Sexual Health

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.

TL;DR

PrEP US NoW is an mHealth app-based social capital intervention designed to improve PrEP uptake among young, Black, sexual minority men by engaging their social networks through Black female facilitators, with a pilot randomized controlled trial ongoing through December 2025.

Key Findings

Black Americans, particularly young, Black, sexual minority men in the Southern United States, experience disproportionately high HIV rates and are less likely to receive state-of-the-art interventions such as PrEP.

  • The disparity in HIV burden is described as 'more profound in the Southern United States'
  • Young, Black, sexual minority men are identified as having 'the highest rates' of HIV in the region
  • This population is 'less likely to receive state-of-the-art interventions such as pre-exposure prophylaxis (PrEP)'
  • Individual-level interventions are noted to often fail to leverage the significant effects of social networks on HIV prevention attitudes and behaviors

The PrEP US NoW intervention was designed to engage young, Black, sexual minority men's social networks through Black female facilitators to enhance social capital and increase PrEP uptake.

  • Intervention capitalizes on the influence of Black women in the social networks of young, Black, sexual minority men
  • The approach involves 'supportive Black female facilitators' leading group discussions
  • The intervention is built on enhancing 'social capital bonds' identified through qualitative research with young, Black, sexual minority men and Black women
  • An existing, evidence-based mobile health app was adapted to create the PrEP US NoW platform

The intervention development phase (Phase 1) involved qualitative data collection to identify core health-promoting elements of social capital, which was used to adapt an existing mHealth app.

  • Phase 1 research activities lasted from November 2019 to June 2024
  • Qualitative information was captured from young, Black, sexual minority men and Black women in existing social support networks
  • The information was applied to adapt 'an existing, evidence-based mobile health app'
  • This qualitative foundation informed the tailoring of the intervention content

The pilot randomized controlled trial (Phase 2) uses a network-based recruitment approach with social network groups comprising five young, Black, sexual minority men and one Black woman each.

  • Six social network groups are planned for the intervention arm, each consisting of '5 young, Black, sexual minority men + 1 Black woman'
  • Participants will be recruited through a 'network-based approach'
  • The trial is unblinded
  • Data collection began in August 2024 and is expected to be completed in December 2025
  • ClinicalTrials.gov identifier: NCT07024745

The intervention arm involves four 60-minute group discussions led by Black women through the modified mHealth app, supplemented by both mobile-based and face-to-face training.

  • Groups engage in 'four 60-minute discussions led by Black women through the modified mobile health app'
  • Participants undergo 'tailored training (mobile-based and face-to-face) for app usage'
  • Participants in the control arm use a control version of the app without Black women-facilitated group discussions
  • Both arms have identical baseline and follow-up survey and HIV testing procedures

Young, Black, sexual minority men in both arms undergo HIV testing and complete surveys at baseline, 1 month, and 3 months, measuring PrEP uptake, discrimination experiences, and PrEP stigma.

  • HIV testing is conducted at baseline, 1 month, and 3 months for young, Black, sexual minority men
  • Follow-up surveys measure 'experiences of discrimination and PrEP stigma' among other factors
  • Surveys are completed electronically at 1 and 3 months post-intervention
  • A sociodemographic survey is completed by both men and women at baseline

Black women facilitators complete a feasibility and acceptability survey at 1 month and participate in web-based qualitative interviews at 3 months to assess the facilitation process.

  • Black women complete 'an electronic survey at 1 month, measuring feasibility and acceptability'
  • Web-based qualitative interviews with Black women are conducted at 3 months
  • These qualitative interviews aim to 'gain more knowledge on the PrEP US NoW facilitation process'
  • Feasibility and acceptability are listed as primary pilot outcomes alongside changes in PrEP uptake

The PrEP US NoW intervention is hypothesized to leverage social capital among young, Black, sexual minority men to promote PrEP care engagement and decrease HIV diagnoses.

  • The intervention is 'thought to leverage essential social capital among young, Black, sexual minority men'
  • Anticipated outcome is that enhanced social capital 'may promote engagement in PrEP care'
  • The ultimate goal is 'decreasing the overall number of HIV diagnoses'
  • Findings will capture 'the intervention's feasibility and acceptability and changes in PrEP uptake'

What This Means

This research describes the design and protocol of a study called PrEP US NoW, which aims to increase the use of HIV prevention medication (PrEP) among young, Black, gay and bisexual men in the Southern United States — a group that faces some of the highest rates of HIV infection in the country but is less likely to use available prevention tools. Rather than focusing solely on individuals, the intervention leverages social networks by involving Black women who are already part of these men's support systems. These women are trained to lead group conversations through a smartphone app, with the goal of building 'social capital' — the trust, support, and shared resources within a community — that may help men engage with HIV prevention services. The study has two phases: a development phase (completed from 2019 to 2024) in which researchers gathered qualitative insights from both young Black men and Black women to understand what makes social networks health-promoting, and an ongoing pilot clinical trial (started August 2024, expected to end December 2025) that tests the app-based intervention in small social network groups. Each group includes five young, Black, sexual minority men and one Black woman facilitator. Men in the intervention arm participate in four one-hour facilitated discussions via the app and are tested for HIV and surveyed at the start and at one and three months later. A control group uses a basic version of the app without the facilitated discussions. This research suggests that addressing HIV prevention through the lens of community and social relationships — rather than only individual behavior — may be a promising approach for populations where social networks play an influential role in health decisions. The study's results will provide early evidence on whether this type of social network-based, app-delivered intervention is feasible, acceptable, and capable of increasing PrEP uptake, which could inform the design of larger trials and future HIV prevention programs targeting Black communities in the South.

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Citation

Sohail M, Hussen S, Dougherty Sheff S, Mugavero M, Schneider J, Hightow-Weidman L, et al.. (2025). 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.. JMIR research protocols. https://doi.org/10.2196/66326