Direct provision versus facility collection of HIV self-tests among female sex workers in Uganda: a cluster-randomized controlled health systems trial

Background: HIV self-testing allows HIV testing at any place and time and without health workers. HIV self-testing may thus be particularly useful for female sex workers (FSWs), who should test frequently but face stigma and financial and time barriers when accessing healthcare facilities. Methods and Findings: We conducted a cluster-randomized controlled health systems trial among FSWs in Kampala, Uganda, to measure the effect of two HIV self-testing delivery models on HIV testing and linkage to care outcomes. FSW peer educator groups (one peer educator and eight participants) were randomized to either: (1) direct provision of HIV self-tests, (2) provision of coupons for free collection of HIV self-tests in a healthcare facility, or (3) standard-of-care HIV testing. We randomized 960 participants in 120 peer educator groups from October 18 to November 16, 2016. Participants’ median age was 28 years (IQR 24-32). Our pre-specified primary outcomes were self-report of any HIV testing at one month and at four months; our pre-specified secondary outcomes were self-report of HIV self-test use, seeking HIV-related medical care, and ART initiation. In addition, we analyzed two secondary outcomes that were not pre-specified: self-report of repeat HIV testing – to understand the intervention effects on frequent testing – and self-reported facility-based testing – to quantify substitution effects. Participants in the direct provision arm were significantly more likely to have tested for HIV than those in the standard-of-care arm, both at one month (RR 1.33, 95% CI 1.17-1.52, p<0.001) and at four months (RR 1.14, 95% CI 1.07-1.22, p<0.001). Participants in the direct provision arm were also significantly more likely to have tested for HIV than those in the facility collection arm, both at one month (RR 1.18, 95% CI 1.07-1.31, p=0.001) and at four months (RR 1.03, 95% CI 1.01-1.05, p=0.02). At one month, fewer participants in the intervention arms had sought medical care for HIV than in the standard-of-care arm, but this difference was not significant and disappeared by four months. There were no statistically significant differences in ART initiation across study arms. At four months, participants in the direct provision arm were significantly more likely to have tested twice for HIV than those in the standard-of-care arm (RR 1.51, 95% CI 1.29-1.77, p<0.001) and those in the facility collection arm (RR 1.22, 95% CI 1.04-1.49, p=0.001). Participants in the HIV self-testing arms almost completely replaced facility-based testing with self-testing. Two adverse events related to HIV self-testing were reported: interpersonal violence and mental distress. Study limitations included self-reported outcomes and limited generalizability beyond FSWs in similar settings. Conclusions: In this study, HIV self-testing appeared to be safe and increased recent and repeat HIV testing among FSWs. HIV self-testing can play an important role in supporting HIV interventions that require frequent HIV testing, such as HIV treatment-as-prevention, behavior change for transmission reduction, and pre-exposure prophylaxis. Direct provision of HIV self-tests is significantly more effective in increasing HIV testing among FSWs than passively offering HIV self-tests for collection in healthcare facilities.