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

Part of paid clinical trials in Houston, Texas.

Sponsor
The University of Texas Health Science Center, Houston
Study ID
NCT06558825
Status
Recruiting
Apply to this trial

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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

Study Details

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.

Key Dates

Start date
Oct 1, 2024
Status verified
Dec 2024
Primary completion
Mar 31, 2025
Completion
Jun 30, 2025

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Experimental: Integrated Intervention to Promote PrEP Uptake
  • Active Comparator: Standard Treatment Condition

Primary Outcome Measure

Number of participants who uptake PrEP [ Time Frame: 12 weeks post intervention ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at HoustonHoustonTexas77054
Angela Heads, PhD
[email protected]
(713) 486-2830
Louis A. Faillace, MD, Department of Psychiatry and Behavioral An, MA
[email protected]
(713) 486-2531

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By condition
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By specialty
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By research site
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston· Houston, TX

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