Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks

HIV Infections Clinical Trial

Official title: Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks

Status Completed

Clinical Trial Summary

This study has two components. The first component is designed to assess and compare the awareness, attitudes and clinical eligibility of Pre-exposure Prophylaxis (PrEP) in criminal justice (CJ) involved women. The second component is designed to evaluate the acceptability and feasibility of strategically delivering PrEP to CJ involved women and their risk network members.

Clinical Trial Description

Risk networks can be leveraged to maximally disseminate effective interventions to women, including PrEP, and thereby potentially avert some of the 50,000 annual incident HIV infections in the U.S. Few studies to date have capitalized on risk networks as a way to identify and engage high-risk individuals, like CJ-involved women, who could markedly benefit from PrEP. This study advances the field by: 1) Using an innovative network-based framework (a non-traditional model of care delivery) to engage a high risk population in PrEP dissemination as HIV prevention; 2) Incorporating a syndemic approach to PrEP that addresses HIV prevention in the context of substance use, psychiatric comorbidities, IPV, and stigma; and 3) Recruiting, enrolling, and retaining high risk networks of CJ-involved women who are difficult to reach by other means. In doing so, this proposal addresses key funding priorities of the Gilead Investigator Sponsored Research program, which includes research on PrEP implementation targeted to high risk populations and delivered in non-traditional clinical settings. ;

Related Conditions & MeSH terms

• HIV Infections

• NCT number: NCT03293290
• Study type: Interventional
• Source: Yale University
• Status: Completed
• Phase: Phase 1
• Start date: December 11, 2017
• Completion date: May 15, 2020