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

Catherine E Oldenburg, Katrina F Ortblad, Michael M Chanda, Kalasa Mwanda, Wendy Nicodemus, Rebecca Sikaundi, Andrew Fullem, Leah G Barresi, Guy Harling, Till Bärnighausen, Catherine E Oldenburg, Katrina F Ortblad, Michael M Chanda, Kalasa Mwanda, Wendy Nicodemus, Rebecca Sikaundi, Andrew Fullem, Leah G Barresi, Guy Harling, Till Bärnighausen

Abstract

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.

Keywords: HIV self-testing; HIV testing; Sub-Saharan Africa; female sex workers.

Conflict of interest statement

Competing interests: None declared.

Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://www.bmj.com/company/products-services/rights-and-licensing/.

Figures

Figure 1
Figure 1
Flow diagram of study enrolment, randomisation and intervention arms. FSW, female sex worker; HIVST, HIV self-testing; STD, sexually transmitted disease; IPV, intimate partner violence.
Figure 2
Figure 2
Map of study sites in Zambia. The black star indicates Lusaka, the site of study coordination and headquarters. The circles indicate locations of study sites, including Kapiri (blue), Chirundu (green) and Livingstone (red).
Figure 3
Figure 3
SPIRIT flow chart of study assessments. HIVST, HIV self-testing.

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