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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT03293290
Recruitment Status : Completed
First Posted : September 26, 2017
Last Update Posted : July 28, 2021
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
HIV Infections Drug: PrEP 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.

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Study Type : Interventional  (Clinical Trial)
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 : December 11, 2017
Actual Primary Completion Date : May 15, 2020
Actual Study Completion Date : May 15, 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: HIV/AIDS

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 Name: TDF/FTC

Primary Outcome Measures :
  1. % PrEP uptake [ Time Frame: Month 1 ]
    # starting PrEP/ # enrolled subjects

  2. % eligible PrEP uptake [ Time Frame: Month 1 ]
    # starting PrEP/ # eligible subjects

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Cis- or trans- female participants are eligible.
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03293290

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United States, Connecticut
Yale Clinical and Community Research, 270 Congress Ave
New Haven, Connecticut, United States, 06519
Sponsors and Collaborators
Yale University
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Principal Investigator: Jaimie Meyer, MD, MS, FACP Yale University
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Responsible Party: Yale University Identifier: NCT03293290    
Other Study ID Numbers: 1606017882
First Posted: September 26, 2017    Key Record Dates
Last Update Posted: July 28, 2021
Last Verified: July 2021

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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
risk networks
Additional relevant MeSH terms:
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HIV Infections
Blood-Borne Infections
Communicable Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Immunologic Deficiency Syndromes
Immune System Diseases