Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders
- Conditions
- Substance Use
- Interventions
- Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use DisordersOther: Standard of care treatment
- Registration Number
- NCT06158607
- 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 problematic substance use. The main question it aims to answer is:
• If the integrated intervention increase PrEP uptake and adherence compared to standard treatment
Participants will
* receive provision of PrEP information through 4 counseling sessions
* prevention navigation
* receive nurse practitioner prescribed PrEP in an addiction treatment setting
Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 60
- 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.
- 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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders - Standard of care treatment Standard of care treatment -
- Primary Outcome Measures
Name Time Method PrEP uptake 12 weeks post intervention Filling the PrEP prescription and taking at least one dose of the medication by two weeks following their visit with the PrEP provider
- Secondary Outcome Measures
Name Time Method Daily PrEP adherence as assessed by the proportion of videos uploaded 12 weeks post PrEP initiation Study retention as assessed by the number of participants that completed the study 12 weeks post enrollment Intervention acceptability as assessed by the Client satisfaction questionnaire 12 weeks post intervention This is a 15 item questionnaire and each is cored from 1(not at all true)-9( absolutely true), higher number indicating more satisfaction
Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations 90 days post PrEP initiation levels of tenofovir (TFV) urine concentrations (\>1000ng/ml) detected in urine shows higher adherence
Daily PrEP adherence as assessed by the proportion of self reported daily adherence 12 weeks post PrEP initiation Enrollment rate as assessed by the number of participants that signed the consent form 12 weeks post intervention Number of sessions attended by participants 12 weeks post enrollment
Trial Locations
- Locations (1)
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
🇺🇸Houston, Texas, United States