Clinical trial NCT06158607: Pre-exposure Prophylaxis (PrEP) Adherence Intervention for Women with Substance Use Disorders
Official title: Development and Pilot Testing of an Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Substance Use
Keywords: Pre-Exposure Prophylaxis
Women
HIV Prevention
Lead sponsor: The University of Texas Health Science Center, Houston
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 60
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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


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).

Primary outcomes:
measure: PrEP uptake
timeFrame: 12 weeks post intervention
Secondary outcomes:
measure: Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations
timeFrame: 90 days post PrEP initiation
measure: Daily PrEP adherence as assessed by the proportion of videos uploaded
timeFrame: 12 weeks post PrEP initiation
measure: Daily PrEP adherence as assessed by the proportion of self reported daily adherence
timeFrame: 12 weeks post PrEP initiation
measure: Enrollment rate as assessed by the number of participants that signed the consent form
timeFrame: 12 weeks post intervention
measure: Number of sessions attended by participants
timeFrame: 12 weeks post enrollment
measure: Study retention as assessed by the number of participants that completed the study
timeFrame: 12 weeks post enrollment
measure: Intervention acceptability as assessed by the Client satisfaction questionnaire
timeFrame: 12 weeks post intervention
Other outcomes:
Locations:
city: Houston
country: United States
facility: Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston
state: Texas
Study officials:
affiliation: The University of Texas Health Science Center, Houston
name: Angela Heads, PhD
role: PRINCIPAL_INVESTIGATOR
References: