Effect of a regular self-testing kits distribution intervention on HIV testing and sexual-behavioral outcomes among MSM in China: a stepped-wedge randomized controlled trial


BACKGROUND: Around one third of MSM have never tested of HIV globally. HIV self-testing (HIVST) has been widely accepted as an approach for hard-to-reach MSM.
METHODS: In this stepped-wedge, non-blinded randomized controlled trial, eligible MSM recruited from four cities were randomly assigned to the intervention. This procedure continued every 3 months until all groups crossed over from control (standard of counseling) to intervention (online HIVST kits distribution). This study was conducted from August 2018 to December 2019. Generalized linear models were used to analyze the study results.
RESULTS: A total of 560 MSM with 140 in each group enrolled, 69.3% were less than 30 years old and 83.2% had a college or higher degree. Among 465 (83.0%) completed at least one follow up, 394 (70.4%) completed the 12-month four-round follow-up and 317 (68.2%) used HIVST. 1,556 HIVST packages were delivered by mail and 1,407 (90.4%) photos of self-testing results returned. Among returned results, 1,162 (82.6%) were used by 560 study MSM and 244 (17.4%) for 182 male partners by HIVST secondary distribution. Twelve MSM were diagnosed as HIV infection and 4 of them were HIV seroconverted during the follow up. HIV positive identification was higher among male partners by HIVST secondary distribution than study MSM (4.9% vs. 2.1%). The intention-to-treat analysis showed a higher probability of receiving HIV testing (estimated risk ratio [RR]=9.21, 95%CI 5.92-14.33), and increased HIV test frequency (estimated risk difference [RD]=0.89, 95%CI 0.82-0.96), and decreased number of condomless anal intercourse (RD=0.46, 95%CI 0.31-0.62) during the intervention periods as compared to the control periods. While there was no effect on the number of male partners between intervention and control periods. Moreover, through secondary distribution of HIVST, the intervention period had increased self-reported proportion of HIV testing (RR=2.23, 95%CI 1.46-3.40) and the frequency of HIV testing (RD=0.26, 95%CI 0.15-0.38) among male partners of MSM participants.
CONCLUSIONS: HIVST was an effective approach in increasing HIV testing of MSM and change their CAI. It can also elevate HIV testing of MSM's male partners trough secondary distribution of HIVST. HIVST should be further extended to scale up HIV testing uptake and safe behaviors among MSM.