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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

Who can join

Ages 18 and older · Women

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.

About the study

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.

What is being tested

• Integrated Intervention to Promote PrEP Uptake (behavioral)
• Standard Treatment Condition (other)

Sponsor: The University of Texas Health Science Center, Houston · Participants: 60 · Started: Oct 1, 2024

Contact the study team

• Angela M Heads, PhD · Phone: (713) 486-2830
• Kaixuan An · Phone: (713) 486-2531

Official record on ClinicalTrials.gov — NCT06558825

Locations in the U.S.

Conditions

• Drug Use and Addiction

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.