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Introduction: In the context of key population HIV testing programmes, identifying new HIV acquisitions, tracking incidence, and responding with prevention and treatment interventions will be critical for achieving HIV epidemic control. Laboratory tests for recently acquired HIV used as part of a "recent infection testing algorithm" (RITA), offer a potential tool to support this work. We implemented a RITA for female sex workers (FSWs) in Zimbabwe to explore opportunities and programmatic benefits., Methods: Between October 2021 and January 2023, recency testing was offered to FSWs attending the Centre for Sexual Health and HIV/AIDS Research (CeSHHAR) Zimbabwe's key populations programme. Dried blood spot (DBS) samples were taken at 86 clinic sites across 10 provinces and Laboratory LAg Avidity and viral load testing conducted. RITA results were analysed and linked to programme data to explore geographical differences and calculate HIV incidence. We describe concurrent efforts in HIV testing for social (social network testing [SNT]) and sexual (index case testing [ICT]) contacts of those testing HIV positive., Results: Among 24,976 FSWs tested at programme sites, 9.5% (2363/24,976) were confirmed HIV positive. We enrolled 55.5% (1311/2363) of eligible HIV-positive FSWs to our study, of whom 11.7% (153/1311) were identified as having recently acquired HIV. It took a median of 37 days (IQR 20-67) for samples to be processed. Enrolment rates varied between provinces but the proportion of recently acquired HIV was similar (range: 18.4% to 4.0%). Overall HIV incidence was 3.4 (95% CI 2.7-4.0) per 100py. Where results could be linked to routinely collected data, we found no evidence of a difference in test-positivity between the ICT and SNT contacts of those with recently acquired compared to those with long-term HIV., Conclusions: Implementation of a RITA was possible within a nationally scaled sex worker programme, and while challenging to implement, can provide an understanding of transmission dynamics and HIV incidence in this context. Sub-optimal recruitment and data linkage limited the interpretation of our findings and opportunities for strategic gains though focusing on HIV prevention efforts., (© 2024 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: Women who engage in sex work in sub-Saharan Africa have a high risk of acquiring HIV infection. HIV incidence has declined among all women in sub-Saharan Africa, but trends among women who engage in sex work are poorly characterised. We synthesised data on HIV incidence among women who engage in sex work in sub-Saharan Africa and compared these with the total female population to understand relative incidence and trends over time., Methods: We searched MEDLINE, Embase, Global Health, and Google Scholar from Jan 1, 1990, to Feb 28, 2024, and grey literature for studies that reported empirical estimates of HIV incidence among women who engage in sex work in any sub-Saharan Africa country. We calculated incidence rate ratios (IRRs) compared with total female population incidence estimates matched for age, district, and year, did a meta-analysis of IRRs, and used a continuous mixed-effects model to estimate changes in IRR over time., Findings: From 32 studies done between 1985 and 2020, 2194 new HIV infections were observed among women who engage in sex work over 51 490 person-years. Median HIV incidence was 4·3 per 100 person years (IQR 2·8-7·0 per 100 person-years). Incidence among women who engage in sex work was eight times higher than matched total population women (IRR 7·8 [95% CI 5·1-11·8]), with larger relative difference in western and central Africa (19·9 [9·6-41·0]) than in eastern and southern Africa (4·9 [3·4-7·1]). There was no evidence that IRRs changed over time (IRR per 5 years: 0·9 [0·7-1·2])., Interpretation: Across sub-Saharan Africa, HIV incidence among women who engage in sex work remains disproportionately high compared with the total female population. However, constant relative incidence over time indicates HIV incidence among women who engage in sex work has declined at a similar rate. Location-specific data for women who engage in sex work incidence are sparse, but improved surveillance and standardisation of incidence measurement approaches could fill these gaps. Sustained and enhanced HIV prevention for women who engage in sex work is crucial to address continuing inequalities and ensure declines in new HIV infections., Funding: Bill & Melinda Gates Foundation, UK Research and Innovation, National Institutes of Health., Translation: For the French translation of the abstract see Supplementary Materials section., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2024 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Introduction: We used a Programme Science platform, to generate evidence to support the implementation of programmes for sex workers in Africa. Female sex workers are estimated to make up 1.6% (1.3%-1.8%) of the population of women aged 15-49 years in Zimbabwe. We highlight how programme science can be used to help distinguish between when, where and with whom programmes need to be implemented and discuss two case studies that exemplify implementing better (Case study 1 (1 June 2019-30 June 2021) Optimizing implementation of a risk differentiated microplanning intervention) and implementing differently (Case study 2 (1 October 2016-30 September 2022) Reorientating implementation of DREAMS for young women selling sex)., Methods: Zimbabwe's nationally scaled programme for sex workers was established in 2009 in partnership with sex workers to provide comprehensive services for sex workers and generate evidence for programme design, implementation and scale up. Since inception, comprehensive data have been collected from all sex workers seeking services. As the scope of service provision has expanded so has the scope of data collection and analysis. At enrolment, sex workers are assigned an alphanumeric unique identifier which links consultations within and across programme sites. We conduct descriptive analyses of the Key Population (KP) programme data to guide programme implementation and redesign, embedding programmatic qualitative enquiry as required., Results: Two case studies describing different approaches to programme optimization are presented. In the first, an optimization exercise was used to strengthen programme implementation ensuring that the KP programme got back on track after SARS-COV-2. In the second, an in-depth review of research and programme data led to a re-orientation of the DREAMS programme to ensure that young women at the highest risk of HIV acquisition were enrolled and had access to DREAMS social support interventions in turn strengthening their uptake of HIV prevention., Conclusions: Optimizing and sustaining HIV care and treatment programmes requires effective delivery with sufficient scale and intensity for population impact. Our programme science approach guided the scale up of the KP programme in Zimbabwe, providing evidence to support strategy, implementation and ongoing management, and importantly helping us distinguish between when we needed to just implement, implement better or implement differently., (© 2024 The Author(s). Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of International AIDS Society.)

Background: The frequency of new HIV infections among female sex workers in sub-Saharan Africa is poorly understood. We used routinely collected data that enable unique identification of repeat HIV testers to assess temporal trends in seroconversion and identify associated risk factors for female sex workers accessing Sisters with a Voice, Zimbabwe's national sex worker programme., Methods: We pooled HIV testing data gathered between Sept 15, 2009, and Dec 31, 2019, from 36 Sisters programme sites in Zimbabwe. We included female sex workers aged 16 years or older with an HIV-negative test and at least one subsequent programme test. We calculated HIV seroconversion rates (using the midpoint between the HIV-positive test and the last negative test as the seroconversion date) and estimated rate ratios to compare 2-year periods by using Poisson regression, with robust SEs to account for clustering by site and adjusting for age and testing frequency to assess temporal trends. We did sensitivity analyses to explore assumptions about seroconversion dates and the effects of variation in follow-up time on our conclusions., Findings: Our analysis included data for 6665 female sex workers, 441 (7%) of whom seroconverted. The overall seroconversion rate was 3·8 (95% CI 3·4-4·2) per 100 person-years at risk. Seroconversion rates fell with time since first negative HIV test. After adjustment, there was evidence of a decrease in seroconversion rates from 2009 to 2019 (p=0·0053). In adjusted analyses, being younger than 25 years, and having a sexually transmitted infection diagnosis at a previous visit, were significantly associated with increased seroconversion rates. Our findings were mostly robust to sensitivity analyses, but when 1 month before an HIV-positive test was used as the seroconversion date, seroconversion rates no longer fell with time., Interpretation: We identified high rates of seroconversion shortly after linkage to programme services, which emphasises the need to strengthen HIV prevention programmes from first contact with female sex workers in Zimbabwe. New infections among female sex workers remain challenging to measure, but longitudinal analysis of routine testing data can provide valuable insights into seroconversion rates and associated risk factors., Funding: UN Population Fund, Deutsche Gesellschaft für Internationale Zusammenarbeit, the Bill & Melinda Gates Foundation, The Global Fund to Fight AIDS, Tuberculosis and Malaria, US President's Emergency Plan for AIDS Relief, US Agency for International Development, and the Elton John AIDS Foundation., Competing Interests: Declaration of interests We declare no competing interests., (Copyright © 2023 The Author(s). Published by Elsevier Ltd. This is an Open Access article under the CC BY 4.0 license. Published by Elsevier Ltd.. All rights reserved.)

Background: Young women who sell sex (YWSS), are underserved by available HIV prevention and care services. The Determined, Resilient, Empowered, AIDS-free, Mentored and Safe (DREAMS) Partnership aimed to reduce the risk of HIV acquisition among vulnerable populations of adolescent girls and young women, including YWSS, in 10 sub-Saharan African countries. We describe 2 methods, respondent-driven sampling (RDS) and peer outreach, used to refer YWSS for DREAMS services in Zimbabwe, and compare the characteristics and engagement of YWSS referred to these services by each method. We hypothesized that RDS would identify YWSS at higher risk of HIV and those who were less engaged with HIV prevention and care services than peer outreach., Objective: We aimed to compare respondent-driven sampling and peer outreach in recruiting and referring high-risk populations for HIV prevention and care services., Methods: We used RDS, a sampling method designed to reach a representative sample of the network of key populations, and peer outreach, a programmatic approach to identify, reach, and refer YWSS for DREAMS between April and July 2017, and January 2017 and July 2018, respectively, in 2 cities in Zimbabwe. For RDS, we conducted detailed mapping to understand sex work typology and geography, and then purposively selected 10 "seed" participants in each city to initiate RDS. For peer outreach, we initiated recruitment through 18 trained and age-matched peer educators using youth-tailored community mobilization. We described the characteristics and service engagement of YWSS who accessed DREAMS services by each referral approach and assessed the association of these characteristics with referral approach using the chi-square test. Analysis was performed with and without restricting the period when RDS took place. We estimated the relative incremental costs of recruiting YWSS using each strategy for referral to DREAMS services., Results: Overall, 5386 and 1204 YWSS were referred for DREAMS services through peer outreach and RDS, respectively. YWSS referred through RDS were more likely to access DREAMS services compared to YWSS referred through peer outreach (501/1204, 41.6% vs 930/5386, 17.3%; P<.001). Regardless of referral approach, YWSS who accessed DREAMS had similar education levels, and a similar proportion tested HIV negative and reported not using a condom at the last sex act. A higher proportion of YWSS accessing DREAMS through RDS were aged 18-19 years (167/501, 33.3% vs 243/930, 26.1%; P=.004) and more likely to be aware of their HIV status (395/501, 78.8% vs 396/930, 42.6%; P<.001) compared to those accessing DREAMS services through peer outreach. The incremental cost per young woman who sells sex recruited was US $7.46 for peer outreach and US $52.81 for RDS., Conclusions: Peer outreach and RDS approaches can reach and refer high-risk but different groups of YWSS for HIV services, and using both approaches will likely improve reach., International Registered Report Identifier (irrid): RR2-DOI 10.1186/s12889-018-5085-6., (©Sungai T Chabata, Rumbidzo Makandwa, Bernadette Hensen, Phillis Mushati, Tarisai Chiyaka, Sithembile Musemburi, Joanna Busza, Sian Floyd, Isolde Birdthistle, James R Hargreaves, Frances M Cowan. Originally published in JMIR Public Health and Surveillance (https://publichealth.jmir.org), 27.07.2022.)

Introduction: Early diagnosis of HIV is critical for epidemic control. To achieve this, successful testing programmes are essential and test positivity is often used as a marker of their performance. The aim of this study was to analyse trends and predictors of HIV test positivity over time and explore how an understanding of seroconversion rates could build on our interpretation of this indicator among female sex workers in Zimbabwe., Methods: We analysed HIV test data from Zimbabwe's nationally scaled sex work programme between 2009 and 2019. We defined test positivity as the proportion of all tests that were HIV positive and measured new diagnoses by estimating seroconversion rates among women with repeat tests, defined as an HIV-positive test after at least one HIV-negative test in the programme. We used logistic regression to analyse test positivity over three time-periods: 2009-2013, 2014-2017 and 2018-2019, adjusting for potential confounding by demographic factors and the mediating effects of time since last HIV test. We calculated the seroconversion rates for the same time-periods., Results: During the 10-year study period, 54,503 tests were recorded in 39,462 women. Between 2009 and 2013, 18% of tests were among women who reported testing in the previous 6 months. By 2018-2019, this had increased to 57%. Between 2018 and 2019, test positivity was 9.6%, compared to 47.9% for 2009-2013 (aOR 6.08 95% CI 5.52-6.70) and 18.8% for 2014-2017 (aOR 2.17 95% CI 2.06-2.28). Adjusting for time since last test reduced effect estimates for 2009-2013 (aOR 4.03 95% CI 3.64-4.45) and 2014-2017 (aOR 1.97 95% CI 1.86-2.09) compared to 2018-2019. Among 7573 women with an initial HIV-negative test in the programme and at least one subsequent test, 464 tested HIV positive at a rate of 3.9 per 100 pyar (95% CI 3.5-4.2)., Conclusions: Test positivity decreased among women testing through the programme over time, while seroconversion rates remained high. These declines were partly driven by changes in individual testing history, reflecting comprehensive coverage of testing services and greater knowledge of HIV status, but not necessarily declining rates of seroconversion. Understanding testing history and monitoring new HIV infections from repeat tests could strengthen the interpretation of test positivity and provide a better understanding of programme performance., (© 2022 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: Young women who sell sex (YWSS) are at disproportionate risk of HIV. Reducing YWSS' vulnerability requires engaging their male sexual partners. To achieve this, we need to understand the characteristics and dynamics of their sexual partnerships to inform effective interventions., Methods: We conducted a mixed-methods study to compare YWSS' qualitative descriptions of male partners with categories reported in a behavioral survey. Data were drawn from enrollment into an evaluation of the DREAMS initiative in Zimbabwe in 2017. As part of a respondent-driven sampling survey, we recruited 40 seed participants from 2 intervention and 4 comparison sites. We conducted semistructured interviews with 19 "seeds," followed by a behavioral survey with 2387 YWSS. We interpreted quantitative and qualitative data together to understand how YWSS perceived male sexual partners, assess how well survey variables related to narrative descriptions, and describe patterns of risk behavior within partnerships., Results: Qualitative data suggest survey categories "husband" and "client" reflect YWSS' perceptions but "regular partner/boyfriend" and "casual partner" do not. In interviews, use of the term "boyfriend" was common, describing diverse relationships with mixed emotional and financial benefits. More than 85% of male partners provided money to YWSS, but women were less likely to report condomless sex with clients than regular partners (11% vs 37%) and more likely to report condomless sex with partners who ever forced them to have sex (37% vs 21%)., Conclusions: Reducing HIV risk among YWSS requires prevention messages and tools that recognize diverse and changing vulnerability within and between sexual relationships with different male partners., Competing Interests: The authors have no funding or conflicts of interest to disclose., (Copyright © 2021 The Author(s). Published by Wolters Kluwer Health, Inc.)

Introduction: Adolescent girls and young women (AGYW), including those who sell sex in sub-Saharan Africa, are especially vulnerable to HIV. Reaching them with effective prevention is a programmatic priority. The HIV prevention cascade can be used to track intervention coverage, and identify gaps and opportunities for programme strengthening. The aim of this study was to characterise gaps in condom use and identify reasons underlying these gaps among young women who sell sex (YWSS) in Zimbabwe using data from enrolment into an impact evaluation of the DREAMS programme. DREAMS provided a package of biomedical, social and economic interventions to AGYW aged 10 to 24 with the aim of reducing HIV incidence., Methods: In 2017, we recruited YWSS aged 18 to 24 using respondent-driven sampling in six sites across Zimbabwe. We measured knowledge about efficacy of, access to, and effective (consistent) use of condoms with the most recent three sexual partners, separately by whether YWSS self-identified as female sex workers (FSW) or not. Among YWSS without knowledge about efficacy of, not having access to, and not effectively using condoms, we described the potential reasons underlying the gaps in the condom cascade. To identify socio-demographic characteristics associated with effective condom use, we used logistic regression modelling. All analyses were RDS-II weighted and restricted to YWSS testing HIV-negative at enrolment., Results: We enrolled 2431 YWSS. Among 1842 (76%) YWSS testing HIV-negative, 66% (n = 1221) self-identified as FSW. 89% of HIV-negative YWSS demonstrated knowledge about efficacy of condoms, 80% reported access to condoms and 58% reported using condoms consistently with the three most recent sexual partners. Knowledge about efficacy of and effective use of condoms was similar regardless of whether or not YWSS self-identified as FSW, but YWSS self-identifying as FSW reported better access to condoms compared to those who did not (87% vs 68%; age- and site-adjusted (adjOR) = 2.69; 95% CI: 2.01 to 3.60; p < 0.001). Women who reported experiencing sexual violence in the past year and common mental disorder in the past week were less likely to use condoms consistently (43% vs. 60%; adjOR = 0.49; 95% CI: 0.35 to 0.68; p < 0.001) and (51% vs. 61%; adjOR = 0.76; 95% CI: 0.60 to 0.97; p = 0.029), respectively., Conclusions: Despite high knowledge about efficacy of and access to condoms, there remain large gaps in self-reported consistent condom use among YWSS. Addressing the structural determinants of YWSS' inconsistent condom use, including violence, could reduce this gap. YWSS who do not self-identify as FSW have less access to condoms and may require additional programmatic intervention., (© 2020 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Introduction: Across sub-Saharan Africa, selling sex puts young women at high risk of HIV. Some young women who sell sex (YWSS) may self-identify as sex workers, while others may not, having implications for how to reach them with HIV prevention. We describe characteristics, sexual behaviours and health service use of YWSS in Zimbabwe, comparing women who identified as female sex workers (FSW) and women who did not (non-identifying-YWSS), and explore factors associated with HIV infection., Methods: We analysed data from respondent-driven sampling (RDS) surveys among YWSS aged 18 to 24 implemented in six sites in Zimbabwe from April to July 2017. RDS was used to enrol YWSS into an impact evaluation of the multi-country DREAMS (Determined, Resilient, Empowered, AIDS-free, Mentored and Safe) Partnership, which provides comprehensive HIV prevention programming to adolescent girls and young women. Women completed an interviewer-administered questionnaire and were offered HIV testing services. We used logistic regression (RDS-II-weighted, normalized by site) to identify factors associated with prevalent HIV infection., Results: Forty-four seeds recruited 2387 YWSS. RDS-adjusted HIV prevalence was 24%; 67% of women identified as FSW. FSW were older and had lower educational attainment than non-identifying-YWSS. While 40% of FSW reported 10+ clients in the previous month, 9% of non-identifying-YWSS did so. FSW were more likely to have accessed HIV-related services, including HIV testing in the last six months (FSW: 70%; non-identifying-YWSS: 60%). Over half of all YWSS described selling sex as their main financial support (FSW: 88%; non-identifying YWSS: 54%). Increasing age, lower educational attainment, younger age of first selling sex and higher number of clients in the previous month were associated with prevalent HIV., Conclusions: YWSS in Zimbabwe have a high prevalence of HIV, reported high numbers of sexual partners and depend financially on selling sex. Non-identifying-YWSS differed socio-demographically to FSW, yet factors associated with HIV risk were similar for all women. Women not identifying as FSW were less likely to access services, suggesting they should be prioritized for HIV prevention. Network-based recruitment may enhance their inclusion in programmes, like DREAMS, which aim to reach young women at highest-risk with comprehensive health, HIV prevention and social protection services., (© 2019 The Authors. Journal of the International AIDS Society published by John Wiley & Sons Ltd on behalf of the International AIDS Society.)

Young female sex-workers (FSW) aged 18-24 are at high risk of HIV due to high numbers of sexual partners, difficulty negotiating condom use, increased risk of gender-based violence, and limited access to services. Here we describe changes in sexual behaviours among young FSW across Zimbabwe between 2013 and 2016, and risk factors for prevalent HIV in 2013 and 2016. FSW ≥ 18 years were recruited using respondent-driven sampling in 14 sites across Zimbabwe in 2013 and 2016 as part of the SAPPH-IRe trial. We collected data on socio-demographics and sexual behaviour and offered HIV testing. Statistical analyses were RDS-II weighted. Characteristics of young FSW aged 18-24 were described, stratified by age. Logistic regression was used to assess difference in sexual behaviours by reported HIV status between 2013 and 2016, and to explore associations with prevalent HIV in 2013 and 2016. 656 young FSW were recruited in 2013 and 503 in 2016. Characteristics of young FSW were similar across both surveys. HIV prevalence was similar at both time points (35% vs 36%) and rose steeply with age. Compared to young FSW in 2013, reported condom-less sex with a steady partner and condom-less sex with clients was higher in 2016 among women self-reporting HIV negative status (OR = 6.41; 95%CI: 3.40-12.09; P<0.001) and (OR = 1.69; 95%CI: 1.14-2.51, P = 0.008), respectively, but not among young FSW self-reporting HIV positive status (OR = 2.35; 95%CI: 0.57-9.76; P = 0.236) and (OR = 1.87; 95%CI: 0.74-4.74; P = 0.186). After adjusting for age in 2016, young FSW who had ever been married had increased odds of testing HIV positive (OR = 1.88; 95% CI 1.04-3.39; P = 0.036) compared with those who had never married. Young FSW who completed secondary education or higher were less likely to test HIV positive (OR = 0.41; 95% CI 0.20-0.83; P = 0.012) compared with those with primary education or less. Young FSW remain at very high risk of HIV. Strategies to identify young FSW when they first start selling and refer them into services that address their economic, social and sexual vulnerabilities are critical.

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.

Young women (aged 15-24) who exchange sex for money or other support are among the highest risk groups for HIV acquisition, particularly in high prevalence settings. To prepare for introduction and evaluation of the DREAMS programme in Zimbabwe, which provides biomedical and social interventions to reduce adolescent girls' and young women's HIV vulnerability, we conducted a rapid needs assessment in 6 towns using a "social mapping" approach. In each site, we talked to adult sex workers and other key informants to identify locations where young women sell sex, followed by direct observation, group discussions and interviews. We collected data on socio-demographic characteristics of young women who sell sex, the structure and organisation of their sexual exchanges, interactions with each other and adult sex workers, and engagement with health services. Over a two-week period, we developed a "social map" for each study site, identifying similarities and differences across contexts and their implications for programming and research. Similarities include the concentration of younger women in street-based venues in town centres, their conflict with older sex workers due to competition for clients and acceptance of lower payments, and reluctance to attend existing services. Key differences were found in the 4 university towns included in our sample, where female students participate in diverse forms of sexual exchange but do not identify themselves as selling sex. In smaller towns where illegal gold panning or trucking routes were found, young women migrated in from surrounding rural areas specifically to sell sex. Young women who sell sex are different from each other, and do not work with or attend the same services as adult sex workers. Our findings are being used to inform appropriate intervention activities targeting these vulnerable young women, and to identify effective strategies for recruiting them into the DREAMS process and impact evaluations.

Background: "Determined, Resilient, AIDS-free, Mentored and Safe" (DREAMS) is a package of biomedical, social and economic interventions offered to adolescent girls and young women aged 10-24 years with the aim of reducing HIV incidence. In four of the six DREAMS districts in Zimbabwe, DREAMS includes an offer of oral pre-exposure prophylaxis (DREAMS+PrEP), alongside interventions to support demand and adherence, to women aged 18-24 who are at highest risk of HIV infection, including young women who sell sex (YWSS). This evaluation study addresses the question: does the delivery of DREAMS+PrEP through various providers reduce HIV incidence among YWSS Zimbabwe? We describe our approach to designing a rigorous study to assess whether DREAMS+PrEP had an impact on HIV incidence., Methods: The study design needed to account for the fact that: 1) DREAMS+PrEP was non-randomly allocated; 2) there is no sampling frame for the target population for the evaluation; 3) there are a small number of DREAMS districts (N = 6), and 4) DREAMS+PrEP is being implemented by various providers. The study will use a cohort analysis approach to compare HIV incidence among YWSS in two DREAMS+PrEP districts to HIV incidence among YWSS in non-DREAMS comparison sites. YWSS will be referred to services and recruited into the cohort through a network-based (respondent-driven) recruitment strategy, and followed-up 12- and 24-months after enrolment. Women will be asked to complete a questionnaire and offered HIV testing. Additional complications of this study include identifying comparable populations of YWSS in the DREAMS+PrEP and non-DREAMS comparison sites, and retention of YWSS over the 24-month period. The primary outcome is HIV incidence among YWSS HIV-negative at study enrolment measured by repeat, rapid HIV testing over 24-months. Inference will be based on plausibility that DREAMS+PrEP had an impact on HIV incidence. A process evaluation will be conducted to understand intervention implementation, and document any contextual factors determining the success or failure of intervention delivery., Discussion: HIV prevention products of known efficacy are available. Innovative studies are needed to provide evidence of how to optimise product use through combination interventions to achieve population impact within different contexts. We describe the design of such a study.