Skip to main content
OpenTrials
Recruiting

NCT Number: NCT06158607

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

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

Recruiting

Interested in participating?

Request Info

Key information

Conditions

Substance Use Chemically-Induced Disorders Mental Disorders Substance-Related Disorders

Age range

18 year–60 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Louis A. Faillace, MD, Department of Psychiatry and Behavioral Sciences, University of Texas Health Science Center at Houston

Houston, Texas, 77054, United States

Location status: Recruiting

Location contact

Angela Heads

CONTACT

[email protected]

7134862830

Kaixuan An

CONTACT

[email protected]

(713) 486-2700

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

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

Behavioral

Provision of PrEP information through 4 counseling sessions, prevention navigation, and nurse practitioner prescribed PrEP in an addiction treatment setting.

Standard of Care Treatment

Other

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 outcomes

  1. 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

  1. Daily PrEP adherence as assessed by the levels of tenofovir (TFV) urine concentrations

    Time frame: 90 days post PrEP initiation

    levels of tenofovir (TFV) urine concentrations (>1000ng/ml) detected in urine shows higher adherence

  2. Daily PrEP adherence as assessed by the proportion of videos uploaded

    Time frame: 12 weeks post PrEP initiation

  3. Daily PrEP adherence as assessed by the proportion of self reported daily adherence

    Time frame: 12 weeks post PrEP initiation

  4. Enrollment rate as assessed by the number of participants that signed the consent form

    Time frame: 12 weeks post intervention

  5. Number of sessions attended by participants

    Time frame: 12 weeks post enrollment

  6. Study retention as assessed by the number of participants that completed the study

    Time frame: 12 weeks post enrollment

  7. Intervention acceptability as assessed by the Client satisfaction questionnaire

    Time frame: 12 weeks post intervention

    This is a 15 item questionnaire and each is cored from 1(not at all true)-9( absolutely true), higher number indicating more satisfaction

Study contacts

Contact information is provided by the study sponsor or research team.

Angela Heads, PhD

CONTACT

[email protected]

(713) 486-2830

Kaixuan An

CONTACT

[email protected]

(713) 486-2531

Sponsors and collaborators

Lead sponsor

The University of Texas Health Science Center, Houston

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Dec 6, 2023
Registry last updated
Dec 30, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.