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

NCT06158607 | Recruiting

• 1 other identifier: HSC-MS-21-0451
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Substance Use

Keywords

Pre-Exposure Prophylaxis; Women; HIV Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations

  90 days post PrEP initiation

• 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

• 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 Arms (2)

Intervention

EXPERIMENTAL

Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders

Standard of care treatment

ACTIVE COMPARATOR

Other: Standard of care treatment

Interventions

Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders BEHAVIORAL

Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting.

Intervention

Standard of care treatment OTHER

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

Standard of care treatment

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• The University of Texas Health Science Center, Houston: lead

Study Sites (1)

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

Houston, Texas, 77054, United States

RECRUITING

Related Publications (1)

• Heads AM, Santa Maria D, Hill MJ, Suchting R, Evans KN, Gaul Z, Yammine L, de Dios C, Schmitz JM. Development and Pilot Testing of an Addiction Clinic-Based Pre-Exposure Prophylaxis Uptake and Adherence Intervention for Women with Substance Use Disorders: Protocol for a Pilot Randomized Trial. JMIR Res Protoc. 2025 May 23;14:e64961. doi: 10.2196/64961.

  PMID: 40409752 DERIVED

MeSH Terms

Conditions

Substance-Related Disorders

Condition Hierarchy (Ancestors)

Chemically-Induced Disorders; Mental Disorders

Study Officials

• Angela Heads, PhD

  The University of Texas Health Science Center, Houston

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Angela Heads, PhD

CONTACT

(713) 486-2830; Angela.M.Heads@uth.tmc.edu

Kaixuan An

CONTACT

(713) 486-2531; Kaixuan.An@uth.tmc.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: November 27, 2023
• First Posted: December 6, 2023
• Study Start: June 7, 2022
• Primary Completion: May 30, 2025
• Study Completion: May 30, 2025
• Last Updated: December 30, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)