Trial design

This cRCT is comparing two models of peer delivery of HIVST in the study sites through incentivised respondent driven peer networks and direct distribution by peer navigators compared with standard of care (referral to HIV testing, prevention and care services by peer navigators) in improving the uptake of HIV testing, prevention and care among young women (18 to 24 years). Eight pairs of peer navigators were randomised and assigned to each study arm with the intention of reaching young women aged 18 to 24 years with HIVST packs (including referral slips) and/or linkage information (including PrEP, contraceptives, ART etc) during the 6 month of community outreach. Peer navigators are randomised to one of three arms: 1) incentivised-peer-networks: peer-navigators recruited participants ‘seeds’ to distribute up to five HIVST packs (including incentivised coupons) and HIV prevention information to peers within social networks. Seeds receive an incentive (20 Rand = US$1.5) for each respondent who contacts a peer-navigator for additional HIVST packs to distribute; (2) peer-navigator-distribution: peer-navigators distribute HIVST packs and information directly to young people; (3) standard of care: peer-navigators distribute referral slips and information. All arms promote sexual health and HIV care and prevention (including PrEP and ART) and provide barcoded clinical referral slips to facilitate linkage to HIV testing, prevention and care services (figure 2).

Flow diagram of trial enrolment, randomisation and intervention arms. AGYW, adolescent girls and young women; ART, antiretroviral; HIVST, HIV self-testing; PNs, peer navigators; PrEP, pre-exposureprophylaxis.

The unit of randomisation is the pair of peer navigators working in each of the 24 areas included in the study. The areas are not adjoining, and each is bordered by a natural boundary (eg, roads or streams) or by a sizeable distance. Although contamination is inevitable in this type of cRCT, the spillover effects are contained by measuring the outcome by exposure to the peer-navigator cluster in multiple ways, including barcoded and colour coded referral slips as well as peer-navigator and ward names that determine participant exposure to specific intervention components. Coupled with this, we are conducting a mixed method process evaluation that provides context and add nuance to our understanding of any contamination.