Development and feasibility testing of a PrEP uptake and adherence intervention for women with trauma-related mental health conditions: Protocol for a randomized controlled trial

Background Experiencing trauma increases susceptibility to HIV among women in the Southern U.S, through factors such as condomless sex, coerced sex, and substance use. Despite the effectiveness of pre-exposure prophylaxis (PrEP), uptake remains low due to various barriers such as low perceived risk, lack of awareness, perceived stigma, and systemic inequities. Tailored interventions are crucial for improving access to PrEP for this vulnerable population. Methods The purpose of the study is to develop an integrated mental health clinic-based behavioral intervention for increasing PrEP uptake and adherence among trauma-experienced women in the Southern US. It will also assess the feasibility, acceptability, and preliminary efficacy of the intervention. The primary aims are to (1) conduct qualitative interviews with 25 trauma-experienced women and 10 providers to explore their knowledge and attitudes about PrEP, to learn about provider practices related to HIV prevention, and to obtain feedback about the potential design of the intervention; (2) develop a mental health clinic-based behavioral PrEP uptake and adherence intervention guided by our findings from Aim 1 and the Information-Motivation-Behavioral Skills (IMB) model; and (3) test the preliminary efficacy, feasibility, and acceptability of the intervention using a randomized controlled trial with 60 women. Conclusions This intervention aims to address a critical gap in HIV prevention by targeting PrEP uptake and adherence among cisgender women with a history of trauma. The findings will inform future interventions designed for this population, promoting greater engagement in HIV prevention services. Trial registration This study is registered on ClinicalTrials.gov (NCT06558825).