A Pilot Feasibility Study to Integrate PrEP into Emergency Departments using Decision Support Tools

Ending the HIV epidemic in the United States will require innovative strategies focused on both HIV prevention and care. While pre-exposure prophylaxis (PrEP) is a highly effective biomedical intervention that can reduce HIV incidence, uptake has been modest, particularly among groups at highest risk for acquiring HIV (e.g., MSM, young people, racial/ethnic minorities, and women of color). Barriers to successful PrEP initiation include structural and individual-level issues as well as social determinants of health (SDoH). Innovative strategies are needed to improve PrEP awareness, access, and uptake in venues that routinely care for vulnerable patients. Emergency Departments (ED) serve as a safety net for underserved individuals that are unlikely to access or engage in routine health services. Efforts to scale-up PrEP and expand its reach have included ED-based PrEP prescribing, yet PrEP uptake, linkage to care and persistence have proven challenging. A focus on application of evidence-based interventions using implementation science (IS) to strengthen PrEP delivery in the ED and urgent cares (UC) to those who will benefit most has been limited to date. This project seeks to use established IS methods to develop, validate, and pilot test a patient-centered Decision Support Tool (DST) to promote PrEP persistence post ED/UC care. Based on the WHO SDoH framework, we seek to develop a DST that can be administered in ED/UC settings and will assist PrEP eligible persons to identify their HIV risk, promote self-efficacy, and provide support for SDoH needs identified through the tool. First, we will use pilot data, previously validated tools, and evidence from the ED PrEP implementation landscape to design a patient- centered PrEP DST using the Consolidated Framework for Implementation Research. We will then refine the DST using a participatory prototyping workshop engaging current, prior and potential PrEP users. The DST will be designed to optimize PrEP initiation, adherence and persistence post-ED/UC care by improving HIV risk assessment, self-efficacy, and by identifying and addressing the multifaceted medical and social needs of the individual patient. Next, we will determine the acceptability of the DST using the Normalization Process Theory across EDs and UCs in the DC-Baltimore region. Finally, we will conduct preliminary effectiveness testing of the DST among 120 PrEP eligible patients through a pilot implementation study at two EDs and one UC in Baltimore and DC comparing PrEP prescription only to PrEP and the DST. The primary outcome will be 4- month PrEP persistence; we will also measure PrEP linkage to care, initiation, persistence, and adherence at 1-week, 1- and 4-months using self-reported, clinical, and biological measures. This project aligns with NIH and EHE priorities as it seeks to improve the PrEP continuum of care in two urban areas with high HIV prevalence rates, reduce health inequities, and improve health outcomes. Implementation research will identify factors that support successful implementation with the goal of using these data to improve PrEP uptake, provide lessons learned, and seek to expand the program to other EDs both locally and nationally. Project Number: 1R34MH142244-01 | Fiscal Year: 2025 | NIH Institute/Center: National Institute of Mental Health (NIMH) | Principal Investigator: Amanda Castel (+1 co-PI) | Institution: GEORGE WASHINGTON UNIVERSITY, WASHINGTON, DC | Award Amount: $731,738 | Activity Code: R34 | Study Section: Population and Public Health Approaches to HIV/AIDS Study Section[PPAH] View on NIH RePORTER: https://reporter.nih.gov/project-details/11257372