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

PHASE1CompletedINTERVENTIONAL
Enrollment

105

Participants

Timeline

Start Date

December 11, 2017

Primary Completion Date

May 15, 2020

Study Completion Date

May 15, 2020

Conditions
HIV Infections
Interventions
DRUG

PrEP

Subjects on PrEP will be followed for 1 year with quarterly assessments by trained research assistants. Study visits will take place at in New Haven and Hartford. At every scheduled visit, participants will receive a comprehensive package of preventive services, including a prescription for the next 30-day supply of TDF/FTC (with 2 refills), a symptom screen for acute HIV, risk-reduction counseling, PrEP adherence support, bleach for cleaning injection equipment, and condoms. HIV rapid testing with Orasure® will be performed quarterly; participants testing newly positive for HIV (representing seroconversions) will be followed with confirmatory testing and referred to care as needed.

Trial Locations (1)

06519

Yale Clinical and Community Research, 270 Congress Ave, New Haven

All Listed Sponsors
lead

Yale University

OTHER

NCT03293290 - Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks | Biotech Hunter | Biotech Hunter