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

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.

Study Overview

• Status: Recruiting
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: Integrated Intervention to Promote PrEP Uptake; Other: Standard Treatment Condition

• Study Type: Interventional
• Enrollment (Estimated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela M Heads, PhD; Phone Number: (713) 486-2830; Email: Angela.M.Heads@uth.tmc.edu
• Study Contact Backup: Name: Kaixuan An; Phone Number: (713) 486-2531; Email: Kaixuan.An@uth.tmc.edu

Study Locations

• United States
  • Texas
    • Houston, Texas, United States, 77054
      • Recruiting
      • Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
      • Contact: Angela Heads, PhD; Phone Number: (713) 486-2830; Email: Angela.M.Heads@uth.tmc.edu
      • Contact: Louis A. Faillace, MD, Department of Psychiatry and Behavioral An, MA; Phone Number: (713) 486-2531; Email: Kaixuan.An@uth.tmc.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Integrated Intervention to Promote PrEP Uptake	Behavioral: Integrated 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.
Active Comparator: Standard Treatment Condition	Other: Standard 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who uptake PrEP	PrEP uptake is defined as obtaining a prescription and taking the first dose.	12 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Participants who adhere to PrEP	PrEP adherence is lab confirmed and is defined as having adequate levels of tenofovir (TFV) (>1000ng/ml).	12 weeks post PrEP initiation
PrEP adherence as assessed by proportion of videos uploaded	In the intervention arm, participants are asked to take a video of themselves taking PrEP. Videos are uploaded through an app, which is offered in the intervention arm only (and not the standard treatment arm). Data will be reported as the number of days a video is uploaded divided by the number of days of the intervention period.	from the time of PrEP initiation to 12 weeks post PrEP initiation
PrEP adherence as assessed by proportion of self-reported daily adherence	In both arms, participants are sent a questionnaires weekly in which they record the number of days they took PrEP over the past seven days. Data will be reported as the number of days PrEP is taken divided by the number of days of the intervention period.	from the time of PrEP initiation to 12 weeks post PrEP initiation
Intervention feasibility as assessed by number of participants enrolled	The number enrolled is the number of participants who signed the consent form.	at the time of enrollment
Intervention feasibility as assessed by number of sessions attended by participants		15 weeks post enrollment
Intervention feasibility as assessed by study retention	Study retention is assessed by the the number of participants who completed the study.	15 weeks post enrollment
Intervention acceptability as assessed by score on a satisfaction questionnaire	This is a 15 item questionnaire and each item is scored from 1 (not at all true) to 9 (absolutely true). Total score ranges from 15 to 135, with a higher score indicating greater satisfaction.	15 weeks post enrollment
Change in PrEP Anticipated Stigma as assessed by the PrEP Anticipated Stigma Scale	Total score ranges from 8 to 32, with a higher score indicating greater stigma.	baseline, 15 weeks post enrollment
Change in perceived HIV risk as assessed by Perceived Risk of HIV Scale	Total score ranges from 10 to 40, with a higher score indicating a greater perceived HIV risk.	baseline, 15 weeks post enrollment
Change in PrEP knowledge as assessed by PrEP Knowledge Questionnaire	Total score ranges from 0 to 6, with a higher score indicating a greater knowledge about PrEP.	baseline, 15 weeks post enrollment
Change in PrEP attitudes as assessed by PrEP Attitudes Measure	Total score ranges from 5.2 to 26, with a higher score indicating a better attitude toward PrEP.	baseline, 15 weeks post enrollment

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Collaborators: National Institute on Drug Abuse (NIDA)
• Investigators: Principal Investigator: Angela Heads, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2024
• Primary Completion (Estimated): March 31, 2025
• Study Completion (Estimated): June 30, 2025

Study Registration Dates

• First Submitted: August 14, 2024
• First Submitted That Met QC Criteria: August 14, 2024
• First Posted (Actual): August 19, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: December 27, 2024
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: Women; HIV Prevention; Pre-Exposure Prophylaxis
• Additional Relevant MeSH Terms: Mental Disorders; Chemically-Induced Disorders; Substance-Related Disorders
• Other Study ID Numbers: HSC-MS-21-0544; 1R34DA055496-01 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No