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

Phase 1

Completed

• Conditions: HIV Infections
• Interventions: Drug: PrEP

• Registration Number: NCT03293290
• Lead Sponsor: Yale University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2017-09-20
• Study First Submitted QC: 2017-09-20
• Study First Posted: 2017-09-26
• Study Start: 2017-12-11
• Primary Completion: 2020-05-15
• Study Completion: 2020-05-15
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-27
• Last Update Posted: 2021-07-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 105

Inclusion Criteria

• Index participants reside in, or planning to reside in New Haven or Hartford, Connecticut,.
• Criminal justice-involved (anticipate release or have been released from prison or jail within 6 months, and/or are under or anticipating transfer to correctional community supervision (i.e. probation or parole)).
• Self-reported HIV negative.

Eligible and enrolled women will then recruit risk network members through respondent driven sampling, using vouchers.

Risk network members must:

• have a unique and valid referral coupon (from Index participant).
• Reside or planning to reside in New Haven or Hartford, Connecticut.
• Self-reported HIV negative
• 18 years of age or older

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Exclusion Criteria

• They are unable or unwilling to provide informed consent.
• Are threatening to staff.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
PrEP	PrEP	For participants who are eligible for PrEP and willing to participate, subjects on PrEP will be followed for 1 year with quarterly assessments.

Primary Outcome Measures

Name	Time	Method
% PrEP uptake	Month 1	# starting PrEP/ # enrolled subjects
% eligible PrEP uptake	Month 1	# starting PrEP/ # eligible subjects

Secondary Outcome Measures

Name	Time	Method
Mean TDF level	12 months	TDF level by dried blood spot testing
Mean % PrEP adherence	12 months	# PrEP pills taken/# PrEP pills prescribed per month
HIV incidence	12 months	New HIV+ by 4th generation HIV Ag/Ab testing

Trial Locations

Locations (1)

Yale Clinical and Community Research, 270 Congress Ave; 🇺🇸 New Haven, Connecticut, United States