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Original Investigation
November 18, 2019

Effect of Internet-Distributed HIV Self-tests on HIV Diagnosis and Behavioral Outcomes in Men Who Have Sex With Men: A Randomized Clinical Trial

Author Affiliations
  • 1Centers for Disease Control and Prevention, Atlanta, Georgia
  • 2Emory University, Atlanta, Georgia
JAMA Intern Med. 2020;180(1):117-125. doi:10.1001/jamainternmed.2019.5222
Key Points

Question  Does provision of HIV self-tests to internet-recruited men who have sex with men increase HIV testing and diagnosis of infection over a 12-month period?

Findings  In this randomized clinical trial of 2665 US participants randomized to 2 groups, more participants in the arm that was mailed HIV self-tests reported testing for HIV 3 or more times during the trial compared with control participants, with 12 infections identified in the self-testing arm in the first 3 months compared with 2 infections in the control arm. Participants who shared the study self-tests reported 34 infections among their social network members.

Meaning  Providing free HIV self-tests helped increase awareness of infection among participants and their social network members.


Importance  Undiagnosed HIV infection results in delayed access to treatment and increased transmission. Self-tests for HIV may increase awareness of infection among men who have sex with men (MSM).

Objective  To evaluate the effect of providing HIV self-tests on frequency of testing, diagnoses of HIV infection, and sexual risk behaviors.

Design, Setting, and Participants  This 12-month longitudinal, 2-group randomized clinical trial recruited MSM through online banner advertisements from March through August 2015. Those recruited were at least 18 years of age, reported engaging in anal sex with men in the past year, never tested positive for HIV, and were US residents with mailing addresses. Participants completed quarterly online surveys. Telephone call notes and laboratory test results were included in the analysis, which was completed from August 2017 through December 2018.

Interventions  All participants had access to online web-based HIV testing resources and telephone counseling on request. Participants were randomized in a 1:1 ratio to the control group or a self-testing (ST) group, which received 4 HIV self-tests after completing the baseline survey with the option to replenish self-tests after completing quarterly surveys. At study completion, all participants were offered 2 self-tests and 1 dried blood spot collection kit.

Main Outcomes and Measures  Primary outcomes were HIV testing frequency (tested ≥3 times during the trial) and number of newly identified HIV infections among participants in both groups and social network members who used the study HIV self-tests. Secondary outcomes included sex behaviors (eg, anal sex, serosorting).

Results  Of 2665 participants, the mean (SD) age was 30 (9.6) years, 1540 (57.8%) were white, and 443 (16.6%) had never tested for HIV before enrollment. Retention rates at each time point were more than 54%, and 1991 (74.7%) participants initiated 1 or more follow-up surveys. More ST participants reported testing 3 or more times during the trial than control participants (777 of 1014 [76.6%] vs 215 of 977 [22.0%]; P < .01). The cumulative number of newly identified infections during the trial was twice as high in the ST participants as the control participants (25 of 1325 [1.9%] vs 11 of 1340 [0.8%]; P = .02), with the largest difference in HIV infections identified in the first 3 months (12 of 1325 [0.9%] vs 2 of 1340 [0.1%]; P < .01). The ST participants reported 34 newly identified infections among social network members who used the self-tests.

Conclusions and Relevance  Distribution of HIV self-tests provides a worthwhile mechanism to increase awareness of HIV infection and prevent transmission among MSM.

Trial Registration  ClinicalTrials.gov identifier: NCT02067039

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