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A process evaluation will be conducted to understand intervention implementation, and document any contextual factors determining the success or failure of intervention delivery. Inference will be based on plausibility that DREAMS+PrEP had an impact on HIV incidence. The primary outcome is HIV incidence among YWSS HIV-negative at study enrolment measured by repeat, rapid HIV testing over 24-months.
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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. Women will be asked to complete a questionnaire and offered HIV testing.
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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. 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. 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. 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. 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). “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.