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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

Cowan, Frances M; Machingura, Fortunate; Chabata, Sungai T; Ali, M Sanni; Busza, Joanna; Steen, Richard; Desmond, Nicola; ... Hargreaves, James R; + view all (2022) 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. Trials , 23 , Article 209. 10.1186/s13063-022-06119-w. Green open access

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Abstract

BACKGROUND: Female sex workers (FSW) in sub-Saharan Africa are disproportionately affected by HIV and are critical to engage in HIV prevention, testing and care services. We describe the design of our evaluation of the 'AMETHIST' intervention, nested within a nationally-scaled programme for FSW in Zimbabwe. We hypothesise that the implementation of this intervention will result in a reduction in the risk of HIV transmission within sex work. METHODS: The AMETHIST intervention (Adapted Microplanning to Eliminate Transmission of HIV in Sex Transactions) is a risk-differentiated intervention for FSW, centred around the implementation of microplanning and self-help groups. It is designed to support uptake of, and adherence to, HIV prevention, testing and treatment behaviours among FSW. Twenty-two towns in Zimbabwe were randomised to receive either the Sisters programme (usual care) or the Sisters programme plus AMETHIST. The composite primary outcome is defined as the proportion of all FSW who are at risk of either HIV acquisition (HIV-negative and not fully protected by prevention interventions) or of HIV transmission (HIV-positive, not virally suppressed and not practicing consistent condom use). The outcome will be assessed after 2 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-II' method to estimate cluster summaries and will adapt Hayes and Moulton's '2-step' method produce adjusted effect estimates. 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: Pan African Clinical Trials Registry PACTR202007818077777 . Registered on 2 July 2020.

Type: Article
Title: 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
Location: England
Open access status: An open access version is available from UCL Discovery
DOI: 10.1186/s13063-022-06119-w
Publisher version: https://doi.org/10.1186/s13063-022-06119-w
Language: English
Additional information: This article is licensed under a Creative Commons Attribution 4.0 International License, which permits use, sharing, adaptation, distribution and reproduction in any medium or format, as long as you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons licence, and indicate if changes were made.
Keywords: Effectiveness, Hidden population, Pragmatic trials, Randomised control trial, Respondent driven sampling, Sex workers, Female, HIV Infections, Health Services, Humans, Randomized Controlled Trials as Topic, Safe Sex, Sex Workers, Zimbabwe
UCL classification: UCL
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health > Infection and Population Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences > Faculty of Population Health Sciences > Institute for Global Health
UCL > Provost and Vice Provost Offices > School of Life and Medical Sciences
URI: https://discovery.ucl.ac.uk/id/eprint/10145645
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