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

Substance Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06158607
• Other study ID #: HSC-MS-21-0451
• Status: Recruiting
• Phase: N/A
• 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
• 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).

Related Conditions & MeSH terms

• Substance Use
• Substance-Related Disorders

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