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

The University of Texas Health Science Center, Houston1 site in 1 country60 target enrollmentOctober 1, 2024

ConditionsSubstance Use

Overview

Phase: N/A
Intervention: Not specified
Conditions: Substance Use
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 60
Locations: 1
Primary Endpoint: Number of participants who uptake PrEP
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

October 1, 2024

End Date

June 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Angela M Heads

Associate Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Number of participants who uptake PrEP

Time Frame: 12 weeks post intervention

PrEP uptake is defined as obtaining a prescription and taking the first dose.

Secondary Outcomes

Number of Participants who adhere to PrEP(12 weeks post PrEP initiation)
PrEP adherence as assessed by proportion of videos uploaded(from the time of PrEP initiation to 12 weeks post PrEP initiation)
Intervention feasibility as assessed by study retention(15 weeks post enrollment)
Intervention feasibility as assessed by number of participants enrolled(at the time of enrollment)
Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale(baseline, 15 weeks post enrollment)
PrEP adherence as assessed by proportion of self-reported daily adherence(from the time of PrEP initiation to 12 weeks post PrEP initiation)
Intervention feasibility as assessed by number of sessions attended by participants(15 weeks post enrollment)
Change in PrEP attitudes as assessed by PrEP Attitudes Measure(baseline, 15 weeks post enrollment)
Intervention acceptability as assessed by score on a satisfaction questionnaire(15 weeks post enrollment)
Change in perceived HIV risk as assessed by Perceived Risk of HIV Scale(baseline, 15 weeks post enrollment)
Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire(baseline, 15 weeks post enrollment)