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

The University of Texas System (UT)

Status: Enrolling

Conditions: Substance Use

Treatments: Other: Standard of care treatment; Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders

Study type: Interventional

Funder types: Other

Identifiers

NCT06158607

HSC-MS-21-0451

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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).

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups

Intervention

Experimental group

Treatment:

Behavioral: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders

Standard of care treatment

Active Comparator group

Treatment:

Other: Standard of care treatment