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Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions

RecruitingNAAges 18 Years - anyFemaleThe University of Texas Health Science Center, Ho…
NCT06558825 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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.
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What it tests

  • Integrated Intervention to Promote PrEP Uptake
  • Standard Treatment Condition
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Where

1 site
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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