Results From a Pilot Study of an Automated Directly Observed Therapy Intervention Using Artificial Intelligence With Conditional Economic Incentives Among Young Adults With HIV.

BACKGROUND: Despite improvements in antiretroviral therapy (ART) availability, suboptimal adherence is common among youth with HIV (YWH) and can increase drug resistance and poor clinical outcomes. Our study examined an innovative mobile app-based intervention that used automated directly observed therapy (aDOT) using artificial intelligence, along with conditional economic incentives (CEIs) to improve ART adherence and enhance viral suppression among YWH. SETTING: We conducted a pilot study of the aDOT-CEI intervention, informed by the operant framework of Key Principles in Contingency Management Implementation, to improve ART adherence among YWH (18-29) in California and Florida who had an unsuppressed HIV viral load. METHODS: We recruited 28 virally unsuppressed YWH from AIDS Healthcare Foundation clinics, who used the aDOT platform for 3 months. Study outcomes included feasibility and acceptability, self-reported ART adherence, and HIV viral load. RESULTS: Participants reported high satisfaction with the app (91%), and 82% said that it helped them take their medication. Comfort with the security and privacy of the app was moderate (55%), and 59% indicated the incentives helped improve daily adherence. CONCLUSIONS: Acceptability and feasibility of the aDOT-CEI intervention were high with potential to improve viral suppression, although some a priori metrics were not met. Pilot results suggest refinements which may improve intervention outcomes, including increased incentive amounts, provision of additional information, and reassurance about app privacy and security. Additional research is recommended to test the efficacy of the aDOT-CEI intervention to improve viral suppression in a larger sample.

Youth Ending the HIV Epidemic (YEHE): Protocol for a pilot of an automated directly observed therapy intervention with conditional economic incentives among young adults with HIV.

BACKGROUND: Young adults have a disproportionately high rate of HIV infection, high rates of attrition at all stages of the HIV care continuum, and an elevated probability of disease progression and transmission. Tracking and monitoring objective measures of antiretroviral therapy (ART) adherence in real time is critical to bolster the accuracy of research data, support adherence, and improve clinical outcomes. However, adherence monitoring often relies on self-reported and retrospective data or requires additional effort from providers to understand individual adherence patterns. In this study, we will monitor medication-taking using a real-time objective measure of adherence that does not rely on self-report or healthcare providers for measurement. METHODS: The Youth Ending the HIV Epidemic (YEHE) study will pilot a novel automated directly observed therapy-conditional economic incentive (aDOT-CEI) intervention to improve ART adherence among youth with HIV (YWH) in California and Florida who have an unsuppressed HIV viral load. The aDOT app uses facial recognition to record adherence each day, and then economic incentives are given based on a participant's confirmed adherence. We will enroll participants in a 3-month pilot study to assess the feasibility and acceptability of the aDOT-CEI intervention using predefined metrics. During and after the trial, a subsample of the pilot participants and staff/providers from participating AIDS Healthcare Foundation (AHF) clinics will participate in individual in-depth interviews to explore intervention and implementation facilitators and barriers. DISCUSSION: YEHE will provide data on the use of an aDOT-CEI intervention to improve adherence among YWH who are not virologically suppressed. The YEHE study will document the feasibility and acceptability and will explore preliminary data to inform a trial to test the efficacy of aDOT-CEI. This intervention has the potential to effectively improve ART adherence and virologic suppression among a key population experiencing health disparities. TRIAL REGISTRATION: The trial registration number is NCT05789875.

Access to Oral Fluid-Based Human Immunodeficiency Virus Self-Tests Increases Testing Among Male Partners of Adolescent Girls in Kenya: A Randomized Controlled Trial.

PURPOSE: The risk of human immunodeficiency virus (HIV) among adolescent girls (AGs) may be reduced if they know the HIV status of their male partners. We assessed the ability of AGs in Siaya County, Kenya, to offer HIV self-tests to their partners to promote partner and couples testing. METHODS: Eligible AGs were 15-19 years old, self-tested HIV-negative, and had a male partner not tested in the past 6 months. Participants were randomly assigned to receive two oral fluid-based self-tests (intervention arm) or a referral coupon for facility-based testing (comparison arm). The intervention included counseling on ways to safely introduce self-tests to partners. Follow-up surveys were conducted within 3 months. RESULTS: Among 349 AGs enrolled, median age was 17 years (interquartile range 16-18), 88.3% of primary partners were noncohabiting boyfriends, and 37.5% were unaware if their partner had ever tested. At 3 months, 93.9% of the intervention arm and 73.9% of the comparison arm reported that partner testing occurred. Compared to the comparison arm, partner testing was more likely in the intervention arm (risk ratio = 1.27; 95% confidence interval 1.15-1.40; p < .001). Among participants whose partners got tested, 94.1% and 81.5% in the intervention and comparison arms, respectively, reported that couples testing occurred; couples testing was more likely in the intervention than comparison arm (risk ratio = 1.15; 95% confidence interval 1.15-1.27; p = .003). Five participants reported partner violence, one study-related. DISCUSSION: Provision of multiple self-tests to AGs for the purpose of promoting partner and couples testing should be considered in Kenya and other settings where AGs face a high risk of HIV acquisition.

Reaching Adolescent Girls and Young Women With HIV Self-Testing and Contraception at Girl-Friendly Drug Shops: A Randomized Trial in Tanzania.

PURPOSE: We hypothesized that an intervention designed to create girl-friendly drug shops would increase access to sexual and reproductive health products and services among adolescent girls and young women (AGYW) (ages 15-24 years) in Tanzania. METHODS: We conducted a four-month randomized trial at 20 drug shops in Shinyanga, Tanzania from August-December 2019 to determine if the Malkia Klabu ("Queen Club") intervention increased AGYW patronage and the provision of HIV self-testing (HIVST), contraception, and health facility referrals to AGYW (primary outcomes). Drug shops were randomized 1:1 to the intervention or comparison arm. All shops were provided with OraQuick HIVST kits to give to AGYW for free. Intervention shops implemented Malkia Klabu, a loyalty program for AGYW created using human-centered design through which AGYW could also access free contraception. We compared outcomes in intention-to-treat analyses using shop observations and shopkeeper records. RESULTS: By endline, shops implementing Malkia Klabu had higher AGYW patronage than comparison shops (rate ratio: 4.4; 95% confidence interval: 2.0, 9.8). Intervention shops distributed more HIVST kits (median per shop: 130.5 vs. 58.5, P = .02) and contraceptives (325.5 vs. 7.0, P < .01) to AGYW and provided more referrals for HIV, family planning, or pregnancy services combined (3.5 vs. 0.5, P = .02) than comparison shops. DISCUSSION: The Malkia Klabu intervention increased AGYW patronage and the provision of HIVST kits, contraception, and referrals to AGYW at drug shops, despite HIVST kits being freely available at all participating shops. Enhancing drug shops with girl-friendly services may be an effective strategy to reach AGYW with sexual and reproductive health services.

A savings intervention to reduce men's engagement in HIV risk behaviors: study protocol for a randomized controlled trial.

BACKGROUND: In much of eastern and southern Africa, the incidence of HIV and other sexually transmitted infections (STIs) remains high despite the scale-up of promising biomedical and behavioral interventions. Studies have documented the crucial role of transactional sex-the exchange of money, material support, or goods, in sexual relationships-and heavy alcohol use in contributing to men's and women's health outcomes. Existing policy responses to this challenge have largely focused on women, through the provision of pre-exposure prophylaxis (PrEP) or structural interventions such as education subsidies and cash transfers. However, the effectiveness of these interventions has been hindered by the relative lack of interventions and programs targeting men's behavior. We describe the protocol for a study that will test an economic intervention designed to reduce men's engagement in HIV/STI-related risk behaviors in Kenya. METHODS: We will conduct a randomized controlled trial among income-earning men in Kenya who are aged 18-39 years and self-report alcohol use and engagement in transactional sex. The study will enroll 1500 participants and randomize them to a control group or savings group. The savings group will receive access to a savings account that includes lottery-based incentives to save money regularly, opportunities to develop savings goals/strategies, and text message reminders about their savings goals. The control group will receive basic health education. Over a period of 24 months, we will collect qualitative and quantitative data from participants and a subset of their female partners. Participants will also be tested for HIV and other STIs at baseline, 12, and 24 months. DISCUSSION: The findings from this study have the potential to address a missing element of HIV/STI prevention efforts in sub-Saharan Africa by promoting upstream and forward-looking behavior and reducing the risk of acquiring HIV/STIs in a high HIV/STI burden setting. If this study is effective, it is an innovative approach that could be scaled up and could have great potential for scientific and public health impact in Kenya. TRIAL REGISTRATION: ClinicalTrials.gov NCT05385484 . Registered on May 23, 2022.

Differentiating the incidence and burden of HIV by age among women who sell sex: a systematic review and meta-analysis.

INTRODUCTION: Young women who sell sex (YWSS) are at heightened risk of HIV acquisition and transmission and are among the least engaged in HIV services. There is insufficient epidemiologic evidence characterizing the burden of HIV among YWSS, particularly as compared to older WSS. These data are needed to design and tailor effective HIV prevention and treatment programmes for this population. METHODS: We conducted two parallel systematic reviews and meta-analyses to define both the immediate and long-term HIV risks for YWSS, including among women engaged in sex work, survival sex and transactional sex. In the first review, we identified and synthesized published studies of HIV incidence comparing estimates for cisgender women ≤24 years of age versus >24. In the second review, we identified and synthesized studies of HIV prevalence, comparing estimates for cisgender women who initiated selling sex <18 versus ≥18 years. In both reviews, we completed a search of four databases for articles in any language and any geographic area published from 1 January 1980 until 12 February 2021. Included articles were assessed for quality and a random effects model was used to calculate pooled effect estimates for each review. RESULTS AND DISCUSSION: We identified 12 studies for the HIV incidence review and 18 studies for the HIV prevalence review. In a meta-analysis, HIV incidence was elevated in younger (5.3 per 100 person-years [PY]; 95% confidence interval [CI]: 3.5, 7.1) compared to older women (2.8 per 100 PY; 95% CI: 1.7, 3.9), although CIs overlapped. HIV prevalence among those who initiated selling sex <18 years of age (28.8; 95% CI: 18.9, 38.7) was higher than those who initiated later (20.5; 95% CI: 12.4, 28.6). CONCLUSIONS: These companion reviews offer an important perspective on the relative HIV risk of engaging in selling sex at a younger age. Our findings highlight the unique and intersectional challenges YWSS face, and the importance of ensuring that health services are tailored to meet their specific needs. Research and programming should routinely stratify data into meaningful age bands to differentiate and intervene within this population.

Adoption of HIV pre-exposure prophylaxis among women at high risk of HIV infection in Kenya.

In 2017, Kenya became one of the first African countries to provide pre-exposure prophylaxis (PrEP) in its national HIV prevention plan. We sought to characterize factors associated with PrEP uptake and persistence among a cohort of women at risk of HIV infection during the early stages of PrEP scale-up in Kenya. HIV-negative women ≥18 years with ≥2 sexual partners in the past 4 weeks were recruited as part of an ongoing cluster randomized trial of an HIV self-testing intervention. PrEP use was assessed at baseline and at 6- and 12-month follow-up visits. Between June 2017 and August 2018, 2,086 were enrolled and had complete baseline data. 138 (6.6%) reported PrEP use during the first year of the study. Although PrEP use increased, persistence on PrEP was low, and less than half of individuals reported continuing PrEP at follow-up visits. In multivariate analyses, PrEP use was associated with recent STIs, having an HIV-positive primary partner, having regular transactional sex in the past 12 months, and being a female sex worker. In the early stages of PrEP scale-up in Kenya, uptake increased modestly among women with risk factors for HIV infection, but overall uptake and persistence was low.

'When I have these kits I have confidence' - HIV self-testing provides agency for women in their sexual decision-making.

Oral fluid-based HIV self-testing (HIVST) has emerged as a promising approach to increasing HIV testing coverage, particularly among high-risk populations. Understanding the experiences of women using self-tests and offering them to their sexual partners (secondary distribution) is crucial for determining the potential of HIVST. Qualitative in-depth interviews were conducted among 32 women at high risk of HIV infection, including women who engage in transactional sex, who participated in a cluster randomised trial of a secondary distribution strategy in western Kenya. Interviews explored how women used self-tests within relationships and how this affected their sexual decision-making. Three key themes emerged: women used HIVST to assess risk prior to engaging in sex with partners; HIVST provided women with increased agency to engage in or end relationships; and women appreciated these benefits and urged expanded access to self-tests. HIVST has the potential to support HIV prevention objectives in settings with high prevalence of HIV.Trial registration: ClinicalTrials.gov identifier: NCT03135067.

Engagement in HIV services over time among young women who sell sex in Zimbabwe.

INTRODUCTION: Young female sex workers (FSW) are disproportionately vulnerable to HIV. Zimbabwe data show higher HIV incidence and lower engagement in services compared to older FSW. Utilizing data from a combination HIV prevention and treatment intervention, we describe engagement in the HIV services over time among FSW 18-24 years, compared to those ≥25 years of age. MATERIALS AND METHODS: Data were collected via respondent-driven sampling (RDS) surveys in 14 communities in 2013 and 2016, with >2500 FSW per survey. They included blood samples for HIV and viral load testing. As the intervention had no significant impact on HIV care cascade outcomes, data were aggregated across study arms. Analyses used RDS-II estimation. RESULTS: Mean age in 2013 and 2016 was 31 and 33 years, with 27% and 17% aged 18-24 years. Overall HIV prevalence was 59% at each timepoint, and 35% and 36% among younger FSW. From 2013 to 2016 there was an increase in young HIV-positive FSW knowing their status (38% vs 60%, OR = 2.51, p<0.01). Outcomes for all FSW improved significantly over time at all steps of the cascade, and the relative change over time was similar among older versus younger FSW for most cascade variables. DISCUSSION: Young FSW had improvements in care cascade outcomes, and proportionate improvements similar to older FSW, yet they remain less engaged in services overall. This implies that the dedicated FSW services in Zimbabwe are having a comparably positive impact across age groups, however more is likely required to address young FSW's unique vulnerabilities and needs.

Efficiency in PrEP Delivery: Estimating the Annual Costs of Oral PrEP in Zimbabwe.

Although oral PrEP is highly effective at preventing HIV acquisition, optimizing continuation among beneficiaries is challenging in many settings. We estimated the costs of delivering oral PrEP to populations at risk of HIV in seven clinics in Zimbabwe. Full annual economic costs of oral PrEP initiations and continuation visits were estimated from the providers' perspective for a six-clinic NGO network and one government SGBV clinic in Zimbabwe (January-December 2018). Disaggregating costs of full initiation and incremental follow-up visits enabled modeling of the impact of duration of continuation on the cost per person-year ($pPY) on PrEP. 4677 people initiated oral PrEP, averaging 2.7 follow-up visits per person. Average cost per person initiated was $238 ($183-$302 across the NGO clinics; $86 in the government facility). The full cost per initiation visit, including central and direct costs, was $178, and the incremental cost per follow-up visit, capturing only additional resources used directly in the follow up visits, was $22. The average duration of continuation was 3.0 months, generating an average $pPY of $943, ranging from $839 among adolescent girls and young women to $1219 in men. Oral PrEP delivery costs varied substantially by scale of initiations and by duration of continuation and type of clinic. Extending the average oral PrEP continuation from 2.7 to 5 visits (about 6 months) would greatly improve service efficiency, cutting the $pPY by more than half.

The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial.

BACKGROUND: HIV self-testing can overcome barriers to HIV testing, but its potential as an HIV prevention strategy for women in sub-Saharan Africa has not been assessed. We examined whether sustained provision of self-tests to women promotes testing among sexual partners and reduces HIV incidence. METHODS: We conducted a pair-matched cluster-randomised trial in 66 community clusters in Siaya County, Kenya. Clusters were communities with a high prevalence of transactional sex, including beach communities along Lake Victoria and inland communities with hotspots for transactional sex such as bars and hotels. Within clusters, we recruited HIV-negative women aged 18 years or older with two or more sexual partners within the past 4 weeks. In each of the 33 cluster pairs, we randomly assigned clusters to an intervention and comparison group. In intervention clusters, we provided participants with multiple self-tests at regular intervals and encouraged secondary distribution of self-tests to sexual partners. In comparison clusters, we provided participants referral cards for facility-based testing. Follow-up visits and HIV testing occurred at 6-month intervals for up to 24 months. The primary outcome of HIV incidence among all participants who contributed at least one HIV test was analysed using discrete-time mixed effects models. This study is registered with ClinicalTrials.gov, NCT03135067. FINDINGS: Between June 4, 2017, and Aug 31, 2018, we enrolled 2090 participants (1033 in the 33 intervention clusters and 1057 in the 33 comparison clusters). Participants' median age was 25 years (IQR 22-31) and 1390 (66·6%) of 2086 participants reported sex work as an income source. 1840 participants completed the 18-month follow-up and 570 participants completed the 24-month follow up, which ended on March 25, 2020, with a median follow-up duration of 17·6 months. HIV incidence was not significantly different between the intervention and comparison groups (1·2 vs 1·0 per 100 person-years; hazard ratio 1·2, 95% CI 0·6-2·3, p=0·64). Social harms related to study participation occurred in three participants (two in the intervention group and one in the comparison group). INTERPRETATION: Sustained provision of multiple self-tests to women at high risk of HIV infection in Kenya enabled secondary distribution of self-tests to sexual partners but did not affect HIV incidence. FUNDING: National Institute of Mental Health; Center for Health Incentives and Behavioral Economics; National Institute of Allergies and Infectious Diseases; University of Pennsylvania Center for AIDS Research.

Community-based HIV self-testing: a cluster-randomised trial of supply-side financial incentives and time-trend analysis of linkage to antiretroviral therapy in Zimbabwe.

BACKGROUND: HIV self-testing (HIVST) requires linkage to post-test services to maximise its benefits. We evaluated effect of supply-side incentivisation on linkage following community-based HIVST and evaluated time-trends in facility-based antiretroviral therapy (ART) initiations. METHODS: From August 2016 to August 2017 community-based distributors (CBDs) in 38 rural Zimbabwean communities distributed HIVST door-to-door in 19-25 day campaigns. Communities were allocated (1:1) using constrained randomisation to either one-off US$50 remuneration per CBD (non-incentive arm), or US$50 plus US$0.20 incentive per client visiting mobile-outreach services (conditional-incentive arm). The primary outcome, assessed by population survey 6 weeks later, was self-reported uptake of any clinic service, analysed with random-effects logistic regression. Separately, non-randomised difference-in-differences in monthly ART initiations were analysed for three time periods (6 months baseline; HIVST campaign; 3 months after) at public clinics with (40 clinics) and without (124 clinics) HIVST distribution in catchment area. FINDINGS: A total of 445 conditional-incentive CBDs distributed 39 205 HIVST kits (mean/CBD: 88; 95% CI: 85 to 92) and 447 non-incentive CBDs distributed 41 173 kits (mean/CBD: 93; 95% CI: 89 to 96). Survey participation was 7146/8566 (83.4%), with 3593 (50.3%) reporting self-testing including 1305 (18.3%) previously untested individuals. Use of clinic services post-HIVST was similar in conditional-incentive (1062/3698, 28.7%) and non-incentive (1075/3448, 31.2%) arms (adjusted risk ratio (aRR) 0.94, 95% CI: 0.86 to 1.03). Confirmatory testing by newly diagnosed/untreated HIVST+clients was, however, higher (conditional-incentive: 25/33, 75.8% vs non-incentive: 20/40, 50.0%: aRR: 1.59, 95% CI: 1.05 to 2.39). In total, 12 808 ART initiations occurred, with no baseline or postcampaign differences between initiation rates in HIVST versus non-HIVST clinics, but initiation rates increased from 7.31 to 9.59 initiations per month in HIVST clinics during distribution, aRR: 1.27, 95% CI 1.17 to 1.39. CONCLUSIONS: Community-based HIVST campaigns achieved high testing uptake, temporally associated with increased demand for ART. Small supply-side incentives did not affect general clinic usage but may have increased confirmatory testing for newly diagnosed HIVST positive participants. TRIAL REGISTRATION NUMBER: PACTR201607001701788.

HIV testing approaches to reach the first UNAIDS 95% target in sub-Saharan Africa.

HIV testing is a crucial first step to accessing HIV prevention and treatment services and to achieving the UNAIDS target of 95% of people living with HIV being aware of their status by 2030. Combined implementation of facility-based and community-based approaches has helped to achieve high levels of HIV testing coverage in many countries including those in sub-Saharan Africa. Approaches such as index testing and self-testing help to reach individuals at higher risk of acquiring HIV, men, and those less likely to use health facilities or community-based services. However, as the proportion of people living with HIV who are aware of their HIV status has risen, the challenge of reaching those who remain undiagnosed or those who are at high risk of acquiring HIV has grown. Demand generation and novel testing approaches will be necessary to reach undiagnosed people living with HIV and to promote frequent retesting among key and priority populations.

Male partner testing and sexual behaviour following provision of multiple HIV self-tests to Kenyan women at higher risk of HIV infection in a cluster randomized trial.

INTRODUCTION: Without significant increases in uptake of HIV testing among men, it will be difficult to reduce HIV incidence to disease elimination levels. Secondary distribution of HIV self-tests by women to their male partners is a promising approach for increasing male testing that is being implemented in several countries. Here, we examine male partner and couples testing outcomes and sexual decision making associated with this approach in a cluster randomized trial. METHODS: We examined data from women at higher risk of HIV participating in the intervention arm of an ongoing pair-matched cluster randomized trial in Kenya. HIV-negative women ≥18 years who self-reported ≥2 partners in the past month were eligible. Participants received self-tests at enrolment and three-monthly intervals. They were encouraged to offer tests to sexual partners with whom they anticipated condomless sex. At six months, we collected data on self-test distribution, male partner and couples testing, and testing and sexual behaviour in the three most recent transactional sex encounters. We used descriptive analyses and generalized estimating equation models to understand how sexual behaviour was influenced by self-test distribution. RESULTS: From January 2018 to April 2019, 921/1057 (87%) participants completed six-month follow-up. Average age was 28 years, 65% were married, and 72% reported income through sex work. Participants received 7283 self-tests over six months, a median of eight per participant. Participants offered a median three self-tests to sexual partners. Of participants with a primary partner, 94% offered them a self-test. Of these, 97% accepted the test. When accepted, couples testing was reported among 91% of participants. Among 1954 transactional sex encounters, 64% included an offer to self-test. When offered self-tests were accepted by 93% of partners, and 84% who accepted conducted couples testing. Compared to partners with an HIV-negative result, condom use was higher when men had a reactive result (56.3% vs. 89.7%, p < 0.01), were not offered a self-test (56.3% vs. 62.0%, p = 0.02), or refused to self-test (56.3% vs. 78.3, p < 0.01). CONCLUSIONS: Providing women with multiple self-tests facilitated male partner and couples testing, and led to safer sexual behaviour. These findings suggest secondary distribution is a promising approach for reaching men and has HIV prevention potential. Clinical Trial Number: NCT03135067.

Estimating the Population Size of Female Sex Workers in Zimbabwe: Comparison of Estimates Obtained Using Different Methods in Twenty Sites and Development of a National-Level Estimate.

BACKGROUND: National-level population size estimates (PSEs) for hidden populations are required for HIV programming and modelling. Various estimation methods are available at the site-level, but it remains unclear which are optimal and how best to obtain national-level estimates. SETTING: Zimbabwe. METHODS: Using 2015-2017 data from respondent-driven sampling (RDS) surveys among female sex workers (FSW) aged 18+ years, mappings, and program records, we calculated PSEs for each of the 20 sites across Zimbabwe, using up to 3 methods per site (service and unique object multipliers, census, and capture-recapture). We compared estimates from different methods, and calculated site medians. We estimated prevalence of sex work at each site using census data available on the number of 15-49-year-old women, generated a list of all "hotspot" sites for sex work nationally, and matched sites into strata in which the prevalence of sex work from sites with PSEs was applied to those without. Directly and indirectly estimated PSEs for all hotspot sites were summed to provide a national-level PSE, incorporating an adjustment accounting for sex work outside hotspots. RESULTS: Median site PSEs ranged from 12,863 in Harare to 247 in a rural growth-point. Multiplier methods produced the highest PSEs. We identified 55 hotspots estimated to include 95% of all FSW. FSW nationally were estimated to number 40,491, 1.23% of women aged 15-49 years, (plausibility bounds 28,177-58,797, 0.86-1.79%, those under 18 considered sexually exploited minors). CONCLUSION: There are large numbers of FSW estimated in Zimbabwe. Uncertainty in population size estimation should be reflected in policy-making.

HIV self-testing services for female sex workers, Malawi and Zimbabwe.

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.

Insights for Implementation Science From 2 Multiphased Studies With End-Users of Potential Multipurpose Prevention Technology and HIV Prevention Products.

BACKGROUND: Lower adherence to biomedical HIV prevention and challenges with persistence among young women underscore the need for methods to identify factors that will achieve higher adoption and use of effective prevention options and inform new approaches. SETTING: South Africa, Kenya, and Zimbabwe. METHODS: We synthesized findings from 2 multiphased studies (TRIO and Quatro) conducted with young women aged 18-30 years that included a crossover clinical study with placebo products, a discrete-choice experiment, and qualitative interviews with women, male partners, and health providers. TRIO evaluated 3 products (tablets, ring, and injections), and Quatro compared 4 vaginal products (ring, insert, film, and gel) for HIV prevention. Both were designed to assess product preferences, choice, and use. RESULTS: Increased experience with placebo products in the crossover study informed young women's product ratings and preferences. Over half changed their mind regarding their most preferred product after trying each one. The integrated qualitative component was vital to understanding what prompted these preference shifts. The discrete choice experiment provided insights on how features not available in placebos, like efficacy and contraception, influence choice and the tradeoffs women may be willing to make to gain a desired product feature. CONCLUSION: The use of multiple research methods allowed for evaluation of varied dimensions of acceptability, preference, and choice in the context of diverse biomedical HIV prevention delivery forms. Findings elucidated the value of product choice with differences in preference within and across settings. Collectively, the 3 methodologies offered important insights about these products informative to enhanced product design development and future implementation.

Enhancing national prevention and treatment services for sex workers in Zimbabwe: a process evaluation of the SAPPH-IRe trial.

Targeted HIV interventions for female sex workers (FSW) combine biomedical technologies, behavioural change and community mobilization with the aim of empowering FSW and improving prevention and treatment. Understanding how to deliver combined interventions most effectively in sub-Saharan Africa is critical to the HIV response. The Sisters' Antiretroviral Programme for Prevention of HIV: an Integrated Response (SAPPH-Ire) randomized controlled trial in Zimbabwe tested an intervention to improve FSW engagement with HIV services. After 2 years, results of the trial showed no significant difference between study arms in proportion of FSW with HIV viral load ≥1000 copies/ml as steep declines occurred in both. We present the results of a process evaluation aiming to track the intervention's implementation, assess its feasibility and accessibility, and situate trial results within the national HIV policy context. We conducted a mixed methods study using data from routine programme statistics, qualitative interviews with participants and respondent driven surveys. The intervention proved feasible to deliver and was acceptable to FSW and providers. Intervention clinics saw more new FSW (4082 vs 2754), performed over twice as many HIV tests (2606 vs 1151) and nearly double the number of women were diagnosed with HIV (1042 vs 546). Community mobilization meetings in intervention sites also attracted higher numbers. We identified some gaps in programme fidelity: offering pre-exposure prophylaxis took time to engage FSW, viral load monitoring was not performed, and ratio of peer educators to FSW was lower than intended. During the trial, reaching FSW with HIV testing and treatment became a national priority, leading to increasing attendance at both intervention and control clinics. Throughout Zimbabwe, antiretroviral therapy coverage improved and HIV-stigma declined. Zimbabwe's changing HIV policy context appeared to contribute to positive improvements across the HIV care continuum for all FSW over the course of the trial. More intense community-based interventions for FSW may be needed to make further gains.

How Can Programs Better Support Female Sex Workers to Avoid HIV Infection in Zimbabwe? A Prevention Cascade Analysis.

BACKGROUND: "HIV prevention cascades" have been proposed to support programs by identifying gaps in demand for, access to, and capability to adhere to HIV prevention tools, but there are few empirical examples to guide development. We apply a prevention cascade framework to examine prevention coverage and factors associated with condoms and/or PrEP adherence among female sex workers. SETTING: Seven sites across Zimbabwe. METHODS: Seven respondent-driven sampling surveys from the intervention sites of a pragmatic cluster-randomized trial in Zimbabwe in 2016 were analyzed, and 611/1439 women testing HIV-negative included. We operationalized key components of an HIV prevention cascade including demand, supply, and capability to adhere to 2 tools for HIV prevention: condoms and pre-exposure prophylaxis (PrEP). We used adjusted logistic regression to identify determinants of adherence to condoms and PrEP in turn, examining the effect of adherence to one tool on adherence to the other. RESULTS: There were 343/611, 54.7%, women reporting adherence to condoms and/or PrEP, leaving almost half uncovered. Although women were aware that condoms prevented HIV and reported good access to them, only 45·5% reported full adherence to condom use. For PrEP, a new technology, there were gaps along all 3 domains of demand, supply, and adherence. Alcohol use decreased adherence to PrEP and condoms. Younger and newer entrants to sex work were less likely to take PrEP every day. CONCLUSIONS: HIV prevention programming among female sex workers in Zimbabwe could consider increasing awareness of PrEP alongside supply, alcohol use interventions, and approaches to engaging younger women.