to detect a difference of 19% (i.e. 62% prevalence of viral suppression in the intervention arm) and 90% power to detect a difference of 23% (66% prevalence of viral suppression). A 66% prevalence of the primary outcome could be achieved by, for example, reaching 80% diagnosis, 91% on ART and 91% viral suppression. With a coefficient of variation of 0.3, the study would have 80% power to detect a difference of 23% and 90% power to detect a difference of 27% in the primary outcome. Statistical Analysis The statistical analysis plan was finalised prior to the conduct of the outcome survey (Supplementary Materials). Consolidated Standards of Reporting Trials (CONSORT) guidelines for analysis of CRTs were followed with CONSERVE guidelines to report the trial modifications made as a result of the COVID-19 pandemic. 41 Cluster-level analyses were used to adjust for between-cluster variability, as recommended for trials with fewer than 15 clusters/arm. Descriptive analysis was used to compare cluster-level characteristics of the two arms, with adjustment for variables that were unbalanced between arms (avoiding variables likely to be affected by the intervention) and for stratum. For each outcome, the risk for each cluster was calculated by arm. The mean and standard deviation (SD) of the log risk was used to estimate the geometric mean and associated 95% confidence interval (CI) for each trial arm. A two-stage analysis was conducted using the clan command in Stata 17.0 42 . In the first stage, a logistic regression model was fitted to estimate the effects on the outcome of the adjustment covariates sex and province. Cluster-summarised observed and predicted statistics were used to calculate ratio-residuals. In the second stage, linear regression of the log ratio-residual on province and arm was used to estimate the risk ratio and 95% CI for the effect of intervention. Significance tests were two-sided with 5% level of significance. Subgroup analysis by sex and age category was conducted to investigate evidence of interaction with study arm. A sensitivity analysis was conducted in which all indeterminate HIV results were coded as positive and virally suppressed. The outcomes are affected by coverage (uptake) of the intervention and therefore a Complier Average Causal Effect (CACE) analysis was conducted to estimate the effect of the trial among participants who attended the CHIEDZA services, by comparing intervention arm participants who attended the CHIEDZA service with comparable individuals in the control arm 43 . Compliance was defined as attending the CHIEDZA service. Survey participants in the intervention arm were coded as compliers if they either had a fingerprint match to CHIEDZA service clients, or self-reported attending the CHIEDZA service. Structural equation modelling was used to create two latent classes, with all compliers in the intervention arm in one class and all non-compliers in the other. The control arm participants were allocated to the two classes based on their similarity to the intervention arm compliers and non-compliers, on the matching variables used in the model. Within the ‘complier’ class, a generalised linear model with a binomial family and logit link was run to estimate the effect of the intervention in this group. The latent class modelling was run twice; first with two predictor variables for class (length of residence and living within median proximity to the community centre), then with 6 variables predictive of compliance (gender, living within median proximity to the community centre, length of residence, sexual debut, age as a binary variable, and SES quintile). Finally, intervention uptake as reported in the survey sample was compared to intervention coverage based on estimates of the population of youth resident in the cluster to explore possible effects of population turnover on outcomes. We used the enumeration data from the survey to estimate the total population of 18-24 year olds in each cluster. The number of 18-24 year olds enumerated was divided by the proportion of the cluster area that was surveyed. We used the date of birth of CHIEDZA service attendees to determine the number of clients in each cluster who were aged 18-24 years when the survey began. The number of clients per cluster divided by the estimated number of youth resident in the cluster gave an indication of service coverage, assuming all clients were still residing in the cluster at the time of the survey. Governance and reporting standards The Trial is registered with Clinical Trials.gov (Trial registration number: NCT03719521). Ethical approval was granted by the Medical Research Council of Zimbabwe (reference number: MRCZ/A/2387), the Institutional Review Board of the Biomedical Research and Training Institute (reference number: AP149/2018) and the London School of Hygiene & Tropical Medicine (LSHTM) Research Ethics Committee (reference number: 12063). Zimbabwe national guidelines stipulate that those aged 16 years and older can give independent consent to accessing HIV and SRH services. At the level of the intervention, as each of the individual service components were established public health interventions (e.g. HIV testing, HIV care, family planning etc), consent was implied when clients took up intervention activities and specific written consent to participate was not obtained. For the outcome survey, written consent was obtained from participants. To facilitate age-appropriate and informed consent, eligible individuals were shown a video of the study procedures enacted and narrated by the study team on a tablet with narration in English, Shona or Ndebele. The video was also available online for participants to watch later and participants were given a brief and simple information sheet to keep. Consent was documented electronically through a signature or fingerprint on the tablet, with a signed paper copy retained by participants. The intervention is described in accordance with the template for intervention description and replication (TIDieR) checklist (Supplementary materials). The trial is reported in accordance with CONSORT for cluster randomized trials (Supplementary materials). 44 The funder had no role in any aspect of study design or analysis, data collection, data analysis, data interpretation, writing of the report, or the decision to submit for publication. Table 1: Characteristics of outcome survey participants Control arm, n (%) n=8730 Intervention arm, n (%) n=8822 Age (years) 18-20 22-24 4513 (51.7) 4217 (48.3) 4660 (52.8) 4162 (47.2) Gender Male Female Non-binary 3539 (40.5) 5189 (59.5) 1 (0.01) 3346 (37.9) 5476 (62.1) 0 Education level attained Did not complete primary Completed primary Completed Form 4 Completed Form 6 Post-secondary 168 (1.9) 1489 (17.1) 5337 (61.1) 1036 (11.9) 700 (8.0) 183 (2.1) 1393 (15.8) 5376 (60.9) 1170 (13.3) 700 (7.9) Main current activity In education Formally employed Informally employed None of the above 2439 (27.9) 424 (4.9) 1557 (17.8) 4310 (49.4) 2482 (28.1) 405 (4.6) 1588 (18.0) 4347 (49.3) Monthly household income US$500 Missing 1452 (19.5) 2143 (28.7) 2252 (30.2) 1312 (17.6) 298 (4.0) 1273 1148 (15.2) 2281 (30.1) 2468 (32.6) 1389 (18.3) 294 (3.9) 1242 Partnership status Married or living together Never married Divorced, widowed or separated 6595 (75.5) 1705 (19.5) 430 (4.9) 6619 (75.0) 1839 (20.9) 364 (4.1) Sexual debut Has had penetrative sexual intercourse Never had penetrative sexual intercourse Missing/refused 5652 (65.0) 3048 (35.0) 30 5554 (63.3) 3215 (36.7) 53 Residence at current address Less than 12 months 12 to 24 months >2 years to 3 years More than 3 years 2051 (23.5) 770 (8.8) 801 (9.2) 5108(58.5) 2159 (24.5) 922 (10.5) 881 (10.0) 4860 (55.1) Table 2: Primary and secondary trial outcomes adjusted for sex Outcome Sample N Cluster-level geometric mean prevalence Risk Ratio (95% CI) p-value Control Intervention Primary outcome VS YLWH 1217 38.3% 41.3% 1.07 (0.88-1.30) 0.47 Secondary outcomes (aligned to UNAIDS 90-90-90 targets) Know HIV diagnosis YLWH 1226 51.5% 51.6% 0.99 (0.76-1.28) 0.93 Taking ART YLWH who know their HIV status 650 96.3% 87.3% 0.91 (0.83-0.99) 0.025 VS YLWH taking ART 599 52.6% 62.7% 1.19 (1.02-1.39) 0.033 VS: viral suppression; YLWH: youth living with HIV; ART: antiretroviral therapy YLWH defined as participants who either had a positive ELISA test on DBS sample or self-reported as HIV positive YLWH who know their HIV status defined as YLWH who either self-reported as HIV positive or had ARVs detected in their DBS sample YLWH taking ART defined as YLWH who either self-reported as taking ART or had ARVS detected in their DBS sample Table 3: Trial outcomes stratified by age and sex Outcome Cluster-level geometric mean prevalence Risk Ratio (95% CI) p-value Interaction p-value Control Intervention Primary outcome stratified by sex and age (years) VS ( in YLWH ) Male Female 36.9% 39.7% 42.8% 41.7% 1.16 (0.79-1.70) 1.05 (0.87-1.28) 0.43 0.60 0.62 18-20 21-24 34.2% 39.3% 30.2% 45.9% 0.90 (0.63-1.27) 1.16 (0.93-1.44) 0.53 0.19 0.18 Secondary outcomes by sex (aligned to UNAIDS 90-90-90 targets) Know HIV diagnosis ( in YLWH) Male Female 49.2% 55.1% 52.3% 52.7% 1.06 (0.68-1.66) 0.96 (0.76-1.21) 0.77 0.70 0.59 Taking ART ( in YLWH* ) Male Female 97.6% 95.6% 88.9% 87.1% 0.91 (0.83-1.00) 0.91 (0.83-1.00) 0.062 0.046 0.88 VS ( in those taking ART ) Male Female 56.1% 52.5% 64.1% 64.5% 1.15 (0.76-1.73) 1.23 (1.03-1.48) 0.50 0.028 0.81 Secondary outcomes by age in years (aligned to UNAIDS 90-90-90 targets) Know HIV diagnosis ( in YLHW ) 18-20 21-24 43.0% 54.7% 50.5% 54.1% 1.15 (0.64-2.08) 0.98 (0.77-1.24) 0.62 0.86 0.52 Taking ART (in YLHW* ) 18-20 21-24 95.2% 96.2% 87.1% 87.2% 0.92 (0.83-1.02) 0.91 (0.82-1.01) 0.12 0.06 0.92 VS ( in those taking ART ) 18-20 21-24 52.8% 53.7% 51.3% 68.8% 0.98 (0.68-1.43) 1.28 (1.11-1.47) 0.93 0.002 0.11 VS: viral suppression; YLWH: youth living with HIV; ART: antiretroviral therapy *Who know their HIV status References UNAIDS. Seizing the moment: Tackling entrenched inequalities to end epidemics. (UNAIDS, Geneva, Switzerland, 2020). Slogrove, A.L. & Sohn, A.H. The global epidemiology of adolescents living with HIV: time for more granular data to improve adolescent health outcomes. Curr Opin HIV AIDS 13 , 170-178 (2018). Zimbabwe Population-based HIV Impact Assessment (ZIMPHIA) 2015-16: Final Report. (Ministry of Health and Child Care (MOHCC) Zimbabwe, Harare, Zimbabwe, 2017). Malawi Population-based HIV Impact Assessment (MPHIA) 2015-16: Final Report. (Ministry of Health Malawi, Malawi, 2017). Zambia Population-based HIV Impact Assessment (ZAMPHIA) 2016: Final Report. (Ministry of Health Zambia, Zambia, 2017). Quinn, T.C. , et al. Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. N Engl J Med 342 , 921-929 (2000). Mellors, J.W. , et al. Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. Science 272 , 1167-1170 (1996). Kurth, A.E., Lally, M.A., Choko, A.T., Inwani, I.W. & Fortenberry, J.D. HIV testing and linkage to services for youth. J Int AIDS Soc 18 , 19433 (2015). Sam-Agudu, N.A., Folayan, M.O. & Ezeanolue, E.E. Seeking wider access to HIV testing for adolescents in sub-Saharan Africa. Pediatric Research 79 , 838-845 (2016). Eba, P.M. & Lim, H. Reviewing independent access to HIV testing, counselling and treatment for adolescents in HIV-specific laws in sub-Saharan Africa: implications for the HIV response. J Int AIDS Soc 20 , 21456 (2017). Strode, A. & Essack, Z. Facilitating access to adolescent sexual and reproductive health services through legislative reform: Lessons from the South African experience. S Afr Med J 107 , 741-744 (2017). Ninsiima, L.R., Chiumia, I.K. & Ndejjo, R. Factors influencing access to and utilisation of youth-friendly sexual and reproductive health services in sub-Saharan Africa: a systematic review. Reprod Health 18 , 135 (2021). Fleischman, J. , et al. Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment. Global health action 15 , 2029335 (2022). Denno, D.M., Hoopes, A.J. & Chandra-Mouli, V. Effective strategies to provide adolescent sexual and reproductive health services and to increase demand and community support. J Adolesc Health 56 , S22-41 (2015). Denno, D.M., Chandra-Mouli, V. & Osman, M. Reaching youth with out-of-facility HIV and reproductive health services: a systematic review. J Adolesc Health 51 , 106-121 (2012). Dziva Chikwari, C. , et al. Differentiated care for youth in Zimbabwe: Outcomes across the HIV care cascade. PLOS Glob Public Health 4 , e0002553 (2024). Simms, V. , et al. Uptake of community-based integrated HIV and sexual and reproductive health services for youth in Zimbabwe. BMC Health Services Res (2024): Under review. Preprint: https://www.researchsquare.com/article/rs-4426663/v1 UNAIDS. 90-90-90. An ambitious treatment target to help end the AIDS epidemic. (Geneva, Switzerland, 2014). Larsson, L. , et al. HIV testing uptake in a sexual and reproductive health service for youth and impact on population prevalence of undiagnosed HIV in Zimbabwe. in 25th International AIDS Conference (Munich, Germany, 2024). Hensen, B. , et al. The impact of community-based, peer-led sexual and reproductive health services on knowledge of HIV status among adolescents and young people aged 15 to 24 in Lusaka, Zambia: The Yathu Yathu cluster-randomised trial. PLoS Med 20 , e1004203 (2023). Ingold, H. , et al. The Self-Testing AfRica (STAR) Initiative: accelerating global access and scale-up of HIV self-testing. J Int AIDS Soc 22 Suppl 1 , e25249 (2019). Hatzold, K. , et al. HIV self-testing: breaking the barriers to uptake of testing among men and adolescents in sub-Saharan Africa, experiences from STAR demonstration projects in Malawi, Zambia and Zimbabwe. J Int AIDS Soc 22 Suppl 1 , e25244 (2019). Simms, V. , et al. Use of biometrics to evaluate intervention coverage and contamination in a cluster randomised trial in Zimbabwe. Implementation Science (2024): Under Review. Dziva Chikwari, C. , et al. The impact of community-based integrated HIV and sexual and reproductive health services for youth on population-level HIV viral load and sexually transmitted infections in Zimbabwe: protocol for the CHIEDZA cluster-randomised trial. Wellcome Open Res 7 , 54 (2022). Wasserheit, J.N. & Aral, S.O. The dynamic topology of sexually transmitted disease epidemics: implications for prevention strategies. J Infect Dis 174 Suppl 2 , S201-213 (1996). Zimbabwe Population-based HIV Impact Assessment 2020 (ZIMPHIA 2020): Final Report. (Ministry of Health and Child Care (MoHCC), Harare, Zimbabwe, 2021). Kawuma, R., Seeley, J., Mupambireyi, Z., Cowan, F. & Bernays, S. "Treatment is not yet necessary": delays in seeking access to HIV treatment in Uganda and Zimbabwe. African journal of AIDS research : AJAR 17 , 217-225 (2018). Seeley, J. , et al. Understanding the Time Needed to Link to Care and Start ART in Seven HPTN 071 (PopART) Study Communities in Zambia and South Africa. AIDS Behav 23 , 929-946 (2019). Adejumo, O.A., Malee, K.M., Ryscavage, P., Hunter, S.J. & Taiwo, B.O. Contemporary issues on the epidemiology and antiretroviral adherence of HIV-infected adolescents in sub-Saharan Africa: a narrative review. J Int AIDS Soc 18 , 20049 (2015). Mackworth-Young, C.R.S. , et al. Putting youth at the centre: co-design of a community-based intervention to improve HIV outcomes among youth in Zimbabwe. Wellcome Res Open 7 , 53 (2022). Mackworth-Young, C. , et al. ‘You can say anything without fear for being judged’: High acceptability of a community-based integrated HIV and sexual and reproductive health service among youth clients in Zimbabwe. in 22nd International Conference on AIDS and STIs in Africa (ICASA) (Harare, Zimbabwe, 2023). Hlahla, K. , et al. Prevalence of substance and hazardous alcohol use and their association with risky sexual behaviour among youth: findings from a population-based survey in Zimbabwe. BMJ open 14 , e080993 (2024). Kim, M.H. , et al. High self-reported non-adherence to antiretroviral therapy amongst adolescents living with HIV in Malawi: barriers and associated factors. J Int AIDS Soc 20 , 21437 (2017). Cohen, M.S. , et al. Antiretroviral Therapy for the Prevention of HIV-1 Transmission. N Engl J Med 375 , 830-839 (2016). Mahiya, I. Urban youth unemployment in the context o a dollarised economy in Zimbabwe. Commonwealth Youth and Development 14 (1) , 97-117 (2017). Mackworth-Young, C.R.S. , et al. "Other risks don't stop": adapting a youth sexual and reproductive health intervention in Zimbabwe during COVID-19. Sex Reprod Health Matters 30 , 2029338 (2022). Zimbabwe Population Census 2012 (Zimbabwe National Statistics Agency (ZimStat), Harare, Zimbabwe, 2012). McCarthy, O.L. , et al. Adapting an evidence-based contraceptive behavioural intervention delivered by mobile phone for young people in Zimbabwe. BMC Health Serv Res 22 , 106 (2022). Mavodza, C.V. , et al. Family Planning Experiences and Needs of Young Women Living With and Without HIV Accessing an Integrated HIV and SRH Intervention in Zimbabwe-An Exploratory Qualitative Study. Front Glob Womens Health 3 , 781983 (2022). Dalwadi, D.A., Ozuna, L., Harvey, B.H., Viljoen, M. & Schetz, J.A. Adverse Neuropsychiatric Events and Recreational Use of Efavirenz and Other HIV-1 Antiretroviral Drugs. Pharmacol Rev 70 , 684-711 (2018). Campbell, M.K., Elbourne, D.R. & Altman, D.G. CONSORT statement: extension to cluster randomised trials. Bmj 328 , 702-708 (2004). Thompson, J.A., Leurent, B., Nash, S., Moulton, L.H. & Hayes, R.J. Cluster randomized controlled trial analysis at the cluster level: The clan command. Stata J 23 , 754-773 (2023). Troncoso, P. & Morales-Gomez, A. Estimating the complier average causal effect via a latent class approach using gsem. Stata J 22 , 404-415 (2022). Campbell, M.K., Piaggio, G., Elbourne, D.R. & Altman, D.G. Consort 2010 statement: extension to cluster randomised trials. Bmj 345 , e5661 (2012). Additional Declarations There is NO Competing Interest. Supplementary Files SupplementaryTables.docx Cite Share Download PDF Status: Published Journal Publication published 24 Jun, 2025 Read the published version in Nature Medicine → Version 1 posted 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. As a division of Research Square Company, we’re committed to making research communication faster, fairer, and more useful. We do this by developing innovative software and high quality services for the global research community. Our growing team is made up of researchers and industry professionals working together to solve the most critical problems facing scientific publishing. Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-5594349","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Article","associatedPublications":[],"authors":[{"id":388690055,"identity":"f317f1c9-2f79-4813-b743-501f0f04ba30","order_by":0,"name":"Rashida Ferrand","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAABE0lEQVRIie3Rv0sDMRTA8XcEcsvTrE/Q3r9wR6EdCvVfyVFIluhYhA49EOLUP0D8RxwLB95ydnYsDnFREFx0EEwVUSTtrQ75bo/wIb8AYrH/GQfJAdLqc2C9fcCflZ0El1+kzwGTqpPAL1LaLjK8aNx6PR0Dpgv3/HY90lbcNvd3MM6AlAyRw9YMc7maAGLTv1y0+sTSaXluYFJUpJYhQmA4lZbBMSkGe7b2BAtPmATSVZCIB+fJHDBzLHm3teai3ZD5dkJy4EkNSJwxv4t/PbMhtSdbDkaPA5KrBhEVY0dWF5ZMcWXyprDogtcnod3B63TWw/SGJU92lAnR5i/mbJaJVOUh8h3+mfMdHxmLxWKxzj4AysxP+10KdjwAAAAASUVORK5CYII=","orcid":"https://orcid.org/0000-0002-7660-9176","institution":"London School of Hygiene and Tropical Medicine","correspondingAuthor":true,"prefix":"","firstName":"Rashida","middleName":"","lastName":"Ferrand","suffix":""},{"id":388690056,"identity":"96a25141-113c-48af-b4f4-ce61adb432b2","order_by":1,"name":"Ethel Dauya","email":"","orcid":"","institution":"Biomedical Research and Training Institute","correspondingAuthor":false,"prefix":"","firstName":"Ethel","middleName":"","lastName":"Dauya","suffix":""},{"id":388690057,"identity":"67be1309-7390-4789-9c1a-b13c731d9bd1","order_by":2,"name":"Chido Dziva Chikwari","email":"","orcid":"","institution":"London School of Hygiene and Tropical Medicine","correspondingAuthor":false,"prefix":"","firstName":"Chido","middleName":"Dziva","lastName":"Chikwari","suffix":""},{"id":388690058,"identity":"c3f8560c-a8c3-4f10-ac4d-d023fa6bda2c","order_by":3,"name":"Tsitsi Bandason","email":"","orcid":"","institution":"Biomedical Research and Training Institute","correspondingAuthor":false,"prefix":"","firstName":"Tsitsi","middleName":"","lastName":"Bandason","suffix":""}],"badges":[],"createdAt":"2024-12-06 14:20:35","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-5594349/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-5594349/v1","draftVersion":[],"editorialEvents":[{"content":"https://doi.org/10.1038/s41591-025-03762-z","type":"published","date":"2025-06-24T04:00:00+00:00"}],"editorialNote":"","failedWorkflow":false,"files":[{"id":71097531,"identity":"60a5fac7-d109-42b7-b057-8fce3545a1f0","added_by":"auto","created_at":"2024-12-11 06:10:27","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":48606,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eFlowchart of participants in the CHIEDZA endline outcome survey (Trial profile)\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-5594349/v1/51d42547f0e88a29ab942244.png"},{"id":71097639,"identity":"40ad4b4c-c12e-4013-95b0-1039850d0da7","added_by":"auto","created_at":"2024-12-11 06:10:28","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":529801,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eParticipants who were HIV positive in the outcome survey\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-5594349/v1/286e20ffa32f8acccde1aa3b.png"},{"id":85368601,"identity":"9fda40af-76ed-4194-b409-5af25251fd88","added_by":"auto","created_at":"2025-06-25 07:09:16","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1602938,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-5594349/v1/63a7edf0-2c48-41d6-b2f2-6b018f5bece0.pdf"},{"id":71097870,"identity":"5fba7b80-87fa-4861-a993-85d10d496b4a","added_by":"auto","created_at":"2024-12-11 06:18:28","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":20465,"visible":true,"origin":"","legend":"","description":"","filename":"SupplementaryTables.docx","url":"https://assets-eu.researchsquare.com/files/rs-5594349/v1/bbb6aacd806ba51b0273dc9c.docx"}],"financialInterests":"There is \u003cb\u003eNO\u003c/b\u003e Competing Interest.","formattedTitle":"Impact of integrated community-based HIV and sexual and reproductive health services for youth aged 16-24 years on population-level HIV outcomes in Zimbabwe: the CHIEDZA cluster randomized trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eThe general global decline in new HIV infections has been much less marked in youth. In 2019, 30% of HIV infections in eastern and southern Africa occurred among women aged 15\u0026ndash;24 years.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e Compared to other age-groups, youth living with HIV are less likely to be diagnosed and those diagnosed have lower rates of HIV viral suppression once they start antiretroviral therapy (ART).\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eHIV testing is a prerequisite for accessing care or prevention services. Population-based surveys from sub-Saharan Africa, where two-thirds of the world\u0026rsquo;s population with HIV lives, show a substantial burden of undiagnosed HIV infection among youth. Only 52%, 48% and 45% of those aged 15\u0026ndash;24 years in Zimbabwe, Malawi and Zambia respectively reported ever having an HIV test in Population HIV Impact Assessments (PHIAs) conducted between 2015\u0026ndash;2017.\u003csup\u003e\u003cspan additionalcitationids=\"CR4\" citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e In these countries, it was estimated that only 40\u0026ndash;50% of 15\u0026ndash;24-year-olds living with HIV were aware of their HIV status compared with 66\u0026ndash;73% of those aged\u0026thinsp;\u0026gt;\u0026thinsp;24 years. Similarly, HIV viral load suppression among youth taking ART was significantly lower than among older people. Youth are therefore a priority group to achieve HIV control.\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e,\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e\u003c/sup\u003e Viral non-suppression is associated not only with morbidity but with increased risk of onward HIV transmission.\u003c/p\u003e \u003cp\u003eYouth face personal, social, legal, and structural barriers to access HIV services.\u003csup\u003e\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e Stigma remains much more pronounced for youth because HIV is often associated with taboo behaviours and promiscuity.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e\u003c/sup\u003e There remain legal constraints with a requirement for consent from guardians to access HIV services, with a varying age threshold for this requirement that can be as high as 18 years in some countries for independent consent.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e Existing HIV services are mostly verticalized and facility-based, and often not geared to address the particular needs of youth. For example, there remains a large unmet need and demand for sexual and reproductive health (SRH) services among youth, including those who are living with HIV,\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e but provision of these alongside HIV prevention and/or care programmes remains the exception rather than the rule.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e,\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e In addition, judgemental provider attitudes result in poor engagement.\u003csup\u003e\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e,\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eAchieving improved HIV outcomes requires that both supply and demand side barriers be addressed. As HIV services are often not a priority for youth, we hypothesized that integrating the provision of SRH services and HIV services would act as a \u0026lsquo;hook\u0026rsquo; and increase uptake. In addition, such a service model, particularly if configured to be youth-friendly could facilitate engagement, be more acceptable, and potentially lead to improved programmatic efficiency.\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e \u003cp\u003eWe conducted a trial (CHIEDZA) in Zimbabwe to investigate the impact on population-level HIV outcomes of community-based HIV testing, treatment and adherence support integrated with comprehensive SRH services and general health counselling for youth aged 16\u0026ndash;24 years. Our rationale was that services situated within communities may be more accessible for youth,\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e and addressing the whole HIV cascade including HIV testing, linkage to care and support to maintain viral suppression may minimise the risk of attrition at each step.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eThe deployment of the intervention across the provinces was staggered, with implementation starting in April 2019 in Harare, July 2019 in Bulawayo and October 2019 in Mashonaland East. The uptake of the different CHIEDZA service components including HIV testing, and HIV virological suppression (VS) among CHIEDZA attendees who were living with HIV, are reported separately.\u003csup\u003e16\u003c/sup\u003e \u003csup\u003e17\u003c/sup\u003e Briefly, 36991 youths accessed the CHIEDZA intervention over the 30-month period.\u0026nbsp;Overall, 84.1% of those eligible had at least one HIV test, resulting in 38,603 HIV tests by 29,826 youth, of which 377 were positive (prevalence of newly diagnosed HIV 1.3%). In addition, 1162 youth accessing CHIEDZA services self-reported being HIV positive.\u003csup\u003e17\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eOutcome survey participant characteristics\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe outcome survey was conducted between October 2021 and June 2022.\u0026nbsp;In total, 18721 youth aged 18-24 years resident in households in the randomly selected road segments were enumerated of whom 17682 (94.5%) were eligible, gave consent and were enrolled (Figure 1). Males and older individuals were less likely to be enrolled (Supplementary Table 1). Of those enrolled, 130 (0.7%) were excluded from analysis of the primary outcome due to missing data leaving 17552 (Figure 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOverall, 60.8% of participants were female and the median age was 20 (IQR 19-22) years. The two arms were balanced with respect to socio-demographic characteristics (Table 1).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn total, 1200 participants had a positive HIV test result on their DBS and an additional 26 participants were categorised as HIV-positive based on their self-report although their DBS test result was negative (20), indeterminate (4) or missing (2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA higher proportion in the intervention than control arm reported having ever had an HIV test (71.1% vs 66.1%, p=0.016) and knowing their HIV status (68.5% vs 63.1%, p=0.057). The difference by arm was more pronounced for those who had tested for HIV in the past 12 months (44.4% (intervention) vs 34.7% (control), p\u0026lt;0.001). The HIV prevalence was 6.2% and 7.8% in intervention and control arms respectively, giving a much larger sample size of YLWH than the expected 21 per cluster based on an anticipated HIV prevalence of 3%. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eParticipants were defined as having an HIV diagnosis if they self-reported as HIV positive (N=435), or if ART drugs were detected in their sample (N=211). Youth living with HIV (YLWH) with an HIV diagnosis were defined as on ART if they self-reported as such (N=386) or if ART drugs were detected N=211) (Figure 2). Notably, of 1226 YLWH overall, 576 (47.0%) were undiagnosed. Out of 791 YLWH who self-reported as negative or of unknown status, 215 (27.2%) had ARVs detected in their blood sample while 294 were not tested for ARVs due to high viral load.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eTrial outcomes\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThere was no difference by arm in the primary outcome i.e. the proportion of YLWH who had VS (41.3% vs 38.3%, RR 1.07 (95% CI 0.88-1.30). There was also no difference by am in the proportion of YLWH who had an HIV diagnosis (51.6% vs 51.5%, RR 0.99 (95% CI 0.76-1.28) (Table 2). In the intervention arm a lower proportion of diagnosed YLWH were taking ART (87.3% vs 96.3%, RR=0.91 (95%CI 0.83-0.99) but a higher proportion of those taking ART were virally suppressed (62.7% vs 52.6%, RR=1.19 (95% CI 1.02-1.39).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWhen stratified by age and sex, there were no differences by arm in the primary outcome (Table 3). \u0026nbsp;There was also no significant interaction between study arm and age or sex for any of the secondary outcomes (Table 3). Three participants had indeterminate HIV test result and did not self-report as HIV positive. In a sensitivity analysis in which they were coded as HIV positive and virally suppressed, results were similar to the primary analysis.\u003c/p\u003e\n\u003cp\u003eAmong a sub-group of participants who resided less than the median distance from the community centers from which CHIEDZA services were or would be delivered and who had lived in the clusters for more than two years, the risk ratio for the primary outcome in the intervention vs the control arm was higher, but did not reach statistical significance (Supplementary Table 2).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eIntervention coverage\u0026nbsp;\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eBased on the estimated population of youth aged 18-24 years in intervention clusters (as estimated from the enumeration in the prevalence survey) and the number of clients who accessed the intervention and would have been the right age for the survey, the intervention coverage would have been approximately 75% of eligible cluster residents (Supplementary Table 2). However, actual reported intervention coverage (proportion of outcome survey participants who reported accessing the intervention in the intervention clusters) was only 23.5% (Supplementary Table 3).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eIntervention effects among those who accessed the intervention\u0026nbsp;\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn a Complier Average Causal Effect (CACE) analysis, corresponding to the primary analysis, there was no difference between arms in the primary outcome or in the proportion of YLWH who had an HIV diagnosis (Supplementary Table 4). A model of the proportion of diagnosed YLWH taking ART failed to converge. Among those taking ART, there was evidence of a higher prevalence of viral suppression in the intervention than in the control arm RR=3.85 (95% CI 1.56, 9.54)). There was little difference between results using the models that used two compliance predictor variables and models that used six (Supplementary Table 4). \u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eDelivery of community-based HIV services covering the whole HIV care cascade including HIV testing and treatment and adherence support, integrated with comprehensive SRH services for youth, had no impact on population-level HIV viral suppression among youth living with HIV, the primary outcome.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe starting point for the trial was that existing strategies have not been sufficient to address the disproportionately worse HIV outcomes in youth compared to other age-groups. Achieving viral suppression requires an individual to access HIV testing, link to HIV care services and initiate and maintain adherence to ART. The CHIEDZA intervention addressed each of these steps (often termed the HIV care cascade), and the combined effect across all these steps was assessed by the primary outcome (proportion of youth with HIV who were virally suppressed). The individual effects on each step of the HIV care cascade were assessed in the secondary outcomes, reflecting the UNAIDS 90-90-90 targets.\u003csup\u003e18\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eCHIEDZA achieved high levels of HIV testing among those who attended CHIEDZA with 84% having at least one HIV test.\u003csup\u003e19\u003c/sup\u003e This translated into a population-level impact on HIV testing (ever tested and testing in the past 12 months) and knowledge of HIV status. This is consistent with findings of the Yathu Yathu trial in Zambia which also offered HIV testing together with SRH services in community hubs to youth and reported substantially increased uptake of HIV testing particularly among adolescent boys aged 15-19 years.\u003csup\u003e20\u003c/sup\u003e While HIV testing is a critical first step to accessing HIV treatment, it is also an entry point to HIV prevention services.\u003csup\u003e8\u003c/sup\u003e In addition, engaging with HIV testing once may help overcome anxiety and fear and potentially promote more regular subsequent HIV testing.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eHowever, there was no observed difference by arm in the proportion of YLWH who were diagnosed (the first step of the HIV care cascade and one of the secondary outcomes), which likely explains the lack of effect of the intervention on the primary outcome. There are a number of likely reasons for this. Firstly, over the past decade there has been a scale-up of a range of HIV testing approaches, including the large-scale HIV Self-testing Africa Initiative (STAR) first launched in Zimbabwe, Malawi and Zambia,\u003csup\u003e21,22\u003c/sup\u003e and this may have diluted any difference between intervention and control clusters.\u003c/p\u003e\n\u003cp\u003eSecondly, the effect of the intervention on outcomes was critically dependent not only the intervention itself but also on coverage, given that outcomes were measured at population-level. We have also shown that both knowledge and utilisation of CHIEDZA services correlated strongly with distance from community centres.\u003csup\u003e23\u003c/sup\u003e Also, intervention coverage may have been compromised by high in- and out- migration among youth. One in four survey participants had been resident in their study community for less than 12 months, and therefore had limited exposure to the intervention. We observed a substantial difference between the proportion of participants in the intervention arm who reported accessing the intervention and the estimated coverage based on the number of attendees as a proportion of the estimated population of youth in the intervention communities (based on estimates obtained through enumeration). It is therefore possible that while the intervention achieved higher coverage than the 23.5% reported, many individuals who had attended the intervention had subsequently migrated out from the intervention communities. Furthermore, it is possible that individuals who were temporarily or not resident in the clusters, for example those who resided in neighbouring areas may have accessed the intervention. While attendees were asked about their age and address, we relied on attendees\u0026rsquo; self-report to confirm eligibility. Such attendees were not necessarily from the control clusters which were separated by significant geographical boundaries (such as rivers, major roads) and with sufficient distance between them to avoid contamination.\u003csup\u003e24\u003c/sup\u003e Indeed, contamination (i.e. individuals resident in control clusters accessing CHIEDZA services) was found to be very low (approximately 3%), when ascertained by comparing the proportion of fingerprint matches of survey participants from the control clusters with those of intervention attendees.\u003csup\u003e23\u003c/sup\u003e Overall, this meant that the participants in the outcome survey were not necessarily representative of individuals who had been exposed to the intervention. In the exploratory subgroup analysis among those who had lived longer in the clusters (longer exposure to intervention) and lived closer to the community centres, a stronger effect of the intervention on the primary outcome was observed, although the effect was not statistically significant.\u003c/p\u003e\n\u003cp\u003eThirdly, despite the intervention being configured to address the well-recognised demand and supply barriers to HIV testing in youth, it is likely that those at highest risk of being HIV-positive were not reached either because they did not access the CHIEDZA services or did not take up HIV testing if they attended. Consistent with Wasserheit and Aral\u0026rsquo;s theory of phase specific dynamics of transmission of sexually transmitted infections, as the HIV incidence declines and preventive interventions are established, the sexual and social networks that drive the epidemic become increasingly located within subpopulations that are characterised by higher risk behaviours and less contact with health care services.\u003csup\u003e25\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe proportion of YLWH who were on ART (coverage of ART) was high in both trial arms, suggesting that current ART services are performing well for youth who know their HIV-positive status and link to care. ART coverage in our population-based survey was higher than that reported in the 2020 Population-based Impact Assessment which could reflect overall improved access to ART over time.\u003csup\u003e26\u003c/sup\u003e The proportion of YLWH (aware of their HIV status) accessing ART in the intervention arm was lower than that in the control arm. The CHIEDZA intervention provided not just testing but also registration into the ART programme, initiation of ART and follow-up care including adherence support for the duration of the intervention. However, the service was available only once-weekly and therefore not at the same frequency as clinic-based services (5-6 days/week). Also, despite counselling, some youth were not yet ready to start ART, which the providers respected.\u003csup\u003e16\u003c/sup\u003e Providers were trained in provision of youth-friendly services with autonomy and choice being a key aspect. Mobility may also have adversely affected linkage to care. However, this highlights one of many challenges of provision of HIV treatment to youth.\u003csup\u003e27,28\u003c/sup\u003e \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe proportion virologically suppressed fell far short of the UNAIDS 90-90-90 targets in both arms. The challenges of adherence among young people are well-recognised,\u003csup\u003e29\u003c/sup\u003e and the PHIAs in the region shown much lower levels of VS among youth compared to other age-groups.\u003csup\u003e3-5\u003c/sup\u003e Notably, among those YLWH taking ART, the proportion who were virally suppressed was higher in the intervention than in the control arm. In a CACE analysis in which outcomes were compared among those who accessed the intervention, the risk of VS among YLWH on ART was more than 3.5 times higher in the intervention than in the control arm, suggesting that the intervention may have been effective in supporting adherence to ART. This was likely due to the multi-modal approach used to support adherence including follow-up by providers of those who did not attend for ART refills, specialist counselling and a peer support group. A community-based service model such as CHIEDZA could be an effective approach to complement existing HIV treatment services, providing support for adherence and even support transition to adult-centred care, while providing holistic health services.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWhile the principal objectives were centred around impact on HIV outcomes, the CHIEDZA trial provides strong evidence of the feasibility of delivering integrated HIV and SRH services to all youth, a group that is often under-served by existing health services. The CHIEDZA service model facilitated uptake of essential services beyond HIV by youth, and addressed an important programmatic gap.\u003csup\u003e17\u003c/sup\u003e Co-designed and co-delivered with youth, it was highly effective in engaging youth- a group that has hitherto been hard to engage.\u003csup\u003e30\u003c/sup\u003e Results from an embedded process evaluation (reported separately) showed that the uptake of other services was very high and the service model was highly acceptable to youth.\u003csup\u003e31\u003c/sup\u003e The model therefore provides a \u003cem\u003epractical template\u003c/em\u003e for provision of youth-friendly services. The model complemented, not duplicated, existing facility-based services, was responsive to context, and\u0026nbsp;promote a holistic approach to service delivery, which while being acceptable to users may also be programmatically more efficient.\u003c/p\u003e\n\u003cp\u003eNotably, CHIEDZA services were considered \u0026ldquo;critical\u0026rdquo; and were selectively endorsed by health authorities to remain open during the COVID-19 pandemic lockdown periods, with operational modifications. An ongoing cost analysis will inform scalability. Such a model offers the potential of incorporating other services such as mental health disorders and substance use, which are not only major causes of morbidity among youth but are also associated with increased risk of HIV infection and worse HIV treatment outcomes.\u003csup\u003e32,33\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThe strengths of the study were the use of an objective biological primary outcome that captured the combined effect across every step of the HIV care cascade including testing and linkage to and adherence to treatment, with secondary outcomes assessing individual steps. The outcome was assessed at population level and has strong public health relevance, both in terms of impact on individual health outcomes and potentially on HIV transmission given the overwhelming body of evidence that those who are virally suppressed cannot sexually transmit HIV (Undetectable=Untransmittable or \u0026ldquo;U=U\u0026rdquo;).\u003csup\u003e34\u003c/sup\u003e The study was well-powered, and high participation rates were achieved in the outcome survey. Studies relying solely on self-report may underestimate the proportion of YLWH who know their status. It is notable that ARVS were detected in 215 YLWH who reported that they were HIV negative or did not know their status, suggesting that they did in fact know their HIV positive status and were on treatment. ARV levels were incorporated into our diagnostic algorithm alongside self-report to obtain a more objective measure of knowledge of HIV status. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe acknowledge several limitations. The trial was conducted in urban and peri-urban settings only as population densities in rural areas are low, making a trial of this magnitude unfeasible. Knowledge of HIV status relied partly on self-report which is subject to social desirability bias, and may have resulted in an over-estimate of the proportion of undiagnosed HIV among YLWH. We did undertake testing of samples for ART levels in those with a viral load of \u0026lt;10,000copies/ml who did not self-report as being HIV-positive. It is however possible that a proportion of those with higher viral loads who did not self-report being HIV-positive knew their status and were taking ART. \u0026nbsp;There was a 60:40 female to male ratio in the outcome survey. While we note that the rate of participation by males was lower than for females, data from the enumeration carried out by the Zimbabwe PHIA in similar areas suggests that this proportion reflects the distribution of females to males in these communities.\u003csup\u003e26\u003c/sup\u003e This was complemented by findings from focus group discussions conducted with study communities reporting that there are fewer men due to outmigration for employment from urban centres either to neighbouring countries or to agricultural or mining areas.\u003csup\u003e35\u003c/sup\u003e Implementation of the intervention coincided with the COVID-19 pandemic which resulted in shutdown of the intervention for two months This as well as the subsequent modification of the intervention likely adversely affected engagement and intervention uptake, particularly among young men.\u003csup\u003e36\u003c/sup\u003e In addition, out-migration may have increased due to the adverse socio-economic consequences of the pandemic.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn summary, there was no effect of the trial intervention on viral suppression among YLWH at population level, but among those that were diagnosed and accessing ART, the intervention significantly improved viral load suppression. Nearly 50% of YLWH remained undiagnosed and were not reached even by services that aimed to address many of the well-known demand and supply barriers to accessing health services. This group needs to be characterised to identify more nuanced strategies for reaching and engaging them, including in HIV care once diagnosed. Innovative and flexible approaches will need to be explored for example use of electronic technologies to provide health-related services and information or ART pick-up points, for youth who are mobile. While community-based settings may overcome some of the demand-side barriers to service provision, mapping and situating services in non-traditional settings that youth frequent such as educational institutions and settings where youth socialise may be needed to improve access. This will need to be coupled with ongoing efforts to address community-level stigma and configuring services to be youth-friendly.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe study was funded by the Wellcome Trust through a Senior Fellowship in Clinical Science to RAF (Grant no 206316/Z/17/Z). Funding to support the menstrual hygiene aspects was provided by the Swiss Development Corporation. Delivery of SMS messaging was supported by the Charlize Theron Africa Outreach Project.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eContributors\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRAF and RJH conceptualised the study. CM, CDC, ED, MT, SB, KK, and RAF developed the intervention with input from OM. CMY, CM, MT, and SB conducted the process evaluation of the intervention. RAF, ED, and CDC coordinated the trial. TB and VS were responsible for data management. VS analysed the data with input from KK, RJH, CDC, and RAF. OM advised on intervention deployment and implementation and facilitated modifications during COVID-19 lockdowns. All authors contributed to writing the report and have seen and approved the final draft.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData Availability\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eData presented in this manuscript will be made available via LSHTM Data Compass at the time of publication. Requests for data should be sent to the corresponding author.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgments\u003c/strong\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eWe thank all participants, the CHIEDZA intervention providers and Trial Steering Committee members. We thank Tino Mavimba for designing the intervention materials and for leading the community engagement initiatives.\u0026nbsp;\u003cstrong\u003e\u003cbr\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e"},{"header":"Methods","content":"\u003cp\u003e\u003cem\u003e\u003cu\u003eStudy design and setting\u0026nbsp;\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eCHIEDZA was a parallel open-label two-arm cluster randomized trial (CRT) conducted across three provinces in Zimbabwe (Harare, Bulawayo, and Mashonaland East). Zimbabwe has experienced an early-onset, sustained generalised HIV epidemic with an HIV prevalence of 11.8% in 2020 among adults aged 15-49 years.\u003csup\u003e26\u003c/sup\u003e Harare is the capital and largest city in Zimbabwe and the population is predominantly of Shona ethnicity; Bulawayo, the second largest city in the country, is situated 440kms from Harare, and is predominantly Ndebele. Mashonaland East province borders Harare and peri-urban settings in this province were selected. In combination, these provinces represented the country\u0026rsquo;s two main ethnic groups.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eA cluster design was used as the intervention was a service which could not be assessed at the level of the individual. A cluster was defined as a geographically demarcated area with an estimated population of approximately 2000\u0026ndash;4000 youth aged 16\u0026ndash;24 years (based on Zimbabwe 2012 Census estimates\u003csup\u003e37\u003c/sup\u003e) that contained a multi-purpose community centre from which the intervention could be delivered. A cluster had to be serviced by a defined primary care clinic that was not serving another study cluster and was situated within the cluster to ensure integration and collaboration with public-sector services. Where possible, natural boundaries were used to form the edge of the cluster to minimise contamination.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIndividuals aged between 16\u0026ndash;24 years and who lived within the boundaries of an intervention cluster were eligible to access the intervention. Those who were ineligible i.e. self-reported being outside the eligible age-range or living outside the cluster boundaries were advised to access services at the nearest health facility.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eRandomization and masking\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eA total of 24 clusters, stratified by province, were randomized in a 1:1 allocation ratio to either the control arm or the intervention arm, so that each province had four intervention and four control clusters. A public randomization ceremony was performed in each province, with representatives of the community, the Ministry of Health and Child Care (MoHCC) and respective City Health or town council health departments, to ensure transparency and buy-in from stakeholders. Within each province, coloured balls were drawn from a bag to allocate each cluster to a trial arm.\u0026nbsp;Given the nature of the intervention, it was not possible to mask either investigators or study communities.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eIntervention design and implementation\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe intervention was co-designed with relevant stakeholders including youth and community members (who often serve as gatekeepers to young people accessing services), service providers and policy makers.\u003csup\u003e30\u003c/sup\u003e A key feature of the intervention design process (reported separately) was to centre youth: participatory workshops were held with youth to achieve consensus on the intervention\u0026rsquo;s content and configuration including the types of services, location of service delivery, types of service providers and the \u0026ldquo;branding\u0026rdquo; of the service.\u003csup\u003e30\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThe trial intervention and the logic model showing how the intervention was intended to achieve its intended effects are described in detail in the published trial protocol.\u003csup\u003e24\u003c/sup\u003e In brief a package of integrated HIV and SRH services was delivered in each intervention cluster. Services included HIV testing - either provider-delivered using a blood-based test or self-testing on site using an oral mucosal test. Those who tested HIV-positive or had previously tested HIV-positive but were not linked to care were offered a choice of receiving HIV care from the CHIEDZA service including ART initiation and drug refills, adherence counselling, viral load monitoring and membership of a peer support group, or linkage to HIV care at the nearest health facility. Youth who were already in HIV care elsewhere could also opt to receive any of these services from CHIEDZA.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOther services included\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eadvice and information on menstrual health and provision of analgesics and reusable menstrual products, pregnancy testing, family planning information, counselling, a choice of short and long-acting contraceptives and emergency contraception, termination of pregnancy, syndromic management of sexually transmitted infections following national guidelines, expedited referral for voluntary male medical circumcision, condoms and HIV risk reduction counselling, and general health counselling with onward referral to other health service providers for relevant care where appropriate e.g. mental health issues or intimate partner violence. Information, education, and counselling materials about SRH, HIV and general health issues were available in the form of video clips, a health manual available at the centres and online, and a series of short evidence-based SMS messages.\u003csup\u003e38\u003c/sup\u003e All CHIEDZA resources can be found at https://www.chiedza.co.zw/resources.\u003c/p\u003e\n\u003cp\u003eAll services were voluntary (clients could choose whichever services they wanted from a menu card) and free-of-cost. Tents were pitched within the community centre, each of which served as a private consultation area. Confidentiality was a key aspect of the intervention and therefore only age, sex and the service component(s) taken up were recorded for each client who accessed the intervention. Clients were registered using a fingerprint which was converted into a Global Unique Identification number using SIPMRINTS software (SIMPRINTS, Cambridge, UK). Fingerprints were used to record every attendance and track service uptake.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe intervention was configured to be \u0026ldquo;youth friendly\u0026rdquo; i.e. able to effectively attract youth, meet their needs responsively and retain them in care. Social activities incorporating music, drama, dance, sport and games were held at community centres to increase their engagement with the intervention.\u0026nbsp;A key barrier to youth accessing services is healthcare provider attitudes and therefore ongoing training, supervision and mentorship of providers was an integral component of the intervention, as was community engagement. This included sensitisation and peer outreach at locations frequented by youth including secondary schools. Activities included flyer distribution, information dissemination, and in-field live demonstrations of CHIEDZA products (e.g. reusable pads, menstrual cups, and condoms) to educate, generate support and strengthen community engagement.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eServices were provided once weekly on the same day every week in each cluster, except for public holidays by a multi-disciplinary team that included\u0026nbsp;two nurses, four community health workers (CHWs), one counsellor and two youth workers. Youth workers provided group education including product demonstrations, information about menstrual products etc, registered the clients, organised social activities and were available for informal conversations with clients. CHWs and nurses undertook consultations and nurses also performed clinical examinations and dispensed ART and contraception. A doctor was available on the phone to provide specialist advice where required. \u0026nbsp;\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe intervention teams underwent a two-week a structured training programme. Additional training to manage LGBQTI+ youth or youth with disabilities was also provided. Debrief meetings were held every 1-2 months whereby challenging consultations and situations were discussed and refresher training was provided.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDuring the implementation period, the intervention was stopped from April to June 2020 in response to the Coronavirus Disease 2019 (COVID-19) pandemic. When service delivery restarted, the intervention was modified as follows: face masks and handwashing were mandatory and the number of individuals present at the community centre at any time point was restricted, opening hours were shortened and all social activities, group health information sessions and community mobilisation activities were stopped. The effects of these adaptations have been reported previously.\u003csup\u003e36,39\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOriginally, a 24-month intervention period was anticipated to achieve optimal coverage within a cluster. An extension of six months was added to mitigate against the effects of the COVID-19-related national control measures including physical distancing, orders to stay home where possible, and restrictions on public gatherings. The start date of the intervention was staggered across provinces by three months with Harare province starting first, followed by Bulawayo, followed by Mashonaland East.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eOther than mapping existing health services (largely facility-based) before trial implementation, the study team delivered no services in the control arm.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eTrial outcomes\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eTrial outcomes were measured at population level. The primary outcome was the proportion of youth living with HIV (YLWH) who were virally suppressed (defined as having an HIV viral load \u0026lt;1000 copies/ml). The secondary outcomes, reflecting the UNAIDS 90-90-90 targets, were proportion of YLWH who knew their HIV status, proportion of YLWH who knew their HIV status who were taking ART, and proportion of YLWH taking ART who were virally suppressed, and enabled assessment of the intervention on each step of the HIV care cascade. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eYLWH were defined as knowing their status if they self-reported as HIV positive or if ARVs were detected. YLWH were defined as taking ART if they self-reported as taking it or if ARVs were detected (see ascertainment of trial outcomes). YLWH were defined as virally suppressed if their viral load was \u0026lt;1000 copies/ml, and those who did not have a viral load result were excluded from this outcome.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eAscertainment of trial outcomes\u0026nbsp;\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eOutcomes were ascertained through a population-based cross-sectional survey conducted among 18\u0026ndash;24-year-olds living in the study clusters at the end of the 30-months intervention period. This age-group was chosen to ensure maximal exposure to the intervention. Surveys were conducted in the eight trial clusters in each province over a three-month period, and the start date of the survey in each province was staggered, reflecting the staggered start date of the intervention.\u003csup\u003e24\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe sampling methodology for the outcome survey combined remote selection methodologies incorporating satellite imagery and traditional random street selection. All streets within a cluster were manually split into 100\u0026mdash;300 metre segments within GIS software (ArcGIS version 10.5), which were then randomly selected. Following community sensitisation, all households (defined as a person or group of related or unrelated persons who live together in the same dwelling or unit(s) of a dwelling, who acknowledge one male or female as head of the household, who share the same housekeeping arrangements, and who are considered a single unit) in each dwelling in the selected street segments were enumerated. All individuals aged 18\u0026ndash;24 years residing in the enumerated households were eligible to participate. If a potentially eligible individual was not available at the time of enumeration, up to three repeat visits were made to enrol the individual.\u003c/p\u003e\n\u003cp\u003eA fingerprint was collected from each participant (as for the intervention). An interviewer-administered questionnaire was used to record sociodemographic data, duration of residence and exposure to the intervention. Participants were asked about knowledge of HIV status, history of HIV testing and care. A DBS sample was collected for anonymised HIV antibody testing and HIV viral load testing (for those who were HIV antibody positive) and for ARV testing (in selected samples).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eDried blood spot (DBS) samples from all YLWH who did not self-report as living with HIV and who had a viral load less than 10,000 copies/ml were tested using LC-MS/MS quantification for the presence of antiretroviral drugs (ARVs): efavirenz, atazanavir, ritonavir, nevirapine, abacavir, lamivudine, zidovudine and dolutegravir. Due to resource constraints, a pragmatic cut-off of 10,000copies/ml was used to indicate testing for ARVs and higher viral loads were assumed to indicate no treatment being taken. Participants were defined as \u0026lsquo;ARVs detected\u0026rsquo; if at least one ARV was detected, with the exception of lamivudine and efavirenz. If only efavirenz (N=70) or lamivudine (N=4) were detected, the participants were not defined as \u0026lsquo;ARVs detected\u0026rsquo;. Efavirenz has been known to be used as a street drug, and the presence of lamivudine alone could not be explained.\u003csup\u003e40\u003c/sup\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eSample size considerations\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe anticipated sample size was 700 youth per cluster (16 800 total). Assuming a conservative estimate of 3% HIV prevalence among 18\u0026ndash;24-year-olds and that the proportion of YLWH who were virally suppressed was 43% in the control arm (60% diagnosed \u0026times; 84% on ART \u0026times; 85% virally suppressed, based on ZIMPHIA estimates), with a coefficient of variation of 0.25, the study would have 80% power to detect a difference of 19% (i.e. 62% prevalence of viral suppression in the intervention arm) and 90% power to detect a difference of 23% (66% prevalence of viral suppression). A 66% prevalence of the primary outcome could be achieved by, for example, reaching 80% diagnosis, 91% on ART and 91% viral suppression. With a coefficient of variation of 0.3, the study would have 80% power to detect a difference of 23% and 90% power to detect a difference of 27% in the primary outcome.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eStatistical Analysis\u0026nbsp;\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe statistical analysis plan was finalised prior to the conduct of the outcome survey (Supplementary Materials).\u0026nbsp;Consolidated Standards of Reporting Trials (CONSORT) guidelines for analysis of CRTs were followed with CONSERVE guidelines to report the trial modifications made as a result of the COVID-19 pandemic.\u003csup\u003e41\u003c/sup\u003e Cluster-level analyses were used to adjust for between-cluster variability, as recommended for trials with fewer than 15 clusters/arm. Descriptive analysis was used to compare cluster-level characteristics of the two arms, with adjustment for variables that were unbalanced between arms (avoiding variables likely to be affected by the intervention) and for stratum.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor each outcome, the risk for each cluster was calculated by arm. The mean and standard deviation (SD) of the log risk was used to estimate the geometric mean and associated 95% confidence interval (CI) for each trial arm. A two-stage analysis was conducted using the \u003cem\u003eclan\u003c/em\u003e command in Stata 17.0\u003csup\u003e42\u003c/sup\u003e. In the first stage, a logistic regression model was fitted to estimate the effects on the outcome of the adjustment covariates sex and province. Cluster-summarised observed and predicted statistics were used to calculate ratio-residuals. In the second stage, linear regression of the log ratio-residual on province and arm was used to estimate the risk ratio and 95% CI for the effect of intervention. Significance tests were two-sided with 5% level of significance. \u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSubgroup analysis by sex and age category was conducted to investigate evidence of interaction with study arm. A sensitivity analysis was conducted in which all indeterminate HIV results were coded as positive and virally suppressed.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe outcomes are affected by coverage (uptake) of the intervention and therefore a Complier Average Causal Effect (CACE) analysis was conducted to estimate the effect of the trial among participants who attended the CHIEDZA services, by comparing intervention arm participants who attended the CHIEDZA service with comparable individuals in the control arm\u003csup\u003e43\u003c/sup\u003e. Compliance was defined as attending the CHIEDZA service. Survey participants in the intervention arm were coded as compliers if they either had a fingerprint match to CHIEDZA service clients, or self-reported attending the CHIEDZA service. Structural equation modelling was used to create two latent classes, with all compliers in the intervention arm in one class and all non-compliers in the other. The control arm participants were allocated to the two classes based on their similarity to the intervention arm compliers and non-compliers, on the matching variables used in the model. Within the \u0026lsquo;complier\u0026rsquo; class, a generalised linear model with a binomial family and logit link was run to estimate the effect of the intervention in this group.\u0026nbsp;The latent class modelling was run twice; first with two predictor variables for class (length of residence and living within median proximity to the community centre), then with 6 variables predictive of compliance (gender, living within median proximity to the community centre, length of residence, sexual debut, age as a binary variable, and SES quintile).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFinally, intervention uptake as reported in the survey sample was compared to intervention coverage based on estimates of the population of youth resident in the cluster to explore possible effects of population turnover on outcomes. We used the enumeration data from the survey to estimate the total population of 18-24 year olds in each cluster. The number of 18-24 year olds enumerated was divided by the proportion of the cluster area that was surveyed. We used the date of birth of CHIEDZA service attendees to determine the number of clients in each cluster who were aged 18-24 years when the survey began. The number of clients per cluster divided by the estimated number of youth resident in the cluster gave an indication of service coverage, assuming all clients were still residing in the cluster at the time of the survey.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\u003cu\u003eGovernance and reporting standards\u0026nbsp;\u003c/u\u003e\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe Trial is registered with Clinical Trials.gov (Trial registration number: NCT03719521).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEthical approval was granted by the Medical Research Council of Zimbabwe (reference number: MRCZ/A/2387), the Institutional Review Board of the Biomedical Research and Training Institute (reference number: AP149/2018) and the London School of Hygiene \u0026amp; Tropical Medicine (LSHTM) Research Ethics Committee (reference number: 12063). \u0026emsp;\u003c/p\u003e\n\u003cp\u003eZimbabwe national guidelines stipulate that those aged 16 years and older can give independent consent to accessing HIV and SRH services. At the level of the intervention, as each of the individual service components were established public health interventions (e.g. HIV testing, HIV care, family planning etc), consent was implied when clients took up intervention activities and specific written consent to participate was not obtained.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eFor the outcome survey, written consent was obtained from participants. To facilitate age-appropriate and informed consent, eligible individuals were shown a video of the study procedures enacted and narrated by the study team on a tablet with narration in English, Shona or Ndebele. The video was also available online for participants to watch later and participants were given a brief and simple information sheet to keep. Consent was documented electronically through a signature or fingerprint on the tablet, with a signed paper copy retained by participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe intervention is described in accordance with the template for intervention description and replication (TIDieR) checklist (Supplementary materials). The trial is reported in accordance with CONSORT for cluster randomized trials (Supplementary materials).\u003csup\u003e44\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003eThe funder had no role in any aspect of study design or analysis, data collection, data analysis, data interpretation, writing of the report, or the decision to submit for publication. \u003cstrong\u003e\u003cbr\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1: Characteristics of outcome survey participants\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 236px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eControl arm, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003en=8730\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntervention arm, n (%)\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003en=8822\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 236px;\"\u003e\n \u003cp\u003e\u003cem\u003eAge (years)\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e18-20\u003c/p\u003e\n \u003cp\u003e22-24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e4513 (51.7)\u003c/p\u003e\n \u003cp\u003e4217 (48.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e4660 (52.8)\u003c/p\u003e\n \u003cp\u003e4162 (47.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 236px;\"\u003e\n \u003cp\u003e\u003cem\u003eGender\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003cp\u003eNon-binary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3539 (40.5)\u003c/p\u003e\n \u003cp\u003e5189 (59.5)\u003c/p\u003e\n \u003cp\u003e1 (0.01)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3346 (37.9)\u003c/p\u003e\n \u003cp\u003e5476 (62.1)\u003c/p\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 236px;\"\u003e\n \u003cp\u003e\u003cem\u003eEducation level attained\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eDid not complete primary\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eCompleted primary\u003c/p\u003e\n \u003cp\u003eCompleted Form 4\u003c/p\u003e\n \u003cp\u003eCompleted Form 6\u003c/p\u003e\n \u003cp\u003ePost-secondary\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e168 (1.9)\u003c/p\u003e\n \u003cp\u003e1489 (17.1)\u003c/p\u003e\n \u003cp\u003e5337 (61.1)\u003c/p\u003e\n \u003cp\u003e1036 (11.9)\u003c/p\u003e\n \u003cp\u003e700 (8.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e183 (2.1)\u003c/p\u003e\n \u003cp\u003e1393 (15.8)\u003c/p\u003e\n \u003cp\u003e5376 (60.9)\u003c/p\u003e\n \u003cp\u003e1170 (13.3)\u003c/p\u003e\n \u003cp\u003e700 (7.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 236px;\"\u003e\n \u003cp\u003e\u003cem\u003eMain current activity\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eIn education\u003c/p\u003e\n \u003cp\u003eFormally employed\u003c/p\u003e\n \u003cp\u003eInformally employed\u003c/p\u003e\n \u003cp\u003eNone of the above\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2439 (27.9)\u003c/p\u003e\n \u003cp\u003e424 (4.9)\u003c/p\u003e\n \u003cp\u003e1557 (17.8)\u003c/p\u003e\n \u003cp\u003e4310 (49.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2482 (28.1)\u003c/p\u003e\n \u003cp\u003e405 (4.6)\u003c/p\u003e\n \u003cp\u003e1588 (18.0)\u003c/p\u003e\n \u003cp\u003e4347 (49.3)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 236px;\"\u003e\n \u003cp\u003e\u003cem\u003eMonthly household income\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003e\u0026lt;US$ 50\u003c/p\u003e\n \u003cp\u003eUS$ 50-100\u003c/p\u003e\n \u003cp\u003eUS$ 101-200\u003c/p\u003e\n \u003cp\u003eUS$ 201-500\u003c/p\u003e\n \u003cp\u003e\u0026gt;US$500\u003c/p\u003e\n \u003cp\u003eMissing\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1452 (19.5)\u003c/p\u003e\n \u003cp\u003e2143 (28.7)\u003c/p\u003e\n \u003cp\u003e2252 (30.2)\u003c/p\u003e\n \u003cp\u003e1312 (17.6)\u003c/p\u003e\n \u003cp\u003e298 (4.0)\u003c/p\u003e\n \u003cp\u003e1273\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e1148 (15.2)\u003c/p\u003e\n \u003cp\u003e2281 (30.1)\u003c/p\u003e\n \u003cp\u003e2468 (32.6)\u003c/p\u003e\n \u003cp\u003e1389 (18.3)\u003c/p\u003e\n \u003cp\u003e294 (3.9)\u003c/p\u003e\n \u003cp\u003e1242\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 236px;\"\u003e\n \u003cp\u003e\u003cem\u003ePartnership status\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eMarried or living together\u003c/p\u003e\n \u003cp\u003eNever married\u003c/p\u003e\n \u003cp\u003eDivorced, widowed or separated\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e6595 (75.5)\u003c/p\u003e\n \u003cp\u003e1705 (19.5)\u003c/p\u003e\n \u003cp\u003e430 (4.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e6619 (75.0)\u003c/p\u003e\n \u003cp\u003e1839 (20.9)\u003c/p\u003e\n \u003cp\u003e364 (4.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 236px;\"\u003e\n \u003cp\u003e\u003cem\u003eSexual debut\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eHas had penetrative sexual intercourse\u003c/p\u003e\n \u003cp\u003eNever had penetrative sexual intercourse\u003c/p\u003e\n \u003cp\u003eMissing/refused\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5652 (65.0)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3048 (35.0)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e5554 (63.3)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e3215 (36.7)\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e53\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 236px;\"\u003e\n \u003cp\u003e\u003cem\u003eResidence at current address\u003c/em\u003e\u003c/p\u003e\n \u003cp\u003eLess than 12 months\u003c/p\u003e\n \u003cp\u003e12 to 24 months\u003c/p\u003e\n \u003cp\u003e\u0026gt;2 years to 3 years\u003c/p\u003e\n \u003cp\u003eMore than 3 years\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2051 (23.5)\u003c/p\u003e\n \u003cp\u003e770 (8.8)\u003c/p\u003e\n \u003cp\u003e801 (9.2)\u003c/p\u003e\n \u003cp\u003e5108(58.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e2159 (24.5)\u003c/p\u003e\n \u003cp\u003e922 (10.5)\u003c/p\u003e\n \u003cp\u003e881 (10.0)\u003c/p\u003e\n \u003cp\u003e4860 (55.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2: Primary and secondary trial outcomes adjusted for sex\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 78px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eOutcome\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 98px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSample\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 69px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eN\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCluster-level geometric mean prevalence\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 127px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRisk Ratio\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(95% CI)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 58px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 76px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eControl\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 601px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ePrimary outcome\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 98px;\"\u003e\n \u003cp\u003eYLWH\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 69px;\"\u003e\n \u003cp\u003e1217\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e38.3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e41.3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 127px;\"\u003e\n \u003cp\u003e1.07 (0.88-1.30)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 58px;\"\u003e\n \u003cp\u003e0.47\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"7\" valign=\"top\" style=\"width: 601px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSecondary outcomes (aligned to UNAIDS 90-90-90 targets)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eKnow HIV diagnosis\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 98px;\"\u003e\n \u003cp\u003eYLWH\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 69px;\"\u003e\n \u003cp\u003e1226\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e51.5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e51.6%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 127px;\"\u003e\n \u003cp\u003e0.99 (0.76-1.28)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 58px;\"\u003e\n \u003cp\u003e0.93\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTaking ART\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 98px;\"\u003e\n \u003cp\u003eYLWH who know their HIV status\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 69px;\"\u003e\n \u003cp\u003e650\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e96.3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e87.3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 127px;\"\u003e\n \u003cp\u003e0.91 (0.83-0.99)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 58px;\"\u003e\n \u003cp\u003e0.025\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 78px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVS\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 98px;\"\u003e\n \u003cp\u003eYLWH taking ART\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 69px;\"\u003e\n \u003cp\u003e599\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 76px;\"\u003e\n \u003cp\u003e52.6%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e62.7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 127px;\"\u003e\n \u003cp\u003e1.19 (1.02-1.39)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 58px;\"\u003e\n \u003cp\u003e0.033\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eVS: viral suppression; YLWH: youth living with HIV; ART: antiretroviral therapy\u003c/p\u003e\n\u003cp\u003eYLWH defined as participants who either had a positive ELISA test on DBS sample or self-reported as HIV positive\u003c/p\u003e\n\u003cp\u003eYLWH who know their HIV status defined as YLWH who either self-reported as HIV positive or had ARVs detected in their DBS sample\u003c/p\u003e\n\u003cp\u003eYLWH taking ART defined as YLWH who either self-reported as taking ART or had ARVS detected in their DBS sample\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 3: Trial outcomes stratified by age and sex\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"680\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eOutcome\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"2\" valign=\"top\" style=\"width: 161px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eCluster-level geometric mean prevalence\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 132px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eRisk Ratio\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e(95% CI)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eInteraction p-value\u003c/strong\u003e\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\u003cstrong\u003eControl\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntervention\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 586px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ePrimary outcome stratified by sex and age (years)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVS (\u003cem\u003ein YLWH\u003c/em\u003e)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eMale\u0026nbsp;\u003c/p\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e36.9%\u003c/p\u003e\n \u003cp\u003e39.7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e42.8%\u003c/p\u003e\n \u003cp\u003e41.7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e1.16 (0.79-1.70)\u003c/p\u003e\n \u003cp\u003e1.05 (0.87-1.28)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0.43\u003c/p\u003e\n \u003cp\u003e0.60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e0.62\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e18-20\u003c/p\u003e\n \u003cp\u003e21-24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e34.2%\u003c/p\u003e\n \u003cp\u003e39.3%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e30.2%\u003c/p\u003e\n \u003cp\u003e45.9%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e0.90 (0.63-1.27)\u003c/p\u003e\n \u003cp\u003e1.16 (0.93-1.44)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0.53\u003c/p\u003e\n \u003cp\u003e0.19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e0.18\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 586px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSecondary outcomes by sex (aligned to UNAIDS 90-90-90 targets)\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eKnow HIV diagnosis (\u003cem\u003ein YLWH)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e49.2%\u003c/p\u003e\n \u003cp\u003e55.1%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e52.3%\u003c/p\u003e\n \u003cp\u003e52.7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e1.06 (0.68-1.66)\u003c/p\u003e\n \u003cp\u003e0.96 (0.76-1.21)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0.77\u003c/p\u003e\n \u003cp\u003e0.70\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e0.59\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTaking ART (\u003cem\u003ein YLWH*\u003c/em\u003e)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e97.6%\u003c/p\u003e\n \u003cp\u003e95.6%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e88.9%\u003c/p\u003e\n \u003cp\u003e87.1%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e0.91 (0.83-1.00)\u003c/p\u003e\n \u003cp\u003e0.91 (0.83-1.00)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0.062\u003c/p\u003e\n \u003cp\u003e0.046\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e0.88\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVS (\u003cem\u003ein those taking ART\u003c/em\u003e)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e56.1%\u003c/p\u003e\n \u003cp\u003e52.5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e64.1%\u003c/p\u003e\n \u003cp\u003e64.5%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e1.15 (0.76-1.73)\u003c/p\u003e\n \u003cp\u003e1.23 (1.03-1.48)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0.50\u003c/p\u003e\n \u003cp\u003e0.028\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e0.81\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"6\" valign=\"top\" style=\"width: 586px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSecondary outcomes by age in years (aligned to UNAIDS 90-90-90 targets)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eKnow HIV diagnosis (\u003cem\u003ein YLHW\u003c/em\u003e)\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e18-20\u003c/p\u003e\n \u003cp\u003e21-24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e43.0%\u003c/p\u003e\n \u003cp\u003e54.7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e50.5%\u003c/p\u003e\n \u003cp\u003e54.1%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e1.15 (0.64-2.08)\u003c/p\u003e\n \u003cp\u003e0.98 (0.77-1.24)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0.62\u003c/p\u003e\n \u003cp\u003e0.86\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e0.52\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTaking ART (in YLHW*\u003cem\u003e)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e18-20\u003c/p\u003e\n \u003cp\u003e21-24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e95.2%\u003c/p\u003e\n \u003cp\u003e96.2%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e87.1%\u003c/p\u003e\n \u003cp\u003e87.2%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e0.92 (0.83-1.02)\u003c/p\u003e\n \u003cp\u003e0.91 (0.82-1.01)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0.12\u003c/p\u003e\n \u003cp\u003e0.06\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e0.92\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd style=\"width: 170px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eVS (\u003cem\u003ein those taking ART\u003c/em\u003e)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e18-20\u003c/p\u003e\n \u003cp\u003e21-24\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e52.8%\u003c/p\u003e\n \u003cp\u003e53.7%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 95px;\"\u003e\n \u003cp\u003e51.3%\u003c/p\u003e\n \u003cp\u003e68.8%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e0.98 (0.68-1.43)\u003c/p\u003e\n \u003cp\u003e1.28 (1.11-1.47)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e0.93\u003c/p\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 94px;\"\u003e\n \u003cp\u003e0.11\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eVS: viral suppression; YLWH: youth living with HIV; ART: antiretroviral therapy\u003c/p\u003e\n\u003cp\u003e*Who know their HIV status\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n \u003cli\u003eUNAIDS. Seizing the moment: Tackling entrenched inequalities to end epidemics. (UNAIDS, Geneva, Switzerland, 2020).\u003c/li\u003e\n \u003cli\u003eSlogrove, A.L. \u0026amp; Sohn, A.H. The global epidemiology of adolescents living with HIV: time for more granular data to improve adolescent health outcomes. \u003cem\u003eCurr Opin HIV AIDS\u003c/em\u003e \u003cstrong\u003e13\u003c/strong\u003e, 170-178 (2018).\u003c/li\u003e\n \u003cli\u003eZimbabwe Population-based HIV Impact Assessment (ZIMPHIA) 2015-16: Final Report. (Ministry of Health and Child Care (MOHCC) Zimbabwe, Harare, Zimbabwe, 2017).\u003c/li\u003e\n \u003cli\u003eMalawi Population-based HIV Impact Assessment (MPHIA) 2015-16: Final Report. (Ministry of Health Malawi, Malawi, 2017).\u003c/li\u003e\n \u003cli\u003eZambia Population-based HIV Impact Assessment (ZAMPHIA) 2016: Final Report. (Ministry of Health Zambia, Zambia, 2017).\u003c/li\u003e\n \u003cli\u003eQuinn, T.C.\u003cem\u003e, et al.\u003c/em\u003e Viral load and heterosexual transmission of human immunodeficiency virus type 1. Rakai Project Study Group. \u003cem\u003eN Engl J Med\u003c/em\u003e \u003cstrong\u003e342\u003c/strong\u003e, 921-929 (2000).\u003c/li\u003e\n \u003cli\u003eMellors, J.W.\u003cem\u003e, et al.\u003c/em\u003e Prognosis in HIV-1 infection predicted by the quantity of virus in plasma. \u003cem\u003eScience\u003c/em\u003e \u003cstrong\u003e272\u003c/strong\u003e, 1167-1170 (1996).\u003c/li\u003e\n \u003cli\u003eKurth, A.E., Lally, M.A., Choko, A.T., Inwani, I.W. \u0026amp; Fortenberry, J.D. HIV testing and linkage to services for youth. \u003cem\u003eJ Int AIDS Soc\u003c/em\u003e \u003cstrong\u003e18\u003c/strong\u003e, 19433 (2015).\u003c/li\u003e\n \u003cli\u003eSam-Agudu, N.A., Folayan, M.O. \u0026amp; Ezeanolue, E.E. Seeking wider access to HIV testing for adolescents in sub-Saharan Africa. \u003cem\u003ePediatric Research\u003c/em\u003e \u003cstrong\u003e79\u003c/strong\u003e, 838-845 (2016).\u003c/li\u003e\n \u003cli\u003eEba, P.M. \u0026amp; Lim, H. Reviewing independent access to HIV testing, counselling and treatment for adolescents in HIV-specific laws in sub-Saharan Africa: implications for the HIV response. \u003cem\u003eJ Int AIDS Soc\u003c/em\u003e \u003cstrong\u003e20\u003c/strong\u003e, 21456 (2017).\u003c/li\u003e\n \u003cli\u003eStrode, A. \u0026amp; Essack, Z. Facilitating access to adolescent sexual and reproductive health services through legislative reform: Lessons from the South African experience. \u003cem\u003eS Afr Med J\u003c/em\u003e \u003cstrong\u003e107\u003c/strong\u003e, 741-744 (2017).\u003c/li\u003e\n \u003cli\u003eNinsiima, L.R., Chiumia, I.K. \u0026amp; Ndejjo, R. Factors influencing access to and utilisation of youth-friendly sexual and reproductive health services in sub-Saharan Africa: a systematic review. \u003cem\u003eReprod Health\u003c/em\u003e \u003cstrong\u003e18\u003c/strong\u003e, 135 (2021).\u003c/li\u003e\n \u003cli\u003eFleischman, J.\u003cem\u003e, et al.\u003c/em\u003e Catalyzing action on HIV/SRH integration: lessons from Kenya, Malawi, and Zimbabwe to spur investment. \u003cem\u003eGlobal health action\u003c/em\u003e \u003cstrong\u003e15\u003c/strong\u003e, 2029335 (2022).\u003c/li\u003e\n \u003cli\u003eDenno, D.M., Hoopes, A.J. \u0026amp; Chandra-Mouli, V. Effective strategies to provide adolescent sexual and reproductive health services and to increase demand and community support. \u003cem\u003eJ Adolesc Health\u003c/em\u003e \u003cstrong\u003e56\u003c/strong\u003e, S22-41 (2015).\u003c/li\u003e\n \u003cli\u003eDenno, D.M., Chandra-Mouli, V. \u0026amp; Osman, M. Reaching youth with out-of-facility HIV and reproductive health services: a systematic review. \u003cem\u003eJ Adolesc Health\u003c/em\u003e \u003cstrong\u003e51\u003c/strong\u003e, 106-121 (2012).\u003c/li\u003e\n \u003cli\u003eDziva Chikwari, C.\u003cem\u003e, et al.\u003c/em\u003e Differentiated care for youth in Zimbabwe: Outcomes across the HIV care cascade. \u003cem\u003ePLOS Glob Public Health\u003c/em\u003e \u003cstrong\u003e4\u003c/strong\u003e, e0002553 (2024).\u003c/li\u003e\n \u003cli\u003eSimms, V.\u003cem\u003e, et al.\u003c/em\u003e Uptake of community-based integrated HIV and sexual and reproductive health services for youth in Zimbabwe. \u003cem\u003eBMC Health Services Res\u0026nbsp;\u003c/em\u003e(2024): Under review. Preprint: https://www.researchsquare.com/article/rs-4426663/v1\u003c/li\u003e\n \u003cli\u003eUNAIDS. 90-90-90. An ambitious treatment target to help end the AIDS epidemic. (Geneva, Switzerland, 2014).\u003c/li\u003e\n \u003cli\u003eLarsson, L.\u003cem\u003e, et al.\u003c/em\u003e HIV testing uptake in a sexual and reproductive health service for youth and impact on population prevalence of undiagnosed HIV in Zimbabwe. in \u003cem\u003e25th International AIDS Conference\u003c/em\u003e (Munich, Germany, 2024).\u003c/li\u003e\n \u003cli\u003eHensen, B.\u003cem\u003e, et al.\u003c/em\u003e The impact of community-based, peer-led sexual and reproductive health services on knowledge of HIV status among adolescents and young people aged 15 to 24 in Lusaka, Zambia: The Yathu Yathu cluster-randomised trial. \u003cem\u003ePLoS Med\u003c/em\u003e \u003cstrong\u003e20\u003c/strong\u003e, e1004203 (2023).\u003c/li\u003e\n \u003cli\u003eIngold, H.\u003cem\u003e, et al.\u003c/em\u003e The Self-Testing AfRica (STAR) Initiative: accelerating global access and scale-up of HIV self-testing. \u003cem\u003eJ Int AIDS Soc\u003c/em\u003e \u003cstrong\u003e22 Suppl 1\u003c/strong\u003e, e25249 (2019).\u003c/li\u003e\n \u003cli\u003eHatzold, K.\u003cem\u003e, et al.\u003c/em\u003e HIV self-testing: breaking the barriers to uptake of testing among men and adolescents in sub-Saharan Africa, experiences from STAR demonstration projects in Malawi, Zambia and Zimbabwe. \u003cem\u003eJ Int AIDS Soc\u003c/em\u003e \u003cstrong\u003e22 Suppl 1\u003c/strong\u003e, e25244 (2019).\u003c/li\u003e\n \u003cli\u003eSimms, V.\u003cem\u003e, et al.\u003c/em\u003e Use of biometrics to evaluate intervention coverage and contamination in a cluster randomised trial in Zimbabwe. \u003cem\u003eImplementation Science\u003c/em\u003e (2024): Under Review.\u003c/li\u003e\n \u003cli\u003eDziva Chikwari, C.\u003cem\u003e, et al.\u003c/em\u003e The impact of community-based integrated HIV and sexual and reproductive health services for youth on population-level HIV viral load and sexually transmitted infections in Zimbabwe: protocol for the CHIEDZA cluster-randomised trial. \u003cem\u003eWellcome Open Res\u003c/em\u003e \u003cstrong\u003e7\u003c/strong\u003e, 54 (2022).\u003c/li\u003e\n \u003cli\u003eWasserheit, J.N. \u0026amp; Aral, S.O. The dynamic topology of sexually transmitted disease epidemics: implications for prevention strategies. \u003cem\u003eJ Infect Dis\u003c/em\u003e \u003cstrong\u003e174 Suppl 2\u003c/strong\u003e, S201-213 (1996).\u003c/li\u003e\n \u003cli\u003eZimbabwe Population-based HIV Impact Assessment 2020 (ZIMPHIA 2020): Final Report. (Ministry of Health and Child Care (MoHCC), Harare, Zimbabwe, 2021).\u003c/li\u003e\n \u003cli\u003eKawuma, R., Seeley, J., Mupambireyi, Z., Cowan, F. \u0026amp; Bernays, S. \u0026quot;Treatment is not yet necessary\u0026quot;: delays in seeking access to HIV treatment in Uganda and Zimbabwe. \u003cem\u003eAfrican journal of AIDS research : AJAR\u003c/em\u003e \u003cstrong\u003e17\u003c/strong\u003e, 217-225 (2018).\u003c/li\u003e\n \u003cli\u003eSeeley, J.\u003cem\u003e, et al.\u003c/em\u003e Understanding the Time Needed to Link to Care and Start ART in Seven HPTN 071 (PopART) Study Communities in Zambia and South Africa. \u003cem\u003eAIDS Behav\u003c/em\u003e \u003cstrong\u003e23\u003c/strong\u003e, 929-946 (2019).\u003c/li\u003e\n \u003cli\u003eAdejumo, O.A., Malee, K.M., Ryscavage, P., Hunter, S.J. \u0026amp; Taiwo, B.O. Contemporary issues on the epidemiology and antiretroviral adherence of HIV-infected adolescents in sub-Saharan Africa: a narrative review. \u003cem\u003eJ Int AIDS Soc\u003c/em\u003e \u003cstrong\u003e18\u003c/strong\u003e, 20049 (2015).\u003c/li\u003e\n \u003cli\u003eMackworth-Young, C.R.S.\u003cem\u003e, et al.\u003c/em\u003e Putting youth at the centre: co-design of a community-based intervention to improve HIV outcomes among youth in Zimbabwe. \u003cem\u003eWellcome Res Open\u003c/em\u003e \u003cstrong\u003e7\u003c/strong\u003e, 53 (2022).\u003c/li\u003e\n \u003cli\u003eMackworth-Young, C.\u003cem\u003e, et al.\u003c/em\u003e \u0026lsquo;You can say anything without fear for being judged\u0026rsquo;: High acceptability of a community-based integrated HIV and sexual and reproductive health service among youth clients in Zimbabwe. in \u003cem\u003e22nd International Conference on AIDS and STIs in Africa (ICASA)\u003c/em\u003e (Harare, Zimbabwe, 2023).\u003c/li\u003e\n \u003cli\u003eHlahla, K.\u003cem\u003e, et al.\u003c/em\u003e Prevalence of substance and hazardous alcohol use and their association with risky sexual behaviour among youth: findings from a population-based survey in Zimbabwe. \u003cem\u003eBMJ open\u003c/em\u003e \u003cstrong\u003e14\u003c/strong\u003e, e080993 (2024).\u003c/li\u003e\n \u003cli\u003eKim, M.H.\u003cem\u003e, et al.\u003c/em\u003e High self-reported non-adherence to antiretroviral therapy amongst adolescents living with HIV in Malawi: barriers and associated factors. \u003cem\u003eJ Int AIDS Soc\u003c/em\u003e \u003cstrong\u003e20\u003c/strong\u003e, 21437 (2017).\u003c/li\u003e\n \u003cli\u003eCohen, M.S.\u003cem\u003e, et al.\u003c/em\u003e Antiretroviral Therapy for the Prevention of HIV-1 Transmission. \u003cem\u003eN Engl J Med\u003c/em\u003e \u003cstrong\u003e375\u003c/strong\u003e, 830-839 (2016).\u003c/li\u003e\n \u003cli\u003eMahiya, I. 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Adverse Neuropsychiatric Events and Recreational Use of Efavirenz and Other HIV-1 Antiretroviral Drugs. \u003cem\u003ePharmacol Rev\u003c/em\u003e \u003cstrong\u003e70\u003c/strong\u003e, 684-711 (2018).\u003c/li\u003e\n \u003cli\u003eCampbell, M.K., Elbourne, D.R. \u0026amp; Altman, D.G. CONSORT statement: extension to cluster randomised trials. \u003cem\u003eBmj\u003c/em\u003e \u003cstrong\u003e328\u003c/strong\u003e, 702-708 (2004).\u003c/li\u003e\n \u003cli\u003eThompson, J.A., Leurent, B., Nash, S., Moulton, L.H. \u0026amp; Hayes, R.J. Cluster randomized controlled trial analysis at the cluster level: The clan command. \u003cem\u003eStata J\u003c/em\u003e \u003cstrong\u003e23\u003c/strong\u003e, 754-773 (2023).\u003c/li\u003e\n \u003cli\u003eTroncoso, P. \u0026amp; Morales-Gomez, A. Estimating the complier average causal effect via a latent class approach using gsem. \u003cem\u003eStata J\u003c/em\u003e \u003cstrong\u003e22\u003c/strong\u003e, 404-415 (2022).\u003c/li\u003e\n \u003cli\u003eCampbell, M.K., Piaggio, G., Elbourne, D.R. \u0026amp; Altman, D.G. Consort 2010 statement: extension to cluster randomised trials. \u003cem\u003eBmj\u003c/em\u003e \u003cstrong\u003e345\u003c/strong\u003e, e5661 (2012).\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"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":"nature-portfolio","isNatureJournal":true,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"","title":"Nature Portfolio","twitterHandle":"","acdcEnabled":false,"dfaEnabled":false,"editorialSystem":"ejp","reportingPortfolio":"","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"","lastPublishedDoi":"10.21203/rs.3.rs-5594349/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-5594349/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cem\u003eWe conducted a \u003c/em\u003ecluster randomized trial of community-based services\u003cem\u003e incorporating HIV testing, treatment and adherence support integrated with sexual and reproductive health services for youth (16-24years) \u003c/em\u003ein Zimbabwe\u003cem\u003e. 24 clusters \u003c/em\u003ewere randomized 1:1 to intervention or control (existing services only). Primary outcome was virological suppression (VS=viral load\u0026lt;1000copies/ml) among youth living with HIV (YLWH), ascertained through a population-level outcome survey of 17,682 youth (18-24years). Secondary outcomes corresponded to UNAIDS 90-90-90 targets. There was no difference by arm in primary outcome (mean cluster prevalence:41.3% (intervention)\u003cem\u003e vs\u003c/em\u003e 38.3% (control); RR:1.07 (95%CI:0.88-1.30)), or in proportion of YLWH who were diagnosed. In the intervention arm, a lower proportion of diagnosed YLWH were taking treatment (RR=0.91 (95%CI:0.83-0.99)), but a higher proportion of those taking treatment had VS (RR=1.18 (95%CI:1.02-1.37)). The intervention did not impact proportion of youth with undiagnosed HIV, which explains the effect on primary outcome. Among those taking ART, the intervention improved VS.\u003c/p\u003e","manuscriptTitle":"Impact of integrated community-based HIV and sexual and reproductive health services for youth aged 16-24 years on population-level HIV outcomes in Zimbabwe: the CHIEDZA cluster randomized trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2024-12-11 06:10:14","doi":"10.21203/rs.3.rs-5594349/v1","editorialEvents":[],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"nature-medicine","isNatureJournal":true,"hasQc":false,"allowDirectSubmit":false,"externalIdentity":"nm","sideBox":"Learn more about [Nature Medicine](http://www.nature.com/nm/)","snPcode":"","submissionUrl":"","title":"Nature Medicine","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"ejp","reportingPortfolio":"Nature Research","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"e061456b-f0e5-46a9-b9c9-41a961ccf7ad","owner":[],"postedDate":"December 11th, 2024","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"published-in-journal","subjectAreas":[{"id":41425828,"name":"Health sciences/Medical research/Epidemiology"},{"id":41425829,"name":"Scientific community and society/Developing world"}],"tags":[],"updatedAt":"2025-06-25T07:09:11+00:00","versionOfRecord":{"articleIdentity":"rs-5594349","link":"https://doi.org/10.1038/s41591-025-03762-z","journal":{"identity":"nature-medicine","isVorOnly":false,"title":"Nature Medicine"},"publishedOn":"2025-06-24 04:00:00","publishedOnDateReadable":"June 24th, 2025"},"versionCreatedAt":"2024-12-11 06:10:14","video":"","vorDoi":"10.1038/s41591-025-03762-z","vorDoiUrl":"https://doi.org/10.1038/s41591-025-03762-z","workflowStages":[]},"version":"v1","identity":"rs-5594349","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-5594349","identity":"rs-5594349","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}