Leveraging family-based assets for Black men who have sex with men in House Ball Communities: Protocol for a cluster randomized controlled trial.

Black men who have sex with men (MSM) continue to have the highest incidence of new human immunodeficiency virus (HIV) diagnoses in the United States but are least likely to be engaged in care or to be virally suppressed. Many Black MSM face multiple stigmas, but some have found refuge in the House Ball Community (HBC)-a national network of Black lesbian, gay, bisexual, and transgender kinship commitments that provide care-giving, affirmation, and survival skills-building for its members. We propose to modify a skills-building and HIV prevention best-evidence, group-level intervention for HIV- negative Black MSM (Many Men Many Voices) into a family-based intervention to focus on asset-building for both HIV-negative and HIV-positive Black MSM within HBC families. The adapted intervention will be re-branded as Our Family Our Voices (OFOV). We proposed a mixed-methods study to test the feasibility and preliminary efficacy of OFOV adapted for HIV status-neutral use with HBC families. First, we will develop the intervention protocol using the ADAPT-ITT model for modifying behavioral interventions. Then, we will conduct a cluster randomized controlled trial with six HBC families in New York City. Families will be randomized to the OFOV intervention or waitlist control arm. Primary outcomes will be HIV testing, HIV pre-exposure prophylaxis use, currently in HIV care and on HIV treatment. Secondary outcomes will be the number of family-based assets, resilience, number of sexual partners, and relative frequency of condomless anal intercourse. The results of the formative research, including the pilot trial, will contribute to the evidence-base regarding the development of HIV status-neutral interventions that respond to the diversity and complexities of HBC families and that recognize the importance of asset-building for facilitating HBC resilience to stigma as a part of the United States' domestic policy objective of ending the HIV epidemic by 2030.