NCT06558825Recruiting
Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions
Development and Pilot Testing of a Mental Health Clinic-Based PrEP Uptake and Adherence Intervention for Women in Treatment for Trauma-Related Conditions
Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
The investigators have previously developed an integrated bio-behavioral intervention to promote PrEP uptake and adherence in cisgender women who are undergoing treatment for trauma-related mental health conditions and who are at a higher risk for HIV. The intervention is delivered within the mental health treatment setting and integrates knowledge, behavioral skills, and motivation to engage in and adhere to PrEP care. The purpose of this study is to assess the preliminary efficacy, feasibility, and acceptability of this intervention. The hypothesis is that, compared to standard treatment, the intervention will be feasible, acceptable, and associated with greater PrEP uptake and adherence.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 14 Aug 2024
- Start date
- 1 Oct 2024
- Primary completion date
- 31 Mar 2025
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Diseases
- HIV
- NCT number
- NCT06558825
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 1 Oct 2024 to the primary completion date, 31 Mar 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Other
- Have psychological distress that would prohibit them from participating in the study;
- Be unable or unwilling to meet study requirements.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
Related publications
- Development and feasibility testing of a PrEP uptake and adherence intervention for women with trauma-related mental health conditions: Protocol for a randomized controlled trial.Contemp Clin Trials Commun · 2026 · PMID 42200033
This page is information, not medical advice. Discuss any trial with your doctor.