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.

Effectiveness of a Couple-Based HIV and Sexually Transmitted Infection Prevention Intervention for Men in Community Supervision Programs and Their Female Sexual Partners: A Randomized Clinical Trial.

Importance: In the United States, the prevalence rates of HIV and sexually transmitted infections (STIs) are higher among individuals in community supervision programs (CSPs) than in the general population. However, to date, no couple-based HIV or STI prevention interventions have been implemented for the large number of men in CSPs. Objective: To determine the effectiveness of a 5-session couple-based prevention intervention, compared with a 1-session counseling, testing, and referral (CTR) program, in reducing HIV and STIs as well as condomless intercourse among men in CSPs and their female sexual partners. Design, Setting, and Participants: A randomized clinical trial was conducted from July 11, 2013 (first recruitment), through May 17, 2016 (last randomization). Participants were drug-involved men mandated to a CSP and their female sexual partners (n = 230 couples or 460 individuals). Participants were recruited from various CSP sites in New York, New York, and randomized into either the PACT (Protect and Connect) intervention condition or the HIV CTR control condition (n = 115 couples or 230 individuals in each arm). Analysis of behavioral outcomes used an intent-to-treat approach. Statistical analyses were conducted from November 1, 2017, through June 1, 2018. Main Outcomes and Measures: Self-reported data on sexual behaviors in the past 90 days were used to assess behavioral outcomes at all time points. Biomarkers were collected at baseline and 12 months, and behavioral outcomes were collected at baseline and 3, 6, and 12 months. Results: A total of 230 couples (460 individuals) were included. The mean (SD) age of participants was 35.0 (12.8) years, and most participants (341 [74.1%]) self-identified as black or African American race/ethnicity. Of the 18 new cases of STIs identified at the 12-month assessment, 10 came from the PACT arm and 8 from the HIV CTR control arm. Compared with the control participants, PACT participants had 33% fewer acts of condomless vaginal and/or anal intercourse with their main partner (incidence rate ratio [IRR], 0.67; 95% CI, 0.45-0.99; P = .04), 70% fewer acts with other partners (IRR, 0.30; 95% CI, 0.12-0.74; P = .009), and 40% fewer acts with all sexual partners (IRR, 0.60; 95% CI, 0.42-0.85; P = .005) over the entire follow-up period. In addition, PACT participants were less likely to report being under the influence of drugs or alcohol the last time they had vaginal and/or anal intercourse with their study partners (odds ratio, 0.55; 95% CI, 0.31-0.96; P = .04) and had 26% fewer sexual partners in the past 90 days (IRR, 0.74; 95% CI, 0.61-0.88; P = .001). At 12 months, HIV and STI incidence did not differ significantly between the 2 arms. Conclusions and Relevance: The PACT intervention appeared to reduce risky sexual behaviors, such as condomless intercourse; this finding suggests that a couple-based HIV and STI prevention intervention program may curb the burgeoning HIV epidemic in CSPs. Clinical Trial Registration: ClinicalTrials.gov identifier: NCT01690494.