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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06158607
Other study ID # HSC-MS-21-0451
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date June 7, 2022
Est. completion date May 30, 2025

Study information

Verified date November 2023
Source The University of Texas Health Science Center, Houston
Contact Angela Heads, PhD
Phone (713) 486-2830
Email Angela.M.Heads@uth.tmc.edu
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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


Recruitment information / eligibility

Status Recruiting
Enrollment 60
Est. completion date May 30, 2025
Est. primary completion date May 30, 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 60 Years
Eligibility 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 Design


Related Conditions & MeSH terms


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.
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

Locations

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

Sponsors (1)

Lead Sponsor Collaborator
The University of Texas Health Science Center, Houston

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Daily PrEP adherence as assessed by the proportion of videos uploaded 12 weeks post PrEP initiation
Secondary Daily PrEP adherence as assessed by the proportion of self reported daily adherence 12 weeks post PrEP initiation
Secondary 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
Secondary Enrollment rate as assessed by the number of participants that signed the consent form 12 weeks post intervention
Secondary Number of sessions attended by participants 12 weeks post enrollment
Secondary Study retention as assessed by the number of participants that completed the study 12 weeks post enrollment
Secondary 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
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