Zambian Peer Educators for HIV Self-Testing (ZEST) Study: Rationale and Design of a Cluster Randomised Trial of HIV Self-Testing among Female Sex Workers in Zambia

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.

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.

This study is one of the first reporting the effectiveness and safety of an HIVST intervention among female sex workers. The results allows for assessment of the feasibility and acceptability of HIV self-test kits in general. They also provide evidence on whether HIVST is used by FSWs if it is accessible via existing distribution points within the health system.

Authors: Catherine Oldenburg, Katrina Ortblad, Michael Chanda, Kalasa Mwanda, Wendy Nicodemus, Rebecca Sikaundi, Andrew Fullem, Leah Barresi, Guy Harling, Till Barnighausen.