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Completed

NCT Number: NCT03293290

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

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Phase 1

Primary location

Yale Clinical and Community Research, 270 Congress Ave

New Haven, Connecticut, 06519, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PrEP

Drug

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

Primary outcomes

  1. % PrEP uptake

    Time frame: Month 1

    # starting PrEP/ # enrolled subjects

  2. % eligible PrEP uptake

    Time frame: Month 1

    # starting PrEP/ # eligible subjects

Secondary outcomes

  1. Mean % PrEP adherence

    Time frame: 12 months

    # PrEP pills taken/# PrEP pills prescribed per month

  2. Mean TDF level

    Time frame: 12 months

    TDF level by dried blood spot testing

  3. HIV incidence

    Time frame: 12 months

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

Sponsors and collaborators

Lead sponsor

Yale University

Other

Registry information

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Sep 26, 2017
Registry last updated
Jul 28, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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