Actively Recruiting
Mental Health Clinic-Based Study to Promote PrEP Uptake and Adherence for Women with Trauma-Related Conditions at Risk for HIV
Led by The University of Texas Health Science Center, Houston · Updated on 2024-12-30
60
Participants Needed
1
Research Sites
38 weeks
Total Duration
On this page
Sponsors
T
The University of Texas Health Science Center, Houston
Lead Sponsor
N
National Institute on Drug Abuse (NIDA)
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating an intervention designed to increase the use and adherence to pre-exposure prophylaxis (PrEP) among cisgender women receiving treatment for trauma-related mental health conditions. These women are at higher risk for HIV infection, and the study aims to test whether this intervention is feasible, acceptable, and more effective than standard treatment in promoting PrEP uptake. The study focuses on women who are currently undergoing mental health treatment, have experienced trauma, and meet CDC criteria for PrEP eligibility. The intervention involves providing PrEP information through three counseling sessions, prevention navigation, and PrEP prescriptions by a nurse practitioner within an addiction treatment setting. Women receiving standard treatment will be given information and referrals to community partners who will evaluate their need for PrEP. The comparison between these two approaches will help determine the intervention's effectiveness in encouraging PrEP usage. Participants will be monitored for PrEP uptake 12 weeks after the intervention. To support participation, women must be fluent in English and have regular access to a smartphone. Researchers will assess feasibility, acceptability, and adherence through evaluations conducted within the mental health setting. Safety and participation requirements will be closely monitored throughout the study period.
CONDITIONS
Official Title
Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 CDC-defined criteria for PrEP
- Fluent in English
- Own or have regular access to a smart phone
You will not qualify if you...
- HIV positive
- Concurrently participating in another HIV prevention program
- Have severe cognitive impairment that interferes with consent, understanding study procedures or participating in therapy
- Have psychological distress that prohibits participation in the study
- Unable or unwilling to meet study requirements
AI-Screening
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Trial Site Locations
Total: 1 location
1
Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, Texas, United States, 77054
Actively Recruiting
Research Team
A
Angela M Heads, PhD
K
Kaixuan An
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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