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

Last updated: December 27, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

N/A

Condition

Opioid Use Disorder

Stimulant Use Disorder

Treatment

Standard of care treatment

Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders

Clinical Study ID

NCT06158607
HSC-MS-21-0451
  • Ages 18-60
  • Female

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Black/African American and Hispanic/Latina cisgender women

  • diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manualof 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

Exclusion Criteria:

  • be concurrently participating in another SUD behavioral treatment program

  • unable to provide informed consent for participation (e.g., have severe cognitiveimpairment that would interfere with their ability to consent, understand studyprocedures 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 beexacerbated by PrEP use).

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Standard of care treatment
Phase:
Study Start date:
June 07, 2022
Estimated Completion Date:
May 30, 2025

Connect with a study center

  • Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston

    Houston, Texas 77054
    United States

    Active - Recruiting

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