Developing a Community Health Worker-delivered PrEP Decision Aid to Facilitate PrEP Initiation in Black Women Seeking HIV Testing Services in Eastern Virginia

/ABSTRACT Black women in the U.S. experience high HIV incidence, accounting for most new HIV diagnoses among all women. Prioritizing HIV prevention efforts to focus on populations impacted by HIV and dissemination of effective interventions are among the top national priorities for addressing HIV in the United States. Pre-exposure prophylaxis is an effective prevention strategy underutilized among Black women and requires innovative delivery approaches to optimize its benefits. Patient decision aids provide evidence-based information to assist patients in making a treatment choice. They are effective in improving patients’ health outcomes. However, they have not been widely used for HIV prevention. The proposed training plan in this Mentored Research Scientist Development Award (K01) application will provide the knowledge and skills for the principal investigator to launch an independent research career focused on translating evidence-based interventions into real-world settings. This proposed research aims to adapt a PrEP decision aid to be delivered by community health workers in HIV testing clinics and explore its preliminary impact in facilitating PrEP initiation among Black women in the U.S. South. HIV testing is the first step of PrEP initiation, and thus integrating PrEP decision aid into routine HIV testing and counseling has the potential to increase PrEP use among Black women. This K01 project includes in-depth qualitative interviews guided by a behavioral framework with Black women and community health workers to inform the adaptation of PrEP decision aid (AIM 1). The adapted PrEP decision aid and HIV testing intervention will be tested using a pilot Type 1 hybrid effectiveness randomized control trial design (n=108 Black women) at an HIV testing center in Eastern Virginia to assess its acceptability, feasibility, and fidelity as well as explore its preliminary effects on PrEP initiation (AIM 2). PrEP eligible Black women will be assessed at baseline and 3 months. Lastly, using a mixed-methods approach and guided by Consolidated Framework for Implementation Research, we will conduct a mixed-methods study with clinic staff (n=20) and a subset of Aim 2 participants (n=20 Black women) to identify factors influencing intervention implementation (AIM 3). Findings will inform a future large-scale hybrid type 2 randomized controlled trial to assess the effectiveness of the intervention. The training plan is built upon principal investigator’s research experience in HIV prevention. The principal investigator will receive training and mentored research experience in developing PrEP intervention for HIV prevention in women, implementation science, clinical trial design, and mixed methods research. The training will be acquired via one-on-one mentorship, formal coursework, workshop seminars, webinars, and attendance of conferences in areas relevant to this project. Project Number: 1K01MH136935-01A1 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: Sylvia Shangani | Institution: BOSTON UNIVERSITY MEDICAL CAMPUS, BOSTON, MA | Award Amount: $179,731 | Activity Code: K01 | Study Section: Special Emphasis Panel[ZRG1 CCHI-C (02)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11085327