Intervention to help women with trauma-related conditions use HIV prevention medication
Development and Pilot Testing of a Mental Health Clinic-Based PrEP Uptake and Adherence Intervention for Women in Treatment for Trauma-Related Conditions
This study is testing a new program to help women dealing with trauma feel more comfortable using HIV prevention medication called PrEP while they receive mental health treatment.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | The University of Texas Health Science Center, Houston Academic / other |
| Locations | 1 site (Houston, Texas) |
| Trial ID | NCT06558825 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are cisgender women currently receiving mental health treatment, have a history of trauma, and are at risk for HIV.
Not a fit: Patients who are HIV positive or currently participating in another HIV prevention program may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly improve HIV prevention among women with trauma-related conditions.
How similar studies have performed: Other studies have shown promise in using integrated interventions for HIV prevention, suggesting potential success for this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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 M 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.