Examining a multicomponent health promotion intervention among Black same gender loving men in southern ending the HIV epidemic in the U.S. jurisdictions: a randomized controlled trial

This protocol describes a hybrid type 2 effectiveness-implementation trial to examine the effectiveness, maintenance, and reach of an mHealth-mediated intervention to promote HIV and psychological health among Black same gender loving men. The intervention was developed by and for Black same gender loving men and seeks to reduce social isolation, increase access to culturally affirming healthcare, and decrease barriers to stable housing and economic empowerment due to interpersonal, institutional, and structural stigma. It does so through promoting individual-level health education and motivation, social support among Black same gender loving men, access to culturally-affirming healthcare, and pathways to stable housing and economic empowerment. This study will be implemented in the Ending the HIV Epidemic in the U.S. jurisdictions in and around Atlanta, GA through a collaboration between NAESM, a Black same gender loving men-led community-based organization in Atlanta, GA, Positive Impact Health Centers, an Atlanta-based comprehensive HIV service organization, and Rutgers School of Public Health in New Jersey. This study will test the latest iteration of the intervention called NPOWER365. We will conduct a 6-month randomized controlled trial to assess the effectiveness of NPOWER365 on HIV-related and psychological health, its moderating effect on intersectional stigma, and its intervention maintenance and reach. We will randomize 350 Black same gender loving men living with HIV to intervention (n = 175) or wait-list control (n = 175) groups and assess daily and longer-lag HIV care (i.e., anti-retroviral treatment adherence) and psychological health (e.g., depressive symptoms, anxiety symptoms) outcomes through baseline and 6-month daily diary studies and 1-, 2-, 4-, and 6-month longer-lag assessments. We will analyze intervention effectiveness, stigma moderation, and implementation outcome data through dynamic structural equation modelling and latent growth curve models. Thus, this study will establish the effectiveness of NPOWER365, a community-led mHealth intervention, for improving HIV behavioral and psychological health for Black same gender loving men living with HIV in four of the Ending the HIV Epidemic jurisdictions with the highest HIV burden. NPOWER365 was designed for implementation and is poised to offer a model for effective HIV and psychological support among Black SGLM in high-stigma, low-resource areas of the U.S. South and beyond. This trial is registered on ClinicalTrials.gov (NCT06315218).