Primrose Matambanadzo

Background: Community-led interventions for female sex workers (FSW) can improve HIV prevention and treatment outcomes by lowering self-stigma and strengthening social cohesion to improve service uptake. In Zimbabwe, the AMETHIST intervention trial integrated peer-led microplanning with self-help groups for FSW and demonstrated improved HIV treatment outcomes. We investigated the role of social cohesion and self-stigma in explaining these findings. Method: We conducted a mixed-method analysis of data collected during AMETHIST. We re-analysed qualitative data from interviews and group discussions to identify narratives linking self-stigma, engagement with microplanners and/or self-help groups and HIV service use. We analysed quantitative data from endline respondent-driven sampling surveys for differences in self-reported measures of social cohesion and self-stigma between trial arms, and between those who did and did not participate in intervention activities or access services. Results: In both arms, FSW self-reported engaging with peer supporters, participating in self-help groups and accessing HIV services. Qualitative narratives suggested peer support and group participation could reduce self-stigma and support service uptake. Lower levels of self-stigma were seen in the intervention arm (58.6% vs 63.2%; aOR 0.77; 95% CI 0.61-0.86). Social cohesion exceeded 50% across the whole sample, but was not associated with study arm, nor with engagement in intervention-related activities. Discussion: Although qualitative data suggested some FSW felt their uptake of services was influenced by intervention components, quantitative analyses did not suggest either variable was on the causal pathway to the outcomes of the intervention. A limitation may have been the measurement of these complex constructs and the high levels of social cohesion across both study arms. Contributions to the literature: - Community-led, empowerment-based interventions are the cornerstone of effective HIV responses for sex workers. The hypothesised mechanisms of improved social cohesion and self-efficacy through which these work to increase HIV services uptake are less well understood. - Our study contributes to evidence on the social mechanisms through which community based interventions work to improve HIV outcomes among female sex workers in Zimbabwe - Our study found that female sex workers who more frequently accessed HIV services were more likely to report higher levels of social cohesion, but was unable to establish whether this was a mechanism along the pathway between intervention engagement and improved HIV outcomes Our study indicated that reductions in self-stigma through peer-led community-based support are important for HIV programme implementation; increasing the uptake of HIV services and improving HIV outcomes

Introduction: Female sex workers (FSWs) in sub-Saharan Africa are at higher risk of HIV acquisition and transmission. However, FSWs’ life experiences are heterogeneous and are important to characterise in order to tailor responses to individual needs. Peer microplanners are FSWs trained to engage other FSWs and offer each individual a tailored package of support. We sought to assess the feasibility, acceptability and fidelity of implementing peer-led assessments of risk. Methods: Between December 2020 and August 2021, we conducted a qualitative process evaluation study of the Adapted Microplanning: Eliminating Transmissible HIV In Sex Transactions (AMETHIST) trial’s peer-led assessment of FSWs’ risk of HIV acquisition and transmission. We enrolled 60 participants (30 FSW and 30 peer microplanners) for semistructured in-depth interviews at 3 of 11 intervention sites. Interview guides and analysis were underpinned by three elements adapted from the UK Medical Research Council’s process evaluation framework: (1) feasibility, (2) acceptability and (3) fidelity. Using a framework analytic approach, data were familiarised, coded with NVivo V.12 software, charted, interpreted and then deductively mapped to these three elements. Results: Peer microplanners used the risk scores to tailor their support to FSW with good fidelity. Some experienced difficulties completing assessments during the initial period of implementation. However, it was feasible for peer microplanners to establish strong relationships, and they used observational and conversational skills to elicit sensitive information from FSW to support their assessment. The assessments and tailored support offered by peer microplanners were acceptable to FSWs, although some did not appear to know they were being assessed. Conclusions: Our findings show that peer microplanners feasibly and acceptably assessed FSW for certain risk factors through a scoring tool and focused their support accordingly. This approach could be integrated into other peer-led interventions to improve prioritisation of HIV programmes.

Background: Sex workers (SWs) are at risk of acquiring HIV infections. Despite this, SWs have low uptake of relevant preventive measures, such as HIV pre-exposure prophylaxis (PrEP). Community-based programs that make PrEP convenient and accessible have the potential to drive PrEP continuation and reduce HIV risk. Objective: This study aims to describe the co-development and piloting of the Together Optimizing PrEP Access in Zimbabwe (TOPAZ) intervention—where SWs have the opportunity to access PrEP refills through pharmacies in Zimbabwe. Methods: Using a participatory process, the TOPAZ intervention will be collaboratively developed with pharmacy owners and SWs. TOPAZ comprises the provision of safe and convenient spaces for PrEP refill pickups bundled with a gift voucher incentive at pharmacies. Formative research comprising focus group discussions and in-depth interviews with SWs, pharmacists, and stakeholders will inform the development of the preliminary model (aim 1). A cluster-randomized pilot trial will evaluate the impact of the PrEP-in-pharmacy intervention, compared to standard clinic-based pickup in the key populations program, on PrEP retention at 3, 6, 9, and 12 months after initiation (aim 2). The outcome of the pilot trial will be a comparison of PrEP retention at 6 months after initiation between study arms. We will also compare PrEP retention among SWs aged between 18 and 24 years at 6 months and among participants remaining active in sex work at 6 months. We will use the Generalized Estimation Equations model to generate risk differences and 95% CIs for PrEP retention in intervention versus comparison arms. Analysis will follow an intent-to-treat approach. Finally, a mixed methods study will be conducted to understand the potential for scaling TOPAZ for SWs; insights from this study will inform the design of a future effectiveness trial (aim 3). Proctor’s implementation outcomes, namely, acceptability, adoption, appropriateness, feasibility, fidelity, and penetration of the pharmacy-based PrEP refill program, will be evaluated by triangulation of program data and qualitative interviews. Results: This study began the enrollment of participants in March 2024. Data collection ended in May 2025. The final comprehensive analysis of the results will be conducted in February 2026 after all the data have been collected and reviewed comprehensively. Conclusions: This study will report on the feasibility, acceptability, and effectiveness of pharmacy-based PrEP refills to improve PrEP continuation among women who sell sex. If successful, this preliminary study will pave the way for a future effectiveness trial to evaluate this intervention more comprehensively. Trial Registration: ClinicalTrials.gov NCT06348069; https://clinicaltrials.gov/study/NCT06348069 International Registered Report Identifier (IRRID): DERR1-10.2196/74141

Recency testing can provide strategic insights as to whether a person newly diagnosed with HIV recently acquired their infection or not. To understand potential biases associated with HIV recency testing, we explored the extent sample type influences whether a person is assigned as being recent. Implementing a laboratory-based Recent Infection Testing Algorithm (RITA) across the Centre for Sexual Health and HIV/AIDS Research (CeSHHAR) key populations programme in Zimbabwe between October 2021 and January 2023, we compared plasma-based and dried-bloodspot (DBS) HIV recency samples. Over the study period, 24,976 individual female sex workers HIV tested, of whom 9.5% (2,363/24,979) newly tested HIV positive. Of these 2,363 women, 55.5% (1311/2,363) were offered and gave consent for a sample to be taken for DBS recency and viral load testing, among whom 11.7% (153/1,311) were classified as having a recent infection. A subset of 464 women were offered and consented to paired sample collection, among whom 10.1% (47) and 12.3% (57) of plasma and DBS samples, respectively, were classified as recent. Overall, categorical determination was good, with 97% of results concordant. Of 58 women with paired sample collection who had a test result classified as recent, 46 (79.3%) were concordant recent on both DBS and plasma, with 12 (20.7%) being discordant. Of these 12 women’s samples, 11 were deemed long-standing by the plasma assay but recent by the paired DBS, and one deemed long-standing by DBS but recent by the paired plasma sample. On average, plasma samples had a higher normalised optical density than DBS samples (mean difference of 0.53). Depending on use-case and setting, there are trade-offs when considering DBS or plasma-based samples between test performance and ease of implementation. Our data can help inform statistical adjustments to harmonise cut-offs on DBS and plasma assays, thereby improving the use and interpretation of recency assays in population-level HIV surveillance activities.

BACKGROUND Sex workers (SWs) are at risk of acquiring HIV infections. Despite this, SWs have low uptake of relevant preventive measures, such as HIV pre-exposure prophylaxis (PrEP). Community-based programs that make PrEP convenient and accessible have the potential to drive PrEP continuation and reduce HIV risk. OBJECTIVE This study aims to describe the co-development and piloting of the Together Optimizing PrEP Access in Zimbabwe (TOPAZ) intervention—where SWs have the opportunity to access PrEP refills through pharmacies in Zimbabwe. METHODS Using a participatory process, the TOPAZ intervention will be collaboratively developed with pharmacy owners and SWs. TOPAZ comprises the provision of safe and convenient spaces for PrEP refill pickups bundled with a gift voucher incentive at pharmacies. Formative research comprising focus group discussions and in-depth interviews with SWs, pharmacists, and stakeholders will inform the development of the preliminary model (aim 1). A cluster-randomized pilot trial will evaluate the impact of the PrEP-in-pharmacy intervention, compared to standard clinic-based pickup in the key populations program, on PrEP retention at 3, 6, 9, and 12 months after initiation (aim 2). The outcome of the pilot trial will be a comparison of PrEP retention at 6 months after initiation between study arms. We will also compare PrEP retention among SWs aged between 18 and 24 years at 6 months and among participants remaining active in sex work at 6 months. We will use the Generalized Estimation Equations model to generate risk differences and 95% CIs for PrEP retention in intervention versus comparison arms. Analysis will follow an intent-to-treat approach. Finally, a mixed methods study will be conducted to understand the potential for scaling TOPAZ for SWs; insights from this study will inform the design of a future effectiveness trial (aim 3). Proctor’s implementation outcomes, namely, acceptability, adoption, appropriateness, feasibility, fidelity, and penetration of the pharmacy-based PrEP refill program, will be evaluated by triangulation of program data and qualitative interviews. RESULTS This study began the enrollment of participants in March 2024. Data collection ended in May 2025. The final comprehensive analysis of the results will be conducted in February 2026 after all the data have been collected and reviewed comprehensively. CONCLUSIONS This study will report on the feasibility, acceptability, and effectiveness of pharmacy-based PrEP refills to improve PrEP continuation among women who sell sex. If successful, this preliminary study will pave the way for a future effectiveness trial to evaluate this intervention more comprehensively. CLINICALTRIAL ClinicalTrials.gov NCT06348069; https://clinicaltrials.gov/study/NCT06348069 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/74141

Recency testing can provide strategic insights as to whether a person newly diagnosed with HIV recently acquired their infection or not. To understand potential biases associated with HIV recency testing, we explored the extent sample type influences whether a person is assigned as being recent. Implementing a laboratory-based Recent Infection Testing Algorithm (RITA) across the Centre for Sexual Health and HIV/AIDS Research (CeSHHAR) key populations programme in Zimbabwe between October 2021 and January 2023, we compared plasma-based and dried-bloodspot (DBS) HIV recency samples. Over the study period, 24,976 individual female sex workers HIV tested, of whom 9.5% (2,363/24,979) newly tested HIV positive. Of these 2,363 women, 55.5% (1311/2,363) were offered and gave consent for a sample to be taken for DBS recency and viral load testing, among whom 11.7% (153/1,311) were classified as having a recent infection. A subset of 464 women were offered and consented to paired sample collection, among whom 10.1% (47) and 12.3% (57) of plasma and DBS samples, respectively, were classified as recent. Overall, categorical determination was good, with 97% of results concordant. Of 58 women with paired sample collection who had a test result classified as recent, 46 (79.3%) were concordant recent on both DBS and plasma, with 12 (20.7%) being dis-concordant. Of these 12 women’s samples, 11 were deemed long-standing by the plasma assay but recent by the paired DBS, and one deemed long-standing by DBS but recent by the paired plasma sample. Depending on use-case and setting, there are trade-offs when considering DBS or plasma-based samples between test performance and ease of implementation. Our data can help inform statistical adjustments to harmonise cut-offs on DBS and plasma assays, thereby improving the use and interpretation of recency assays in population-level HIV surveillance activities.