Differentiated Prevention And Care To Reduce The Risk of HIV Acquisition And Transmission Among Female Sex Workers In Zimbabwe: Study Protocol For The ‘AMETHIST’ Cluster Randomised Trial
Abstract Background: Female sex workers (FSW) in sub-Saharan Africa are disproportionately affected by HIV and are critical to engage in both HIV prevention and care. Here we describe our approach to evaluation of the AMETHIST intervention for FSW, adapted to the African context and set in Zimbabwe where there is a nationally-scaled programme for sex workers (Sisters). We hypothesise this intervention will raise uptake and adherence to prevention and treatment among FSW resulting in a reduction in their risk of HIV acquisition/transmission.Methods: The AMETHIST intervention (Adapted Microplanning to Eliminate Transmission of HIV in Sex Transactions) aims to provide risk differentiated prevention and care to FSW through microplanning and self help groups. Twenty two towns with the Sisters programme were randomised using restricted randomisation to either the Sisters programme or the Sister programme plus AMETHIST. The primary outcome is composite and is defined as the proportion of HIV positive FSW at risk of HIV transmission combined with the proportion of HIV negative FSW at risk of HIV acquisition. The outcome will be assessed after two years of intervention delivery in a respondent-driven sampling survey (total n=4400; n=200 FSW recruited at each site). Primary analysis will use the ‘RDS-2’ method to estimate cluster summaries and will adapt Hayes and Moulton’s ‘2-step’ method to adjust effect estimates for individual-level confounders and further adjust for cluster baseline prevalence. An in-depth process evaluation guided by our project trajectory will be undertaken.Discussion: Innovative pragmatic trials are needed to generate evidence on effectiveness of combination interventions in HIV prevention and treatment in different contexts. We describe the design and analysis of such a study.Trial Registration: The trial was registered at Pan African Clinical Trials Registry (PACTR202007818077777) on 2 July 2020.