RecruitingNot ApplicableNCT06558825

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

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

Sponsor

The University of Texas Health Science Center, Houston

Enrollment

60 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Substance Use

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

Sex: FEMALEMin Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a program to help women with trauma-related mental health conditions (like PTSD) learn about and start using PrEP — a daily medication that prevents HIV infection. It aims to improve HIV prevention in women who may be at higher risk. **You may be eligible if...** - You are a woman currently in mental health treatment with a history of trauma - You are HIV negative and sexually active with male partners in the past 6 months - You are not currently using PrEP and meet CDC criteria for needing HIV prevention - You are fluent in English and have regular access to a smartphone **You may NOT be eligible if...** - You are HIV positive - You are participating in another HIV prevention program - You have severe cognitive impairment or psychological distress that would prevent participation Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

BEHAVIORALIntegrated Intervention to Promote PrEP Uptake

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

OTHERStandard Treatment Condition

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

Locations(1)

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

Houston, Texas, United States

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NCT06558825

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