A Pilot Feasibility HIV prevention Study Linking Incarcerated Women to Post-Release Pre-exposure prophylaxis (PrEP) Services

ABSTRACT This application proposes to adapt a Formerly Incarcerated Transitions (FIT) program for mostly African American women, often with health disparities, who are released from incarceration and at high risk for HIV acquisition. We propose to refer eligible incarcerated women for HIV pre-exposure prophylaxis (PrEP), a highly

effective biomedical prevention strategy. Our novel HIV prevention program, FIT for PrEP (F4P), will leverage the infrastructure of a successful FIT program, revise and adapt it to link these at-risk women post- release to PrEP services with adjunctive social services. Guided by the 5-steps of the Centers for Disease Control and

Prevention’s ADAPT framework (Assess, Select, Prepare, Pilot, Implement), F4P is modified specifically to address the individual and structural barriers that women face during community re-entry preventing post- release PrEP use. Previously, we completed steps 1 (Assess the target population’s needs) and 2 (Select the

intervention to adapt). This application targets step 3 (Prepare) by pre-testing and refining the intervention to address the needs of the target population, and step 4 (Pilot) by testing the adapted intervention. We propose to refine our novel F4P program, which increases access to HIV PrEP to women experiencing incarceration

(WEI). Peer Community Health Workers (CHW) with incarceration histories will begin meeting with WEI before their release to provide PrEP education, needed social support, serve as role models, and link WEI to post- release health care including PrEP. CHW will also address WEI’s social determinants of health during the

community re-entry period. We will refine our novel F4P program based upon feedback from WEI, CHWs, and FIT clinicians using iterative Plan-Do-Study-Act (PDSA) cycles. We plan to randomize sixty WEI to either the F4P program or Stay Healthy cardiovascular prevention (attention) control arm and use quantitative

and qualitative approaches to assess the acceptability and feasibility of the F4P program. To gain preliminary evidence for efficacy, PrEP initiation will be compared between the two groups at week 12 in aim 3. In addition, the other PrEP care continuum steps will be measured to inform the future efficacy trial. The PI and Co-

I’s are experienced and have long-standing collaborations conducting research and implementing programs within the NC women’s prison, FIT programs and NC community health centers. This application is both innovative and highly significant because F4P expands the current HIV correctional prevention paradigm to

biomedical prevention (PrEP). F4P builds on the successful FIT model to target WEI, a high- risk yet understudied US population. It strives to reduce health disparities among a socially and economically marginalized group of African American women. The resulting data on F4P’s acceptability, feasibility, and

preliminary effect will inform a R01 application to evaluate the intervention’s efficacy in increasing WEI’s post- release PrEP adherence and retention in care.