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IntroductionMeasuring linkage after community-based testing, particularly HIV self-testing (HIVST), is challenging. Here, we use data from studies of community-based HIVST distribution, conducted within the STAR Initiative, to assess initiation of antiretroviral therapy (ART) and factors driving differences in linkage rates.MethodsFive STAR studies evaluated HIVST implementation in Malawi, Zambia and Zimbabwe. New ART initiations during the months of intervention at clinics in HIVST and comparison areas were presented graphically, and study effects combined using meta-analysis. Meta-regression was used to estimate associations between the impact of community-based HIVST distribution and indicators of implementation context, intensity and reach. Effect size estimates used (1) prespecified trial definitions of ART timing and comparator facilities and (2) exploratory definitions accounting for unexpected diffusion of HIVST into comparison areas and periods with less distribution of HIVST than was expected.ResultsCompared with arms with standard testing only, ART initiations were higher in clinics in HIVST distribution areas in 4/5 studies. The prespecified meta-analysis found positive but variable effects of HIVST on facility ART initiations (RR: 1.14, 95% CI 0.93 to 1.40; p=0.21). The exploratory meta-analysis found a stronger impact of HIVST distribution on ART initiations (RR: 1.29, 95% CI 1.08 to 1.55, p=0.02).ART initiations were higher in studies with greater self-reported population-level intensity of HIVST use (RR: 1.12; 95% CI 1.04 to 1.21; p=0.02.), but did not differ by national-level indicators of ART use among people living with HIV, number of HIVST kits distributed per 1000 population, or self-reported knowledge of how to link to care after a reactive HIVST.ConclusionCommunity-based HIVST distribution has variable effect on ART initiations compared with standard testing service alone. Optimising both support for and approach to measurement of effective and timely linkage or relinkage to HIV care and prevention following HIVST is needed to maximise impact and guide implementation strategies.

IntroductionAs countries approach the UNAIDS 95-95-95 targets, there is a need for innovative and cost-saving HIV testing approaches that can increase testing coverage in hard-to-reach populations. The HIV Self-Testing Africa-Initiative distributed HIV self-test (HIVST) kits using unincentivised HIV testing counsellors across 31 public facilities in Malawi, South Africa, Zambia and Zimbabwe. HIVST was distributed either through secondary (partner’s use) distribution alone or primary (own use) and secondary distribution approaches.MethodsWe evaluated the costs of adding HIVST to existing HIV testing from the providers’ perspective in the 31 public health facilities across the four countries between 2018 and 2019. We combined expenditure analysis and bottom-up costing approaches. We also carried out time-and-motion studies on the counsellors to estimate the human resource costs of introducing and demonstrating how to use HIVST for primary and secondary use.ResultsA total of 41 720 kits were distributed during the analysis period, ranging from 1254 in Zimbabwe to 27 678 in Zambia. The cost per kit distributed through the primary distribution approach was $4.27 in Zambia and $9.24 in Zimbabwe. The cost per kit distributed through the secondary distribution approach ranged from $6.46 in Zambia to $13.42 in South Africa, with a wider variation in the average cost at facility-level. From the time-and-motion observations, the counsellors spent between 20% and 44% of the observed workday on HIVST. Overall, personnel and test kit costs were the main cost drivers.ConclusionThe average costs of distributing HIVST kits were comparable across the four countries in our analysis despite wide cost variability within countries. We recommend context-specific exploration of potential efficiency gains from these facility-level cost variations and demand creation activities to ensure continued affordability at scale.

Introduction\ud Despite improvements in prevention of mother‐to‐child transmission (PMTCT) of HIV outcomes, there remain unacceptably high numbers of mother‐to‐child transmissions (MTCT) of HIV. Programmes and research collect multiple sources of PMTCT data, yet this data is rarely integrated in a systematic way. We conducted a data integration exercise to evaluate the Zimbabwe national PMTCT programme and derive lessons for strengthening implementation and documentation.\ud \ud Methods\ud We used data from four sources: research, Ministry of Health and Child Care (MOHCC) programme, Implementer – Organization for Public Health Interventions and Development, and modelling. Research data came from serial population representative cross‐sectional surveys that evaluated the national PMTCT programme in 2012, 2014 and 2017/2018. MOHCC and Organization for Public Health Interventions and Development collected data with similar indicators for the period 2018 to 2019. Modelling data from 2017/18 UNAIDS Spectrum was used. We systematically integrated data from the different sources to explore PMTCT programme performance at each step of the cascade. We also conducted spatial analysis to identify hotspots of MTCT.\ud \ud Results\ud We developed cascades for HIV‐positive and negative‐mothers, and HIV exposed and infected infants to 24 months post‐partum. Most data were available on HIV positive mothers. Few data were available 6‐8 weeks post‐delivery for HIV exposed/infected infants and none were available post‐delivery for HIV‐negative mothers. The different data sources largely concurred. Antenatal care (ANC) registration was high, although women often presented late. There was variable implementation of PMTCT services, MTCT hotspots were identified. Factors positively associated with MTCT included delayed ANC registration and mobility (use of more than one health facility) during pregnancy/breastfeeding. There was reduced MTCT among women whose partners accompanied them to ANC, and infants receiving antiretroviral prophylaxis. Notably, the largest contribution to MTCT was from postnatal women who had previously tested negative (12/25 in survey data, 17.6% estimated by Spectrum modelling). Data integration enabled formulation of interventions to improve programmes.\ud \ud Conclusions\ud Data integration was feasible and identified gaps in programme implementation/documentation leading to corrective interventions. Incident infections among mothers are the largest contributors to MTCT: there is need to strengthen the prevention cascade among HIV‐negative women.

Background Qualitative research networks (QRNs) bring together researchers from diverse contexts working on multi-country studies. The networks may themselves form a consortium or may contribute to a wider research agenda within a consortium with colleagues from other disciplines. The purpose of a QRN is to ensure robust methods and processes that enable comparisons across contexts. Under the Self-Testing Africa (STAR) initiative and the REACHOUT project on community health systems, QRNs were established, bringing together researchers across countries to coordinate multi-country qualitative research and to ensure robust methods and processes allowing comparisons across contexts. QRNs face both practical challenges in facilitating this iterative exchange process across sites and conceptual challenges interpreting findings between contexts. This paper distils key lessons and reflections from both QRN experiences on how to conduct trustworthy qualitative research across different contexts with examples from Bangladesh, Ethiopia, Kenya, Indonesia, Malawi, Mozambique, Zambia and Zimbabwe. Methods The process of generating evidence for this paper followed a thematic analysis method: themes initially identified were refined during several rounds of discussions in an iterative process until final themes were agreed upon in a joint learning process. Results Four guiding principles emerged from our analysis: a) explicit communication strategies that sustain dialogue and build trust and collective reflexivity; b) translation of contextually embedded concepts; c) setting parameters for contextualizing, and d) supporting empirical and conceptual generalisability. Under each guiding principle, we describe how credibility, dependability, confirmability and transferability can be enhanced and share good practices to be considered by other researchers. Conclusions Qualitative research is often context-specific with tools designed to explore local experiences and understandings. Without efforts to synthesise and systematically share findings, common understandings, experiences and lessons are missed. The logistical and conceptual challenges of qualitative research across multiple partners and contexts must be actively managed, including a shared commitment to continuous ‘joint learning’ by partners. Clarity and agreement on concepts and common methods and timelines at an early stage is critical to ensure alignment and focus in intercountry qualitative research and analysis processes. Building good relationships and trust among network participants enhance the quality of qualitative research findings.

Achieving HIV treatment targets such as 95-95-95 will help control the HIV epidemic. Key to this is implementation of efficient models that optimise patient engagement. WHO recommend multi-month dispensing of antiretroviral therapy (ART) for up to six months for stable patients because of positive effects in reducing the burden on health systems and time and opportunity costs for patients. Six-month dispensing intervals through differentiated community-based models demonstrate non-inferiority to 3-month facility-collection models. In this issue of the Lancet Global Health, Risa Hoffman and colleagues add to this evidence by reporting on a pragmatic non-inferiority cluster randomised trial of facility-based multi-month dispensing in Malawi and Zambia (INTERVAL).

BackgroundWe compared community-led versus an established community-based HIV self-testing (HIVST) model in rural Zimbabwe using a cluster-randomised trial.MethodsForty village groups were randomised 1:1 using restricted randomisation to community-led HIVST, where communities planned and implemented HIVST distribution for 4 weeks, or paid distribution (PD), where distributors were paid US$50 to distribute kits door-to-door over 4 weeks. Individual level primary outcomes compared household survey responses by arm 4 months post-intervention for: (1) newly diagnosed HIV during/within 4 months following HIVST distribution, (2) linkage to confirmatory testing, pre-exposure prophylaxis or voluntary medical male circumcision during/within 4 months following HIVST distribution. Participants were not masked to allocation; analysis used masked data. Trial analysis used random-effects logistic regression.Distribution costs compared: (1) community-led HIVST, (2) PD HIVST and (3) PD costs when first implemented in 2016/2017.ResultsFrom October 2018 to August 2019, 27 812 and 36 699 HIVST kits were distributed in community-led and PD communities, respectively. We surveyed 11 150 participants and 5683 were in community-led arm. New HIV diagnosis was reported by 211 (3.7%) community-led versus 197 (3.6%) PD arm participants, adjusted OR (aOR) 1.1 (95% CI 0.72 to 1.56); 318 (25.9%) community-led arm participants linked to post-test services versus 361 (23.9%) in PD arm, aOR 1.1 (95% CI 0.75 to 1.49.Cost per HIVST kit distributed was US$6.29 and US$10.25 for PD and community-led HIVST, both lower than 2016/2017 costs for newly implemented PD (US$14.52). No social harms were reported.ConclusionsCommunity-led HIVST can perform as well as paid distribution, with lower costs in the first year. These costs may reduce with programme maturity/learning.Trial registration numberPACTR201811849455568.

Supplemental Digital Content is available in the text, Objectives: The current study identifies young people's preferences for HIV self-testing (HIVST) delivery, determines the relative strength of preferences and explores underlying behaviors and perceptions to inform youth-friendly services in southern Africa. Design: A mixed methods design was adopted in Malawi and Zimbabwe and includes focus group discussions, in-depth interviews and discrete choice experiments. Methods: The current study was conducted during the formative phase of cluster-randomized trials of oral-fluid HIVST distribution. Young people aged 16–25 years were purposively selected for in-depth interviews (n = 15) in Malawi and 12 focus group discussions (n = 107) across countries. Representative samples of young people in both countries (n = 341) were administered discrete choice experiments on HIVST delivery, with data analyzed to estimate relative preferences. The qualitative results provided additional depth and were triangulated with the quantitative findings. Results: There was strong concordance across methods and countries based on the three triangulation parameters: product, provider and service characteristics. HIVST was highly accepted by young people, if provided at no or very low cost. Young people expressed mixed views on oral-fluid tests, weighing perceived benefits with accuracy concerns. There was an expressed lack of trust in health providers and preference for lay community distributors. HIVST addressed youth-specific barriers to standard HIV testing, with home-based distribution considered convenient. Issues of autonomy, control, respect and confidentiality emerged as key qualitative themes. Conclusion: HIVST services can be optimized to reach young people if products are provided through home-based distribution and at low prices, with respect for them as autonomous individuals.

HIV testing is a necessary step for uptake of HIV prevention and treatment services. Since 2008 there have been large scale initiatives to intensify access to and uptake of HIV testing among untested populations at risk through provider-initiated HIV testing and counselling (PITC)1, community-based approaches2 and partner notification3, with Sub-Saharan Africa, the region worst affected by the HIV epidemic4, being most critically in need of these initiatives. As for other health interventions5,6 however, inequalities in uptake of HIV testing have been recorded7, and they may persist despite intensification of HIV testing efforts and treatment scale-up8.

To present findings from implementation and scale-up of human immunodeficiency virus (HIV) self-testing programmes for female sex workers in Malawi and Zimbabwe, 2013-2018.In Zimbabwe, we carried out formative research to assess the acceptability and accuracy of HIV self-testing. During implementation we evaluated sex workers' preferences for, and feasibility of, distribution of test kits before the programme was scaled-up. In Malawi, we conducted a rapid ethnographic assessment to explore the context and needs of female sex workers and resources available, leading to a workshop to define the distribution approach for test kits. Once distribution was implemented, we conducted a process evaluation and established a system for monitoring social harm.In Zimbabwe, female sex workers were able to accurately self-test. The preference study helped to refine systems for national scale-up through existing services for female sex workers. The qualitative data helped to identify additional distribution strategies and mediate potential social harm to women. In Malawi, peer distribution of test kits was the preferred strategy. We identified some incidents of social harm among peer distributors and female sex workers, as well as supply-side barriers to implementation which hindered uptake of testing.Involving female sex workers in planning and ongoing implementation of HIV self-testing is essential, along with strategies to mitigate potential harm. Optimal strategies for distribution and post-test support are context-specific and need to consider existing support for female sex workers and levels of trust and cohesion within their communities.Présenter les résultats de la mise en œuvre et de l’élargissement de programmes d'autodépistage du virus de l'immunodéficience humaine (VIH) pour les travailleuses du sexe au Malawi et au Zimbabwe entre 2013 et 2018.Au Zimbabwe, nous avons réalisé une recherche préparatoire pour évaluer l'acceptabilité et la précision de l'autotest du VIH. Au cours de la mise en œuvre, nous avons évalué la faisabilité et les préférences des travailleuses du sexe à l’égard de la distribution des trousses de dépistage avant d'élargir le programme. Au Malawi, nous avons réalisé une évaluation ethnographique rapide pour étudier le contexte, les besoins des travailleuses du sexe et les ressources disponibles, ce qui a donné lieu à un atelier dont l'objectif était de définir la méthode de distribution des trousses de dépistage. Une fois la distribution mise en place, nous avons évalué le processus et établi un système de suivi des dommages sociaux.Au Zimbabwe, les travailleuses du sexe étaient en mesure de procéder à un autodépistage précis. L'étude des préférences a permis de perfectionner les systèmes en vue d'un développement national par l'intermédiaire des services existants pour les travailleuses du sexe. Les données qualitatives ont aidé à définir d'autres stratégies de distribution et les dommages sociaux indirects que peuvent subir les femmes. Au Malawi, la distribution de trousses de dépistage par des pairs a été la stratégie privilégiée. Nous avons identifié quelques cas de dommages sociaux entre des travailleuses du sexe assurant la distribution et d'autres travailleuses du sexe, ainsi que des obstacles du côté de l'offre qui ont limité l'utilisation du test.La participation des travailleuses du sexe à la planification et à la mise en œuvre continue de l'autodépistage du VIH est essentielle, de même que les stratégies visant à réduire les dommages potentiels. Pour être optimales, les stratégies en matière de distribution et de soutien post-test doivent tenir compte du contexte, du soutien existant apporté aux travailleuses du sexe et du degré de confiance et de cohésion au sein de leurs communautés.Presentar los resultados de la implementación y ampliación de los programas de autodiagnóstico del virus de la inmunodeficiencia humana (VIH) para trabajadoras sexuales en Malawi y Zimbabwe, 2013-2018.En Zimbabwe, se llevó a cabo una investigación formativa para evaluar la aceptabilidad y exactitud del autodiagnóstico del VIH. Durante la implementación, se evaluaron las preferencias de las trabajadoras sexuales y la viabilidad de la distribución de los kits de pruebas antes de ampliar el programa. En Malawi, se realizó una evaluación etnográfica rápida para explorar el contexto y las necesidades de las trabajadoras sexuales y los recursos disponibles, que condujo a un taller para definir el enfoque de distribución de los kits de pruebas. Una vez implementada la distribución, se llevó a cabo una evaluación del proceso y se estableció un sistema para el seguimiento de los daños sociales.En Zimbabwe, las trabajadoras sexuales pudieron autoevaluarse con precisión. El estudio de preferencias contribuyó a perfeccionar los sistemas de ampliación nacional mediante los servicios existentes para las trabajadoras sexuales. Los datos cualitativos ayudaron a identificar estrategias de distribución adicionales y a mediar en posibles daños sociales para las mujeres. En Malawi, la estrategia preferida fue la distribución de kits de pruebas entre pares. Se identificaron algunos incidentes de daño social entre distribuidores pares y trabajadoras sexuales, así como barreras de suministro para la implementación que dificultaban la realización de las pruebas.Es esencial involucrar a las trabajadoras sexuales en la planificación y la implementación continua del autodiagnóstico del VIH, junto con estrategias para reducir los daños potenciales. Las estrategias óptimas para la distribución y el apoyo posterior a las pruebas son específicas para cada contexto y deben tener en cuenta el apoyo existente a las trabajadoras sexuales y los niveles de confianza y cohesión dentro de sus comunidades.طرح النتائج المترتبة على تنفيذ برامج الفحص الذاتي لفيروس نقص المناعة البشرية (HIV) وتوسيع نطاقها، وذلك على العاملات في المجال الجنسي في ملاوي وزمبابوي، خلال الفترة من 2013 إلى 2018.قمنا في زيمبابوي بإجراء بحثاً مركباً لتقييم إمكانية قبول الفحص الذاتي لفيروس نقص المناعة البشرية، وكذلك مدى دقة هذا الفحص. وقمنا أثناء التنفيذ بتقييم تفضيلات العاملات في المجال الجنسي تجاه توزيع أطقم الفحص الذاتي، ومدى جدوى ذلك، قبل أن يتم توسيع البرنامج. أما في ملاوي، فقد قمنا بإجراء تقييم إثنوغرافي سريع لاستكشاف سياق واحتياجات العاملات في المجال الجنسي والموارد المتاحة، مما أدى إلى ورشة عمل لتحديد أسلوب توزيع أطقم الفحص. وبمجرد إتمام التوزيع، قمنا بإجراء تقييم للعملية وأنشأنا نظامًا لمراقبة التضرر الاجتماعي.تمكن العاملات في المجال الجنسي في زمبابوي من إجراء الفحص الذاتي بدقة. ساعدت دراسة التفضيلات في تحسين الأنظمة الخاصة بالتوسع الوطني من خلال الخدمات الحالية للعاملات في المجال الجنسي. ساعدت البيانات النوعية في تحديد استراتيجيات التوزيع الإضافية، والتوسط في التضرر الاجتماعي المحتمل للسيدات. وفي ملاوي، كان توزيع الأقران لأطقم الفحص هو الاستراتيجية المفضلة. قمنا بتحديد بعض حوادث التضرر الاجتماعي بين الموزعين من الأقران والعاملات في المجال الجنسي، وكذلك الحواجز من جانب الإمداد في سبيل التنفيذ، والتي أعاقت انتشار الفحص.إن إشراك العاملات في المجال الجنسي في التخطيط والتنفيذ المستمر للفحص الذاتي لفيروس نقص المناعة البشرية، لهو أمر ضروري، وذلك إلى جانب استراتيجيات تخفيف الضرر المحتمل. تعتمد الاستراتيجيات المثلى للتوزيع، ودعم ما بعد الفحص، على السياق، وهي بحاجة إلى النظر في الدعم الحالي للعاملات في المجال الجنسي، ومستويات.旨在介绍 2013 年至 2018 年马拉维和津巴布韦针对女性性工作者实施与推广人体免疫缺损病毒（艾滋病毒）自我检测方案的调查结果。.我们在津巴布韦境内开展了形成性研究，以评估艾滋病毒自我检测的可接受性和准确性。推广方案之前，我们在实施过程中评估了性工作者对检测试剂盒分发的偏好与可行性。我们在马拉维进行了一次快速的人种学评估，以探讨女性性工作者的背景与需求以及可用的资源，并为此举办了一场研讨会以确定检测试剂盒的分发方法。实施分发后，我们进行了流程评估并建立了一个社会危害监测系统。.在津巴布韦境内，女性性工作者能够准确地进行自我检测。这项偏好研究利用为女性性工作者提供的现有服务，帮助完善该系统在全国范围内推广。对于女性而言，定性数据有助于制定其他分发策略并调解潜在的社会危害。在马拉维境内，同行之间分发检测试剂盒是首选的策略。我们在同行分发者与女性性工作者之间发现了一些社会危害事件，以及供应方面的实施障碍，这妨碍了检测试剂盒的分发。.让女性性工作者参与规划和持续实施艾滋病毒自我检测至关重要，同时还要制定减轻潜在危害的策略。最佳的分发与检测后支持策略取决于具体情况并且需要考虑对女性性工作者的现有支持及其社区内的信任和凝聚力程度。.Представить результаты внедрения и расширения сферы действия программ по самостоятельному тестированию на наличие вируса иммунодефицита человека (ВИЧ) среди работниц секс-индустрии в Малави и Зимбабве в период с 2013 по 2018 год.В Зимбабве авторы провели формативное исследование для оценки приемлемости и точности результатов самостоятельного тестирования на ВИЧ. Во время осуществления программы (до начала расширения сферы ее действия) оценивались предпочтения работниц секс-индустрии относительно распространения наборов для самотестирования и возможности осуществления их пожеланий. В Малави авторы провели ускоренную этнографическую оценку для изучения контекста и потребностей работниц секс-индустрии, а также для оценки имеющихся ресурсов. В результате был проведен семинар для определения подхода к распространению наборов для самотестирования. Как только наборы были распространены, авторы провели оценку процесса и разработали систему мониторинга социального вреда.Работницы секс-индустрии в Зимбабве были в состоянии точно выполнить самостоятельное тестирование. Исследование предпочтений помогло уточнить систему расширения сферы действия программы в национальном масштабе, которая использовала уже имеющиеся возможности для работниц секс-индустрии. Данные качественного характера помогли выявить дополнительные стратегии распространения наборов для самотестирования и уменьшить потенциальный социальный вред для женщин. В Малави предпочтительной стратегией распространения наборов для самотестирования было распределение через самих работниц. Авторы выявили некоторые случаи социального вреда, имевшие место среди распространителей наборов для самотестирования и работниц секс-индустрии. Имелись также препятствия со стороны поставщиков, которые снижали эффективность работы программы.Вовлечение работниц секс-индустрии в процесс планирования и постоянного осуществления самотестирования на ВИЧ имеет чрезвычайную важность наряду с разработкой стратегий уменьшения потенциального социального вреда. Оптимальные стратегии распространения тестов и последующей поддержки зависят от контекста. Необходимо учитывать наличие имеющейся поддержки работниц секс-индустрии, а также уровень доверия и сплоченности в их сообществах.

Key Points Question How is the demand for HIV self-testing influenced by pricing and distribution strategies? Findings In a randomized clinical trial of 4000 adults in Zimbabwe, demand for HIV self-testing declined substantially from 32.5% among those offered self-administered tests for free to 6.9% among those offered the tests for US $0.50 and below 3% at prices of US $1 or greater. Price sensitivity was higher among rural residents, men, and those who had never had an HIV test; in urban areas, demand was higher with pharmacy- than clinic-based distribution. Meaning This study suggests that demand for HIV self-testing is highly price sensitive in low-income settings; free distribution of self-tests may help promote their use in high-priority population segments., This randomized clinical trial evaluates the effectiveness of various pricing and distribution methods for a self-administered test for HIV diagnosis in Zimbabwe., Importance HIV self-testing is a promising approach for increasing awareness of HIV status in sub-Saharan Africa, particularly in Zimbabwe, where HIV prevalence is 13%. Evidence is lacking, however, on the optimal pricing policies and delivery strategies for maximizing the effect of HIV self-testing. Objective To assess demand for HIV self-testing among adults and priority-population subgroups under alternative pricing and distribution strategies. Design, Setting, and Participants This randomized clinical trial recruited study participants between February 15, 2018, and April 25, 2018, in urban and rural communities in Zimbabwe. A factorial design was used to randomize participants to a combination of self-test price, distribution site, and promotional message. Individuals and their household members had to be at least 16 years old to be eligible for participation. This intention-to-treat population comprised 3996 participants. Interventions Participants were given a voucher that could be redeemed for an HIV self-test within 1 month at varying prices (US $0-$3) and distribution sites (clinics or pharmacies in urban areas, and retail stores or community health workers in rural areas). Vouchers included randomly assigned promotional messages that emphasized the benefits of HIV testing. Main Outcomes and Measures Proportion of participants who obtained self-tests in each trial arm, measured by distributor records. Results Among the 4000 individuals enrolled, 3996 participants were included. In total, the mean (SD) age was 35 (14.7) years, and most participants (2841 [71.1%]) were female. Self-testing demand was highly price sensitive; 260 participants (32.5%) who were offered free self-tests redeemed their vouchers, compared with 55 participants (6.9%) who were offered self-tests for US $0.50 (odds ratio [OR], 0.14; 95% CI, 0.10-0.19), a reduction in demand of more than 25 percentage points. Demand was below 3% in the $1, $2, and $3 groups, which was statistically significantly lower than the demand in the free distribution group: in pooled analyses, demand was considerably lower among participants in higher-than-$0 price groups compared with the free distribution group (2.8% vs 32.5%; OR, 0.05; 95% CI, 0.04-0.07). In urban areas, demand was statistically significantly higher with pharmacy-based distribution compared with clinic-based distribution (6.8% vs 2.9%; adjusted OR, 2.78; 95% CI, 1.74-4.45). Price sensitivity was statistically significantly higher among rural residents, men, and those who had never received testing before. Promotional messages did not influence demand. Conclusions and Relevance This study found that demand for HIV self-testing in Zimbabwe was highly price sensitive, suggesting that free distribution may be essential for promoting testing among high-priority population groups; additionally, pharmacy-based distribution was preferable to clinic-based distribution in urban areas. Trial Registration ClinicalTrials.gov identifier: NCT03559959

Introduction HIV self‐testing (HIVST) is recommended by the World Health Organization in addition to other testing modalities to increase uptake of HIV testing, particularly among harder‐to‐reach populations. This study provides the first empirical evidence of the costs of door‐to‐door community‐based HIVST distribution in Malawi, Zambia and Zimbabwe. Methods HIVST kits were distributed door‐to‐door in 71 sites across Malawi, Zambia and Zimbabwe from June 2016 to May 2017. Programme expenditures, supplemented by on‐site observation and monitoring and evaluation data were used to estimate total economic and unit costs of HIVST distribution, by input and site. Inputs were categorized into start‐up, capital and recurrent costs. Sensitivity and scenario analyses were performed to assess the impact of key parameters on unit costs. Results In total, 152,671, 103,589 and 93,459 HIVST kits were distributed in Malawi, Zambia and Zimbabwe over 12, 11 and 10 months respectively. Across these countries, 43% to 51% of HIVST kits were distributed to men. The average cost per HIVST kit distributed was US$8.15, US$16.42 and US$13.84 in Malawi, Zambia and Zimbabwe, respectively, with pronounced intersite variation within countries driven largely by site‐level fixed costs. Site‐level recurrent costs were 70% to 92% of full costs and 20% to 62% higher than routine HIV testing services (HTS) costs. Personnel costs contributed from 26% to 52% of total costs across countries reflecting differences in remuneration approaches and country GDP. Conclusions These early door‐to‐door community HIVST distribution programmes show large potential, both for reaching untested populations and for substantial economies of scale as HIVST programmes scale‐up and mature. From a societal perspective, the costs of HIVST appear similar to conventional HTS, with the higher providers’ costs substantially offsetting user costs. Future approaches to minimizing cost and/or maximize testing coverage could include unpaid door‐to‐door community‐led distribution to reach end‐users and integrating HIVST into routine clinical services via direct or secondary distribution strategies with lower fixed costs.

Introduction The prevalence of undiagnosed HIV is declining in Africa, and various HIV testing approaches are finding lower positivity rates. In this context, the epidemiological impact and cost‐effectiveness of community‐based HIV self‐testing (CB‐HIVST) is unclear. We aimed to assess this in different sub‐populations and across scenarios characterized by different adult HIV prevalence and antiretroviral treatment programmes in sub‐Saharan Africa. Methods The synthesis model was used to address this aim. Three sub‐populations were considered for CB‐HIVST: (i) women having transactional sex (WTS); (ii) young people (15 to 24 years); and (iii) adult men (25 to 49 years). We assumed uptake of CB‐HIVST similar to that reported in epidemiological studies (base case), or assumed people use CB‐HIVST only if exposed to risk (condomless sex) since last HIV test. We also considered a five‐year time‐limited CB‐HIVST programme. Cost‐effectiveness was defined by an incremental cost‐effectiveness ratio (ICER; cost‐per‐disability‐adjusted life‐year (DALY) averted) below US$500 over a time horizon of 50 years. The efficiency of targeted CB‐HIVST was evaluated using the number of additional tests per infection or death averted. Results In the base case, targeting adult men with CB‐HIVST offered the greatest impact, averting 1500 HIV infections and 520 deaths per year in the context of a simulated country with nine million adults, and impact could be enhanced by linkage to voluntary medical male circumcision (VMMC). However, the approach was only cost‐effective if the programme was limited to five years or the undiagnosed prevalence was above 3%. CB‐HIVST to WTS was the most cost‐effective. The main drivers of cost‐effectiveness were the cost of CB‐HIVST and the prevalence of undiagnosed HIV. All other CB‐HIVST scenarios had an ICER above US$500 per DALY averted. Conclusions CB‐HIVST showed an important epidemiological impact. To maximize population health within a fixed budget, CB‐HIVST needs to be targeted on the basis of the prevalence of undiagnosed HIV, sub‐population and the overall costs of delivering this testing modality. Linkage to VMMC enhances its cost‐effectiveness.

Introduction The ability to achieve an accurate test result and interpret it correctly is critical to the impact and effectiveness of HIV self‐testing (HIVST). Simple and easy‐to‐use devices, instructions for use (IFU) and other support tools have been shown to be key to good performance in sub‐Saharan Africa and may be highly contextual. The objective of this study was to explore the utility of cognitive interviewing in optimizing the local understanding of manufacturers’ IFUs to achieve an accurate HIVST result. Methods Functionally literate and antiretroviral therapy‐naive participants were purposefully selected between May 2016 and June 2017 to represent intended users of HIV self‐tests from urban and rural areas in Malawi and Zambia. Participants were asked to follow IFUs for HIVST. We then conducted cognitive interviews and observed participants while they attempted to complete the HIVST steps using a structured guide, which mirrored the steps in the IFU. Qualitative data were analysed using a thematic approach. Results Of a total of 61 participants, many successfully performed most steps in the IFU. Some had difficulties in understanding these and made errors, which could have led to incorrect test results, such as incorrect use of buffer and reading the results prematurely. Participants with lower levels of literacy and inexperience with standard pictorial images were more likely to struggle with IFUs. Difficulties tended to be more pronounced among those in rural settings. Ambiguous terms and translations in the IFU, unfamiliar images and symbols, and unclear order of the steps to be followed were most commonly linked to errors and lower comprehension among participants. Feedback was provided to the manufacturer on the findings, which resulted in further optimization of IFUs. Conclusions Cognitive interviewing identifies local difficulties in conducting HIVST from manufacturer‐translated IFUs. It is a useful and practical methodology to optimize IFUs and make them more understandable.

BACKGROUND: Providing HIV testing at health facilities remains the most common approach to ensuring access to HIV treatment and prevention services for the millions of undiagnosed HIV-infected individuals in sub-Saharan Africa. We sought to explore the costs of providing these services across three southern African countries with high HIV burden. METHODS: Primary costing studies were undertaken in 54 health facilities providing HIV testing services (HTS) in Malawi, Zambia and Zimbabwe. Routinely collected monitoring and evaluation data for the health facilities were extracted to estimate the costs per individual tested and costs per HIV-positive individual identified. Costs are presented in 2016 US dollars. Sensitivity analysis explored key drivers of costs. RESULTS: Health facilities were testing on average 2290 individuals annually, albeit with wide variations. The mean cost per individual tested was US$5.03.9 in Malawi, US$4.24 in Zambia and US$8.79 in Zimbabwe. The mean cost per HIV-positive individual identified was US$79.58, US$73.63 and US$178.92 in Malawi, Zambia and Zimbabwe respectively. Both cost estimates were sensitive to scale of testing, facility staffing levels and the costs of HIV test kits. CONCLUSIONS: Health facility based HIV testing remains an essential service to meet HIV universal access goals. The low costs and potential for economies of scale suggests an opportunity for further scale-up. However low uptake in many settings suggests that demand creation or alternative testing models may be needed to achieve economies of scale and reach populations less willing to attend facility based services.

Background While barriers to uptake of antenatal care (ANC) among pregnant women have been explored, much less is known about how integrating prevention of mother-to-child transmission (PMTCT) programmes within ANC services affects uptake. We explored barriers to uptake of integrated ANC services in a poor Zimbabwean community. Methods A cross-sectional survey was conducted among post-natal women at Mbare Clinic, Harare, between September 2010 and February 2011. Collected data included participant characteristics and ANC uptake. Logistic regression was conducted to determine factors associated with ANC registration. In-depth interviews were held with the first 21 survey participants who either did not register or registered after twenty-four weeks gestation to explore barriers. Interviews were analysed thematically. Results Two hundred and ninety-nine participants (mean age 26.1 years) were surveyed. They came from ultra-poor households, with mean household income of US$181. Only 229 (76.6%) had registered for ANC, at a mean gestation of 29.5 weeks. In multivariable analysis, household income was positively associated with ANC registration, odds ratio (OR) for a $10-increase in household income 1.02 (95% confidence interval, CI, 1.0–1.04), as was education which interacted with having planned the pregnancy (OR for planned pregnancy with completed ordinary level education 3.27 (95%CI 1.55–6.70). Divorced women were less likely to register than married women, OR 0.20 (95%CI 0.07–0.58). In the qualitative study, barriers to either ANC or PMTCT services limited uptake of integrated services. Women understood the importance of integrated services for PMTCT purposes and theirs and the babies’ health and appeared unable to admit to barriers which they deemed “stupid/irresponsible”, namely fear of HIV testing and disrespectful treatment by nurses. They represented these commonly recurring barriers as challenges that “other women” faced. The major proffered personal barrier was unaffordability of user fees, which was sometimes compounded by unsupportive husbands who were the breadwinners. Conclusion Women who delayed/did not register were aware of the importance of ANC and PMTCT but were either unable to afford or afraid to register. Addressing the identified challenges will not only be important for integrated PMTCT/ANC services but will also provide a model for dealing with challenges as countries scale up ‘treat all’ approaches. Electronic supplementary material The online version of this article (10.1186/s12884-018-1898-7) contains supplementary material, which is available to authorized users.

Summary Background Couples' HIV testing and counselling (CHTC) is associated with greater engagement with HIV prevention and care than individual testing and is cost-effective, but uptake remains suboptimal. Initiating discussion of CHTC might result in distrust between partners. Offering incentives for CHTC could change the focus of the pre-test discussion. We aimed to determine the impact of incentives for CHTC on uptake of couples testing and HIV case diagnosis in rural Zimbabwe. Methods In this cluster-randomised trial, 68 rural communities (the clusters) in four districts receiving mobile HIV testing services were randomly assigned (1:1) to incentives for CHTC or not. Allocation was not masked to participants and researchers. Randomisation was stratified by district and proximity to a health facility. Within each stratum random permutation was done to allocate clusters to the study groups. In intervention communities, residents were informed that couples who tested together could select one of three grocery items worth US$1·50. Standard mobilisation for testing was done in comparison communities. The primary outcome was the proportion of individuals testing with a partner. Analysis was by intention to treat. 3 months after CHTC, couple-testers from four communities per group individually completed a telephone survey to evaluate any social harms resulting from incentives or CHTC. The effect of incentives on CHTC was estimated using logistic regression with random effects adjusting for clustering. The trial was registered with the Pan African Clinical Trial Registry, number PACTR201606001630356. Findings From May 26, 2015, to Jan 29, 2016, of 24 679 participants counselled with data recorded, 14 099 (57·1%) were in the intervention group and 10 580 (42·9%) in the comparison group. 7852 (55·7%) testers in the intervention group versus 1062 (10·0%) in the comparison group tested with a partner (adjusted odds ratio 13·5 [95% CI 10·5–17·4]). Among 427 (83·7%) of 510 eligible participants who completed the telephone survey, 11 (2·6%) reported that they were pressured or themselves pressured their partner to test together; none regretted couples' testing. Relationship unrest was reported by eight individuals (1·9%), although none attributed this to incentives. Interpretation Small non-monetary incentives, which are potentially scalable, were associated with significantly increased CHTC and HIV case diagnosis. Incentives did not increase social harms beyond the few typically encountered with CHTC without incentives. The intervention could help achieve UNAIDS 90-90-90 targets. Funding The study was funded by the UK Department for International Development, Irish AID, and Swedish SIDA, through Population Services International Zimbabwe under the Integrated Support Program.

Introduction New HIV testing strategies are needed to reach the United Nations’ 90‐90‐90 target. HIV self‐testing (HIVST) can increase uptake, but users’ perspectives on optimal models of distribution and post‐test services are uncertain. We used discrete choice experiments (DCEs) to explore the impact of service characteristics on uptake along the testing cascade. Methods DCEs are a quantitative survey method that present respondents with repeated choices between packages of service characteristics, and estimate relative strengths of preferences for service characteristics. From June to October 2016, we embedded DCEs within a population‐based survey following door‐to‐door HIVST distribution by community volunteers in two rural Zimbabwean districts: one DCE addressed HIVST distribution preferences; and the other preferences for linkage to confirmatory testing (LCT) following self‐testing. Using preference coefficients/utilities, we identified key drivers of uptake for each service and simulated the effect of changes of outreach and static/public clinics’ characteristics on LCT. Results Distribution and LCT DCEs surveyed 296/329 (90.0%) and 496/594 (83.5%) participants; 81.8% and 84.9% had ever‐tested, respectively. The strongest distribution preferences were for: (1) free kits – a $1 increase in the kit price was associated with a disutility (U) of −2.017; (2) door‐to‐door kit delivery (U = +1.029) relative to collection from public/outreach clinic; (3) telephone helpline for pretest support relative to in‐person or no support (U = +0.415); (4) distributors from own/local village (U = +0.145) versus those from external communities. Participants who had never HIV tested valued phone helplines more than those previously tested. The strongest LCT preferences were: (1) immediate antiretroviral therapy (ART) availability: U = +0.614 and U = +1.052 for public and outreach clinics, respectively; (2) free services: a $1 user fee increase decreased utility at public (U = −0.381) and outreach clinics (U = −0.761); (3) proximity of clinic (U = −0.38 per hour walking). Participants reported willingness to link to either location; but never‐testers were more averse to LCT. Simulations showed the importance of availability of ART: ART unavailability at public clinics would reduce LCT by 24%. Conclusions Free HIVST distribution by local volunteers and immediately available ART were the strongest relative preferences identified. Accommodating LCT preferences, notably ensuring efficient provision of ART, could facilitate “resistant testers” to test while maximizing uptake of post‐test services.

Implementation of cotrimoxazole prophylaxis (CTX-p) among HIV-exposed children is poor in southern Africa. We conducted a multi-methods study to investigate the barriers to delivery of CTX-p to HIV exposed infants in Zimbabwe at each step of the care cascade. Here we report findings of the qualitative component designed to investigate issues related to adherence conducted among women identified as HIV positive whose babies were started on CTX-p postnatally. Between Feb-Dec 2011, the first 19 HIV infected mothers identified were invited for in-depth interview 4-5months postnatally. Interviews were recorded, transcribed, translated and analysed thematically. Of note, Zimbabwe also provides nevirapine prophylaxis for HIV-exposed babies, so the majority were giving nevirapine and CTX-p to their babies. All women desired their baby's health above all else, and were determined to do all they could to ensure their wellbeing. They did not report problems remembering to give drugs. The baby's apparent good health was a huge motivator for continued adherence. Testimonies from women whose babies had tested HIV negative strengthened the resolve to adhere. However, most women reported that their husbands were less engaged in HIV care, refusing to be HIV tested and in some cases stealing drugs prescribed for their wives for themselves. In two instances the man stopped the woman from giving CTX-p to the baby either because of fear of side effects or not appreciating its importance: "he said if I kept giving CTX-p he would take the baby away from me and give him to his mother." Stigma continues to be an important issue. Mothers reported being reluctant to disclose their HIV status to other people so found it difficult to collect prescription refills from the HIV clinic for fear of being seen by friends/relatives. Some women reported that it was hard to administer the drugs if there were people around at home. Other challenges faced were stock-outs of CTX-p at the clinic, which occurred four times during the study. The baby would then go without CTX-p if the woman could not afford buying at a private pharmacy. The study highlights that adherence knowledge and desire alone is insufficient to overcome the familial and structural barriers to maintaining CTX-p. Improving adherence to CTX-p among HIV exposed infants will require interventions to improve male involvement, reduce HIV stigma at facilities and ensure adequate supply of drugs. (Published: 11 November 2012) Citation: Abstracts of the Eleventh International Congress on Drug Therapy in HIV Infection Sibanda E et al. Journal of the International AIDS Society 2012, 15 (Suppl 4):18061 http://www.jiasociety.org/index.php/jias/article/view/18061 | http://dx.doi.org/10.7448/IAS.15.6.18061

A systematic review designed to explore whether cotrimoxazole prophylaxis for HIV increases bacterial resistance to other classes of antibiotics. There is suggestive evidence that cotrimoxazole protects against antibiotic resistance., Background. Trimethoprim-sulfamethoxazole (TMP-SMX) prophylaxis has long been recommended for immunosuppressed HIV-infected adults and children born to HIV-infected women. Despite this, many resource-limited countries have not implemented this recommendation, partly because of fear of widespread antimicrobial resistance not only to TMP-SMX, but also to other antibiotics. We aimed to determine whether TMP-SMX prophylaxis in HIV-infected and/or exposed individuals increases bacterial resistance to antibiotics other than TMP-SMX. Methods. A literature search was conducted in Medline, Global Health, Embase, Web of Science, ELDIS, and ID21. Results. A total of 501 studies were identified, and 17 met the inclusion criteria. Only 8 studies were of high quality, of which only 2 had been specifically designed to answer this question. Studies were classified as (1) studies in which all participants were infected and/or colonized and in which rates of bacterial resistance were compared between those taking or not taking TMP-SMX and (2) studies comparing those who had a resistant infection with those who were not infected. Type 1 studies showed weak evidence that TMP-SMX protects against resistance. Type 2 studies provided more convincing evidence that TMP-SMX protects against infection. Conclusion. There was some evidence that TMP-SMX prophylaxis protects against resistance to other antibiotics. However, more carefully designed studies are needed to answer the question conclusively.

BACKGROUND: Implementation of cotrimoxazole prophylaxis (CTX-p) among HIV-exposed infants (HEI) is poor in southern Africa. We conducted a study to investigate barriers to delivery of CTX-p to HEI in Zimbabwe at each step of the care cascade. Here we report findings of the qualitative component designed to investigate issues related to adherence conducted among women identified as HIV positive whose babies were started on CTX-p postnatally. Of note, Zimbabwe also provided nevirapine prophylaxis for HIV exposed babies, so the majority were giving nevirapine and CTX-p to their babies. METHODS: Between Feb-Dec 2011, the first 20 HIV infected mothers identified were invited for in-depth interview 4-5months postnatally. Interviews were recorded, transcribed, translated and analysed thematically. RESULTS: All women desired their baby's health above all else, and were determined to do all they could to ensure their wellbeing. They did not report problems remembering to give drugs. The baby's apparent good health was a huge motivator for continued adherence. However, most women reported that their husbands were less engaged in HIV care, refusing to be HIV tested and in some cases stealing drugs prescribed for their wives for themselves. In two instances the man stopped the woman from giving CTX-p to the baby either because of fear of side effects or not appreciating its importance. Stigma continues to be an important issue. Mothers reported being reluctant to disclose their HIV status to other people so found it difficult to collect prescription refills from the HIV clinic for fear of being seen by friends/relatives. Some women reported that it was hard to administer the drugs if there were people around at home. Other challenges faced were stock-outs of CTX-p at the clinic, which occurred three times in 2011. The baby would then go without CTX-p if the woman could not afford buying at a private pharmacy. CONCLUSIONS: The study highlights that adherence knowledge and desire alone is insufficient to overcome the familial and structural barriers to maintaining CTX-p. Improving adherence to CTX-p among HEI will require interventions to improve male involvement, reduce HIV stigma in communities and ensure adequate supply of drugs.