Status:
ACTIVE_NOT_RECRUITING
Trauma Intervention to Optimize PrEP Among Women Who Inject Drugs
Lead Sponsor:
Drexel University
Collaborating Sponsors:
National Institute on Drug Abuse (NIDA)
Conditions:
HIV Infections
Opioid Use
Eligibility:
FEMALE
18+ years
Phase:
NA
Brief Summary
The goal of this randomized controlled trial is to test the effectiveness of "TIARAS," a trauma intervention designed to reduce HIV acquisition risk among women who inject drugs (WWID). To be eligible...
Detailed Description
In the United States, recent outbreaks coast-to-coast forewarn of a possible resurgence of HIV, especially among women who inject drugs (WWID), particularly if access, uptake, and adherence to effecti...
Eligibility Criteria
Inclusion
- a) HIV-negative cisgender female, b) age ≥ 18 years, c) speaks/reads English d) reporting past 6 months day non-prescription injection drug use and any of the following: NEW PrEP PATIENT: prescribed daily oral or injectable PrEP at Prevention Point Philadelphia or Courage Medicine within 30 days. For injectable PrEP, they will be considered new if they have received a prescription but are within two weeks of receiving their first injection. or NON-ADHERENT DAILY ORAL PrEP PATIENT: initiated PrEP at Prevention Point Philadelphia or Courage Medicine 30 or more days ago who reports any non-adherence or reports consistent adherence but has PrEP-related drug levels indicating non-adherence (verified with urine-based tenofovir testing) or NON-ADHERENT INJECTABLE PrEP PATIENT: initiated injectable PrEP at Prevention Point Philadelphia or Courage Medicine but is 8 or more days late to receive their next injection (verified in participant's electronic medical record)
Exclusion
- a) Unable to provide informed consent; b); unwilling or unable to return to the SSP daily for the next 90 days; c) unwilling to provide specimen for PrEP-related clinical monitoring and adherence monitoring; d) pregnant.
Key Trial Info
Start Date :
June 17 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 31 2026
Estimated Enrollment :
219 Patients enrolled
Trial Details
Trial ID
NCT05192434
Start Date
June 17 2022
End Date
December 31 2026
Last Update
December 23 2025
Active Locations (1)
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1
Prevention Point Philadelphia
Philadelphia, Pennsylvania, United States, 19143