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

March 31, 2026 updated by: Boston Medical Center

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).

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

284

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

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

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.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Injected opioids within the past 6 months (by self-report)
  • Willingness to provide contact information for two family members or friends
  • Willingness to sign medical records release forms
  • Ability to speak English
  • Plans to reside in Boston area for the next 6 months
  • Are medically cleared to take PrEP and MOUD (normal renal and PrEP-related labs)

Exclusion Criteria:

  • Persons with previous HIV diagnosis (by self-report; confirmed via HIV test result)
  • Express desire to harm themselves or others
  • Individuals who are pregnant at baseline
  • Individuals who are already enrolled in an interventional study

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CHORUS+
The baseline questionnaire for participants in this arm will be followed by a 30-minute motivational interviewing (MI) session with the peer recovery coach (PRC), and will assess readiness for change and provide information about PrEP. The PRC will also assess readiness for MOUD, and this will be further explored during subsequent visits.
Behavioral: CHORUS+
The CHORUS+ intervention will include a baseline interview with a peer recovery coach to encourage uptake of HIV PrEP (pre-exposure prophylaxis) and medications for opioid use disorder (MOUD) through motivational interviewing (MI). Participants will also be offered HIV self-testing on the day of recruitment, HIV PrEP (if they are HIV negative) and MOUD. Participants will then receive peer coaching for 6 months to increase adherence to PrEP and or MOUD.
Active Comparator: Usual care- control
Participants in this arm will receive passive referral for care. there will be no PRC MI session and they will not be offered PrEP or MOUD.
Other: Standard of care
Normal protocols for care of participants who inject opioids will be followed.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to HIV PrEP at 6 months Adherence to HIV PrEP
Time Frame: 6 months
This outcome will be assessed by the proportion of individuals who have dried blood spot tenofovir-diphosphate (TFV-DP) blood level 700 fmol/punch or greater at 6 months post-enrollment.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Adherence to PrEP at 3 and 12 months
Time Frame: 3 months. 12 months
Adherence will be assessed by self-report and chart review of active medication refills for PrEP and appointments attended.
3 months. 12 months
Receipt of medication for opioid use disorder (MOUD)
Time Frame: 3 months, 6 months, and 12 months
Receipts will be assessed by any of the following: (1) chart review of active medication refills for MOUD, (2) self-report, (3) urine toxicology results checked during study visit, and (4) chart review for appointments attended.
3 months, 6 months, and 12 months
Test results for gonorrhea
Time Frame: Baseline, 3 months, 6 months, and 12 months
Results will be assessed as negative or positive.
Baseline, 3 months, 6 months, and 12 months
Test results for chlamydia
Time Frame: Baseline, 3 months, 6 months, and 12 months
Results will be assessed as negative or positive.
Baseline, 3 months, 6 months, and 12 months
Test results for syphilis
Time Frame: Baseline, 3 months, 6 months, and 12 months
Results will be assessed as negative or positive.
Baseline, 3 months, 6 months, and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boston Medical Center

Collaborators

National Institute on Drug Abuse (NIDA)
Victory Programs Mobile Prevention Services Van and Navigation Center

Investigators

  • Principal Investigator: Sabrina A Assoumou, MD MPH, Boston Medical Center, Infectious Diseases

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 Major Dates

Study Start (Actual)

December 19, 2024

Primary Completion (Estimated)

July 1, 2027

Study Completion (Estimated)

June 30, 2028

Study Registration Dates

First Submitted

March 3, 2023

First Submitted That Met QC Criteria

March 3, 2023

First Posted (Actual)

March 15, 2023

Study Record Updates

Last Update Posted (Actual)

April 6, 2026

Last Update Submitted That Met QC Criteria

March 31, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H-43487
  • R01DA058367 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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