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

Last updated: December 27, 2024
Sponsor: The University of Texas Health Science Center, Houston
Overall Status: Active - Recruiting

Phase

N/A

Condition

Stimulant Use Disorder

Opioid Use Disorder

Treatment

Integrated Intervention to Promote PrEP Uptake

Standard Treatment Condition

Clinical Study ID

NCT06558825
HSC-MS-21-0544
1R34DA055496-01
  • Ages > 18
  • Female

Study 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

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 andPrevention (CDC)-defined criteria for PrEP;

  • Fluent in English;

  • Own or have regular access to a smart phone.

Exclusion

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 thestudy;

  • Be unable or unwilling to meet study requirements.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Integrated Intervention to Promote PrEP Uptake
Phase:
Study Start date:
October 01, 2024
Estimated Completion Date:
June 30, 2025

Connect with a study center

  • Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston

    Houston, Texas 77054
    United States

    Active - Recruiting

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