RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

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

Quick Facts

Study Start:2022-06-07
Study Completion:2025-05-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06158607

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 60 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. * Black/African American and Hispanic/Latina cisgender women
  2. * diagnosed with a Substance use disorder (SUD) per Diagnostic and Statistical Manual of Mental Illnesses (DSM)-5 criteria
  3. * HIV negative
  4. * sexually active with an opposite sex partner within the past 6 months
  5. * not using PrEP for HIV prevention at the time of screening
  6. * able to speak, read, and write in English; and
  7. * own or have regular access to a smart phone.
  1. * be concurrently participating in another SUD behavioral treatment program
  2. * 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
  3. * have psychological distress that would prohibit them from participating in the study
  4. * be unable or unwilling to meet study requirements
  5. * be ineligible for PrEP based on Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP based on substance use and sexual risk
  6. * have medical contraindications for PrEP (e.g., known renal impairment which can be exacerbated by PrEP use).

Contacts and Locations

Study Contact

Angela Heads, PhD
CONTACT
(713) 486-2830
Angela.M.Heads@uth.tmc.edu
Kaixuan An
CONTACT
(713) 486-2531
Kaixuan.An@uth.tmc.edu

Principal Investigator

Angela Heads, PhD
PRINCIPAL_INVESTIGATOR
The University of Texas Health Science Center, Houston

Study Locations (Sites)

Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, Texas, 77054
United States

Collaborators and Investigators

Sponsor: The University of Texas Health Science Center, Houston

  • Angela Heads, PhD, PRINCIPAL_INVESTIGATOR, The University of Texas Health Science Center, Houston

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-06-07
Study Completion Date2025-05-30

Study Record Updates

Study Start Date2022-06-07
Study Completion Date2025-05-30

Terms related to this study

Keywords Provided by Researchers

  • Pre-Exposure Prophylaxis
  • Women
  • HIV Prevention

Additional Relevant MeSH Terms

  • Substance Use