Clinical trial NCT03293290: Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks
Official title: Project EMPOWERING: Evidence-based PrEP for Justice-Involved Women and Their Risk Networks
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
Keywords: HIV pre-exposure prophylaxis
criminal justice
women
risk networks
Lead sponsor: Yale University
Sponsor class: OTHER
First posted: 2017-09-26
Enrollment: 105
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: PREVENTION

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.

Eligibility criteria: 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.

Primary outcomes:
measure: % PrEP uptake
timeFrame: Month 1
measure: % eligible PrEP uptake
timeFrame: Month 1
Secondary outcomes:
measure: Mean % PrEP adherence
timeFrame: 12 months
measure: Mean TDF level
timeFrame: 12 months
measure: HIV incidence
timeFrame: 12 months
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale Clinical and Community Research, 270 Congress Ave
state: Connecticut
Study officials:
affiliation: Yale University
name: Jaimie Meyer, MD, MS, FACP
role: PRINCIPAL_INVESTIGATOR
References:
citation: Meyer JP, Price CR, Ye Y, Qin Y, Tracey D, Demidont AC, Melbourne K, Altice FL. A PrEP Demonstration Project Using eHealth and Community Outreach to Justice-Involved Cisgender Women and Their Risk Networks. AIDS Behav. 2022 Dec;26(12):3807-3817. doi: 10.1007/s10461-022-03709-2. Epub 2022 Jun 7.