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Purpose

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

Condition

Eligibility

Eligible Ages
Between 18 Years and 60 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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

Phase
N/A
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Prevention
Masking
Single (Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
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.
Active Comparator
Standard of care treatment
  • 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

Recruiting Locations

Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
Houston, Texas 77054
Contact:
Angela Heads
713-486-2830
Angela.M.Heads@uth.tmc.edu

More Details

Status
Recruiting
Sponsor
The University of Texas Health Science Center, Houston

Study Contact

Angela Heads, PhD
(713) 486-2830
Angela.M.Heads@uth.tmc.edu

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.