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

The University of Texas System (UT)

Status

Enrolling

Conditions

Substance Use

Treatments

Other: Standard Treatment Condition

Behavioral: Integrated Intervention to Promote PrEP Uptake

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT06558825

1R34DA055496-01 (U.S. NIH Grant/Contract)

HSC-MS-21-0544

Details and patient eligibility

About

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.