Behavioral intervention to improve PrEP adherence for women with substance use disorders

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.