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Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders

RecruitingNAAges 18 Years - 60 YearsFemaleThe University of Texas Health Science Center, Ho…
NCT06158607 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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

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📋 Eligibility rules (as published)
Inclusion Criteria: * 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 Criteria: * 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).
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What it tests

  • Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
  • Standard of care treatment
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Where

1 site
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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