An effectiveness trial of WINGS+PrEP: a syndemic mHealth intervention to increase PrEP uptake among women impacted by heavy alcohol use and partner violence in the criminal legal system

PROJECT SUMMARY The proposed hybrid type 1 Effectiveness and Implementation randomized controlled trial (RCT) will evaluate an m-Health syndemic intervention (WINGS+PrEP) that aims to increase HIV pre-exposure prophylaxis (PrEP) initiation and adherence among women in community supervision programs (CSPs) including probation, parole and alternative-to-incarceration (ATI) programs) in New York City (NYC) who report hazardous drinking. To date, very few PrEP interventions, have focused on cis-gender women, and none have targeted the large population of women in CSPs, who due to racialized drug laws, are disproportionately Black and Latinx. Advancing an effective PrEP intervention for women in CSPs holds promise for reducing HIV disparities by reaching a disproportionately large number of Black and Latinx women who remain at high risk for HIV. PrEP presents a unique opportunity for women to engage in a female-controlled HIV prevention strategy, which is vitally important within the context of hazardous drinking and violent partners. To date, however, there are no evidence-based syndemic-focused PrEP interventions for women that address hazardous drinking and IPV exposure. The proposed study intervention (WING+PrEP) is a 3-session syndemic focused intervention that combines an evidence-based mHealth Alcohol Screening, Brief Intervention and Referral to Treatment (SBIRT) tool, and an evidence-based mHealth IPV SBIRT tool - WINGS with an evidence-based PrEP intervention that includes a PrEP decision making aid with novel peer navigation and telemedicine components. The proposed RCT will be conducted with 300 women in CSPs Eligible women will be randomly assigned to: (1) WINGS+PrEP or (2) PrEP Alone that consists of the same evidence-based PrEP decision making aid single session with peer navigation. Both conditions will be delivered by Fortune Society a large community based organization that serves women in CSPs. Repeated assessments will occur at baseline and 3, 6, and 12-months post intervention. This study will be guided by the PRISM/RE-AIM(S) implementation science framework with a health equity lens and will examine how multilevel contextual factors may influence the reach, effectiveness, adoption, implementation, maintenance and sustainability (RE-AIMS) of WINGS+PrEP and PrEP and how these contextual factors and processes may interact to promote or impede health equity. If WINGS+PrEP is found to be effective, it's low threshold format is designed to be scaled up in CSP settings nationwide to curb HIV infection and to reduce HIV disparities among women from heavily impacted communities.