RECRUITING

Pre-exposure Prophylaxis (PrEP) Uptake and Adherence Intervention for Women with Trauma-related Conditions

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 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.

Official Title

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

Quick Facts

Study Start:2024-10-01
Study Completion:2025-06-30
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06558825

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
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Currently undergoing mental health treatment;
  2. * Have a history of trauma;
  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. * Eligible for PrEP based on having at least one Centers for Disease Control and Prevention (CDC)-defined criteria for PrEP;
  7. * Fluent in English;
  8. * Own or have regular access to a smart phone.
  1. * HIV positive;
  2. * Concurrently participating in another HIV prevention program;
  3. * Have severe cognitive impairment that would interfere with their ability to consent, understand study procedures and/or effectively participate in therapy;
  4. * Have psychological distress that would prohibit them from participating in the study;
  5. * Be unable or unwilling to meet study requirements.

Contacts and Locations

Study Contact

Angela M 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 Date2024-10-01
Study Completion Date2025-06-30

Study Record Updates

Study Start Date2024-10-01
Study Completion Date2025-06-30

Terms related to this study

Keywords Provided by Researchers

  • Pre-Exposure Prophylaxis
  • Women
  • HIV Prevention

Additional Relevant MeSH Terms

  • Substance Use