Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders

Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders

The goal of this clinical trial is to test an addiction-clinic based behavioral intervention for increasing PrEP uptake and adherence among women who engage in high-risk sexual behaviors and problematic substance use. The main question it aims to answer is:

• If the integrated intervention increase PrEP uptake and adherence compared to standard treatment

Participants will

• receive provision of PrEP information through 4 counseling sessions
• prevention navigation
• receive nurse practitioner prescribed PrEP in an addiction treatment setting

Researchers will compare intervention group with standard treatment to see if the integrated intervention help increase PrEP uptake and adherence

Study Overview

• Status: Recruiting
• Conditions: Substance Use
• Intervention / Treatment: Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders; Other: Standard of care treatment

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

Contacts and Locations

• Study Contact: Name: Angela 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: Kaixuan An; Phone Number: (713) 486-2700; Email: Kaixuan.An@uth.tmc.edu
      • Contact: Angela Heads; Phone Number: 7134862830; Email: Angela.M.Heads@uth.tmc.edu

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Black/African American and Hispanic/Latina cisgender women
• diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 criteria
• 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
• able to speak, read, and write in English; and
• own or have regular access to a smart phone.

Exclusion Criteria:

• be concurrently participating in another SUD behavioral treatment program
• unable to provide informed consent for participation (e.g., 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
• be ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk
• have medical contraindications for PrEP (e.g., known renal impairment which can be exacerbated by PrEP use).

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: Intervention	Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders; Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting.
Active Comparator: Standard of care treatment	Other: Standard of care treatment; Participants in substance use 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
PrEP uptake	Filling the PrEP prescription and taking at least one dose of the medication by two weeks following their visit with the PrEP provider	12 weeks post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Daily PrEP adherence as assessed by the proportion of videos uploaded		12 weeks post PrEP initiation
Daily PrEP adherence as assessed by the proportion of self reported daily adherence		12 weeks post PrEP initiation
Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations	levels of tenofovir (TFV) urine concentrations (>1000ng/ml) detected in urine shows higher adherence	90 days post PrEP initiation
Enrollment rate as assessed by the number of participants that signed the consent form		12 weeks post intervention
Number of sessions attended by participants		12 weeks post enrollment
Study retention as assessed by the number of participants that completed the study		12 weeks post enrollment
Intervention acceptability as assessed by the Client satisfaction questionnaire	This is a 15 item questionnaire and each is cored from 1(not at all true)-9( absolutely true), higher number indicating more satisfaction	12 weeks post intervention

Collaborators and Investigators

• Sponsor: The University of Texas Health Science Center, Houston
• Investigators: Principal Investigator: Angela Heads, PhD, The University of Texas Health Science Center, Houston

Study record dates

Study Major Dates

• Study Start (Actual): June 7, 2022
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 30, 2025

Study Registration Dates

• First Submitted: November 27, 2023
• First Submitted That Met QC Criteria: November 27, 2023
• First Posted (Actual): December 6, 2023

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-21-0451

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