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

Opioid Use Disorder Clinical Trial

— CHORUS+  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05769218
• Other study ID #: H-43487
• Secondary ID: R01DA058367
• Status: Not yet recruiting
• Phase: N/A
• Start date: August 15, 2024
• Est. completion date: June 2026

Study information

• Verified date: May 2024
• Source: Boston Medical Center
• Contact: Sabrina A Assoumou, MD MPH
• Phone: 617-414-2896
• Email: sabrina.assoumou[@]bmc.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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).

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 284
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Exclusion Criteria:

• Individuals with HIV (self report)

• Express desire to harm themselves or others -

Related Conditions & MeSH terms

• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

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.

Other:
• Standard of care
Normal protocols for care of participants who inject opioids will be followed.

Locations

Country	Name	City	State
United States	Boston Medical Center Faster Paths Bridge Clinic	Boston	Massachusetts
United States	Victory Programs Mobile Prevention Services Van and Navigation Center	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Boston Medical Center	National Institute on Drug Abuse (NIDA), Victory Programs Mobile Prevention Services Van and Navigation Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Adherence to HIV PrEP at 6 months Adherence to HIV PrEP	This outcome will be assessed by measured by the proportion of individuals who have dried blood spot tenofovir-diphosphate (TFV-DP) blood level 52.0 ng/ mL or greater at 6 months post-enrollment.	6 months
Secondary	Adherence to PrEP at 3 and 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
Secondary	Receipt of medication for opioid use disorder (MOUD)	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
Secondary	Test results for gonorrhea	Results will be assessed as negative or positive.	Baseline, 3 months, 6 months, and 12 months
Secondary	Test results for chlamydia	Results will be assessed as negative or positive.	Baseline, 3 months, 6 months, and 12 months
Secondary	Test results for syphilis	Results will be assessed as negative or positive.	Baseline, 3 months, 6 months, and 12 months