Background HIV testing and knowledge of status are starting points for HIV treatment and prevention interventions. Among female sex workers (FSWs), HIV testing and status knowledge remain far from universal. HIV self-testing (HIVST) is an alternative to existing testing services for FSWs, but little evidence exists how it can be effectively and safely implemented. Here, we describe the rationale and design of a cluster randomised trial designed to inform implementation and scale-up of HIVST programmes for FSWs in Zambia.
Methods The Zambian Peer Educators for HIV Self-Testing (ZEST) study is a 3-arm cluster randomised trial taking place in 3 towns in Zambia. Participants (N=900) are eligible if they are women who have exchanged sex for money or goods in the previous 1 month, are HIV negative or status unknown, have not tested for HIV in the previous 3 months, and are at least 18 years old. Participants are recruited by peer educators working in their communities. Participants are randomised to 1 of 3 arms: (1) direct distribution (in which they receive an HIVST from the peer educator directly); (2) fixed distribution (in which they receive a coupon with which to collect the HIVST from a drug store or health post) or (3) standard of care (referral to existing HIV testing services only, without any offer of HIVST). Participants are followed at 1 and 4 months following distribution of the first HIVST. The primary end point is HIV testing in the past month measured at the 1-month and 4-month visits.
Ethics and dissemination This study was approved by the Institutional Review Boards at the Harvard T.H. Chan School of Public Health in Boston, USA and ERES Converge in Lusaka, Zambia. The findings of this trial will be presented at local, regional and international meetings and submitted to peer-reviewed journals for publication.
Trial registration number Pre-results; NCT02827240.
- female sex workers
- HIV testing
- HIV self-testing
- Sub-Saharan Africa
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Contributors CEO, KFO, MMC, KM, WN, RS, AF, LGB, GH and TB conceived and designed the study. CEO, KFO and LGB created tables and figures. CEO, KFO and MMC wrote first draft of the manuscript. CEO, KFO, MMC, KM, WN, RS, AF, LGB, GH and TB read and critically revised the manuscript.
Funding The Zambian Peer Educators for HIV Self-Testing Study is funded by the International Initiative for Impact Evaluation (3ie). CEO is supported in part by the National Institute on Drug Abuse T32-DA013911 and the National Institute of Mental Health R25-MH083620. KFO is supported in part by the National Institute of Allergy and Infectious Disease T32-AI007535. TB is supported in part by the National Institute of Child Health and Human Development R01-HD084233 and the National Institute of Allergy and Infectious Diseases R01-AI124389 and R01-AI112339.
Competing interests None declared.
Ethics approval Ethical approval was obtained for the Zambian Peer Educators for HIV Self-Testing Study from the Harvard T.H. Chan School of Public Health Institutional Review Board in Boston, Massachusetts and the ERES Converge Institutional Review Board in Lusaka, Zambia.
Provenance and peer review Not commissioned; externally peer reviewed.
Data sharing statement On completion of the trial, de-identified data will be available through the International Initiative for Impact Evaluation (3ie)'s public data access repository on Dataverse.
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