NCT06558825 Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions
| NCT ID | NCT06558825 |
| Status | Recruiting |
| Phase | — |
| Sponsor | The University of Texas Health Science Center, Houston |
| Condition | Substance Use |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2024-10-01 |
| Primary Completion | 2025-03-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2024-10-01 with a primary completion date of 2025-03-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility 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.
Contact & Investigator
Angela Heads, PhD
PRINCIPAL INVESTIGATOR
The University of Texas Health Science Center, Houston
Frequently Asked Questions
Who can join the NCT06558825 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Substance Use. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06558825 currently recruiting?
Yes, NCT06558825 is actively recruiting participants. Contact the research team at Angela.M.Heads@uth.tmc.edu for enrollment information.
Where is the NCT06558825 trial being conducted?
This trial is being conducted at Houston, United States.
Who is sponsoring the NCT06558825 clinical trial?
NCT06558825 is sponsored by The University of Texas Health Science Center, Houston. The principal investigator is Angela Heads, PhD at The University of Texas Health Science Center, Houston. The trial plans to enroll 60 participants.