A Phase 1 interventional study of PrEP in HIV Infections, sponsored by Yale University. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-07-28.
Sponsored by Yale University · Phase 1, Interventional, and Prevention
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.
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.
Eligible and enrolled women will then recruit risk network members through respondent driven sampling, using vouchers.
Risk network members must:
Exclusion Criteria:
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.
Also known as: TDF/FTC
% PrEP uptake
# starting PrEP/ # enrolled subjects
Time frame: Month 1
% eligible PrEP uptake
# starting PrEP/ # eligible subjects
Time frame: Month 1
Mean % PrEP adherence
# PrEP pills taken/# PrEP pills prescribed per month
Time frame: 12 months
Mean TDF level
TDF level by dried blood spot testing
Time frame: 12 months
HIV incidence
New HIV+ by 4th generation HIV Ag/Ab testing
Time frame: 12 months
This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Yale University