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

Sponsor
Yale University (Other)
Overall Status
Completed
CT.gov ID
NCT03293290
Collaborator
(none)
105
Enrollment
1
Location
1
Arm
29.1
Actual Duration (Months)
3.6
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
Phase 1

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 Design

Study Type:
Interventional
Actual Enrollment :
105 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Prevention
Official Title:
Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks
Actual Study Start Date :
Dec 11, 2017
Actual Primary Completion Date :
May 15, 2020
Actual Study Completion Date :
May 15, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: PrEP

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

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.
Other Names:
  • TDF/FTC

    		•

    Outcome Measures

    Primary Outcome Measures

    1. % PrEP uptake [Month 1]

      # starting PrEP/ # enrolled subjects

    2. % eligible PrEP uptake [Month 1]

      # starting PrEP/ # eligible subjects

    Secondary Outcome Measures

    1. Mean % PrEP adherence [12 months]

      # PrEP pills taken/# PrEP pills prescribed per month

    2. Mean TDF level [12 months]

      TDF level by dried blood spot testing

    3. HIV incidence [12 months]

      New HIV+ by 4th generation HIV Ag/Ab testing

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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

    Exclusion Criteria:

    • They are unable or unwilling to provide informed consent.

    • Are threatening to staff.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Yale Clinical and Community Research, 270 Congress Ave New Haven Connecticut United States 06519

    Sponsors and Collaborators

    • Yale University

    Investigators

    • Principal Investigator: Jaimie Meyer, MD, MS, FACP, Yale University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Yale University
    ClinicalTrials.gov Identifier:
    NCT03293290
    Other Study ID Numbers:
    • 1606017882
    First Posted:
    Sep 26, 2017
    Last Update Posted:
    Jul 28, 2021
    Last Verified:
    Jul 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Product Manufactured in and Exported from the U.S.:
    Yes
    Keywords provided by Yale University
    HIV pre-exposure prophylaxis
    criminal justice
    women
    risk networks
    Additional relevant MeSH terms:
    HIV Infections

    Study Results

    No Results Posted as of Jul 28, 2021