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BackgroundCouples' 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.MethodsIn 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.FindingsFrom 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.InterpretationSmall 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.FundingThe 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.

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]

Background: In Malawi, female sex workers (FSW) have high HIV incidence and regular testing is suggested. HIV self-testing (HIVST) is a safe and acceptable alternative to standard testing services. This study assessed; whether social harms were more likely to be reported after HIVST distribution to FSW by peer distributors than after facility-based HIV testing and whether FSW regretted HIVST use or experienced associated relationship problems. Methods: Peer HIVST distributors, who were FSW, were recruited in Blantyre district, Malawi between February and July 2017. Among HIVST recipients a prospective cohort was recruited. Interviews were conducted at baseline and at end-line, 3 months later. Participants completed daily sexual activity diaries. End-line data were analysed using logistic regression to assess whether regret or relationship problems were associated with HIVST use. Sexual activity data were analysed using Generalised Estimating Equations to assess whether HIVST use was temporally associated with an increase in social harms. Results: Of 265 FSW recruited and offered HIVST, 131 completed both interviews. Of these, 31/131(23.7%) reported initial regret after HIVST use, this reduced to 23/131(17.6%) at the 3-month follow-up. Relationship problems were reported by 12/131(9.2%). Regret about HIVST use was less commonly reported in those aged 26–35 years compared to those aged 16–25 years (OR immediate regret—0.40 95% CI 0.16–1.01) (OR current regret—0.22 95% CI 0.07 – 0.71) and was not associated with the HIVST result. There was limited evidence that reports of verbal abuse perpetrated by clients in the week following HIVST use were greater than when there was no testing in the preceding week. There was no evidence for increases in any other social harms. There was some evidence of coercion to test, most commonly initiated by the peer distributor. Conclusions: Little evidence was found that the peer distribution model was associated with increased levels of social harms, however programmes aimed at reaching FSW need to carefully consider possible unintended consequences of their service delivery approaches, including the potential for peer distributors to coerce individuals to test or disclose their test results and alternative distribution models may need to be considered. [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: 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. Keywords: HIV testing, community-based HIV self-testing; cost-effectiveness; mathematical modelling; HIV; benefits and cost, 1 | INTRODUCTION The ambitious UNAIDS targets, set in 2014, of diagnosing 90% of people living with HIV, having 90% of those diagnosed on antiretroviral treatment (ART) and having virological [...]

Introduction: HIV self-testing (HIVST) was first proposed as an additional option to standard HIV testing services in the 1980s. By 2015, two years after the first HIVST kit was approved for the American market and the year in which Unitaid invested in the 'HIV Self-Testing AfRica (STAR) Initiative,' HIVST remained unexplored with negligible access in low- and middle-income countries (LMIC). However, rapid progress had been made. This commentary outlines the interlinked market, regulatory and policy barriers that had inhibited product development and kept HIVST out of LMIC policy. We detail the components of STAR that enabled rapid HIVST scale-up, including critical investments in implementation, research, market forecasting, and engagement with manufacturers and regulators. Discussion: The STAR Initiative has generated crucial information about how to distribute HIVST products effectively, ethically and efficiently. Service delivery models range from clinic-based distribution to workplace and partner-delivered approaches to reach first-time male testers, to community outreach to sex workers and general population 'hotspots.' These data directly informed supportive policy, notably the 2016 WHO guidelines strongly recommending HIVST as an additiona testing approach, and regulatory change through support for WHO prequalification of the first HIVST kit in 2017. In July 2015, only two countries had national HIVST policies and were implementing HIVST. Three years later, 59 countries have policies, actively implemented in 28, with an additional 53 countries reporting policies under development. By end-November 2018 several quality-assured HIVST products had been registered, including two WHO prequalified tests. STAR Initiative countries have drafted regulations governing in vitro diagnostics, including HIVST products. With enabling policies, pre-qualification and regulations in place, donor procurement of kits has increased rapidly, to a forecasted estimate of 16 million HIVST kits procured by 2020. Conclusions: The STAR Initiative provided a strong foundation to introduce HIVST in LMICs and allow for rapid scale-up based on the wealth of multi-country evidence gathered. Together with sustained coordination and acceleration of market development work, HIVST can help address the testing gap and provide a focused and cost-effective means to expand access to treatment and prevention services. Keywords: HIV testing; HIV self-testing; market shaping; scale-up; prevention; linkage to care; cost effectiveness, 1 | INTRODUCTION HIV testing is the gateway to treatment and care and expanded prevention coverage. The first of the United Nations' 90-90-90 Fast Track targets to end the HIV [...]

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: 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 empirica 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. Keywords: HIV self-testing; costs and cost analysis; community; Malawi; Zambia; Zimbabwe, 1 | INTRODUCTION In East and Southern Africa, freely available HIV services have led to a 42% reduction in AIDS-related deaths between 2010 and 2016. Despite such gains, 24% of [...]

Introduction: Social, structural and systems barriers inhibit uptake of HIV testing. HIV self-testing (HIVST) has shown promising uptake by otherwise underserved priority groups including men, young people and first-time testers. Here, we use characteristics of HIVST kit recipients to investigate delivery to these priority groups during HIVST scale-up in three African countries. Methods: Kit distributors collected individual-level age, sex and testing history from all clients. These data were aggregated and analysed by country (Malawi, Zambia and Zimbabwe) for five distribution models: local community-based distributor (CBD: door-to-door, street and local venues), workplace distribution (WD), integration into HIV testing services (IHTS), or pubic health facilities (IPHF) and during demand creation for voluntary male medical circumcision (VMMC). Used kits were collected and re-read from CBD and IHTS recipients. Results: Between May 2015 and July 2017, 628,705 HIVST kits were distributed in Malawi (172,830), Zambia (190,787) and Zimbabwe (265,091). Community-based models, the first to be established, accounted for 519,658 (82.7%) of kits distributed, with 275,419 (53.0%) used kits returned. Subsequent model diversification delivered 54,453 (8.7%) test-kits through IHTS, 23,561 (3.7%) through VMMC, 21,183 (3.4%) through IPHF and 9850 (1.7%) through WD. Men took 294,508 (48.2%) kits, and 263,073 (43.1%) went to young people (16 to 24 years). A higher proportion of male self-testers (65,577; 22.3%) were first-time testers than women (54,096; 17.1%) with this apparent in Zimbabwe (16.2% vs. 11.4%), Zambia (25.4% vs. 17.7%) and Malawi (27.9% vs. 25.9%). The highest proportions of first-time testers were in young (16 to 24 years) and older (>50 years) men (country-ranges: 18.7% to 35.9% and 13.8% to 26.8% respectively). Most IHTS clients opted for HIVST in preference to standard HTS in each of 12 delivery sites, with those selecting HIVST having lower HIV prevalence, potentially due to self-selection. Conclusions: HIVST delivered at scale using several different models reached a high proportion of men, young people and first-time testers in Malawi, Zambia and Zimbabwe, some of whom may not have tested otherwise. As men and young people have limited uptake under standard facility-and community-based HIV testing, innovative male- and youth-sensitive approaches like HIVST may be essential to reaching UNAIDS fast-track targets for 2020. Keywords: HIV self-testing; HIV testing; men; adolescents; stigma; Malawi; Zambia; Zimbabwe, 1 | INTRODUCTION In 2016, 36.7 million people were living with HIV (PLHIV), with 1.8 million new HIV infections and one million HIV/AIDS-related deaths [1]. Despite substantial progress toward the [...]

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 helpines 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. Keywords: discrete choice experiments; HIV self-testing; HIV testing; Zimbabwe; HIV; preferences, 1 | INTRODUCTION HIV testing is an important entry point for uptake of prevention, treatment and care services. The United Nations 90-90-90 targets are that by 2020, 90% of people [...]

Introduction: Scale-up of HIV self-testing (HIVST) will play a key role in meeting the United Nation's 90-90-90 targets. Delayed re-reading of used HIVST devices has been used by early implementation studies to validate the performance of self-test kits and to estimate HIV positivity among self-testers. We investigated the stability of results on used devices under controlled conditions to assess its potential as a quality assurance approach for HIVST scale-up. Methods: 444 OraQuick[R] HIV-1/2 rapid antibody tests were conducted using commercial plasma from two HIV-positive donors and HIV-negative plasma (high-reactive n = 148, weak-reactive n = 148 and non-reactive n = 148) and incubated them for six months under four conditions (combinations of high and low temperatures and humidity). Devices were reread daily for one week, weekly for one subsequent month and then once a month by independent readers unaware of the previous results. We used multistage transition models to investigate rates of change in device results, and between storage conditions. Results and discussion: There was a high incidence of device instability. Forty-three (29%) of 148 initially non-reactive results became false weak-reactive results. These changes were observed across all incubation conditions, the earliest on Day 4 (n = 9 kits). No initially HIV-reactive results changed to a non-reactive result. There were no significant associations between storage conditions and hazard of results transition. We observed substantial statistical agreement between independent re-readers over time (agreement range: 0.74 to 0.96). Conclusions: Delayed re-reading of used OraQuick[R] HIV-1/2 rapid antibody tests is not currently a valid methodologica approach to quality assurance and monitoring as we observed a high incidence (29%) of true non-reactive tests changing to false weak-reactive and therefore its use may overestimate true HIV positivity. Keywords: HIV self-testing; Quality assurance; Delayed re-reading; Visual stability; False reactive; Misdiagnosis; HIV testing, 1 | INTRODUCTION HIV self-testing (HIVST) is being scaled-up using a variety of distribution models throughout Africa, the Americas, Asia and Europe [1-4]. No clear monitoring and evaluation or external [...]

Introduction: HIV self-testing (HIVST) is being introduced as a new way for more undiagnosed people to know their HIV status. As countries start to implement HIVST, assuring the quality and regulating in vitro diagnostics, including HIVST, are essential. We aimed to document the emerging regulatory landscape and perceptions of key stakeholders involved in HIVST policy and regulation prior to implementation in three low- and middle-income countries. Methods: Between April and August 2016, we conducted semi-structured interviews in Malawi, Zambia and Zimbabwe to understand the relationships between different stakeholders on their perceptions of current and future HIVST regulation and the potential impact on implementation. We purposively sampled and interviewed 66 national-level key stakeholders from the Ministry of Health and the regulatory, laboratory, logistical, donor and non-governmental sectors. We used a thematic approach to analysis with an inductively developed common coding framework to allow inter-country comparison of emerging themes. Results: In all countries, the national reference laboratory was monitoring the quality of HIVST kits entering the public sector. In Malawi, there was no legal mandate to regulate medical devices, in Zambia one regulatory body with a clear mandate had started developing regulations and in Zimbabwe the mandate to regulate was overlapping between two bodies. Stakeholders indicated that they had a poor understanding of the process and requirements for HIVST regulation, as well as lack of clarity and coordination between organizational roles. The need for good collaboration between sectors, a strong post-market surveilance model for HIVST and technical assistance to develop regulators capacity was noted as priorities. Key informants identified technical working groups as a potential way collaboration could be improved upon to accelerate the regulation of HIVST. Conclusion: Regulation of in vitro diagnostic devices, including HIVST, is now being recognized as important by regulators after a regional focus on pharmaceuticals. HIVST is providing an opportunity for each country to develop similar regulations to others in the region leading to a more coherent regulatory environment for the introduction of new devices. Keywords: quality assurance; policy; in vitro diagnostics; post market; implementation; harmonization, 1 | INTRODUCTION The World Health Organization (WHO) defines HIV self-testing (HIVST) as 'a process in which a person collects his or her own specimen (oral fluid or blood) and [...]

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]. [...]

A retrospective facility-based costing study was undertaken to estimate the comparative cost per visit of five integrated sexual and reproductive health and HIV (human immuno-deficiency virus) services (provider perspective) within five clinic sites. These five clinics were part of four service delivery models: Non-governmental-organisation (NGO) directly managed model (Chitungwiza and New Africa House sites), NGO partner managed site (Mutare site), private-public-partnership (PPP) model (Chitungwiza Profam Clinic), and NGO directly managed outreach (operating from New Africa House site. In addition client cost exit interviews (client perspective) were conducted among 856 female clients exiting integrated services at three of the sites. Our costing approach involved first a facility bottom-up costing exercise (February to April 2015), conducted to quantify and value each resource input required to provide individual SRH and HIV services. Secondly overhead financial expenditures were allocated top-down from central office to sites and then respective integrated service based on pre-defined allocation factors derived from both the site facility observations and programme data for the prior 12 months. Costs were assessed in 2015 United States dollars (USD). Costs were assessed for HIV testing and counselling, screening and treatment of sexually transmitted infections, tuberculosis screening with smear microscopy, family planning, and cervical cancer screening and treatment employing visual inspection with acetic acid and cervicography and cryotherapy. Variability in costs per visit was evident across the models being highest for cervical cancer screening and cryotherapy (range: US$6.98—US$49.66). HIV testing and counselling showed least variability (range; US$10.96—US$16.28). In general the PPP model offered integrated services at the lowest unit costs whereas the partner managed site was highest. Significant client costs remain despite availability of integrated sexual and reproductive health and HIV services free of charge in our Zimbabwe study setting. Situating services closer to communities, incentives, transport reimbursements, reducing waiting times and co-location of sexual and reproductive health and HIV services may help minimise impact of client costs. [ABSTRACT FROM AUTHOR]