NCT06158607Recruiting
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
Source: ClinicalTrials.gov · Last updated 30 Dec 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 27 Nov 2023
- Start date
- 7 Jun 2022
- Primary completion date
- 30 May 2025
- Lead sponsor
- The University of Texas Health Science Center, Houston
- Diseases
- HIV
- NCT number
- NCT06158607
What you commit to
- Study type: Interventional
- Planned participants: 60
- From 7 Jun 2022 to the primary completion date, 30 May 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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
- 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).
Other
- be concurrently participating in another SUD behavioral treatment program
- have psychological distress that would prohibit them from participating in the study
- be unable or unwilling to meet study requirements
Who the study is looking for
- 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.
Age in the registry: 18 years to 60 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston Coordinator of this site? Confirm its status | Houston | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.