An mHealth App-Based Social Capital Intervention (PrEP US NoW) to Improve Sexual Health and Uptake of Pre-Exposure Prophylaxis Among Young, Black, Sexual Minority Men: Protocol for Intervention Development and a Pilot Randomized Controlled Trial.

Abstract

Background: Black Americans are disproportionately impacted by HIV. This disparity is more profound in the Southern United States, with the highest rates being among young, Black, sexual minority men, who are also less likely to receive state-of-the-art interventions such as pre-exposure prophylaxis (PrEP). Individual-level interventions to increase PrEP uptake do not often capitalize on the opportunity to leverage the significant effects of this group's social networks, including Black women, on attitudes, beliefs, and behaviors around HIV prevention.

Objective: To increase PrEP use, an intervention, PrEP US NoW, was designed to engage young, Black, sexual minority men's social networks in discussions with supportive Black female facilitators and ultimately enhance their social capital.

Methods: First, qualitative information on core health-promoting elements of social capital bonds was captured among young, Black, sexual minority men and Black women in extant social support networks. This information was then applied to adapt an existing, evidence-based mobile health app to create the PrEP US NoW pilot through an unblinded randomized controlled trial. Six social network groups (5 young, Black, sexual minority men + 1 Black woman) will participate in the intervention arm. These will be recruited through a network-based approach and will undergo tailored training (mobile-based and face-to-face) for app usage. At baseline, men will undergo HIV testing and both men and women will complete a sociodemographic survey. The groups in the intervention arm will engage in four 60-minute discussions led by Black women through the modified mobile health app. After the intervention, young, Black, sexual minority men will complete surveys electronically at 1 and 3 months (accompanied by HIV testing) on additional factors such as experiences of discrimination and PrEP stigma. The Black women will complete an electronic survey at 1 month, measuring feasibility and acceptability, and will participate in web-based qualitative interviews at 3 months to gain more knowledge on the PrEP US NoW facilitation process. Participants in the control arm will not engage in Black women-facilitated group discussions and will use a control version of the app. The baseline and follow-up surveys and HIV testing will be documented similarly to the intervention arm.

Results: Phase 1 (development) of PrEP US NoW research activities lasted from November 2019 to June 2024. Data collection for the phase 2 randomized controlled trial began in August 2024 and is expected to be completed in December 2025. The findings will capture the intervention's feasibility and acceptability and changes in PrEP uptake among young, Black, sexual minority men.

Conclusions: The development and pilot implementation trial of the PrEP US NoW intervention is thought to leverage essential social capital among young, Black, sexual minority men, which may promote engagement in PrEP care, thus decreasing the overall number of HIV diagnoses.

Trial registration: ClinicalTrials.gov NCT07024745; https://clinicaltrials.gov/study/NCT07024745.

International registered report identifier (irrid): DERR1-10.2196/66326.