eTest: a limited-interaction, longitudinal randomized controlled trial of a mobile health platform that enables real-time phone counseling after HIV self-testing among high-risk men who have sex with men.

Background: HIV disproportionately affects men who have sex with men (MSM) in the USA, and new infections continue to increase, particularly among African American (AA) and Hispanic/Latino (H/L) MSM. Rates of HIV testing are particularly low among AA and H/L MSM, and innovative approaches to encourage testing may help address high incidence in these men. HIV self-testing (HST) may be an important tool for increasing rates and frequency of testing. HST may be particularly well-suited for AA and H/L MSM, given that stigma and mistrust of medical care contribute to low testing rates. Despite its promise, however, many are concerned that HST does not sufficiently connect users with critical post-testing resources, such as confirmatory testing and care among those who test positive, and that these limitations may result in delayed linkage to care.

Methods: We developed a mobile health platform (eTest) that monitors when HST users open their tests in real time, allowing us to provide timely, "active" follow-up counseling and referral over the phone. In this study, 900 high-risk MSM (with targets of 40% AA, 35% H/L) who have not tested in the last year will be recruited from social media and other gay-oriented websites in several major cities. Over 12 months, participants will be randomly assigned to receive (1) HST with post-test phone counseling and referral (eTest condition), (2) HST without active follow-up (standard condition), or (3) reminders to get tested for HIV at a local clinic (control) every 3 months. Primary outcomes include rates of HIV testing, receipt of additional HIV prevention services, and PrEP initiation verified by clinical medical records.

Discussion: This study tests whether providing more active counseling and referral after HST encourages more regular HIV testing and engagement with other prevention services among MSM, compared to more passive approaches or clinic-based testing alone. It will also explore the cost-effectiveness and emotional/behavioral effects of these two strategies.

Trial Registration: ClinicalTrials.gov identifier NCT03654690 . Registered on 31 August 2018.