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

The University of Texas Health Science Center, Houston1 site in 1 country60 target enrollmentJune 7, 2022

ConditionsSubstance Use

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Substance Use
Sponsor: The University of Texas Health Science Center, Houston
Enrollment: 60
Locations: 1
Primary Endpoint: PrEP uptake
Status: Recruiting
Last Updated: last year

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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

Registry

clinicaltrials.gov

Start Date

June 7, 2022

End Date

May 30, 2025

Last Updated

last year

Study Type

Interventional

Study Design

Parallel

Sex

Female

Investigators

Sponsor

The University of Texas Health Science Center, Houston

Responsible Party

Principal Investigator

Angela M Heads

Associate Professor

The University of Texas Health Science Center, Houston

Eligibility Criteria

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).

Outcomes

Primary Outcomes

PrEP uptake

Time Frame: 12 weeks post intervention

Filling the PrEP prescription and taking at least one dose of the medication by two weeks following their visit with the PrEP provider

Secondary Outcomes

Daily PrEP adherence as assessed by the proportion of videos uploaded(12 weeks post PrEP initiation)
Study retention as assessed by the number of participants that completed the study(12 weeks post enrollment)
Intervention acceptability as assessed by the Client satisfaction questionnaire(12 weeks post intervention)
Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations(90 days post PrEP initiation)
Daily PrEP adherence as assessed by the proportion of self reported daily adherence(12 weeks post PrEP initiation)
Enrollment rate as assessed by the number of participants that signed the consent form(12 weeks post intervention)
Number of sessions attended by participants(12 weeks post enrollment)