Cluster Randomized Controlled Trial of Using PrEP Doing It for Ourselves Protective Styles: A Multilevel Intervention to Improve HIV Testing and PrEP Uptake Among Southeastern U.S. At-risk Populations

HIV disproportionately affects people living in the United States Southeast, threatening progress toward the Ending the HIV Epidemic (EHE) initiative's 2030 goals. Therefore, interventions that consider the lived experiences and needs of this at-risk population are urgently needed to support individuals in these geographic areas from medication precontemplation to uptake to maintenance.

Under the leadership of the Principal Investigator and in partnership with communities, an established Community Advisory Council (CAC), an online telehealth platform (Q Care Plus), and beauty salon stylists, the research team co-developed Using PrEP, Doing it for Ourselves (UPDOs) Protective Styles, an e-Health intervention that strongly considers the unique needs of at-risk individuals. This intervention consists of training for stylists to become opinion leaders (trusted gatekeepers who share health information in the community) in HIV prevention (i.e., PrEP), and a 6-week web-based edutainment video series (six 20-minute episodes), structured debrief blogs, and telehealth service access. The CAC was invaluable in this development process, having collaborated with the research team across sexual health-based projects that informed and contributed to UPDOs preliminary research.

UPDOs web content shares core concepts by telling the stories of at-risk individuals in the US Southeast from various backgrounds and role-plays the PrEP decision-making process. Pilot research conducted by the research team found UPDOs acceptable, improved PrEP trust, increased knowledge-for both PrEP-aware and PrEP-unaware participants-and decreased perceptions of PrEP stigma within personal relationships. This proposed effectiveness-implementation type-I hybrid study will test UPDOs effectiveness in a larger, more geographically diverse sample using a cluster-randomized control trial and examine implementation determinants of UPDOs. In collaboration with Q Care Plus, a secure online platform to access telehealth services for home-delivered HIV testing and PrEP prescriptions, the research team will track how many at-risk individuals within counties of increased HIV infections reach out to a provider, get HIV testing, start PrEP, and maintain PrEP as prescribed.

A cohort of 32 beauty salons will be randomized to either an intervention group (n=16) or control group (n=16). Salons (1 salon = 1 cluster) will be randomized to UPDOs (edutainment videos + blogs + Q Care Plus) or usual care (CDC videos + website) conditions. Once salons are randomized, the recruitment and enrollment period of customers will occur over 24 months. Study participation will include data collection at baseline with follow-up measures at 6, 12, 24, 32, and 52 weeks. To assess implementation outcomes and context, the UPDOs Protective Styles research team will perform a mixed methods approach guided by the Consolidated Framework for Implementation Research (CFIR).

Although pre-exposure prophylaxis [PrEP] (an oral or injectable medication that is effective in preventing HIV) has been effective in decreasing HIV acquisition, PrEP uptake for increasingly at-risk populations in the US Southeast remains low. PrEP uptake is as low as 2% for some at-risk communities due to factors influencing decision-making to take PrEP, such as lack of awareness, distrust, stigma, and access. There is an urgent need to provide specific strategies to improve PrEP uptake in ways that are acceptable and feasible for individuals in the US Southeast. Engaging non-traditional settings, such as beauty salons, is one promising strategy. Additionally, engaging communities of interest is effective in reducing HIV for difficult-to-reach at-risk populations and should be prioritized.