Behavioral intervention to improve PrEP adherence for women with substance use disorders
Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
NA · The University of Texas Health Science Center, Houston · NCT06158607
This study is testing a new support program to help Black and Hispanic women with substance use issues take their PrEP medication more regularly and effectively.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Female |
| Sponsor | The University of Texas Health Science Center, Houston (other) |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06158607 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to evaluate a behavioral intervention designed to enhance the uptake and adherence of Pre-Exposure Prophylaxis (PrEP) among Black/African American and Hispanic/Latina women with substance use disorders. Participants will receive four counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP within an addiction treatment setting. The study will compare the effectiveness of this integrated intervention against standard treatment to determine its impact on PrEP adherence and uptake.
Who should consider this trial
Good fit: Ideal candidates for this study are Black/African American and Hispanic/Latina cisgender women who are HIV negative, diagnosed with a substance use disorder, and sexually active with an opposite sex partner.
Not a fit: Patients who are currently participating in another substance use disorder treatment program or are ineligible for PrEP based on CDC criteria may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve HIV prevention among women with substance use disorders.
How similar studies have performed: While there have been studies focusing on PrEP adherence, this specific integrated intervention approach targeting women with substance use disorders is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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).
Where this trial is running
Houston, Texas
- Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston — Houston, Texas, United States (RECRUITING)
Study contacts
- Principal investigator: Angela Heads, PhD — The University of Texas Health Science Center, Houston
- Study coordinator: Angela Heads, PhD
- Email: Angela.M.Heads@uth.tmc.edu
- Phone: (713) 486-2830
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Substance Use, Pre-Exposure Prophylaxis, Women, HIV Prevention