HIV self-testing and coupons distribution by persons using PrEP to create demand for combination HIV prevention services among men who have sex with men (MSM) and transgender women: a randomized clinical trial in the context of the ImPrEP project

Background: – Despite progress in HIV treatment in Latin America, prevention efforts lag. This study assessed whether the secondary distribution of HIV self-testing (HIVST) and coupons by MSM and transgender women using PrEP is feasible and could create demand for combination HIV prevention services.Settings: – Sub-study of the ImPrEP project conducted at two sites in Rio de Janeiro, Brazil, and three sites in Lima, Peru.Methods: – A randomized controlled trial among persons using oral PrEP for at least 6 months. Participants were randomized 1:1 to receive either five HIVST kits with coupons or five coupons alone and were instructed to distribute these within their networks. Outcomes included intervention efficacy (percentage of persons recruited) and recruitment efficacy (percentage of participants who recruited at least one person).Trial: – NCT03642314 (clinicaltrials.gov) Results: – 694 participants using PrEP were enrolled: 351 (50.6%) HIVST + coupons arm and 343 (49.4%) coupons only arm. 3470 coupons were distributed, and 2472 (71.2%) were delivered for recruitment purposes. Overall, 321 individuals were recruited (Brazil: 155; Peru: 166). The coupon-only arm was more effective in recruiting individuals in Peru (21.9% vs. 12.0%, RR:0.55[95%CI:0.41-073]), and Brazil (28.4% vs. 22.4%, RR:0.75[95%CI:0.52-1.02]). Recruitment efficacy did not differ across arms in either country. Most individuals recruited (84.5%) thought that receiving coupons or HIVST motivated them attend the service.Conclusion: – Both HIVST and coupons were successful in recruiting MSM and transgender women for combination HIV prevention services. Peer engagement of persons using PrEP can contribute to demand creation and strengthen linkage across the HIV prevention cascade.