Yale Clinical and Community Research, 270 Congress Ave
New Haven, Connecticut, 06519, United States
NCT Number: NCT03293290
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.
Looking for future studies?
Notify Me18 year and older
Female
Interventional
Phase 1
New Haven, Connecticut, 06519, United States
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Eligible and enrolled women will then recruit risk network members through respondent driven sampling, using vouchers.
Risk network members must:
Exclusion criteria
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
Time frame: Month 1
# starting PrEP/ # enrolled subjects
Time frame: Month 1
# starting PrEP/ # eligible subjects
Time frame: 12 months
# PrEP pills taken/# PrEP pills prescribed per month
Time frame: 12 months
TDF level by dried blood spot testing
Time frame: 12 months
New HIV+ by 4th generation HIV Ag/Ab testing
Yale University
Other
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.
Published trials that share one or more normalized conditions with this study.
NCT05732675
Behavior, Bisexuality
Ho Chi Minh City, Vietnam
View Trial DetailsNCT07750834
Acquired Immunodeficiency Syndrome, Behavior
Khartoum, Omdurman, Sudan
View Trial DetailsNCT06012136
Acquired Immunodeficiency Syndrome, Blood-Borne Infections
Las Vegas, Nevada, United States
View Trial DetailsNCT04680390
Behavior, Blood-Borne Infections
San Francisco, California, United States
View Trial Details