JMIR Publications

ABSTRACT

Background:

Gay, bisexual, and other men who have sex with men (MSM) continue to be disproportionately affected by the HIV epidemic in the United States, particularly Black/African-American MSM (BMSM) and Hispanic/Latino MSM (HLMSM). Previous HIV self-testing programs have yielded high testing rates, although these studies predominantly enrolled White, non-Hispanic MSM. Mobile health (mHealth) tools can support HIV prevention, testing, and treatment. This protocol details an implementation study of mailing free HIV self-tests (HIVST) nested within a randomized controlled trial (RCT) designed to assess the benefit of a mobile application (app) for increasing uptake of HIV prevention and other social services

Objective:

The study was a comparative effectiveness trial of innovative recruitment and testing promotion strategies intended to effectively reach cisgender BMSM and HLMSM. We evaluated the use of a mobile app for increasing access to care.

Methods:

Study development began with individual and group consultations that elicited feedback from three core groups: 1) HIV care practitioners and researchers, 2) HIV service organization leaders from study states, and 3) BMSM and HLMSM living within study states. Upon completion of the formative qualitative work, participants from 11 states, based on the observed areas of highest rate of new HIV diagnoses among Black and Hispanic MSM, were recruited through social networking websites and smartphone applications. After eligibility was verified, participants were consented and randomized to the intervention arm (access to the Know@Home mobile app) or the control arm (referral to web resources). We provided all participants with HIVSTs. The evaluation of the efficacy of a mobile phone application (app) to support linkage to post-test prevention services that included STI testing, PrEP initiation, ART treatment, and acquisition of condoms and compatible lubricant has been planned. Data on these outcomes were obtained from several sources, including HIVST reporting surveys, the 4-month follow-up survey, laboratory analyses of dried blood spot (DBS) cards returned by the participant, and data obtained from state health department surveillance systems. Where possible, relevant subgroup analyses are planned.

Results:

During the formative development phase, nine consultations were conducted: six in-depth individual discussions and three group consultations. From February 2020 through February 2021, we enrolled 2,093 MSM in the RCT from 11 states: 1,149 BMSM and 944 HLMSM.

Conclusions:

This study was designed and implemented to be able to evaluate the effectiveness of recruitment strategies to reach the populations, and of the mobile app with regards to linkage to HIV prevention or treatment services. Data were also obtained to allow for the analyses of cost and cost-effectiveness related to study enrollment, HIV testing uptake, identification of previously undiagnosed HIV, sexually transmitted infection testing and treatment, and linkage to HIV prevention or treatment services. Clinical Trial: NCT04219878, registered January 20, 2020.