The effect of providing women sustained access to HIV self-tests on male partner testing, couples testing, and HIV incidence in Kenya: a cluster-randomised trial

Background HIV self-testing can overcome barriers to HIV testing, but its potential as an HIV prevention strategy for women in sub-Saharan Africa has not been assessed. We examined whether sustained provision of self-tests to women promotes testing among sexual partners and reduces HIV incidence. Methods We conducted a pair-matched cluster-randomised trial in 66 community clusters in Siaya County, Kenya. Clusters were communities with a high prevalence of transactional sex, including beach communities along Lake Victoria and inland communities with hotspots for transactional sex such as bars and hotels. Within clusters, we recruited HIV-negative women aged 18 years or older with two or more sexual partners within the past 4 weeks. In each of the 33 cluster pairs, we randomly assigned clusters to an intervention and comparison group. In intervention clusters, we provided participants with multiple self-tests at regular intervals and encouraged secondary distribution of self-tests to sexual partners. In comparison clusters, we provided participants referral cards for facility-based testing. Follow-up visits and HIV testing occurred at 6-month intervals for up to 24 months. The primary outcome of HIV incidence among all participants who contributed at least one HIV test was analysed using discrete-time mixed effects models. This study is registered with ClinicalTrials.gov, NCT03135067. Findings Between June 4, 2017, and Aug 31, 2018, we enrolled 2090 participants (1033 in the 33 intervention clusters and 1057 in the 33 comparison clusters). Participants' median age was 25 years (IQR 22-31) and 1390 (66.6%) of 2086 participants reported sex work as an income source. 1840 participants completed the 18-month follow-up and 570 participants completed the 24-month follow up, which ended on March 25, 2020, with a median follow-up duration of 17.6 months. HIV incidence was not significantly different between the intervention and comparison groups (1.2 vs 1.0 per 100 person-years; hazard ratio 12, 95% CI 0.6-2.3, p=0.64). Social harms related to study participation occurred in three participants (two in the intervention group and one in the comparison group). Interpretation Sustained provision of multiple self-tests to women at high risk of HIV infection in Kenya enabled secondary distribution of self-tests to sexual partners but did not affect HIV incidence. Copyright (C) 2021 Published by Elsevier Ltd. All rights reserved.