Study protocol: a pilot randomised waitlist-controlled trial of a dyadic mobile health intervention for black sexual-minority male couples with HIV in the USA

Abstract

IntroductionHIV 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 randomised controlled trial of a mobile health 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 and analysisEighty 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 randomised 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 predefined 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 adherence by comparing the intervention and waitlist-control arms on self-reported and biological (hair sample) measures of adherence.Ethics and disseminationStudy staff will obtain electronic consent from all participants. This study has been approved by the University of California (UCSF) Institutional Review Board. Study staff will work with the Community Advisory Board at the UCSF Center for AIDS Prevention Studies Board to disseminate results to participants and the community via open discussions, presentations, journal publications and/or social media.Trial registration numberNCT04951544.

mHealth-Based Gamification Interventions Among Men Who Have Sex With Men in the HIV Prevention and Care Continuum: Systematic Review and Meta-Analysis

“…In addition, a secondary reference search was performed, yielding 1 more relevant record. Consequently, a total of 26 articles were included in the qualitative analysis [ 13 24-48 undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined ]. Furthermore, of the 26 articles, 6 RCTs were chosen for the meta-analysis [ 24 29 30 32 33 39 ].…”

“…These nonrandomized studies were not further included in the meta-analysis. We did not evaluate the study quality of the other 10 studies [ 26 27 31 37 38 40 41 44 46 47 ], as they were designed as study protocols or feasibility studies that did not report results for the outcomes of interest in our review.…”

“…Authors of the initial publications were contacted when additional information was needed. Because of multiple classifications proposed for the term gamification, the components in each digital gamified intervention were analyzed through the lens of the Octalysis gamification framework [ 23 ], which comprises 8 core drives into which various gamification elements can be placed, namely, epic meaning and calling, development and accomplishment, empowerment creativity and feedback, ownership and possession, social influence and relatedness, scarcity and impatience, unpredictability and curiosity, and loss and avoidance (Table S3-2 in Multimedia Appendix 2 [ 13 24-48 undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined undefined ]). Laine et al [ 49 ] mapped their interview results from schoolchildren to the Octalysis framework to better establish a digital gamification-based intervention for promoting active school transport.…”

Feasibility and Acceptability Pilot Test of Connecting Latinos en Parejas: A Couples-Based HIV Prevention Intervention for Latino Male Couples

“…Although interventions for male couples exist (Frye et al, 2021;Mitchell, 2015;National Institutes of Health RePORT, 2015;Starks et al, 2022;Stephenson et al, 2011Stephenson et al, , 2021, none have been developed and evaluated within a Latino cultural context focused on the unique constellation of factors salient to Latino male couples. With the exception of a small number focused on Black/ African American men (Clinicaltrials.gov: NCT01394900 and NCT04951544;Kim et al, 2021), dyadic interventions have sampled predominantly White, sexual minority men who reported high levels of education and employment; thus, the generalizability of these interventions to communities most disproportionately impacted by the epidemic is unknown (Gamarel et al, 2022).…”

“…Furthermore, the impact can extend to future relationships, as individuals implement skills and strategies with new partners. In addition to the exemplar completed and published couple-based HIV-related intervention studies referenced above, there are a number of HIV-related couples interventions being implemented, including for male couples in the United States (Kim et al, 2021; Newcomb et al, 2022; Starks et al, 2021), sexual and gender minority couples in the United States (Tabrisky et al, 2021), young heterosexual couples in the United States (Trent et al, 2022), and several interventions at various stages of evaluation among heterosexual couples in South Africa (Clinicaltrials.gov: NCT03809364, NCT05231707, and NCT05310773), Malawi (Clinicaltrials.gov: NCT04906616), Mozambique (Clinicaltrials.gov: NCT03149237 and NCT04071470), Kenya (Kwena et al, 2021), Zambia (Clinicaltrials.gov: NCT04729413), and Kazakhstan (Clinicaltrials.gov: NCT03555396). None have centered the unique context facing Latino men and their same sex partners.…”