Background: Self-testing may increase HIV testing and decrease the time people with HIV are unaware of their status, but there is concern that absence of counseling may result in increased HIV risk.
Setting: Seattle, Washington.
Methods: We randomly assigned 230 high-risk HIV-negative men who have sex with men to have access to oral fluid HIV self-tests at no cost versus testing as usual for 15 months. The primary outcome was self-reported number of HIV tests during follow-up. To evaluate self-testing's impact on sexual behavior, we compared the following between arms: non-HIV-concordant condomless anal intercourse and number of male condomless anal intercourse partners in the last 3 months (measured at 9 and 15 months) and diagnosis with a bacterial sexually transmitted infection (STI: early syphilis, gonorrhea, and chlamydial infection) at the final study visit (15 months). A post hoc analysis compared the number of STI tests reported during follow-up.
Results: Men randomized to self-testing reported significantly more HIV tests during follow-up (mean = 5.3, 95% confidence interval = 4.7 to 6.0) than those randomized to testing as usual (3.6, 3.2 to 4.0; P < 0.0001), representing an average increase of 1.7 tests per participant over 15 months. Men randomized to self-testing reported using an average of 3.9 self-tests. Self-testing was noninferior with respect to all markers of HIV risk. Men in the self-testing arm reported significantly fewer STI tests during follow-up (mean = 2.3, 95% confidence interval = 1.9 to 2.7) than men in the control arm (3.2, 2.8 to 3.6; P = 0.0038).
Conclusions: Access to free HIV self-testing increased testing frequency among high-risk men who have sex with men and did not impact sexual behavior or STI acquisition.
Trial registration: ClinicalTrials.gov NCT01161446.