Effectiveness of a Culturally Tailored HIV and Sexually Transmitted Infection Prevention Intervention for Black Women in Community Supervision Programs: A Randomized Clinical Trial.

Importance: Concentrated epidemics of HIV and sexually transmitted infections (STIs) have persisted among Black women in community supervision programs (CSPs) in the United States. Accumulating research has highlighted the effectiveness of culturally tailored HIV/STI interventions for Black women; however, there is a dearth of such interventions for the large number of Black women in CSPs. Objective: To determine the effectiveness of a 5-session culturally tailored group-based intervention (Empowering African-American Women on the Road to Health [E-WORTH]) with individualized computerized modules and streamlined HIV testing in reducing STIs and condomless sex vs a 1-session streamlined HIV testing control condition. Design, Setting, and Participants: This randomized clinical trial was conducted from November 18, 2015, (first recruitment) to August 20, 2019 (last 12-month follow-up). Black women mandated to probation, parole, or alternative-to-incarceration programs in New York City who had a history of drug use were recruited and randomized to receive either E-WORTH or a streamlined HIV testing control condition. Both conditions were delivered by Black female staff at a large CSP. The analysis took an intention-to-treat approach. Intervention: E-WORTH included a 1-hour individual HIV testing and orientation session and 4 weekly 90-minute group sessions. The control condition included one 30-minute session of HIV testing and information. Main Outcomes and Measures: Primary outcomes were incidence of any STI (biologically assayed chlamydia, gonorrhea, and Trichomonas vaginalis) at the 12-month assessment and the number of condomless acts of vaginal or anal intercourse in the past 90 days during the 12-month period. Results: A total of 352 participants who identified as Black or African American were enrolled, including 79 (22.5%) who also identified as Latinx. The mean (SD) age was 32.4 (11.0) years. A total of 172 participants (48.9%) were assigned to the E-WORTH condition, and 180 (51.1%) were assigned to the control condition. Compared with control participants, participants assigned to the E-WORTH condition had 54% lower odds of testing positive for any STI at the 12-month follow-up (odds ratio, 0.46; 95% CI, 0.25-0.88; P = .01) and reported 38% fewer acts of condomless vaginal or anal intercourse during the 12-month period (incidence rate ratio, 0.62; 95% CI, 0.39-0.97; P = .04). Conclusions and Relevance: The magnitudes of effects found across biological and behavioral outcomes in this randomized clinical trial indicate the feasibility and effectiveness of implementing E-WORTH in real-world CSPs. The findings lend further evidence to the promise of culturally tailored HIV/STI interventions for Black women. Trial Registration: ClinicalTrials.gov Identifier: NCT02391233.

The effectiveness of a group-based computerized HIV/STI prevention intervention for black women who use drugs in the criminal justice system: study protocol for E-WORTH (Empowering African-American Women on the Road to Health), a Hybrid Type 1 randomized controlled trial.

BACKGROUND: This paper describes the study protocol of a hybrid type I randomized controlled trial that evaluates the effectiveness and cost-effectiveness of implementing Empowering African-American Women on the Road to Health (E-WORTH), an Afrocentric, group-based, computerized human immunodeficiency virus (HIV)/sexually transmitted infection (STI) prevention intervention for controlled substance-using black women in community corrections settings in New York City. METHODS/DESIGN: We provide an overview of E-WORTH's hybrid type I design, which is guided by the Consolidated Framework for Implementation Research (CFIR). E-WORTH combines HIV/STI and intimate partner violence (IPV) prevention components and tests the comparative effectiveness of E-WORTH and streamlined HIV testing versus streamlined HIV testing alone in decreasing biologically confirmed HIV and STI incidence, sexual risk, and IPV, as well as in improving access to HIV and STI prevention services and care. DISCUSSION: This paper provides an overview of E-WORTH's intervention protocol and serves as a framework for using hybrid type I designs, guided by the CFIR conceptual framework, to evaluate HIV/STI and IPV prevention interventions in community corrections settings. We discuss how E-WORTH's hybrid type I design advances implementation science through its effectiveness and cost-effectiveness aims as well as through a mixed-methods study that evaluates multilevel theory-driven factors (structural, organizational, staffing, and client) guided by the CFIR that influences the implementation of E-WORTH in a criminal justice setting. This study also addresses the novel challenges and opportunities of implementing an intervention that targets specific racial subgroup(s) in a community corrections setting that services all populations, implementing a group-based intervention with technological components in such settings, and employing community-based participatory research strategies to guide recruitment and retention efforts. TRIAL REGISTRATION: ClinicalTrials.gov, NCT02391233 . Registered on 17 March 2015.