Increasing HIV Testing and Viral Suppression via Stigma Reduction in a Social Networking Mobile Health Intervention Among Black and Latinx Young Men and Transgender Women Who Have Sex With Men (HealthMpowerment): Protocol for a Randomized Controlled Trial (Preprint)

Abstract

BACKGROUND Stigma and discrimination related to sexuality, race, ethnicity, and HIV status negatively impact HIV testing, engagement in HIV care, and consistent viral suppression among young Black and Latinx men who have sex with men and transgender women who have sex with men (YBLMT). Few interventions have addressed the effects of intersectional stigma among youth living with HIV and those at-risk for HIV within the same virtual space. OBJECTIVE Building on the success of the HealthMpowerment mobile health (mHealth) intervention (HMP 1.0), and with the input of a youth advisory board, HMP 2.0 is an app-based intervention that promotes user-generated content and engagement to reduce intersectional stigma and elicit social support to improve HIV-related outcomes among YBLMT. The primary objective of this study is to test whether participants randomized to HMP 2.0 report improvement in HIV prevention and care continuum outcomes compared to an information-only control arm. We will also explore whether participant engagement, as measured by quantitative and qualitative paradata, mediates stigma- and HIV care-related outcomes. Finally, we will assess whether changes in intersectional stigma and improvements in HIV care continuum outcomes differ between the two HMP 2.0 intervention networks (researcher-driven vs. peer-referred) and examine the role of social network dynamics in shaping these differences. METHODS We will enroll 1,050 YBLMT ages 15-29 affected by HIV across the United States of America (US). Using an HIV-status stratified randomized trial design, participants will be randomly assigned into one of three app-based conditions (information-only app-based control arm, a researcher-created network arm of HMP 2.0, or a peer-referred network arm of HMP 2.0). Behavioral assessments will occur at baseline, 3, 6, 9 and 12 months. For participants living with HIV, self-collected biomarkers (viral load) are scheduled for baseline, 6, and 12 months. For HIV-negative participants, up to three HIV self-testing kits will be available during the study period. RESULTS Research activities began in September 2018 and are ongoing. The University of Pennsylvania serves as the Central IRB of Record for this study (Penn Protocol #829805) and has approved the trial protocol and all study materials. Institutional reliance agreements have been established with the University of North Carolina at Chapel Hill, Duke University, and SUNY Downstate. Study recruitment began July 20, 2020. Forty-nine participants have been enrolled as of September 1, 2020. CONCLUSIONS Among a large sample of US-based YBLMT, the current study will assess whether HMP 2.0, an app-based intervention designed to ameliorate stigma and its negative sequalae, can increase routine HIV testing among HIV-negative participants and consistent viral suppression among participants living with HIV. CLINICALTRIAL This trial is registered on ClinicalTrials.gov with record number: NCT03678181. The original record is available at https://clinicaltrials.gov/ct2/show/study/NCT03678181 and archived by WebCite at http://www.webcitation.org/75FomRrBl