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

Status: Recruiting
Location: See location...
Intervention Type: Other, Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: Female
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
Texas
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
RECRUITING
Houston
Contact Information
Primary
Angela M Heads, PhD
Angela.M.Heads@uth.tmc.edu
(713) 486-2830
Backup
Kaixuan An
Kaixuan.An@uth.tmc.edu
(713) 486-2531
Time Frame
Start Date: 2024-10-01
Estimated Completion Date: 2025-06-30
Participants
Target number of participants: 60
Treatments
Experimental: Integrated Intervention to Promote PrEP Uptake
Active_comparator: Standard Treatment Condition
Related Therapeutic Areas
Sponsors
Collaborators: National Institute on Drug Abuse (NIDA)
Leads: The University of Texas Health Science Center, Houston

This content was sourced from clinicaltrials.gov