Intervention to help women with trauma-related conditions use HIV prevention medication

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 study evaluates an integrated bio-behavioral intervention designed to enhance the uptake and adherence of Pre-Exposure Prophylaxis (PrEP) among cisgender women undergoing treatment for trauma-related mental health conditions. The intervention is implemented within a mental health treatment setting and focuses on providing knowledge, behavioral skills, and motivation to engage with PrEP care. The study aims to assess the feasibility, acceptability, and preliminary efficacy of this intervention compared to standard treatment, with the hypothesis that it will lead to higher PrEP uptake and adherence rates.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Currently undergoing mental health treatment;
* Have a history of trauma;
* 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;
* Eligible for PrEP based on having at least one Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP;
* Fluent in English;
* Own or have regular access to a smart phone.

Exclusion Criteria:

* HIV positive;
* Concurrently participating in another HIV prevention program;
* 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.

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 M 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.