RECRUITING

PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The US opioid overdose epidemic has been accompanied by an increase in human immunodeficiency (HIV) among persons who inject drugs. HIV pre-exposure prophylaxis (PrEP) is an FDA approved medication taken daily orally by individuals who are HIV negative, but who are at increased risk for HIV. In order to obtain PrEP, a prescription is needed. Before being prescribed HIV PrEP, it is recommended by the Centers for Disease Control and Prevention (CDC) to obtain an HIV test first. Although home HIV self-test kits are recommended by the CDC and are locally available, uptake remains low. CHORUS+ (Comprehensive HIV, Hepatitis C, and Opioid Use Disorder Response to the Unaddressed Syndemic +) is a theory-based, peer-delivered, mobile phone-supported intervention focused on enhancing uptake and adherence to HIV PrEP (primary outcome), and continuation of MOUD (secondary outcome) among persons who inject opioids. At recruitment, the intervention will include HIV self-testing, rapid initiation of PrEP and MOUD, and 6-month peer recovery coaching (PRC) to support adherence to these medications. This research study seeks to determine the efficacy of a novel intervention to increase the uptake of evidence-based measures to prevent HIV and treat opioid use disorder. The efficacy of this multi-site, two-arm randomized control trial of CHORUS+ and usual care \[passive referral\]. This study is not testing the efficacy of PrEP or HIV home testing which is already known. In addition the investigators will determine the influence of HIV self-testing on PrEP uptake and adherence. In the CHORUS+/ intervention arm, there will be a baseline in-person session with the participant to encourage uptake of PrEP and MOUD using motivational interviewing (MI).

Official Title

PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study

Quick Facts

Study Start:2024-12-19
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05769218

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Injected opioids within the past 6 months (by self-report)
  2. * Willingness to provide contact information for two family members or friends
  3. * Willingness to sign medical records release forms
  4. * Ability to speak English
  5. * Plans to reside in Boston area for the next 6 months
  1. * Individuals with HIV (self report)
  2. * Express desire to harm themselves or others
  3. * Individuals who are pregnant at baseline
  4. * Individuals who are already enrolled in an interventional study

Contacts and Locations

Study Contact

Sabrina A Assoumou, MD MPH
CONTACT
617-414-2857
sabrina.assoumou@bmc.org
Sarah Miller
CONTACT
617-414-2857
sarah.miller@bmc.org

Principal Investigator

Sabrina A Assoumou, MD MPH
PRINCIPAL_INVESTIGATOR
Boston Medical Center, Infectious Diseases

Study Locations (Sites)

Boston Medical Center Faster Paths Bridge Clinic
Boston, Massachusetts, 02118
United States
Victory Programs Mobile Prevention Services Van and Navigation Center
Boston, Massachusetts, 02118
United States

Collaborators and Investigators

Sponsor: Boston Medical Center

  • Sabrina A Assoumou, MD MPH, PRINCIPAL_INVESTIGATOR, Boston Medical Center, Infectious Diseases

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-12-19
Study Completion Date2026-06

Study Record Updates

Study Start Date2024-12-19
Study Completion Date2026-06

Terms related to this study

Keywords Provided by Researchers

  • Medication for opioid use disorder
  • Human immunodeficiency (HIV)
  • Pre-exposure prophylaxis (PrEP)
  • Peer recovery coaching (PRC)
  • Motivational interviewing (MI)
  • HIV self testing
  • People who inject opioids (PWIO)

Additional Relevant MeSH Terms

  • Opioid Use Disorder