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Williams, Emee Awai Rai, Georgia Artzberger, Audrey Safir, and 15 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7594652/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 8 You are reading this latest preprint version Abstract Background Cholera remains a significant public health threat in many low- and middle-income countries (LMICs). Rapid diagnostic tests (RDTs) offer a promising tool for improving surveillance and timely response, particularly as programs like Gavi’s Diagnostics Support Platform expand access. To realize the full potential of RDTs, effective national distribution strategies are essential. Objective This study aimed to document lessons learned from Nepal’s first government-led, large-scale distribution of cholera RDTs in 2024, to inform successful strategies for national and global scale-up. Methods We conducted a mixed-methods evaluation of the 2024 cholera RDT rollout in Nepal. Data collection included quantitative surveys with laboratory technicians and clinicians from health facilities, provincial public health laboratories (PPHLs), and government stakeholders. In-depth interviews were conducted with clinicians, laboratory technicians, medical recorders, and government officials to explore implementation experiences. Results Nepal’s experiences rolling out cholera RDTs offer important lessons in supply chain management. Procurement : Support from Gavi and technical partners was vital for securing RDTs. Opportunities exist to simplify application processes, and delays should be anticipated. Importation : Timely coordination with the Ministry of Finance was necessary to obtain duty exemption certificates and avoid customs fees. Surveillance site selection : Facilities selected for RDT distribution needed both reporting mechanisms and connections for confirmatory testing. However, extending RDTs to lower-level, rural facilities is important for greater impact. Demand forecasting and stock management : Allocation decisions benefited from combining surveillance data with local knowledge. Rigorous and systematic data on RDT usage can inform forecasting for future years. Stock tracking systems and redistribution mechanisms are critical to preventing both stock-outs and wastage. Distribution pathway : Provincial-led distribution and stockpiles facilitated rapid delivery and responsiveness. Shipping : Coordinating RDT shipments with other supplies and standardizing delivery procedures is important for efficiency. Training and Communication : In-person training and clear communication on both RDT use and distribution across all levels of government and health facilities facilitate implementation. Conclusion Nepal’s experiences provide practical, transferable lessons on cholera RDT distribution that can guide similar efforts in other cholera-endemic countries. cholera rapid diagnostic tests distribution supply chain management qualitative research implementation science Figures Figure 1 Figure 2 Background Cholera remains a critical global health challenge, especially in poor and vulnerable communities. 1 Rapid diagnostic tests (RDTs) for cholera can enhance efforts to control cholera by enabling greater detection and faster response. 2 , 3 However, RDTs are only recently becoming more widely available. Historically, countries had to request RDTs from the World Health Organization (WHO) when an outbreak emerged. The WHO would supply a limited number of RDTs for targeted use. Now, with leading cholera control organizations such as Gavi, the Vaccine Alliance, and the Global Task Force for Cholera Control (GTFCC) supporting broader use of cholera RDTs as a screening tool, countries are being encouraged to use RDTs more widely within national surveillance systems. This shift to more widespread use of RDTs requires countries to develop detailed RDT distribution plans to ensure timely access and availability. Prior studies on supply chain management for other medical commodities highlight the importance of accurate demand forecasting, sufficient procurement, quality assurance, equitable distribution, inventory management, robust logistics systems, and appropriate training. 4 Different distribution strategies have been employed for other health products, such as push systems—where central authorities estimate and supply commodities to facilities—and pull systems—where health facilities request supplies based on need. 5 Centralized supply chains involve direct national-level distribution to health facilities, whereas decentralized systems engage district or provincial intermediaries. Additionally, some systems integrate diagnostic test distribution with existing medical supply chains, while others operate in vertical silos. 6 Research is needed to understand how these supply chain principles apply in the context of cholera RDTs, and how they should be adapted or prioritized to support effective and sustainable nationwide distribution. To the authors’ knowledge, no research has been published to date on the unique considerations involved in supply chain management and nationwide distribution of cholera RDTs. Most published research on rapid diagnostic tests—whether for cholera or other diseases—focuses on diagnostic performance, correct usage, and health impact. Ensuring cholera RDT availability and access is a critical precursor to adoption and impact, yet little research has addressed implementation and scale-up strategies. The Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework highlights the importance of reach and implementation in evaluating interventions. 7 , 8 More evidence is needed to identify cholera RDT distribution barriers and develop strategies to prevent stock-outs and improve access. 4 Our study focuses on these dimensions to generate evidence that can guide RDT implementation efforts in low- and middle-income countries (LMICs). 7 , 8 Following a pilot of cholera RDTs in 2023 9 , Nepal undertook its first large-scale, government-led distribution of cholera RDTs in 2024—the inaugural year of Gavi’s Diagnostics Support Platform. We conducted an evaluation of this national rollout to document successes, identify challenges, and develop recommendations to guide future RDT distribution in pursuit of Nepal’s cholera elimination goal. Methods Study context Cholera is endemic in Nepal, with sporadic outbreaks annually, particularly during the monsoon season from May to September. 10 , 11 Nepal's Early Warning and Reporting System (EWARS) is a network of hospitals that monitor and report on six high-priority diseases, one being cholera. At the time of our study, 118 hospitals were designated as EWARS sentinel sites. 12 The Epidemiology and Disease Control Division (EDCD) is a government entity in Nepal responsible for the surveillance, prevention, and control of infectious diseases, including cholera. There are seven provinces in Nepal, and each province has a Provincial Public Health Laboratory (PPHL) responsible for conducting diagnostic testing, supporting disease surveillance, and providing laboratory guidance, while the Provincial Public Health Directorate (PHD) oversees overall health program implementation, coordination, and resource allocation within the province. The National Public Health Laboratory (NPHL) in Nepal serves as the central reference laboratory, overseeing laboratory standards, quality assurance, and diagnostic capacity, including providing technical guidance, training, and support to PPHLs. In 2023, the EDCD applied to the Gavi Diagnostics Support Platform, a global initiative aimed at expanding access to rapid diagnostic tests for infectious diseases in LMICs 13 , and was awarded 43,600 cholera RDTs for the 2024 cholera season. In 2024, Nepal updated their National Cholera Elimination Plan (NCEP) (currently under final review), which serves as a comprehensive framework to prevent, detect, and respond to cholera outbreaks to reduce the cholera disease burden and mortality. 14 RDTs are highlighted as a key strategy for enhancing cholera surveillance. Data collection methods Quantitative Surveys We collected quantitative data through three separate surveys. First, we asked all 118 EWARS health facilities to complete an online survey through REDCap 15 every month from January through November 2024. A designated laboratory technician responsible for cholera RDTs at each facility entered RDT stock levels, usage, and results monthly. Second, we selected a sub-sample of 94 EWARS health facilities from all seven provinces of Nepal to participate in a more in-depth, phone-based facility survey after the cholera season. Our sample size was based on the universe of EWARS facilities (n = 118), an assumed point estimate of 50%, and alpha of 0.05; with 94 facilities, we expected to be able to estimate our facility-level indicators with a precision of 4.7 percentage points. Selection was designed to include all EWARS facilities in Bagmati and Sudurpashchim provinces, where RDTs were distributed first, as well as a mix of rural/urban and public/private/teaching EWARS facilities of varying sizes from each of the other five provinces. Separate surveys on RDT implementation, training, and perceptions were completed by a laboratory technician and clinician at each facility who worked with cholera patients or samples. Third, we conducted a phone-based survey in January 2025 with representatives from each of the seven PPHLs and key government stakeholders on RDT management and roll-out. Participants from health facilities and PPHLs received 500 Nepali Rupees (~ 4 USD) for completing each survey. Qualitative interviews We selected 12 EWARS health facilities near Kathmandu in the Bagmati province that had received cholera RDTs to participate in our qualitative investigation. Bagmati was selected given logistical feasibility and because Bagmati EWARS facilities were among the first to receive cholera RDTs from the government in 2024. Within each facility, we invited one clinician, one laboratory technician, and one medical recorder (responsible for reporting health data to national databases) to participate in a qualitative interview. A total of 12 clinicians, 12 laboratory technicians, and 9 medical recorders agreed to be interviewed between August - September 2024. We also interviewed a total of 10 government stakeholders who had some role in cholera RDT implementation in Nepal. Six government stakeholders were interviewed in June 2024. Eight government stakeholders were interviewed in September 2024, including four who had participated in round 1 of interviews and four new stakeholders. Interviews were conducted by four study staff members who were trained in qualitative interviewing techniques, in English or Nepali depending on the participants’ preference. We developed semi-structured interview guides covering topics related to cholera RDT roll-out (see Supplementary Materials). One observer also attended each interview to take detailed notes. Interviews were conducted at the EWARS health facilities and government offices in a location of the participants’ choosing. Interviews were audio-recorded with participant consent and transcribed into English for analysis. Data analysis Quantitative data Quantitative data were cleaned using R version 4.3.1 statistical software 16 , then analyzed in StataNow/BE version 18.5 17 . We calculated descriptive statistics (medians and percentages) for key indicators. Qualitative data Interviews were transcribed and translated into English. All transcriptions were reviewed by study staff fluent in both English and Nepali to ensure accuracy. Qualitative data analysis was conducted through an iterative, team-based approach. First, transcripts were reviewed to develop a codebook capturing themes relevant to the procurement, transport, and distribution of RDTs. Coding was performed using Taguette (Rampin & Rampin, 2021). 18 Researchers trained in qualitative analysis independently coded the transcripts. Each coded transcript was reviewed by another researcher to ensure consistency and rigor. Any disagreements in coding were discussed as a group to reach a consensus decision. Once coding was complete, the quotes within each theme were examined to identify key emerging points and patterns related to the challenges, successes, and lessons learned in RDT distribution. Ethical approval Ethical approval was obtained from the JHU Institutional Review Board (IRB00025777 and IRB00028398) and the Nepal Health Research Council (Reg. No. 44612023). Results We present our findings organized by key supply chain domains, including procurement, importation, surveillance site selection, demand forecasting, stock management, distribution pathways, shipping, and training and communication on RDT distribution. Procurement Strategies/successes : Nepal government stakeholders reported receiving shipments of cholera RDTs from Gavi in April (13,000 RDTs), July (20,000 RDTs), and August (10,660 RDTs) of 2024. This quantity represents a major increase over the 6,000 RDTs received through the pilot study in 2023. Government participants noted that the Gavi Diagnostics Platform was vital to obtaining the larger quantity of RDTs to support the new NCEP, and that Gavi’s continued support is needed to maintain an RDT supply for the country. Government representatives believed the Gavi application for cholera RDTs was straightforward. They noted the usefulness of technical assistance from external partners in developing the application. “In the NCEP for surveillance, RDT based cholera surveillance is there, and we'll keep that in place. But for securing the RDT, we have specifically mentioned that it will be secured through in-kind contribution from Gavi. We are very clear that this might not be the time that the country can invest in the RDT kits.” – Government stakeholder, end of cholera season 2024 Challenges : Government participants reported the second and third shipments of RDTs to Nepal were delayed due to manufacturing problems. Anticipating the prompt arrival of the second shipment, the government distributed the first shipment to two provinces. Bagmati and Sudurpashchim provinces were prioritized due to their high number of EWARS facilities, anticipated cholera caseload, and their involvement in an ongoing cholera research study. However, when the second shipment was delayed, facilities in the other five provinces remained without RDTs for most of the 2024 cholera season. Importation Strategies/successes : The first shipment of cholera RDTs arrived in Nepal just before the monsoon season, creating urgency for expedited processing. Despite some delays and incurrence of customs fees, the shipment was cleared in about 15 days – well ahead of the typical 1-2 month timeframe. The customs process was mastered for subsequent RDT shipments, including coordination between the Ministry of Finance and Ministry of Health and Population to secure RDT custom fee waivers. Challenges : Government participants highlighted that the procedures for customs clearance are extensive and complex, and manufacturing or shipping delays increased the pressure to clear customs more rapidly than usual. Additionally, customs levy a fee if materials remain in storage for over a week; in the case of the first shipment, these fees were covered by a research study. Surveillance Site Selection Strategies/successes : Government participants explained that the 118 EWARS facilities were selected to receive RDTs because they reported into the national EWARS system. Non-EWARS facilities report monthly aggregate case counts for each disease through the Health Management Information System (HMIS), which could not be used to record individual RDT usage information. In contrast, EWARS enables real-time monitoring of RDT deployment and results. Additionally, EWARS facilities are connected to laboratories, which play a crucial role in conducting and confirming RDT findings. In 2024, cholera RDT distribution expanded significantly, reaching all 118 EWARS facilities—an increase from 103 in 2023—and extending to non-EWARS facilities for the first time. Three of the seven PPHLs distributed RDTs to non-EWARS facilities, each providing a mean of 30 RDTs to one or two sites. Of all PPHLs, 86% reported having a systematic process for distributing RDTs to EWARS facilities, while 57% felt they had a systematic approach for distributing RDTs to non-EWARS facilities. Additionally, 43% of PPHLs agreed that all facilities in their province with cholera patients had access to RDTs, and 30% of government stakeholders believed there was a systematic process to ensure suspected cholera cases in non-EWARS facilities receive an RDT. Though still limited, this is a marked improvement over 2023, when no RDTs were distributed to non-EWARS facilities outside of research settings. Challenges : Although access to RDTs in non-EWARS facilities expanded in 2024, it remained limited compared to EWARS facilities. Many participants from all stakeholder groups suggested that RDT distribution to smaller health facilities and remote areas could be enhanced. Participants highlighted in interviews that making RDTs more accessible at local health posts by expanding the supply chain would improve surveillance and support clinical assessments in underserved areas. "RDTs should be more in remote areas rather than urban areas, because most of the people in city, they are well educated, they follow the hygiene. Why I'm saying remote areas is because they don't wash their hands, there is more chance of cholera, and there is no specific test for cholera. They don't even know hanging drops, or what stool analysis is. So, … if we do the RDT test, we can save more people from cholera in rural areas rather than the urban or industrial areas." – Clinician, EWARS health facility, Bagmati province Demand Forecasting & Stock Management Strategies/successes: Government participants explained that the number of RDTs each facility would receive were determined by EDCD, then distributed by PPHLs. Allotments were based on: 1) the total number of EWARS facilities, 2) anticipated caseloads of AGE, diarrhea, and cholera at each facility, and 3) local knowledge of disease burdens. Final RDT allocations were based on a comparison of data from HMIS and EWARS, which reported differing case numbers due to their use of aggregate versus individual-level reporting, respectively. “In HMIS, data is in bulk form. There are lots of data from 10,000-11,000 health facilities… On the other hand, in EWARS, there is line listing of cases and the data is more accurate. So, we took the average of both HMIS and EWARS and triangulated the data and planned accordingly. In EWARS, there are 13,000 AGE cases while in HMIS, the number is 300,000-400,000. So, if we take EWARS data, the 43,000 RDTs are enough for the AGE cases; however, if we take the HMIS data, the 43,000 RDTs are not enough. So, we took the average data of both and estimated the quantity of RDTs required by each EWARS site.” – Government stakeholder, beginning of cholera season 2024 The RDT allotments resulted in very few stock-outs and expirations. In surveys, 100% of PPHLs and 90% of EWARS facilities reported no stock-outs after receiving their initial RDT allotments. Facilities and PPHLs noted they were responsible for monitoring their own stock levels and requesting re-supplies as needed. Some facilities said they avoided reporting stock-outs because they were able to quickly obtain additional RDTs from nearby facilities. In qualitative interviews, both laboratory and clinician participants noted that facilities sometimes shared excess RDTs to prevent shortages. “Recently, we received about 280 kits. However, someplace else needed kits urgently, so we decided to send them most of it, keeping only about 50 for ourselves. So far, we haven’t faced a situation where we needed more kits. Whenever we ask, we’ve been getting them. So, there hasn’t been a problem… We are also not getting as many samples as we had expected. Maybe that’s why the available kits have been sufficient for us. EDCD has informed us to notify them beforehand if any crisis arises or if the stock is about to run out, and they will send us more.” – Laboratory technician, EWARS health facility, Bagmati province In interviews, some laboratory technicians expressed concern about kits expiring before use, while others felt confident they would use their supplies in time. Survey results indicated that 82 out of 88 EWARS facilities said none or very few RDTs expired before use. Among PPHLs, one reported no expirations, three reported very few expirations, and three reported that some RDTs expired—although this referred to kits received in 2023. Challenges: Although only 9 facilities (10%) reported running out of RDTs at some point in 2024, those that had a stock-out remained without RDTs for an average of 74 days (SD 56), with one facility reporting the stock out continued several months later. Only one facility reported that they were able to successfully request a re-stock. Several laboratory and clinician participants indicated uncertainty about the process for requesting RDT re-stocks. One laboratory technician said their hospital created its own demand form for requesting additional supplies. While PPHL said they tracked the number of RDTs initially received and sent to EWARS facilities, they noted that systematic procedures for monitoring stocks at facilities and deployment of the stockpile were needed. According to monthly surveys, most facilities reported having a surplus of cholera RDTs at the end of 2024, indicating potential overstock of RDTs in some facilities that could lead to wastage (Figure 2). The median number of unused RDTs remaining in 58 reporting health facilities in November 2024 was 90 (SD 89) (range 0-345). RDTs received in 2024 were expected to remain valid through the 2025 cholera season. However, government participants explained that reverse logistics of taking RDTs back from facilities with an overstock for redistribution was challenging as many facilities were hesitant to relinquish their supplies due to uncertainties about future RDT availability. Distribution Pathway Strategies/successes: Government participants explained that after RDTs were received at the central level, they were sent to PPHLs. PPHLs were responsible for distributing RDTs to the EWARS facilities in their province based on the allotments determined by EDCD. PPHLs also served as stockpiles for their provinces, receiving a buffer stock of RDTs in addition to the RDTs intended for EWARS facilities. Participants said the buffer stock enabled PPHLs, in coordination with PHD, to decide how and when to deploy RDTs, such as sending them to non-EWARS facilities where cholera cases emerged, Public Health Offices for outbreak response, or EWARS facilities experiencing shortages. Government stakeholders also noted that PPHLs were responsible for retrieving excess stock from facilities and could retain unused and unexpired RDTs for the next cholera season. Government stakeholders believed PPHLs were well-positioned to manage provincial distribution as they had direct knowledge of where cholera cases were detected and where RDTs were needed in their provinces. Their ability to distribute RDTs quickly was identified by government participants as a key advantage, as obtaining supplies from EDCD could take up to a month. By managing the stockpile, government participants said PPHLs had better oversight of where RDTs were deployed, allowing them to anticipate and prepare for incoming samples requiring culture confirmation. They also mentioned that PPHLs have regular communication with EDCD, ensuring coordination, and their involvement reduces EDCD’s burden. "If outbreak occurs somewhere, PPHL and PHD are going to respond and at that time, they will take the RDTs with them. If province does not have stock at that time, EDCD will supply which takes a long time and the process is also long... For PPHLs, it is very easy to send them to district or EWARS or non EWARS site because many people are connected with the PPHL and district health office... Places from PPHL are near." – Government stakeholder, beginning of cholera season Surveyed PPHLs reported receiving RDTs in Bagmati in May 2024, Sudurpashchim in July 2024, and other provinces in August and September 2024. In surveys, 100% of PPHLs reported receiving at least or more than the allocated number of RDTs intended for distribution and stockpile in their province. All PPHLs reported distributing the RDTs to EWARS facilities in their province based on the allotments specified by EDCD. According to facility survey data, 79% of surveyed facilities in Bagmati received cholera RDTs by June (n=26), 100% of surveyed facilities in Sudurpashchim by July (n=10), and 81% of facilities in other provinces by August (n=21) or September (n=18) (Figure 1). On average, facilities reported receiving 175 RDTs in their initial allotment from the government (SD 90.3; range 30-500). Challenges : Government and laboratory participants noted that PPHLs are often located near capital cities of each province, which can be far from some EWARS facilities. Shipping Strategies/successes: Government participants explained that EDCD was responsible for coordinating the distribution of cholera RDTs, directing the Management Division to handle logistics and ship the allocated number of RDTs to each PPHL. PHD said they assisted in ensuring RDTs reached EWARS facilities. The participants noted that RDTs were often sent in contracted vehicles already delivering other medical supplies, though sometimes separate transport was required due to differences in distribution points. In some cases, PPHLs arranged their own pickups to expedite the process. EDCD described informing PPHLs about the cholera RDTs through their regular disease surveillance communication channels and including PPHLs in provincial-level cholera RDT training. Upon arrival, PPHLs said they received a list detailing the allocation for each EWARS facility and were required to sign and stamp a document confirming receipt. RDTs were shipped to facilities through various mechanisms, with most PPHLs using more than one method: 1) Health officers from the facilities traveling to the province headquarters where PPHLs are based picked up RDTs for their facilities (used by 71% [5 of 7] PPHLs); 2) PPHLs transported RDTs during their routine monitoring visits to health facilities (used by 71% [5 of 7] PPHLs); and 3) If no staff were traveling, PPHLs sent RDTs to facilities via private courier (used by 43% [3 of 7] PPHLs). Facilities sometimes arranged and paid for their own transportation if urgent restocking was needed. One PPHL coordinated with a local NGO engaged in a cholera research project to assist with delivery. Flexibility in delivery methods helped ensure timely receipt of RDTs at health facilities. Laboratory technicians noted that they signed paperwork when they received RDTs from PPHLs, similar to paperwork received with other types of medical commodities. Most laboratory technicians and clinicians reported that the process of receiving cholera RDTs was easy and straightforward. Some noted that this relative ease could have been due to their location in Kathmandu or proximity to distribution centers, which facilitated quicker access compared to more remote facilities. Clinicians and laboratory technicians also appreciated when RDTs were delivered directly to their facilities. Challenges: Some distribution coordinators reported confusion around where to deliver the cholera RDTs, as most medical commodities are delivered to PHLMCs instead of PPHLs. Participants also described how the varying delivery mechanisms for RDTs caused some confusion and coordination burden. Many clinician and laboratory interviewees were uncertain about whether they needed to submit an official request to receive their initial allotment of RDTs or if they would be delivered automatically. “There's a challenge in receiving the kits. PPHL doesn’t send us those kits. If the kits somehow came directly to us in a systematic way, it would be much easier. That way, we wouldn’t have to coordinate or handle it ourselves.” – Laboratory technician, EWARS health facility, Bagmati province Government stakeholders noted that the quantity of RDTs being shipped was relatively small. They explained that delivery trucks had to be filled with other medical supplies before transporting the RDTs, as sending small shipments over long distances from Kathmandu to the PPHLs was not economical, resulting in some delays. PPHLs faced similar challenges in distributing small quantities of RDTs to health facilities scattered across their provinces. Road blockages during the rainy season further delayed deliveries in some provinces. PPHL interviewees mentioned that when a cholera case was identified at night in a facility without RDTs, PPHL staff had to immediately transport RDTs from the stockpile, a task complicated by difficult terrain and adverse weather conditions. "Cholera kit quantity is quite small, so we had to send it with other commodities during distribution to PPHL... [PPHLs] have to use their vehicle, field, manpower, to distribute the cholera kit within the designated time... If [RDTs] are sent along with other commodities of PPHL, there might not be a problem... In spite of the quantity, it has to reach there. So, that might result in more expenditure and time than expected." – Government stakeholder, end of cholera season Training and Communication Strategies/successes: Communication between divisions of EDCD, PPHLs, PHDs, local NGOs, and health facilities about RDT distribution were noted as strengths by many participants. Successful coordination facilitated timely entry of RDTs into an electronic tracking system (e-LMIS) and prompt sharing of distribution lists to facilitate shipments. Effective communication also helped rectify and prevent distribution issues. PPHLs also coordinated successfully by notifying EDCD when RDTs were delivered and distributed, plus coordinating with health facilities to prevent stock outs. Strong communication between laboratory technicians across health facilities also facilitated sharing of RDT supplies. Local NGO support with distribution of RDTs was also viewed positively by government, clinician, and laboratory participants. EDCD organized and conducted virtual trainings for laboratory technicians, clinicians, and medical recorders at EWARS facilities and PPHLs in each province prior to distributing cholera RDTs. Participants in the training viewed it as helpful for orienting them about the cholera RDTs. Challenges: Government staff noted that limited orientation for distributors led to some shipment errors with the first batch of RDTs; misunderstanding about the number of boxes (kits) and the number of individual RDTs per box caused fewer RDTs to be shipped than intended. “For the distribution, [the government] coordinated with the Management Division. And we have identified certain pitfalls over there. And we have rectified that. We identified so because that orientation helped us to bring all the stakeholders in one platform. So, during that time, the PPHL really flagged the issue. We resolved it… Management Division did not send the RDT to the quantity which was recommended by us. So, that was identified at that time. And we also followed up with the reaching of the RDTs to the provincial and how they are distributing it.” – Government stakeholder, beginning of cholera season 2024 Although the EDCD training was viewed positively by participants, it typically reached only one to two individuals per facility. Laboratory, clinician, and medical recorder interviewees noted that information from the training was not consistently shared with other staff, and there was limited guidance on distribution logistics. Discussion Cholera RDTs are a relatively new tool with limited large-scale implementation to date. Nepal’s 2024 nationwide rollout represents one of the first government-led efforts to distribute RDTs across an entire country. Nepal successfully distributed cholera RDTs nationally, overcoming challenges related to shipping logistics, manufacturing delays, importation clearance procedures, and uncertainties in demand. Although manufacturing delays resulted in some health facilities not receiving RDTs until late in the 2024 cholera season, the Nepal government was able to quickly deploy RDTs to health facilities upon receipt of the shipments centrally, even in the midst of the monsoon season. Careful planning about the locations for distribution and quantities of RDTs required, as well as designation of central stockpiles for each province, resulted in the country being able to successfully supply RDTs to EWARS and some non-EWARS facilities nationwide. This paper is the first to describe the successes, challenges, and recommendations for nation-wide cholera RDT distribution; results on RDT usage and reporting will be published separately. Nepal’s experiences rolling out cholera RDTs offer important lessons in supply chain management that are relevant not only for strengthening future efforts within the country but also for informing RDT implementation in other cholera-endemic settings. Our evaluation highlights the following key recommendations for cholera RDT distribution across the major supply chain domains we examined. Procurement : External support—such as that provided by Gavi—was vital for securing a reliable supply of cholera RDTs. Continued support from technical partners and simplification of the application process for cholera RDTs would further strengthen procurement. Anticipating and planning for manufacturing and shipment delays is also essential to manage disruptions. Planning for such delays could include establishing contingency strategies, such as reverting to the standard culture testing protocol or initiating nationwide distribution of smaller RDT quantities from initial batches while awaiting additional shipments. Importation : Timely coordination with the Ministry of Finance is necessary to secure duty exemption certificates and custom fee waivers. These steps must be completed before shipment arrival to avoid customs storage fees and ensure a smooth importation process. Surveillance Unit Selection : Facilities selected to receive cholera RDTs must have a mechanism for reporting on RDT usage, as this data is critical for monitoring and planning. Additionally, these facilities must be connected to a laboratory for confirmatory testing. The greatest impact of RDT distribution may be realized by expanding access in non-EWARS health facilities, which number over 11,000 in Nepal 19 , where diagnostic capacity is often limited and the burden of cholera can be high. Demand Forecasting : RDT allocations should be informed by both the number of facilities and anticipated cholera caseloads. Surveillance data should also be supplemented with community-level insights on disease burden, particularly given the potential for under- or over-reporting in formal systems. Nepal used primarily a push system for stocking, in which the federal government made decisions about RDT quantities to ship to each facility. Incorporating some pull system elements, enabling health facilities and PPHLs to contribute local information on consumption and demand, could be useful for guiding stocking decisions. 5 High-quality, timely reporting on both cholera cases and RDT usage is essential to improve forecasting and ensure that facilities receive adequate supplies before the monsoon season. Demand estimates must balance the risk of stock-outs with the risk of overstocking, which can lead to kit expiration and wastage. Drug expiration is a commonly reported issue in medication supply chains, often occurring due to challenges with limited shelf-life of drugs upon arrival in country, inaccurate forecasting leading to overstocking, and distribution challenges. 20 To avoid this, standardized systems are essential for tracking RDT stocks at health facilities and notifying central distributors when re-stocks are needed. A systematic process for requesting additional RDTs is important. Facilities should also be informed about the possibility of redistributing unused or excess RDTs to avoid wastage, or initial distribution could occur in smaller increments, allowing central stockpiles to be deployed based on emerging needs. Distribution Pathway : Nepal’s cholera RDT supply chain followed a structure similar to that used for medical commodities in many LMICs, with national-level procurement and distribution from a central store down to regional and district levels. 5 However, instead of District Hospitals managing local distribution as is typically done 5 , Nepal used PPHLs to distribute RDTs to facilities in their province. As cholera RDTs are included in the WHO Essential Diagnostics List 21 , integrating their distribution with that of other essential medical commodities could improve efficiency and enhance long-term sustainability. Regardless of which bodies are involved, engagement of peripheral-level actors in distributing RDTs within their provinces streamlines the process and alleviates pressure on national-level systems. Maintaining provincial-level stockpiles also enabled rapid distribution of additional RDTs as needs arose, though more guidance on how provinces should deploy the buffer stocks could be useful. Shipping : Whenever possible, cholera RDT shipments should be coordinated with shipments of other medical supplies to increase efficiency, though differences in distribution points must be considered. Systematic documentation of shipment contents is critical for transparency and inventory tracking. Additionally, advance notice about incoming shipments helps authorities plan for timely storage and distribution. Although flexibility in delivery methods enabled rapid distribution, adopting more standardized delivery procedures could help reduce logistical burden. Finally, initial RDT stocks should be delivered ahead of the monsoon season to avoid weather-related disruptions and ensure RDTs are readily available during the peak cholera transmission period. Training and Communication : Comprehensive training that covers distribution and re-stocking procedures, preferably in person, is essential for clinicians and laboratory staff as well as for logistics and distribution personnel. Maintaining open communication through clear and well-established channels between and within government authorities and health facilities is key to effective RDT roll-out. Strengths and Limitations Our mixed-methods analysis enabled us to quantify key aspects of RDT distribution, including stock-outs and stakeholder perspectives on distribution methods and success, while also integrating qualitative insights on distribution experiences. This approach not only allowed us to assess the reach of distribution but also to understand the underlying reasons for how it was carried out and the factors influencing its successes and challenges. A key strength of our study was the research team’s strong connections and collaboration with the Nepal government, which facilitated participation from a diverse range of government and health facility stakeholders. Several limitations of our study should also be noted. Quantitative data on RDT distribution were provided by one laboratory technician per facility; while respondents received advance notice to compile the necessary information and field staff made efforts to cross-check figures for accuracy, the reported data may still contain inaccuracies. Qualitative interviews were conducted only with participants from facilities in Bagmati Province, meaning perspectives from more rural facilities and those more heavily impacted by RDT shipment delays were not represented. Additionally, interviews were limited to EWARS facilities, so the views of non-EWARS facilities and their insights on how RDTs could be deployed to their settings were not captured. Social desirability bias may have also made participants reluctant to acknowledge challenges. They may have also emphasized positive opinions about cholera RDTs to align with the research team's expectations and/or enhance the chances of receiving future RDT shipments. Nonetheless, we were able to capture a broad range of perspectives on RDT distribution in Nepal, including a range of successes, challenges, and recommendations. Conclusion Nepal successfully distributed cholera RDTs to all seven provinces, heightening the country’s ability to identify and respond to cholera outbreaks. Key lessons learned from the 2024 distribution process include the importance of securing external support for RDT procurement, anticipating potential shipment delays, timely coordination to obtain duty exemption certificates, incorporating RDT shipments with other medical commodities, and establishing provincial-led distribution and stockpiles. Leveraging enhanced data from 2024, including local perspectives on supply needs, will inform forecasting to limit stock-outs and wastage of cholera RDTs in the future. Increasing RDT access in lower-level health facilities, standardizing delivery procedures, and in-person, comprehensive training on distribution processes would also bolster cholera surveillance efforts. Funding for such programmatic support activities, in addition to the RDTs themselves, could enhance the effectiveness of RDT deployment. This paper contributes valuable evidence to the cholera RDT literature by documenting the implementation of the distribution process, highlighting potential challenges that other countries may face, and providing insights on strategies that worked. These lessons can enhance the success of cholera RDT rollouts both in Nepal, as additional RDTs are rolled out through the second round of the Gavi Diagnostics Support Platform, and in other countries planning similar efforts. List of abbreviations EDCD Epidemiology and Disease Control Division EWARS Early Warning and Reporting System GTFCC Global Task Force for Cholera Control HMIS Health Management Information System LMIC Low- and middle-income countries NCEP National Cholera Elimination Plan NGO Non-governmental Organization NPHL National Public Health Laboratory PHD Public Health Directorate PPHL Provincial Public Health Laboratory RDT Rapid Diagnostic Test RE-AIM Reach, Effectiveness, Adoption, Implementation, Maintenance framework REDCap Research Electronic Data Capture application WHO World Health Organization Declarations Ethics approval and consent to participate Ethical approval was obtained from the JHU Institutional Review Board (IRB00025777 and IRB00028398) and the Nepal Health Research Council (Reg. No. 44612023). All procedures carried out in this study were in accordance with the ethical standards of the Declaration of Helsinki. All individuals interviewed for this publication provided written informed consent. Clinical trial number : N/A Consent for publication Not applicable. Availability of data and materials The data underlying this study cannot be made publicly available due to compliance with our Institutional Review Board (IRB)-approved protocol and consent form, which ensured participants' anonymity and confidentiality. Given the qualitative nature of the data, participants are highly identifiable, even with anonymization efforts. Public availability would compromise participant privacy and potentially endanger their employment or livelihood, as some participants voiced concerns about the cholera RDT program and/or healthcare system. While we are open to sharing our data upon request, access will be granted only under a signed agreement prohibiting further dissemination or sharing of the transcripts. Please contact Amanda Debes, Principal Investigator, at [email protected] for data access requests. Competing interests The authors declare that they have no competing interests. Funding This study was funded by Gavi, the Vaccine Alliance (CP 12563 1 23 A23 to DAS), administered through the Johns Hopkins Bloomberg School of Public Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. Authors' contributions KNW contributed to the design of the work, acquisition, analysis, and interpretation of data, and drafted the manuscript. EAR and GA contributed to the design of the work, acquisition, analysis, and interpretation of data. AS and MN contributed to the analysis and interpretation of data. ETB contributed to the conception and design of the work, as well as acquisition, analysis, and interpretation of data. PC and SD contributed to the acquisition and interpretation of data. HRP, MP, CBJ, JL, DK, and YL contributed to the interpretation of data. KK contributed to the design of the work, acquisition, and interpretation of data. DCB contributed to the conception and design of the work, acquisition, and interpretation of data. MM contributed to the design of the work and interpretation of data. DAS contributed to the conception and design of the work and interpretation of data. AKD contributed to the conception and design of the work, acquisition, analysis, and interpretation of data, and substantively revised the manuscript. All authors approved the submitted version and agree to be accountable for all aspects of the work. Acknowledgements The authors would like to thank the staff from the Group for Technical Assistance (GTA) Foundation, Kathmandu, Nepal for their support in carrying out this study. We also acknowledge the support of the International Vaccine Institute. Additionally, we extend our thanks to Nepal’s Epidemiology and Disease Control Division (EDCD), Management Division, National Public Health Laboratory (NPHL), Provincial Public Health Laboratories (PPHL), Bagmati Province Health Directorate (PHD), and Early Warning and Reporting System (EWARS) sites for their collaboration and participation in this study. Declaration of generative AI and AI-assisted technologies in the writing process During the preparation of this work the authors used ChatGPT to improve language and readability. After using this tool/service, the authors reviewed and edited the content and take full responsibility for the content of the publication. References Global Task Force on Cholera Control. About Cholera. 2025. https://www.gtfcc.org/about-cholera/ Debes AK, Murt KN, Waswa E, et al. Laboratory and Field Evaluation of the Crystal VC-O1 Cholera Rapid Diagnostic Test. Am J Trop Med Hyg . 2021;104(6):2017-2023. doi:10.4269/ajtmh.20-1280 FIND - Diagnosis for all. 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RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. Front Public Health . 2019;7:64. doi:10.3389/fpubh.2019.00064 Glasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. Am J Public Health . 1999;89(9):1322-1327. Baumgartner ET, Williams KN, Rai E, et al. Enhancing national cholera surveillance using rapid diagnostic tests (RDTs): A mixed methods evaluation. PLoS Negl Trop Dis . 2025;19(5):e0013019. doi:10.1371/journal.pntd.0013019 Roskosky M, Acharya B, Shakya G, et al. Feasibility of a Comprehensive Targeted Cholera Intervention in The Kathmandu Valley, Nepal. Am J Trop Med Hyg . 2019;100(5):1088-1097. doi:10.4269/ajtmh.18-0863 Pandav RS. CHOLERA OVERVIEW-NEPAL. 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Bull World Health Organ . 2017;95(8):594-598. doi:10.2471/BLT.16.186650 The Selection and Use of Essential in Vitro Diagnostics: Report of the Third Meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (Including the Third WHO Model List of Essential in Vitro Diagnostics) . Geneva: World Health Organization; 2021 (WHO Technical Report Series, No. 1031). Licence: CC BY-NC-SA 3.0 IGO. Accessed June 10, 2025. https://www.who.int/publications/i/item/9789240019102 Additional Declarations No competing interests reported. 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1","display":"","copyAsset":false,"role":"figure","size":74322,"visible":true,"origin":"","legend":"\u003cp\u003eMonth in 2024 in which facilities reported receiving cholera RDTs, by province.\u003c/p\u003e","description":"","filename":"2.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7594652/v1/6e9cd472010c33050c3adfa1.jpg"},{"id":92052425,"identity":"a9973088-3a2f-42a5-b599-1a3a65b1a7d1","added_by":"auto","created_at":"2025-09-24 06:13:41","extension":"jpg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":66150,"visible":true,"origin":"","legend":"\u003cp\u003eMedian number of RDTs remaining at health facilities in November 2024 (after the end of the cholera season in September), by province. NOTE: n indicates the number of facilities reporting for each province.\u003c/p\u003e","description":"","filename":"1.jpg","url":"https://assets-eu.researchsquare.com/files/rs-7594652/v1/2e59c2fa672940b0f64f9876.jpg"},{"id":92054108,"identity":"4a4c67d6-90b3-4fe3-8944-f99c22603cad","added_by":"auto","created_at":"2025-09-24 06:29:46","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":985915,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7594652/v1/2362bb65-1127-4ba9-a6b6-afcaac7fb406.pdf"},{"id":92052423,"identity":"cdd04609-982d-4fc2-a7f2-375c243e1f5d","added_by":"auto","created_at":"2025-09-24 06:13:41","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"supplement","size":91622,"visible":true,"origin":"","legend":"","description":"","filename":"RISEinterviewguidemedicalrecorder2024.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7594652/v1/c579472b071e463e0fa64acc.pdf"},{"id":92054104,"identity":"d65f7d0e-20d9-4de3-a65b-dda7cfd10b7e","added_by":"auto","created_at":"2025-09-24 06:29:41","extension":"pdf","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":103468,"visible":true,"origin":"","legend":"","description":"","filename":"RISEinterviewguidelabtechnicians2024.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7594652/v1/deca0a1564c85e51fdbde422.pdf"},{"id":92053197,"identity":"2da7c42a-9c70-41dd-ada8-6e32e123c1af","added_by":"auto","created_at":"2025-09-24 06:21:41","extension":"pdf","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":78464,"visible":true,"origin":"","legend":"","description":"","filename":"RISEinterviewguidestakeholders2024.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7594652/v1/962933b551c185613cd6822d.pdf"},{"id":92052436,"identity":"a3ad230d-5869-4ec9-88c1-e1322119ea19","added_by":"auto","created_at":"2025-09-24 06:13:41","extension":"pdf","order_by":3,"title":"","display":"","copyAsset":false,"role":"supplement","size":76170,"visible":true,"origin":"","legend":"","description":"","filename":"RISEinterviewguidephysicians2024.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7594652/v1/e00d1c5aca923d400de39300.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Evaluating the planning for and distribution of cholera rapid diagnostic tests in Nepal","fulltext":[{"header":"Background","content":"\u003cp\u003eCholera remains a critical global health challenge, especially in poor and vulnerable communities.\u003csup\u003e\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e\u003c/sup\u003e Rapid diagnostic tests (RDTs) for cholera can enhance efforts to control cholera by enabling greater detection and faster response.\u003csup\u003e\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e,\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e\u003c/sup\u003e However, RDTs are only recently becoming more widely available. Historically, countries had to request RDTs from the World Health Organization (WHO) when an outbreak emerged. The WHO would supply a limited number of RDTs for targeted use. Now, with leading cholera control organizations such as Gavi, the Vaccine Alliance, and the Global Task Force for Cholera Control (GTFCC) supporting broader use of cholera RDTs as a screening tool, countries are being encouraged to use RDTs more widely within national surveillance systems. This shift to more widespread use of RDTs requires countries to develop detailed RDT distribution plans to ensure timely access and availability.\u003c/p\u003e\u003cp\u003ePrior studies on supply chain management for other medical commodities highlight the importance of accurate demand forecasting, sufficient procurement, quality assurance, equitable distribution, inventory management, robust logistics systems, and appropriate training.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e Different distribution strategies have been employed for other health products, such as push systems\u0026mdash;where central authorities estimate and supply commodities to facilities\u0026mdash;and pull systems\u0026mdash;where health facilities request supplies based on need.\u003csup\u003e\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e\u003c/sup\u003e Centralized supply chains involve direct national-level distribution to health facilities, whereas decentralized systems engage district or provincial intermediaries. Additionally, some systems integrate diagnostic test distribution with existing medical supply chains, while others operate in vertical silos.\u003csup\u003e\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e\u003c/sup\u003e Research is needed to understand how these supply chain principles apply in the context of cholera RDTs, and how they should be adapted or prioritized to support effective and sustainable nationwide distribution.\u003c/p\u003e\u003cp\u003eTo the authors\u0026rsquo; knowledge, no research has been published to date on the unique considerations involved in supply chain management and nationwide distribution of cholera RDTs. Most published research on rapid diagnostic tests\u0026mdash;whether for cholera or other diseases\u0026mdash;focuses on diagnostic performance, correct usage, and health impact. Ensuring cholera RDT availability and access is a critical precursor to adoption and impact, yet little research has addressed implementation and scale-up strategies. The Reach, Effectiveness, Adoption, Implementation, Maintenance (RE-AIM) framework highlights the importance of reach and implementation in evaluating interventions.\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e More evidence is needed to identify cholera RDT distribution barriers and develop strategies to prevent stock-outs and improve access.\u003csup\u003e\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e\u003c/sup\u003e Our study focuses on these dimensions to generate evidence that can guide RDT implementation efforts in low- and middle-income countries (LMICs).\u003csup\u003e\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e,\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eFollowing a pilot of cholera RDTs in 2023\u003csup\u003e9\u003c/sup\u003e, Nepal undertook its first large-scale, government-led distribution of cholera RDTs in 2024\u0026mdash;the inaugural year of Gavi\u0026rsquo;s Diagnostics Support Platform. We conducted an evaluation of this national rollout to document successes, identify challenges, and develop recommendations to guide future RDT distribution in pursuit of Nepal\u0026rsquo;s cholera elimination goal.\u003c/p\u003e"},{"header":"Methods","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e\u003ch2\u003eStudy context\u003c/h2\u003e\u003cp\u003eCholera is endemic in Nepal, with sporadic outbreaks annually, particularly during the monsoon season from May to September.\u003csup\u003e\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e,\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e\u003c/sup\u003e Nepal's Early Warning and Reporting System (EWARS) is a network of hospitals that monitor and report on six high-priority diseases, one being cholera. At the time of our study, 118 hospitals were designated as EWARS sentinel sites.\u003csup\u003e\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e\u003c/sup\u003e The Epidemiology and Disease Control Division (EDCD) is a government entity in Nepal responsible for the surveillance, prevention, and control of infectious diseases, including cholera. There are seven provinces in Nepal, and each province has a Provincial Public Health Laboratory (PPHL) responsible for conducting diagnostic testing, supporting disease surveillance, and providing laboratory guidance, while the Provincial Public Health Directorate (PHD) oversees overall health program implementation, coordination, and resource allocation within the province. The National Public Health Laboratory (NPHL) in Nepal serves as the central reference laboratory, overseeing laboratory standards, quality assurance, and diagnostic capacity, including providing technical guidance, training, and support to PPHLs.\u003c/p\u003e\u003cp\u003eIn 2023, the EDCD applied to the Gavi Diagnostics Support Platform, a global initiative aimed at expanding access to rapid diagnostic tests for infectious diseases in LMICs\u003csup\u003e\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e\u003c/sup\u003e, and was awarded 43,600 cholera RDTs for the 2024 cholera season. In 2024, Nepal updated their National Cholera Elimination Plan (NCEP) (currently under final review), which serves as a comprehensive framework to prevent, detect, and respond to cholera outbreaks to reduce the cholera disease burden and mortality.\u003csup\u003e\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u003c/sup\u003e RDTs are highlighted as a key strategy for enhancing cholera surveillance.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eData collection methods\u003c/h3\u003e\n\u003cdiv id=\"Sec5\" class=\"Section2\"\u003e\u003ch2\u003eQuantitative Surveys\u003c/h2\u003e\u003cp\u003eWe collected quantitative data through three separate surveys. First, we asked all 118 EWARS health facilities to complete an online survey through REDCap\u003csup\u003e\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e\u003c/sup\u003e every month from January through November 2024. A designated laboratory technician responsible for cholera RDTs at each facility entered RDT stock levels, usage, and results monthly. Second, we selected a sub-sample of 94 EWARS health facilities from all seven provinces of Nepal to participate in a more in-depth, phone-based facility survey after the cholera season. Our sample size was based on the universe of EWARS facilities (n\u0026thinsp;=\u0026thinsp;118), an assumed point estimate of 50%, and alpha of 0.05; with 94 facilities, we expected to be able to estimate our facility-level indicators with a precision of 4.7 percentage points. Selection was designed to include all EWARS facilities in Bagmati and Sudurpashchim provinces, where RDTs were distributed first, as well as a mix of rural/urban and public/private/teaching EWARS facilities of varying sizes from each of the other five provinces. Separate surveys on RDT implementation, training, and perceptions were completed by a laboratory technician and clinician at each facility who worked with cholera patients or samples. Third, we conducted a phone-based survey in January 2025 with representatives from each of the seven PPHLs and key government stakeholders on RDT management and roll-out. Participants from health facilities and PPHLs received 500 Nepali Rupees (~\u0026thinsp;4 USD) for completing each survey.\u003c/p\u003e\u003c/div\u003e\n\u003ch3\u003eQualitative interviews\u003c/h3\u003e\n\u003cp\u003eWe selected 12 EWARS health facilities near Kathmandu in the Bagmati province that had received cholera RDTs to participate in our qualitative investigation. Bagmati was selected given logistical feasibility and because Bagmati EWARS facilities were among the first to receive cholera RDTs from the government in 2024. Within each facility, we invited one clinician, one laboratory technician, and one medical recorder (responsible for reporting health data to national databases) to participate in a qualitative interview. A total of 12 clinicians, 12 laboratory technicians, and 9 medical recorders agreed to be interviewed between August - September 2024. We also interviewed a total of 10 government stakeholders who had some role in cholera RDT implementation in Nepal. Six government stakeholders were interviewed in June 2024. Eight government stakeholders were interviewed in September 2024, including four who had participated in round 1 of interviews and four new stakeholders.\u003c/p\u003e\u003cp\u003eInterviews were conducted by four study staff members who were trained in qualitative interviewing techniques, in English or Nepali depending on the participants\u0026rsquo; preference. We developed semi-structured interview guides covering topics related to cholera RDT roll-out (see Supplementary Materials). One observer also attended each interview to take detailed notes. Interviews were conducted at the EWARS health facilities and government offices in a location of the participants\u0026rsquo; choosing. Interviews were audio-recorded with participant consent and transcribed into English for analysis.\u003c/p\u003e\u003cdiv id=\"Sec7\" class=\"Section2\"\u003e\u003ch2\u003eData analysis\u003c/h2\u003e\u003cdiv id=\"Sec8\" class=\"Section3\"\u003e\u003ch2\u003eQuantitative data\u003c/h2\u003e\u003cp\u003eQuantitative data were cleaned using R version 4.3.1 statistical software\u003csup\u003e\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e\u003c/sup\u003e, then analyzed in StataNow/BE version 18.5\u003csup\u003e17\u003c/sup\u003e. We calculated descriptive statistics (medians and percentages) for key indicators.\u003c/p\u003e\u003c/div\u003e\u003c/div\u003e\n\u003ch3\u003eQualitative data\u003c/h3\u003e\n\u003cp\u003eInterviews were transcribed and translated into English. All transcriptions were reviewed by study staff fluent in both English and Nepali to ensure accuracy. Qualitative data analysis was conducted through an iterative, team-based approach. First, transcripts were reviewed to develop a codebook capturing themes relevant to the procurement, transport, and distribution of RDTs. Coding was performed using Taguette (Rampin \u0026amp; Rampin, 2021).\u003csup\u003e\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e\u003c/sup\u003e Researchers trained in qualitative analysis independently coded the transcripts. Each coded transcript was reviewed by another researcher to ensure consistency and rigor. Any disagreements in coding were discussed as a group to reach a consensus decision. Once coding was complete, the quotes within each theme were examined to identify key emerging points and patterns related to the challenges, successes, and lessons learned in RDT distribution.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003e\u003cem\u003eEthical approval\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval was obtained from the JHU Institutional Review Board (IRB00025777 and IRB00028398) and the Nepal Health Research Council (Reg. No. 44612023).\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eWe present our findings organized by key supply chain domains, including procurement, importation, surveillance site selection, demand forecasting, stock management, distribution pathways, shipping, and training and communication on RDT distribution.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eProcurement\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStrategies/successes\u003c/em\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eNepal government stakeholders reported receiving shipments of cholera RDTs from Gavi in April (13,000 RDTs), July (20,000 RDTs), and August (10,660 RDTs) of 2024. This quantity represents a major increase over the 6,000 RDTs received through the pilot study in 2023. Government participants noted that the Gavi Diagnostics Platform was vital to obtaining the larger quantity of RDTs to support the new NCEP, and that Gavi’s continued support is needed to maintain an RDT supply for the country. Government representatives believed the Gavi application for cholera RDTs was straightforward. They noted the usefulness of technical assistance from external partners in developing the application.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e“In the NCEP for surveillance, RDT based cholera surveillance is there, and we'll keep that in place. But for securing the RDT, we have specifically mentioned that it will be secured through in-kind contribution from Gavi. We are very clear that this might not be the time that the country can invest in the RDT kits.” – Government stakeholder, end of cholera season 2024\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChallenges\u003c/em\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eGovernment participants reported the second and third shipments of RDTs to Nepal were delayed due to manufacturing problems. Anticipating the prompt arrival of the second shipment, the government distributed the first shipment to two provinces. Bagmati and Sudurpashchim provinces were prioritized due to their high number of EWARS facilities, anticipated cholera caseload, and their involvement in an ongoing cholera research study. However, when the second shipment was delayed, facilities in the other five provinces remained without RDTs for most of the 2024 cholera season.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eImportation\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStrategies/successes\u003c/em\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eThe first shipment of cholera RDTs arrived in Nepal just before the monsoon season, creating urgency for expedited processing. Despite some delays and incurrence of customs fees, the shipment was cleared in about 15 days – well ahead of the typical 1-2 month timeframe. The customs process was mastered for subsequent RDT shipments, including coordination between the Ministry of Finance and Ministry of Health and Population to secure RDT custom fee waivers.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChallenges\u003c/em\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eGovernment participants highlighted that the procedures for customs clearance are extensive and complex, and manufacturing or shipping delays increased the pressure to clear customs more rapidly than usual. Additionally, customs levy a fee if materials remain in storage for over a week; in the case of the first shipment, these fees were covered by a research study.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSurveillance Site Selection\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStrategies/successes\u003c/em\u003e:\u003c/p\u003e\n\u003cp\u003eGovernment participants explained that the 118 EWARS facilities were selected to receive RDTs because they reported into the national EWARS system. Non-EWARS facilities report monthly aggregate case counts for each disease through the Health Management Information System (HMIS), which could not be used to record individual RDT usage information. In contrast, EWARS enables real-time monitoring of RDT deployment and results. Additionally, EWARS facilities are connected to laboratories, which play a crucial role in conducting and confirming RDT findings.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eIn 2024, cholera RDT distribution expanded significantly, reaching all 118 EWARS facilities—an increase from 103 in 2023—and extending to non-EWARS facilities for the first time. Three of the seven PPHLs distributed RDTs to non-EWARS facilities, each providing a mean of 30 RDTs to one or two sites. Of all PPHLs, 86% reported having a systematic process for distributing RDTs to EWARS facilities, while 57% felt they had a systematic approach for distributing RDTs to non-EWARS facilities. Additionally, 43% of PPHLs agreed that all facilities in their province with cholera patients had access to RDTs, and 30% of government stakeholders believed there was a systematic process to ensure suspected cholera cases in non-EWARS facilities receive an RDT. Though still limited, this is a marked improvement over 2023, when no RDTs were distributed to non-EWARS facilities outside of research settings.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChallenges\u003c/em\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAlthough access to RDTs in non-EWARS facilities expanded in 2024, it remained limited compared to EWARS facilities. Many participants from all stakeholder groups suggested that RDT distribution to smaller health facilities and remote areas could be enhanced. Participants highlighted in interviews that making RDTs more accessible at local health posts by expanding the supply chain would improve surveillance and support clinical assessments in underserved areas.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\"RDTs should be more in remote areas rather than urban areas, because\u0026nbsp;most of the people in city, they are well educated,\u0026nbsp;they follow the hygiene. Why I'm saying remote areas is because they don't wash their hands, there is more chance of cholera, and there is no specific test for cholera. They don't even know hanging drops, or what stool analysis is. So, … if we do the RDT test, we can save more people from cholera in rural areas rather than the urban or industrial areas.\" – Clinician, EWARS health facility, Bagmati province\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDemand Forecasting \u0026amp; Stock Management\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStrategies/successes:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eGovernment participants explained that the number of RDTs each facility would receive were determined by EDCD, then distributed by PPHLs. Allotments were based on: 1) the total number of EWARS facilities, 2) anticipated caseloads of AGE, diarrhea, and cholera at each facility, and 3) local knowledge of disease burdens. Final RDT allocations were based on a comparison of data from HMIS and EWARS, which reported differing case numbers due to their use of aggregate versus individual-level reporting, respectively.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e“In HMIS, data is in bulk form. There are lots of data from 10,000-11,000 health facilities… On the other hand, in EWARS, there is line listing of cases and the data is more accurate. So, we took the average of both HMIS and EWARS and triangulated the data and planned accordingly. In EWARS, there are 13,000 AGE cases while in HMIS, the number is 300,000-400,000. So, if we take EWARS data, the 43,000 RDTs are enough for the AGE cases; however, if we take the HMIS data, the 43,000 RDTs are not enough. So, we took the average data of both and estimated the quantity of RDTs required by each EWARS site.” – Government stakeholder, beginning of cholera season 2024\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eThe RDT allotments resulted in very few stock-outs and expirations. In surveys, 100% of PPHLs and 90% of EWARS facilities reported no stock-outs after receiving their initial RDT allotments. Facilities and PPHLs noted they were responsible for monitoring their own stock levels and requesting re-supplies as needed. Some facilities said they avoided reporting stock-outs because they were able to quickly obtain additional RDTs from nearby facilities. In qualitative interviews, both laboratory and clinician participants noted that facilities sometimes shared excess RDTs to prevent shortages.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e“Recently, we received about 280 kits. However, someplace else needed kits urgently, so we decided to send them most of it, keeping only about 50 for ourselves. So far, we haven’t faced a situation where we needed more kits. Whenever we ask, we’ve been getting them. So, there hasn’t been a problem… We are also not getting as many samples as we had expected. Maybe that’s why the available kits have been sufficient for us. EDCD has informed us to notify them beforehand if any crisis arises or if the stock is about to run out, and they will send us more.” – Laboratory technician, EWARS health facility, Bagmati province\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eIn interviews, some laboratory technicians expressed concern about kits expiring before use, while others felt confident they would use their supplies in time. Survey results indicated that 82 out of 88 EWARS facilities said none or very few RDTs expired before use. Among PPHLs, one reported no expirations, three reported very few expirations, and three reported that some RDTs expired—although this referred to kits received in 2023.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChallenges:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAlthough only 9 facilities (10%) reported running out of RDTs at some point in 2024, those that had a stock-out remained without RDTs for an average of 74 days (SD 56), with one facility reporting the stock out continued several months later. Only one facility reported that they were able to successfully request a re-stock. Several laboratory and clinician participants indicated uncertainty about the process for requesting RDT re-stocks.\u0026nbsp;One laboratory technician said their hospital created its own demand form for requesting additional supplies. While PPHL said they tracked the number of RDTs initially received and sent to EWARS facilities, they noted that systematic procedures for monitoring stocks at facilities and deployment of the stockpile were needed.\u003c/p\u003e\n\u003cp\u003eAccording to monthly surveys, most facilities reported having a surplus of cholera RDTs at the end of 2024, indicating potential overstock of RDTs in some facilities that could lead to wastage (Figure 2). The median number of unused RDTs remaining in 58 reporting health facilities in November 2024 was 90 (SD 89) (range 0-345). RDTs received in 2024 were expected to remain valid through the 2025 cholera season. However, government participants explained that reverse logistics of taking RDTs back from facilities with an overstock for redistribution was challenging as many facilities were hesitant to relinquish their supplies due to uncertainties about future RDT availability.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDistribution Pathway\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStrategies/successes:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eGovernment participants explained that after RDTs were received at the central level, they were sent to PPHLs. PPHLs were responsible for distributing RDTs to the EWARS facilities in their province based on the allotments determined by EDCD. PPHLs also served as stockpiles for their provinces, receiving a buffer stock of RDTs in addition to the RDTs intended for EWARS facilities. Participants said the buffer stock enabled PPHLs, in coordination with PHD, to decide how and when to deploy RDTs, such as sending them to non-EWARS facilities where cholera cases emerged, Public Health Offices for outbreak response, or EWARS facilities experiencing shortages. Government stakeholders also noted that PPHLs were responsible for retrieving excess stock from facilities and could retain unused and unexpired RDTs for the next cholera season.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eGovernment stakeholders believed PPHLs were well-positioned to manage provincial distribution as they had direct knowledge of where cholera cases were detected and where RDTs were needed in their provinces. Their ability to distribute RDTs quickly was identified by government participants as a key advantage, as obtaining supplies from EDCD could take up to a month. By managing the stockpile, government participants said PPHLs had better oversight of where RDTs were deployed, allowing them to anticipate and prepare for incoming samples requiring culture confirmation. They also mentioned that PPHLs have regular communication with EDCD, ensuring coordination, and their involvement reduces EDCD’s burden.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\"If outbreak occurs somewhere, PPHL and PHD are going to respond and at that time, they will take the RDTs with them. If province does not have stock at that time, EDCD will supply which takes a long time and the process is also long... For PPHLs, it is very easy to send them to district or EWARS or non EWARS site because many people are connected with the PPHL and district health office... Places from PPHL are near.\"\u0026nbsp;\u003c/em\u003e–\u003cem\u003e\u0026nbsp;Government stakeholder, beginning of cholera season\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSurveyed PPHLs reported receiving RDTs in Bagmati in May 2024, Sudurpashchim in July 2024, and other provinces in August and September 2024. In surveys, 100% of PPHLs reported receiving at least or more than the allocated number of RDTs intended for distribution and stockpile in their province. All PPHLs reported distributing the RDTs to EWARS facilities in their province based on the allotments specified by EDCD. According to facility survey data, 79% of surveyed facilities in Bagmati received cholera RDTs by June (n=26), 100% of surveyed facilities in Sudurpashchim by July (n=10), and 81% of facilities in other provinces by August (n=21) or September (n=18) (Figure 1). On average, facilities reported receiving 175 RDTs in their initial allotment from the government (SD 90.3; range 30-500).\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChallenges\u003c/em\u003e:\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eGovernment and laboratory participants noted that PPHLs are often located near capital cities of each province, which can be far from some EWARS facilities.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eShipping\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStrategies/successes:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eGovernment participants explained that EDCD was responsible for coordinating the distribution of cholera RDTs, directing the Management Division to handle logistics and ship the allocated number of RDTs to each PPHL. PHD said they assisted in ensuring RDTs reached EWARS facilities.\u0026nbsp;The participants noted that RDTs were often sent in contracted vehicles already delivering other medical supplies, though sometimes separate transport was required due to differences in distribution points. In some cases, PPHLs arranged their own pickups to expedite the process. EDCD described informing PPHLs about the cholera RDTs through their regular disease surveillance communication channels and including PPHLs in provincial-level cholera RDT training.\u0026nbsp;Upon arrival, PPHLs said they received a list detailing the allocation for each EWARS facility and were required to sign and stamp a document confirming receipt.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eRDTs were shipped to facilities through various mechanisms, with most PPHLs using more than one method: 1) Health officers from the facilities traveling to the province headquarters where PPHLs are based picked up RDTs for their facilities (used by 71% [5 of 7] PPHLs); 2) PPHLs transported RDTs during their routine monitoring visits to health facilities (used by 71% [5 of 7] PPHLs); and 3) If no staff were traveling, PPHLs sent RDTs to facilities via private courier (used by 43% [3 of 7] PPHLs). Facilities sometimes arranged and paid for their own transportation if urgent restocking was needed. One PPHL coordinated with a local NGO engaged in a cholera research project to assist with delivery. Flexibility in delivery methods helped ensure timely receipt of RDTs at health facilities.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eLaboratory technicians noted that they signed paperwork when they received RDTs from PPHLs, similar to paperwork received with other types of medical commodities. Most laboratory technicians and clinicians reported that the process of receiving cholera RDTs was easy and straightforward. Some noted that this relative ease could have been due to their location in Kathmandu or proximity to distribution centers, which facilitated quicker access compared to more remote facilities. Clinicians and laboratory technicians also appreciated when RDTs were delivered directly to their facilities.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChallenges:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eSome distribution coordinators reported confusion around where to deliver the cholera RDTs, as most medical commodities are delivered to PHLMCs instead of PPHLs. Participants also described how the varying delivery mechanisms for RDTs caused some confusion and coordination burden.\u0026nbsp;Many clinician and laboratory interviewees were uncertain about whether they needed to submit an official request to receive their initial allotment of RDTs or if they would be delivered automatically.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e“There's a challenge in receiving the kits. PPHL doesn’t send us those kits. If the kits somehow came directly to us in a systematic way, it would be much easier. That way, we wouldn’t have to coordinate or handle it ourselves.” – Laboratory technician, EWARS health facility, Bagmati province\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eGovernment stakeholders noted that the quantity of RDTs being shipped was relatively small. They explained that delivery trucks had to be filled with other medical supplies before transporting the RDTs, as sending small shipments over long distances from Kathmandu to the PPHLs was not economical, resulting in some delays. PPHLs faced similar challenges in distributing small quantities of RDTs to health facilities scattered across their provinces. Road blockages during the rainy season further delayed deliveries in some provinces.\u0026nbsp;PPHL interviewees mentioned that when a cholera case was identified at night in a facility without RDTs, PPHL staff had to immediately transport RDTs from the stockpile, a task complicated by difficult terrain and adverse weather conditions.\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e\"Cholera kit quantity is quite small, so we had to send it with other commodities during distribution to PPHL... [PPHLs] have to use their vehicle, field, manpower, to distribute the cholera kit within the designated time... If [RDTs] are sent along with other commodities of PPHL, there might not be a problem... In spite of the quantity, it has to reach there. So, that might result in more expenditure and time than expected.\" – Government stakeholder, end of cholera season\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTraining and Communication\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eStrategies/successes:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eCommunication between divisions of EDCD, PPHLs, PHDs, local NGOs, and health facilities about RDT distribution were noted as strengths by many participants. Successful coordination facilitated timely entry of RDTs into an electronic tracking system (e-LMIS) and prompt sharing of distribution lists to facilitate shipments. Effective communication also helped rectify and prevent distribution issues. PPHLs also coordinated successfully by notifying EDCD when RDTs were delivered and distributed, plus coordinating with health facilities to prevent stock outs. Strong communication between laboratory technicians across health facilities also facilitated sharing of RDT supplies. Local NGO support with distribution of RDTs was also viewed positively by government, clinician, and laboratory participants.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eEDCD organized and conducted virtual trainings for laboratory technicians, clinicians, and medical recorders at EWARS facilities and PPHLs in each province prior to distributing cholera RDTs. Participants in the training viewed it as helpful for orienting them about the cholera RDTs.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003eChallenges:\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eGovernment staff noted that limited orientation for distributors led to some shipment errors with the first batch of RDTs; misunderstanding about the number of boxes (kits) and the number of individual RDTs per box caused fewer RDTs to be shipped than intended.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cem\u003e“For the distribution, [the government] coordinated with the Management Division. And we have identified certain pitfalls over there. And we have rectified that. We identified so because that orientation helped us to bring all the stakeholders in one platform. So, during that time, the PPHL really flagged the issue. We resolved it… Management Division did not send the RDT to the quantity which was recommended by us. So, that was identified at that time. And we also followed up with the reaching of the RDTs to the provincial and how they are distributing it.” – Government stakeholder, beginning of cholera season 2024\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003eAlthough the EDCD training was viewed positively by participants, it typically reached only one to two individuals per facility. Laboratory, clinician, and medical recorder interviewees noted that information from the training was not consistently shared with other staff, and there was limited guidance on distribution logistics.\u0026nbsp;\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eCholera RDTs are a relatively new tool with limited large-scale implementation to date. Nepal’s 2024 nationwide rollout represents one of the first government-led efforts to distribute RDTs across an entire country. Nepal successfully distributed cholera RDTs nationally, overcoming challenges related to shipping logistics, manufacturing delays, importation clearance procedures, and uncertainties in demand. Although manufacturing delays resulted in some health facilities not receiving RDTs until late in the 2024 cholera season, the Nepal government was able to quickly deploy RDTs to health facilities upon receipt of the shipments centrally, even in the midst of the monsoon season. Careful planning about the locations for distribution and quantities of RDTs required, as well as designation of central stockpiles for each province, resulted in the country being able to successfully supply RDTs to EWARS and some non-EWARS facilities nationwide. This paper is the first to describe the successes, challenges, and recommendations for nation-wide cholera RDT distribution; results on RDT usage and reporting will be published separately. Nepal’s experiences rolling out cholera RDTs offer important lessons in supply chain management that are relevant not only for strengthening future efforts within the country but also for informing RDT implementation in other cholera-endemic settings.\u003c/p\u003e\n\u003cp\u003eOur evaluation highlights the following key recommendations for cholera RDT distribution across the major supply chain domains we examined.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eProcurement\u003c/em\u003e\u003c/strong\u003e: External support—such as that provided by Gavi—was vital for securing a reliable supply of cholera RDTs. Continued support from technical partners and simplification of the application process for cholera RDTs would further strengthen procurement. Anticipating and planning for manufacturing and shipment delays is also essential to manage disruptions. Planning for such delays could include establishing contingency strategies, such as reverting to the standard culture testing protocol or initiating nationwide distribution of smaller RDT quantities from initial batches while awaiting additional shipments.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eImportation\u003c/em\u003e\u003c/strong\u003e: Timely coordination with the Ministry of Finance is necessary to secure duty exemption certificates and custom fee waivers. These steps must be completed before shipment arrival to avoid customs storage fees and ensure a smooth importation process.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eSurveillance Unit Selection\u003c/em\u003e\u003c/strong\u003e: Facilities selected to receive cholera RDTs must have a mechanism for reporting on RDT usage, as this data is critical for monitoring and planning. Additionally, these facilities must be connected to a laboratory for confirmatory testing. The greatest impact of RDT distribution may be realized by expanding access in non-EWARS health facilities, which number over 11,000 in Nepal\u003csup\u003e19\u003c/sup\u003e, where diagnostic capacity is often limited and the burden of cholera can be high.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDemand Forecasting\u003c/em\u003e\u003c/strong\u003e: RDT allocations should be informed by both the number of facilities and anticipated cholera caseloads. Surveillance data should also be supplemented with community-level insights on disease burden, particularly given the potential for under- or over-reporting in formal systems.\u0026nbsp;Nepal used primarily a push system for stocking, in which the federal government made decisions about RDT quantities to ship to each facility. Incorporating some pull system elements, enabling health facilities and PPHLs to contribute local information on consumption and demand, could be useful for guiding stocking decisions.\u003csup\u003e5\u003c/sup\u003e High-quality, timely reporting on both cholera cases and RDT usage is essential to improve forecasting and ensure that facilities receive adequate supplies before the monsoon season.\u003c/p\u003e\n\u003cp\u003eDemand estimates must balance the risk of stock-outs with the risk of overstocking, which can lead to kit expiration and wastage.\u0026nbsp;Drug expiration is a commonly reported issue in medication supply chains, often occurring due to challenges with limited shelf-life of drugs upon arrival in country, inaccurate forecasting leading to overstocking, and distribution challenges.\u003csup\u003e20\u003c/sup\u003e To avoid this, standardized systems are essential for tracking RDT stocks at health facilities and notifying central distributors when re-stocks are needed. A systematic process for requesting additional RDTs is important. Facilities should also be informed about the possibility of redistributing unused or excess RDTs to avoid wastage, or initial distribution could occur in smaller increments, allowing central stockpiles to be deployed based on emerging needs.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eDistribution Pathway\u003c/em\u003e\u003c/strong\u003e: Nepal’s cholera RDT supply chain followed a structure similar to that used for medical commodities in many LMICs, with national-level procurement and distribution from a central store down to regional and district levels.\u003csup\u003e5\u003c/sup\u003e However, instead of District Hospitals managing local distribution as is typically done\u003csup\u003e5\u003c/sup\u003e, Nepal used PPHLs to distribute RDTs to facilities in their province.\u0026nbsp;As cholera RDTs are included in the WHO Essential Diagnostics List\u003csup\u003e21\u003c/sup\u003e, integrating their distribution with that of other essential medical commodities could improve efficiency and enhance long-term sustainability. Regardless of which bodies are involved, engagement of peripheral-level actors in distributing RDTs within their provinces streamlines the process and alleviates pressure on national-level systems. Maintaining provincial-level stockpiles also enabled rapid distribution of additional RDTs as needs arose, though more guidance on how provinces should deploy the buffer stocks could be useful.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eShipping\u003c/em\u003e\u003c/strong\u003e: Whenever possible, cholera RDT shipments should be coordinated with shipments of other medical supplies to increase efficiency, though differences in distribution points must be considered. Systematic documentation of shipment contents is critical for transparency and inventory tracking. Additionally, advance notice about incoming shipments helps authorities plan for timely storage and distribution. Although flexibility in delivery methods enabled rapid distribution, adopting more standardized delivery procedures could help reduce logistical burden. Finally, initial RDT stocks should be delivered ahead of the monsoon season to avoid weather-related disruptions and ensure RDTs are readily available during the peak cholera transmission period.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTraining and Communication\u003c/em\u003e\u003c/strong\u003e: Comprehensive training that covers distribution and re-stocking procedures, preferably in person, is essential for clinicians and laboratory staff as well as for logistics and distribution personnel. Maintaining open communication through clear and well-established channels between and within government authorities and health facilities is key to effective RDT roll-out.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStrengths and Limitations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eOur mixed-methods analysis enabled us to quantify key aspects of RDT distribution, including stock-outs and stakeholder perspectives on distribution methods and success, while also integrating qualitative insights on distribution experiences. This approach not only allowed us to assess the reach of distribution but also to understand the underlying reasons for how it was carried out and the factors influencing its successes and challenges. A key strength of our study was the research team’s strong connections and collaboration with the Nepal government, which facilitated participation from a diverse range of government and health facility stakeholders.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSeveral limitations of our study should also be noted. Quantitative data on RDT distribution were provided by one laboratory technician per facility; while respondents received advance notice to compile the necessary information and field staff made efforts to cross-check figures for accuracy, the reported data may still contain inaccuracies. Qualitative interviews were conducted only with participants from facilities in Bagmati Province, meaning perspectives from more rural facilities and those more heavily impacted by RDT shipment delays were not represented. Additionally, interviews were limited to EWARS facilities, so the views of non-EWARS facilities and their insights on how RDTs could be deployed to their settings were not captured. Social desirability bias may have also made participants reluctant to acknowledge challenges. They may have also emphasized positive opinions about cholera RDTs to align with the research team's expectations and/or enhance the chances of receiving future RDT shipments. Nonetheless, we were able to capture a broad range of perspectives on RDT distribution in Nepal, including a range of successes, challenges, and recommendations.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eNepal successfully distributed cholera RDTs to all seven provinces, heightening the country\u0026rsquo;s ability to identify and respond to cholera outbreaks. Key lessons learned from the 2024 distribution process include the importance of securing external support for RDT procurement, anticipating potential shipment delays, timely coordination to obtain duty exemption certificates, incorporating RDT shipments with other medical commodities, and establishing provincial-led distribution and stockpiles. Leveraging enhanced data from 2024, including local perspectives on supply needs, will inform forecasting to limit stock-outs and wastage of cholera RDTs in the future. Increasing RDT access in lower-level health facilities, standardizing delivery procedures, and in-person, comprehensive training on distribution processes would also bolster cholera surveillance efforts. Funding for such programmatic support activities, in addition to the RDTs themselves, could enhance the effectiveness of RDT deployment. This paper contributes valuable evidence to the cholera RDT literature by documenting the implementation of the distribution process, highlighting potential challenges that other countries may face, and providing insights on strategies that worked. These lessons can enhance the success of cholera RDT rollouts both in Nepal, as additional RDTs are rolled out through the second round of the Gavi Diagnostics Support Platform, and in other countries planning similar efforts.\u003c/p\u003e"},{"header":"List of abbreviations","content":"\u003cp\u003eEDCD\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Epidemiology and Disease Control Division\u003c/p\u003e\n\u003cp\u003eEWARS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Early Warning and Reporting System\u003c/p\u003e\n\u003cp\u003eGTFCC \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Global Task Force for Cholera Control\u003c/p\u003e\n\u003cp\u003eHMIS\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Health Management Information System\u003c/p\u003e\n\u003cp\u003eLMIC \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Low- and middle-income countries\u003c/p\u003e\n\u003cp\u003eNCEP\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;National Cholera Elimination Plan\u003c/p\u003e\n\u003cp\u003eNGO\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Non-governmental Organization\u003c/p\u003e\n\u003cp\u003eNPHL \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;National Public Health Laboratory\u003c/p\u003e\n\u003cp\u003ePHD \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Public Health Directorate\u003c/p\u003e\n\u003cp\u003ePPHL \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Provincial Public Health Laboratory\u003c/p\u003e\n\u003cp\u003eRDT\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Rapid Diagnostic Test\u003c/p\u003e\n\u003cp\u003eRE-AIM\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;\u0026nbsp;Reach, Effectiveness, Adoption, Implementation, Maintenance framework\u003c/p\u003e\n\u003cp\u003eREDCap\u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;Research Electronic Data Capture application\u003c/p\u003e\n\u003cp\u003eWHO \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp;World Health Organization\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthics approval and consent to participate\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEthical approval was obtained from the JHU Institutional Review Board (IRB00025777 and IRB00028398) and the Nepal Health Research Council (Reg. No. 44612023). All procedures carried out in this study were in accordance with the ethical standards of the Declaration of Helsinki. All individuals interviewed for this publication provided written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eClinical trial number\u003c/strong\u003e: N/A\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe data underlying this study cannot be made publicly available due to compliance with our Institutional Review Board (IRB)-approved protocol and consent form, which ensured participants\u0026apos; anonymity and confidentiality. Given the qualitative nature of the data, participants are highly identifiable, even with anonymization efforts. Public availability would compromise participant privacy and potentially endanger their employment or livelihood, as some participants voiced concerns about the cholera RDT program and/or healthcare system. While we are open to sharing our data upon request, access will be granted only under a signed agreement prohibiting further dissemination or sharing of the transcripts. Please contact Amanda Debes, Principal Investigator, at
[email protected] for data access requests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was funded by Gavi, the Vaccine Alliance (CP 12563 1 23 A23 to DAS), administered through the Johns Hopkins Bloomberg School of Public Health. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026apos; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eKNW contributed to the design of the work, acquisition, analysis, and interpretation of data, and drafted the manuscript. EAR and GA contributed to the design of the work, acquisition, analysis, and interpretation of data. AS and MN contributed to the analysis and interpretation of data. ETB contributed to the conception and design of the work, as well as acquisition, analysis, and interpretation of data. PC and SD contributed to the acquisition and interpretation of data. HRP, MP, CBJ, JL, DK, and YL contributed to the interpretation of data. KK contributed to the design of the work, acquisition, and interpretation of data. DCB contributed to the conception and design of the work, acquisition, and interpretation of data. MM contributed to the design of the work and interpretation of data. DAS contributed to the conception and design of the work and interpretation of data. AKD contributed to the conception and design of the work, acquisition, analysis, and interpretation of data, and substantively revised the manuscript. All authors approved the submitted version and agree to be accountable for all aspects of the work.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors would like to thank the staff from the Group for Technical Assistance (GTA) Foundation, Kathmandu, Nepal for their support in carrying out this study. We also acknowledge the support of the International Vaccine Institute. Additionally, we extend our thanks to Nepal\u0026rsquo;s Epidemiology and Disease Control Division (EDCD), Management Division, National Public Health Laboratory (NPHL), Provincial Public Health Laboratories (PPHL), Bagmati Province Health Directorate (PHD), and Early Warning and Reporting System (EWARS) sites for their collaboration and participation in this study.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eDeclaration of generative AI and AI-assisted technologies in the writing process\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDuring the preparation of this work the authors used ChatGPT to improve language and readability. After using this tool/service, the authors reviewed and edited the content and take full responsibility for the content of the publication.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\n\u003cli\u003eGlobal Task Force on Cholera Control. About Cholera. 2025. https://www.gtfcc.org/about-cholera/\u003c/li\u003e\n\u003cli\u003eDebes AK, Murt KN, Waswa E, et al. Laboratory and Field Evaluation of the Crystal VC-O1 Cholera Rapid Diagnostic Test. \u003cem\u003eAm J Trop Med Hyg\u003c/em\u003e. 2021;104(6):2017-2023. doi:10.4269/ajtmh.20-1280\u003c/li\u003e\n\u003cli\u003eFIND - Diagnosis for all. \u003cem\u003eTarget Product Profile for a Rapid Diagnostic Test for Surveillance of Cholera\u003c/em\u003e.; 2024. https://www.finddx.org/wp-content/uploads/2024/04/20240403_tpp_surveillance_cholera_FV_EN.pdf\u003c/li\u003e\n\u003cli\u003eKuupiel D, Bawontuo V, Drain PK, Gwala N, Mashamba-Thompson TP. Supply chain management and accessibility to point-of-care testing in resource-limited settings: a systematic scoping review. \u003cem\u003eBMC Health Serv Res\u003c/em\u003e. 2019;19(1):519. doi:10.1186/s12913-019-4351-3\u003c/li\u003e\n\u003cli\u003eYadav P. Health Product Supply Chains in Developing Countries: Diagnosis of the Root Causes of Underperformance and an Agenda for Reform. \u003cem\u003eHealth Syst Reform\u003c/em\u003e. 2015;1(2):142-154. doi:10.4161/23288604.2014.968005\u003c/li\u003e\n\u003cli\u003eYadav P, Lydon P, Oswald J, Dicko M, Zaffran M. Integration of vaccine supply chains with other health commodity supply chains: A framework for decision making. \u003cem\u003eVaccine\u003c/em\u003e. 2014;32(50):6725-6732. doi:10.1016/j.vaccine.2014.10.001\u003c/li\u003e\n\u003cli\u003eGlasgow RE, Harden SM, Gaglio B, et al. RE-AIM Planning and Evaluation Framework: Adapting to New Science and Practice With a 20-Year Review. \u003cem\u003eFront Public Health\u003c/em\u003e. 2019;7:64. doi:10.3389/fpubh.2019.00064\u003c/li\u003e\n\u003cli\u003eGlasgow RE, Vogt TM, Boles SM. Evaluating the public health impact of health promotion interventions: the RE-AIM framework. \u003cem\u003eAm J Public Health\u003c/em\u003e. 1999;89(9):1322-1327.\u003c/li\u003e\n\u003cli\u003eBaumgartner ET, Williams KN, Rai E, et al. Enhancing national cholera surveillance using rapid diagnostic tests (RDTs): A mixed methods evaluation. \u003cem\u003ePLoS Negl Trop Dis\u003c/em\u003e. 2025;19(5):e0013019. doi:10.1371/journal.pntd.0013019\u003c/li\u003e\n\u003cli\u003eRoskosky M, Acharya B, Shakya G, et al. Feasibility of a Comprehensive Targeted Cholera Intervention in The Kathmandu Valley, Nepal. \u003cem\u003eAm J Trop Med Hyg\u003c/em\u003e. 2019;100(5):1088-1097. doi:10.4269/ajtmh.18-0863\u003c/li\u003e\n\u003cli\u003ePandav RS. CHOLERA OVERVIEW-NEPAL. Presented at: 9th Global Task Force on Cholera Control (GTFCC) Annual Meeting; June 2022. https://www.gtfcc.org/wp-content/uploads/2022/04/9th-annual-meeting-gtfcc-2022-rajesh-pandav.pdf\u003c/li\u003e\n\u003cli\u003eNepal Ministry of Health and Population, Department of Health Services, Epidemiology and Disease Control Division. \u003cem\u003eEWARS Weekly Bulletin\u003c/em\u003e.; 2024. https://www.edcd.gov.np/uploads/resource/66b789b21340b.pdf\u003c/li\u003e\n\u003cli\u003eGavi, the Vaccine Alliance. Global deployment of rapid diagnostic tests to boost fight against cholera. June 4, 2025. https://www.gavi.org/news/media-room/global-deployment-rapid-diagnostic-tests-boost-fight-against-cholera\u003c/li\u003e\n\u003cli\u003eGovernment of Nepal. \u003cem\u003eNational Preparedness and Response Plan for Acute Gastroenteritis/ Cholera Outbreaks in Nepal: July 2017 to July 2022\u003c/em\u003e.; 2017. https://www.edcd.gov.np/uploads/resource/5b7e3b0f9c562.pdf\u003c/li\u003e\n\u003cli\u003eHarris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap) - A metadata-driven methodology and workflow process for providing translational research informatics support. \u003cem\u003eJ Biomed Inf\u003c/em\u003e. 2009;42(2):377-381. doi:10.1016/j.jbi.2008.08.010\u003c/li\u003e\n\u003cli\u003eR Core Team. R: A language and environment for statistical computing. \u003cem\u003eR Found Stat Comput\u003c/em\u003e. 2025;Vienna, Austria(Computer Program). http://www.R-project.org/\u003c/li\u003e\n\u003cli\u003eStataCorp. Stata Statistical Software: Release 18.3 [Software]. 2024;College Station, TX:StataCorp LLC.\u003c/li\u003e\n\u003cli\u003eRampin R, Rampin V. Taguette: open-source qualitative data analysis. \u003cem\u003eJ Open Source Softw\u003c/em\u003e. 2021;6(68):3522.\u003c/li\u003e\n\u003cli\u003eMinistry of Health and Population. Nepal Health Facility Registry. Accessed June 9, 2025. https://nhfr.mohp.gov.np/\u003c/li\u003e\n\u003cli\u003eKamba PF, Ireeta ME, Balikuna S, Kaggwa B. Threats posed by stockpiles of expired pharmaceuticals in low- and middle-income countries: a Ugandan perspective. \u003cem\u003eBull World Health Organ\u003c/em\u003e. 2017;95(8):594-598. doi:10.2471/BLT.16.186650\u003c/li\u003e\n\u003cli\u003e\u003cem\u003eThe Selection and Use of Essential in Vitro Diagnostics: Report of the Third Meeting of the WHO Strategic Advisory Group of Experts on In Vitro Diagnostics, 2020 (Including the Third WHO Model List of Essential in Vitro Diagnostics)\u003c/em\u003e. Geneva: World Health Organization; 2021 (WHO Technical Report Series, No. 1031). Licence: CC BY-NC-SA 3.0 IGO. Accessed June 10, 2025. https://www.who.int/publications/i/item/9789240019102\u003c/li\u003e\n\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":true,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"
[email protected]","identity":"bmc-health-services-research","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bhsr","sideBox":"Learn more about [BMC Health Services Research](http://bmchealthservres.biomedcentral.com/)","snPcode":"","submissionUrl":"https://www.editorialmanager.com/BHSR/default.aspx","title":"BMC Health Services Research","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"em","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"cholera, rapid diagnostic tests, distribution, supply chain management, qualitative research, implementation science","lastPublishedDoi":"10.21203/rs.3.rs-7594652/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7594652/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e\u003cp\u003eCholera remains a significant public health threat in many low- and middle-income countries (LMICs). Rapid diagnostic tests (RDTs) offer a promising tool for improving surveillance and timely response, particularly as programs like Gavi\u0026rsquo;s Diagnostics Support Platform expand access. To realize the full potential of RDTs, effective national distribution strategies are essential.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e\u003cp\u003eThis study aimed to document lessons learned from Nepal\u0026rsquo;s first government-led, large-scale distribution of cholera RDTs in 2024, to inform successful strategies for national and global scale-up.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e\u003cp\u003eWe conducted a mixed-methods evaluation of the 2024 cholera RDT rollout in Nepal. Data collection included quantitative surveys with laboratory technicians and clinicians from health facilities, provincial public health laboratories (PPHLs), and government stakeholders. In-depth interviews were conducted with clinicians, laboratory technicians, medical recorders, and government officials to explore implementation experiences.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e\u003cp\u003eNepal\u0026rsquo;s experiences rolling out cholera RDTs offer important lessons in supply chain management. \u003cem\u003eProcurement\u003c/em\u003e: Support from Gavi and technical partners was vital for securing RDTs. Opportunities exist to simplify application processes, and delays should be anticipated. \u003cem\u003eImportation\u003c/em\u003e: Timely coordination with the Ministry of Finance was necessary to obtain duty exemption certificates and avoid customs fees. \u003cem\u003eSurveillance site selection\u003c/em\u003e: Facilities selected for RDT distribution needed both reporting mechanisms and connections for confirmatory testing. However, extending RDTs to lower-level, rural facilities is important for greater impact. \u003cem\u003eDemand forecasting and stock management\u003c/em\u003e: Allocation decisions benefited from combining surveillance data with local knowledge. Rigorous and systematic data on RDT usage can inform forecasting for future years. Stock tracking systems and redistribution mechanisms are critical to preventing both stock-outs and wastage. \u003cem\u003eDistribution pathway\u003c/em\u003e: Provincial-led distribution and stockpiles facilitated rapid delivery and responsiveness. \u003cem\u003eShipping\u003c/em\u003e: Coordinating RDT shipments with other supplies and standardizing delivery procedures is important for efficiency. \u003cem\u003eTraining and Communication\u003c/em\u003e: In-person training and clear communication on both RDT use and distribution across all levels of government and health facilities facilitate implementation.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e\u003cp\u003eNepal\u0026rsquo;s experiences provide practical, transferable lessons on cholera RDT distribution that can guide similar efforts in other cholera-endemic countries.\u003c/p\u003e","manuscriptTitle":"Evaluating the planning for and distribution of cholera rapid diagnostic tests in Nepal","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-24 06:13:36","doi":"10.21203/rs.3.rs-7594652/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2025-11-06T14:39:56+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"271283556702418623076561360668064247076","date":"2025-10-30T14:18:09+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"28294392189929698850545826517752045740","date":"2025-10-20T17:57:07+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-10-20T12:15:52+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-10-15T17:48:47+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-09-22T05:59:42+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-09-16T05:30:30+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Health Services Research","date":"2025-09-16T05:25:51+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"
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