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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.
Such a strategy requires regular HIV testing for individuals who are at ongoing risk of HIV, including FSWs.
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).The trial seeks to determine the effectiveness and safety of these two HIVST delivery approaches, compared with standard of care, for improving HIV testing coverage and knowledge of HIV status.The intervention tested in the Zambian Peer Educators for HIV Self-Testing (ZEST) study, as well as data collected throughout the course of the study, was guided a priori by a theory of change developed through mental models and deductive development.19 Briefly, we theorised that the distribution of HIV self-test kits via peer educators would lead to improved status knowledge by reducing barriers to HIV testing such as stigma hours of clinic operation.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.
Additionally, the trial will measure the impact of HIVST using the two distribution approaches on a number of important safety end points.