To inform World Health Organization (WHO) guidance, we assessed the effect of HIV self-testing (HIVST) on uptake and frequency of testing, as well as identification of HIV-positive persons, linkage to care, social harm and risk behavior. A systematic search identified five randomized controlled trials comparing HIVST to standard HIV testing services among 4,145 total participants from four countries. All offered free oral-fluid rapid tests for HIVST and were among men. Meta-analysis of two RCTs among men who have sex with men showed frequency of testing nearly doubled, resulting in two more tests in a 12-15 month period. Meta-analysis of two RCTs showed HIVST also doubled the likelihood of an HIV-positive diagnosis. Across all RCTs, there was no indication of harm attributable to HIVST and potential increases in risk-taking behavior appeared to be minimal. WHO now recommends HIVST as an additional HIV testing approach.
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