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 US at-risk populations

Duke University, Durham NC

Investigators

Abstract

HIV disproportionately affects people living in the United States southeast threatening progress toward the Ending the HIV Endemic initiative’s 2030 goals. Although Pre-exposure Prophylaxis (PrEP), an oral or injectable medication that if taken is highly effective in preventing HIV, at-risk people in the US southeast have not equitably benefited from its use due to multiple complex factors. For example, lack of awareness and knowledge to PrEP, not trusting PrEP, PrEP stigma, providers not knowing about or offering PrEP, accessibility, and cost. Thus, interventions that take into consideration the lived experiences and needs of this at-risk population are urgently needed to take a person in these geographic areas from medication precontemplation to uptake to maintenance. 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 people, consisting of a 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 (i.e., 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 share core concepts by telling the stories of at-risk people in the US southeast from various backgrounds and role-plays the PrEP decision-making process. Pilot research found UPDOs acceptable, improved PrEP trust, increased knowledge – for both PrEP aware and 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, we will track how many at-risk people 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, we will use a mixed methods approach guided by the Consolidated Framework for Implementation Research (CFIR).