Integrated Biomedical-Behavioral HIV Prevention for Women in Non-carceral Correctional Supervision Programs: A Hybrid Type II Trial of E-WORTH South in Alabama - PROJECT SUMMARY/ABSTRACT This study targets HIV prevention needs among women in non-carceral supervision programs (e.g., probation, parole, mandatory drug stays) through E-WORTH South, an evidence-based intervention tailored for the South. Black women in the U.S. South face HIV diagnosis rates thirteen times higher than their counterparts, with those under non-carceral supervision who use substances in Deep South states like Alabama experiencing significant overlapping challenges. This population represents 29.9% of Alabama's supervised population and 54% of those in drug court programs, despite comprising only 13.8% of the state's female population. Formative research revealed 37.5% report survival sex, 50% report condomless sex with unknown- status partners, none were unaware of biomedical prevention, 100% lacked trusted providers, and all used substances for coping with past adversity. E-WORTH South builds on E-WORTH, the only CDC-endorsed intervention targeting this population. The original E-WORTH demonstrated 54% lower odds of STI infection (OR=0.46) and 38% fewer condomless sex acts (IRR=0.62) but was developed in New York City. E-WORTH South maintains evidence-based fidelity while adapting to Deep South contexts, addressing criminal legal system involvement, geographic challenges, and their intersection. The intervention incorporates Deep South- specific challenges including medical mistrust and transportation obstacles, biomedical prevention via injectable PrEP (cabotegravir), DoxyPEP, and linkage to community prescribers. This hybrid Type II randomized controlled trial will evaluate E-WORTH South among 230 women aged 18-65 under non-carceral supervision across two Alabama counties representing diverse urban and rural/urban contexts. Co-primary outcomes assessed at 6 months: (1) PrEP uptake, verified through medical record review and self-reported survey data; and (2) condomless sex reduction, measured as frequency of condomless vaginal and anal sex acts in the past 90 days. Secondary/exploratory outcomes include substance use reduction, PrEP persistence, HIV/STI testing, healthcare engagement, and provider trust at 6 and 12 months. All sites receive Implementation Facilitation using an internal facilitator model. Implementation outcomes assessed via RE-AIM and CFIR identify site-level predictors of implementation success and assess whether facilitation reduces differences between high- and low-capacity sites. Economic evaluation includes microcosting and budget impact analysis to inform real-world scaling. Each HIV case prevented saves an estimated $420,000 in lifetime treatment costs. This hybrid Type II design evaluates clinical effectiveness (Aim 1: RCT), implementation processes (Aim 2: facilitation strategy, predictors, differences), and cost-effectiveness (Aim 3: micro-costing, budget impact), providing evidence for real-world translation. Findings will inform strategies for scaling HIV prevention interventions among women in criminal legal system settings nationally, addressing NIDA- highlighted topics for pragmatic HIV implementation science.
