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Recruiting NCT06158607

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

No phase Interventional Substance Use

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Addiction Clinic-Based PrEP Adherence Intervention for Women with Substance Use Disorders, Standard of care treatment.
Who it may be relevant to
Registry conditions: Substance Use. Basic parameters: 18 years — 60 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • 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

Primary outcome measures

  • PrEP uptake [Time frame: 12 weeks post intervention]
Secondary outcome measures (7)
  • Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations [Time frame: 90 days post PrEP initiation]
  • Daily PrEP adherence as assessed by the proportion of videos uploaded [Time frame: 12 weeks post PrEP initiation]
  • Daily PrEP adherence as assessed by the proportion of self reported daily adherence [Time frame: 12 weeks post PrEP initiation]
  • Enrollment rate as assessed by the number of participants that signed the consent form [Time frame: 12 weeks post intervention]
  • Number of sessions attended by participants [Time frame: 12 weeks post enrollment]
  • Study retention as assessed by the number of participants that completed the study [Time frame: 12 weeks post enrollment]
  • Intervention acceptability as assessed by the Client satisfaction questionnaire [Time frame: 12 weeks post intervention]

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).

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Prevention

Study locations

United States · 1 center
  • Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Tex — Houston

Publications

  • Heads AM, Santa Maria D, Hill MJ, Suchting R, Evans KN, Gaul Z, Yammine L, de Dios C, Schmitz JM. Development and Pilot Testing of an Addiction Clinic-Based Pre-Exposure Prophylaxis Uptake and Adherence Intervention for Women with Substance Use Disorders: Protocol for a Pilot Randomized Trial. JMIR Res Protoc. 2025 May 23;14:e64961. doi: 10.2196/64961. PMID 40409752

Identifiers

NCT: NCT06158607 · HSC-MS-21-0451

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗