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NCT Number: NCT06558825

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

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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Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

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

Houston, Texas, 77054, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Integrated Intervention to Promote PrEP Uptake

Behavioral

Provision of PrEP information through 3 counseling sessions, prevention navigation, and nurse practitioner-prescribed PrEP in an addiction treatment setting.

Standard Treatment Condition

Other

Participants in trauma treatment will be given information and referral to a community partner who will evaluate them to determine if they could benefit from PrEP for HIV prevention

Primary outcomes

  1. Number of participants who uptake PrEP

    Time frame: 12 weeks post intervention

    PrEP uptake is defined as obtaining a prescription and taking the first dose.

Secondary outcomes

  1. Number of Participants who adhere to PrEP

    Time frame: 12 weeks post PrEP initiation

    PrEP adherence is lab confirmed and is defined as having adequate levels of tenofovir (TFV) (>1000ng/ml).

  2. PrEP adherence as assessed by proportion of videos uploaded

    Time frame: from the time of PrEP initiation to 12 weeks post PrEP initiation

    In the intervention arm, participants are asked to take a video of themselves taking PrEP. Videos are uploaded through an app, which is offered in the intervention arm only (and not the standard treatment arm). Data will be reported as the number of days a video is uploaded divided by the number of days of the intervention period.

  3. PrEP adherence as assessed by proportion of self-reported daily adherence

    Time frame: from the time of PrEP initiation to 12 weeks post PrEP initiation

    In both arms, participants are sent a questionnaires weekly in which they record the number of days they took PrEP over the past seven days. Data will be reported as the number of days PrEP is taken divided by the number of days of the intervention period.

  4. Intervention feasibility as assessed by number of participants enrolled

    Time frame: at the time of enrollment

    The number enrolled is the number of participants who signed the consent form.

  5. Intervention feasibility as assessed by number of sessions attended by participants

    Time frame: 15 weeks post enrollment

  6. Intervention feasibility as assessed by study retention

    Time frame: 15 weeks post enrollment

    Study retention is assessed by the the number of participants who completed the study.

  7. Intervention acceptability as assessed by score on a satisfaction questionnaire

    Time frame: 15 weeks post enrollment

    This is a 15 item questionnaire and each item is scored from 1 (not at all true) to 9 (absolutely true). Total score ranges from 15 to 135, with a higher score indicating greater satisfaction.

  8. Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale

    Time frame: baseline, 15 weeks post enrollment

    Total score ranges from 8 to 32, with a higher score indicating greater stigma.

  9. Change in perceived HIV risk as assessed by Perceived Risk of HIV Scale

    Time frame: baseline, 15 weeks post enrollment

    Total score ranges from 10 to 40, with a higher score indicating a greater perceived HIV risk.

  10. Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire

    Time frame: baseline, 15 weeks post enrollment

    Total score ranges from 0 to 6, with a higher score indicating a greater knowledge about PrEP.

  11. Change in PrEP attitudes as assessed by PrEP Attitudes Measure

    Time frame: baseline, 15 weeks post enrollment

    Total score ranges from 5.2 to 26, with a higher score indicating a better attitude toward PrEP.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Collaborators

  • National Institute on Drug Abuse (NIDA)

Registry information

Official study title

Development and Pilot Testing of a Mental Health Clinic-Based PrEP Uptake and Adherence Intervention for Women in Treatment for Trauma-Related Conditions

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 19, 2024
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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