Recruiting

PrEP Adherence

Sponsor:

The University of Texas Health Science Center, Houston

Code:

NCT06158607

Conditions

Substance Use

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

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

Standard of care treatment

Study Details

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

Conditions

Substance Use

Study ID

NCT06158607

Start date

Jun 7, 2022

Status verified date

Dec, 2024

Completion date

May 30, 2025

Anticipated

Primary completion date

May 30, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Enrollment

60 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Prevention

Interventions and Outcome Measures

Arms

experimental: Intervention

active comparator: Standard of care treatment

Interventions

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.

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 measure

  • PrEP uptake [ Time Frame: 12 weeks post intervention ]

Central Contacts and Locations

Central contacts

Angela Heads, PhD

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

Kaixuan An

(713) 486-2531Kaixuan.An@uth.tmc.edu

Locations

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

Recruiting

Houston, Texas, United States, 77054

Contacts

Angela Heads

7134862830Angela.M.Heads@uth.tmc.edu

Kaixuan An

(713) 486-2700Kaixuan.An@uth.tmc.edu

More Information

Sponsor

The University of Texas Health Science Center, Houston

Last update posted

Dec 30, 2024

Last verified

Dec, 2024

Keywords

  • Pre-Exposure Prophylaxis
  • Women
  • HIV Prevention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by The University of Texas Health Science Center, Houston on 2024-12-30.