Abstract

BackgroundHIV 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.MethodsWe 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.DiscussionThis 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 registrationClinicalTrials.gov identifier NCT03654690. Registered on 31 August 2018.

Highlights

  • Background and rationale {6a} overall Human immunodeficiency virus (HIV) incidence in the USA has remained stable in recent years, new infections continue to increase in certain groups of men who have sex with men (MSM) [1]

  • Past modeling studies have suggested that this scenario may account for up to 50% of new infections [6, 7], prompting calls to increase the access and availability of HIV testing [8]

  • We did not find differences in testing for sexually-transmitted infections or initiating Pre-exposure prophylaxis (PrEP) across the conditions. These results suggest that delivering HIV self-testing (HST) kits to high-risk MSM at regular intervals could increase HIV testing rates and encourage more regular testing

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Summary

Introduction

Background and rationale {6a} overall HIV incidence in the USA has remained stable in recent years, new infections continue to increase in certain groups of men who have sex with men (MSM) [1]. Past modeling studies have suggested that this scenario may account for up to 50% of new infections [6, 7], prompting calls to increase the access and availability of HIV testing [8]. Despite their elevated risk, fewer than 60% of MSM report having been tested in the last 12 months, and only 20% have been tested more than once in the past year [9, 10]. HIV disproportionately affects men who have sex with men (MSM) in the USA, and new infections continue to increase, among African American (AA) and Hispanic/Latino (H/L) MSM. 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

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