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Study Protocol: A Pilot Randomized Control Trial of A Dyadic Mobile Health Intervention for Black Sexual-Minority Male Couples with HIV


 Background: HIV care engagement is lower among Black sexual-minority men relative to other racial/ethnic groups of sexual minority men. Being in a primary relationship is generally associated with more successful HIV care engagement across various populations. However, among Black sexual-minority men, the association between primary-relationship status and HIV-related outcomes is inconsistent across the HIV care continuum. Given the ubiquity of mobile technology access and use among racial/ethnic minority communities, leveraging mobile technology for HIV care engagement appears a promising intervention strategy. This paper outlines the protocol of the LetSync study, a pilot randomized-controlled trial of an mHealth app intervention developed using the Framework of Dyadic HIV Care Engagement to improve care-engagement outcomes among Black sexual-minority male couples living with HIV.Methods/Design: Eighty Black sexual-minority men in couples (n= 160) will be enrolled to pilot test the LetSync app. At least one member of each dyad must be both HIV-positive and self-identify as Black/African American. Couples will be randomized to either a waitlist-control arm or an intervention that uses relationship-based approach to improve HIV care engagement. We will assess feasibility and acceptability of trial procedures and intervention protocols based on pre-defined metrics of feasibility and acceptability. Execution of the study will yield the opportunity to conduct analyses to test the measurement and analysis protocol on antiretroviral therapy (ART) adherence by comparing the intervention and waitlist-control arms on self-reported and biological (hair sample) measures of adherence. Discussion: Limited prior research suggests that mobile-health technology could be a promising approach to improving HIV care engagement among Black sexual-minority men. The LetSync intervention harnesses relationship dynamics to facilitate improvement in HIV care engagement by focusing on dyadically developed and jointly executed strategies for dealing with issues related to HIV care engagement among Black sexual-minority men in couples.Trial RegistrationThe study was registered on ClinicalTrials.gov (NCT04951544) on July 7, 2021.