Status:
RECRUITING
Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders
Lead Sponsor:
The University of Texas Health Science Center, Houston
Conditions:
Substance Use
Eligibility:
FEMALE
18-60 years
Phase:
NA
Brief Summary
The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problemat...
Eligibility Criteria
Inclusion
- Black/African American and Hispanic/Latina cisgender women
- diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 criteria
- HIV negative
- sexually active with an opposite sex partner within the past 6 months
- not using PrEP for HIV prevention at the time of screening
- able to speak, read, and write in English; and
- own or have regular access to a smart phone.
Exclusion
- be concurrently participating in another SUD behavioral treatment program
- unable to provide informed consent for participation (e.g., have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy
- have psychological distress that would prohibit them from participating in the study
- be unable or unwilling to meet study requirements
- be ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk
- have medical contraindications for PrEP (e.g., known renal impairment which can be exacerbated by PrEP use).
Key Trial Info
Start Date :
June 7 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 30 2025
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT06158607
Start Date
June 7 2022
End Date
May 30 2025
Last Update
December 30 2024
Active Locations (1)
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1
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, Texas, United States, 77054