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Background: HIV self-testing (HIVST) can use either oral-fluid or blood-based tests. Studies have shown strong preferences for self-testing compared to facility-based services. Despite availability of low-cost blood-based HIVST options, to date, HIVST implementation in sub-Saharan Africa has largely been oral-fluid-based. We investigated whether users preferred blood-based (i.e. using blood sample derived from a finger prick) or oral fluid-based HIVST in rural and urban Malawi. Methods: At clinics providing HIV testing services (n = 2 urban; n = 2 rural), participants completed a semi-structured questionnaire capturing sociodemographic data before choosing to test using oral-fluid-based HVST, blood-based HIVST or provider-delivered testing. They also completed a self-administered questionnaire afterwards, followed by a confirmatory test using the national algorithm then appropriate referral. We used simple and multivariable logistic regression to identify factors associated with preference for oral-fluid or blood-based HIVST. Results: July to October 2018, N = 691 participants enrolled in this study. Given the choice, 98.4% (680/691) selected HIVST over provider-delivered testing. Of 680 opting for HIVST, 416 (61.2%) chose oral-fluid-based HIVST, 264 (38.8%) chose blood-based HIVST and 99.1% (674/680) reported their results appropriately. Self-testers who opted for blood-based HIVST were more likely to be male (50.3% men vs. 29.6% women, p < 0.001), attending an urban facility (43% urban vs. 34.6% rural, p = 0.025) and regular salary-earners (49.5% regular vs. 36.8% non-regular, p = 0.012). After adjustment, only sex was found to be associated with choice of self-test (adjusted OR 0.43 (95%CI: 0.3–0.61); p-value < 0.001). Among 264 reporting blood-based HIVST results, 11 (4.2%) were HIV-positive. Blood-based HIVST had sensitivity of 100% (95% CI: 71.5–100%) and specificity of 99.6% (95% CI: 97.6–100%), with 20 (7.6%) invalid results. Among 416 reporting oral-fluid-based HIVST results 18 (4.3%) were HIV-positive. Oral-fluid-based HIVST had sensitivity of 88.9% (95% CI: 65.3–98.6%) and specificity of 98.7% (95% CI: 97.1–99.6%), with no invalid results. Conclusions: Offering both blood-based and oral-fluid-based HIVST resulted in high uptake when compared directly with provider-delivered testing. Both types of self-testing achieved high accuracy among users provided with a pre-test demonstration beforehand. Policymakers and donors need to adequately plan and budget for the sensitisation and support needed to optimise the introduction of new quality-assured blood-based HIVST products. [ABSTRACT FROM AUTHOR]

Objective 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. Methods 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. Findings 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. Conclusion 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. Objectif Presenter les resultats de la mise en reuvre et de I'elargissement de programmes d'autodepistage du virus de l'immunodeficience humaine (VIH) pour les travailleuses du sexe au Malawi et au Zimbabwe entre 2013 et 2018. Methodes Au Zimbabwe, nous avons realise une recherche preparatoire pour evaluer l'acceptabilite et la precision de l'autotest du VIH. Au cours de la mise en reuvre, nous avons evalue la faisabilite et les preferences des travailleuses du sexe a l'egard de la distribution des trousses de depistage avant d'elargir le programme. Au Malawi, nous avons realise une evaluation ethnographique rapide pour etudier le contexte, les besoins des travailleuses du sexe et les ressources disponibles, ce qui a donne lieu a un atelier dont l'objectif etait de definir la methode de distribution des trousses de depistage. Une fois la distribution mise en place, nous avons evalue le processus et etabli un systeme de suivi des dommages sociaux. Resultats Au Zimbabwe, les travailleuses du sexe etaient en mesure de proceder a un autodepistage precis. Letude des preferences a permis de perfectionner les systemes en vue d'un developpement national par l'intermediaire des services existants pour les travailleuses du sexe. Les donnees qualitatives ont aide a definir d'autres strategies de distribution et les dommages sociaux indirects que peuvent subir les femmes. Au Malawi, la distribution de trousses de depistage par des pairs a ete la strategie privilegiee. Nous avons identifie quelques cas de dommages sociaux entre des travailleuses du sexe assurant la distribution et d'autres travailleuses du sexe, ainsi que des obstacles du cote de l'offre qui ont limite l'utilisation du test. Conclusion La participation des travailleuses du sexe a la planification et a la mise en reuvre continue de l'autodepistage du VIH est essentielle, de meme que les strategies visant a reduire les dommages potentiels. Pour etre optimales, les strategies en matiere de distribution et de soutien post-test doivent tenir compte du contexte, du soutien existant apporte aux travailleuses du sexe et du degre de confiance et de cohesion au sein de leurs communautes. Objetivo Presentar los resultados de la implementacion y ampliacion de los programas de autodiagnostico del virus de la inmunodeficiencia humana (VIH) para trabajadoras sexuales en Malawi y Zimbabwe, 2013-2018. Metodos En Zimbabwe, se llevo a cabo una investigacion formativa para evaluar la aceptabilidad y exactitud del autodiagnostico del VIH. Durante la implementacion, se evaluaron las preferencias de las trabajadoras sexuales y la viabilidad de la distribucion de los kits de pruebas antes de ampliar el programa. En Malawi, se realizo una evaluacion etnografica rapida 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 distribucion de los kits de pruebas. Una vez implementada la distribucion, se llevo a cabo una evaluacion del proceso y se establecio un sistema para el seguimiento de los danos sociales. Resultados En Zimbabwe, las trabajadoras sexuales pudieron autoevaluarse con precision. El estudio de preferencias contribuyo a perfeccionar los sistemas de ampliacion nacional mediante los servicios existentes para las trabajadoras sexuales. Los datos cualitativos ayudaron a identificar estrategias de distribucion adicionales y a mediar en posibles danos sociales para las mujeres. En Malawi, la estrategia preferida fue la distribucion de kits de pruebas entre pares. Se identificaron algunos incidentes de dano social entre distribuidores pares y trabajadoras sexuales, asi como barreras de suministro para la implementacion que dificultaban la realizacion de las pruebas. Conclusion Es esencial involucrar a las trabajadoras sexuales en la planificacion y la implementacion continua del autodiagnostico del VIH, junto con estrategias para reducir los danos potenciales. Las estrategias optimas para la distribucion y el apoyo posterior a las pruebas son especificas para cada contexto y deben tener en cuenta el apoyo existente a las trabajadoras sexuales y los niveles de confianza y cohesion dentro de sus comunidades., Introduction Female sex workers are a marginalized group who are disproportionately affected by human immunodeficiency virus (HIV) infection. (1) Despite reduction in HIV infections in the general population, the prevalence [...]

Introduction: HIV self-testing (HIVST) provides couples and individuals with a discreet, convenient and empowering testing option. As with all HIV testing, potential harms must be anticipated and mitigated to optimize individual and public health benefits. Here, we describe social harms (SHs) reported during HIVST implementation in Malawi, and propose a framework for grading and responding to harms, according to their severity. Methods: We report findings from six HIVST implementation studies in Malawi (2011 to 2017) that included substudies investigating SH reports. Qualitative methods included focus group discussions, in-depth interviews and critical incident interviews. Earlier studies used intensive quantitative methods (post-test questionnaires for intimate partner violence, household surveys, investigation of all deaths in HIVST communities). Later studies used post-marketing reporting with/without community engagement. Pharmacovigilance methodology (whereby potentially life-threatening/changing events are defined as 'serious') was used to grade SH severity, assuming more complete passive reporting for serious events. Results: During distribution of 175,683 HIVST kits, predominantly under passive SH reporting, 25 serious SHs were reported from 19 (0.011%) self-testers, including 15 partners in eight couples with newly identified HIV discordancy, and one perinatally infected adolescent. There were no deaths or suicides. Marriage break-up was the most commonly reported serious SH (sixteen individuals; eight couples), particularly among serodiscordant couples. Among new concordant HIV-positive couples, blame and frustration was common but rarely (one episode) led to serious SHs. Among concordant HIV-negative couples, increased trust and stronger relationships were reported. Coercion to test or disclose was generally considered 'well-intentioned' within established couples. Women felt empowered and were assertive when offering HIVST test kits to their partners. Some women who persuaded their partner to test, however, did report SHs, including verbal or physical abuse and economic hardship. Conclusions: After more than six years of large-scale HIVST implementation and in-depth investigation of SHs in Malawi, we identified approximately one serious reported SH per 10,000 HIVST kits distributed, predominantly break-up of married serodiscordant couples. Both 'active' and 'passive' reporting systems identified serious SH events, although with more complete capture by 'active' systems. As HIVST is scaled-up, efforts to support and further optimize community-led SH monitoring should be prioritized alongside HIVST distribution. Keywords: HIV/AIDS; HIV self-test; HIV testing; social harms; Malawi, 1 | INTRODUCTION Despite concerted efforts to scale-up HIV testing services, in 2017, approximately 25% of people with HIV remain undiagnosed [1]. Globally, men, young people and key populations are [...]

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. Keywords: HIV self-test; performance; in vitro diagnosis; instructions for use; Zambia; Malawi, 1 | INTRODUCTION HIV self-testing (HIVST) is increasingly being introduced as a testing approach recommended by the World Health Organization (WHO) to reach those who may not otherwise test [1,2]. [...]

Background Undiagnosed HIV infection remains substantial in key population subgroups including adolescents, older adults, and men, driving ongoing transmission in sub-Saharan Africa. We evaluated the impact, safety, and costs of community-led delivery of HIV self-testing (HIVST), aiming to increase HIV testing in underserved subgroups and stimulate demand for antiretroviral therapy (ART). Methods and findings This cluster-randomised trial, conducted between October 2018 and July 2019, used restricted randomisation (1:1) to allocate 30 group village head clusters in Mangochi district, Malawi to the community-led HIVST intervention in addition to the standard of care (SOC) or the SOC alone. The intervention involved mobilising community health groups to lead the design and implementation of 7-day HIVST campaigns, with cluster residents ([greater than or equal to]15 years) eligible for HIVST. The primary outcome compared lifetime HIV testing among adolescents (15 to 19 years) between arms. Secondary outcomes compared: recent HIV testing (in the last 3 months) among older adults ([greater than or equal to]40 years) and men; cumulative 6-month incidence of ART initiation per 100,000 population; knowledge of the preventive benefits of HIV treatment; and HIV testing stigma. Outcomes were measured through a post-intervention survey and at neighboring health facilities. Analysis used intention-to-treat for cluster-level outcomes. Community health groups delivered 24,316 oral fluid-based HIVST kits. The survey included 90.2% (3,960/4,388) of listed participants in the 15 community-led HIVST clusters and 89.2% (3,920/4,394) of listed participants in the 15 SOC clusters. Overall, the proportion of men was 39.0% (3,072/7,880). Most participants obtained primary-level education or below, were married, and reported a sexual partner. Lifetime HIV testing among adolescents was higher in the community-led HIVST arm (84.6%, 770/910) than the SOC arm (67.1%, 582/867; adjusted risk difference [RD] 15.2%, 95% CI 7.5% to 22.9%; p < 0.001), especially among 15 to 17 year olds and boys. Recent testing among older adults was also higher in the community-led HIVST arm (74.5%, 869/1,166) than the SOC arm (31.5%, 350/1,111; adjusted RD 42.1%, 95% CI 34.9% to 49.4%; p < 0.001). Similarly, the proportions of recently tested men were 74.6% (1,177/1,577) and 33.9% (507/1,495) in the community-led HIVST and SOC arms, respectively (adjusted RD 40.2%, 95% CI 32.9% to 47.4%; p < 0.001). Knowledge of HIV treatment benefits and HIV testing stigma showed no differences between arms. Cumulative incidence of ART initiation was respectively 305.3 and 226.1 per 100,000 population in the community-led HIVST and SOC arms (RD 72.3, 95% CI -36.2 to 180.8; p = 0.18). In post hoc analysis, ART initiations in the 3-month post-intervention period were higher in the community-led HIVST arm than the SOC arm (RD 97.7, 95% CI 33.4 to 162.1; p = 0.004). HIVST uptake was 74.7% (2,956/3,960), with few adverse events (0.6%, 18/2,955) and at US$5.70 per HIVST kit distributed. The main limitations include the use of self-reported HIV testing outcomes and lack of baseline measurement for the primary outcome. Conclusions In this study, we found that community-led HIVST was effective, safe, and affordable, with population impact and coverage rapidly realised at low cost. This approach could enable community HIV testing in high HIV prevalence settings and demonstrates potential for economies of scale and scope. Trial registration Clinicaltrials.gov NCT03541382., Author(s): Pitchaya P. Indravudh 1,2,*, Katherine Fielding 3,4, Moses K. Kumwenda 2, Rebecca Nzawa 2, Richard Chilongosi 5, Nicola Desmond 2,6, Rose Nyirenda 7, Melissa Neuman 3, Cheryl C. Johnson [...]