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Comprehensive HIV, Hepatitis C, and Opioid Use Disorder Response to the Unaddressed Syndemic + (CHORUS+)

Primary Purpose

Opioid Use Disorder

Status
Not yet recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
CHORUS+
Standard of care
Sponsored by
Boston Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Opioid Use Disorder focused on measuring 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)

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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 -

Sites / Locations

  • Boston Medical Center Faster Paths Bridge Clinic
  • Victory Programs Mobile Prevention Services Van and Navigation Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CHORUS+

Usual care- control

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.
Test results for gonorrhea
Results will be assessed as negative or positive.
Test results for chlamydia
Results will be assessed as negative or positive.
Test results for syphilis
Results will be assessed as negative or positive.

Full Information

First Posted
March 3, 2023
Last Updated
September 16, 2023
Sponsor
Boston Medical Center
Collaborators
National Institute on Drug Abuse (NIDA), Victory Programs Mobile Prevention Services Van and Navigation Center
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1. Study Identification

Unique Protocol Identification Number
NCT05769218
Brief Title
Comprehensive HIV, Hepatitis C, and Opioid Use Disorder Response to the Unaddressed Syndemic +
Acronym
CHORUS+
Official Title
PrEP and MOUD Rapid Access for Persons Who Inject Drugs: the CHORUS+ Study
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
February 2024 (Anticipated)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Boston Medical Center
Collaborators
National Institute on Drug Abuse (NIDA), Victory Programs Mobile Prevention Services Van and Navigation Center

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Opioid Use Disorder
Keywords
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)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
284 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CHORUS+
Arm Type
Experimental
Arm Description
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.
Arm Title
Usual care- control
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
CHORUS+
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Standard of care
Intervention Description
Normal protocols for care of participants who inject opioids will be followed.
Primary Outcome Measure Information:
Title
Adherence to HIV PrEP at 6 months Adherence to HIV PrEP
Description
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.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Adherence to PrEP at 3 and 12 months
Description
Adherence will be assessed by self-report and chart review of active medication refills for PrEP and appointments attended.
Time Frame
3 months. 12 months
Title
Receipt of medication for opioid use disorder (MOUD)
Description
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.
Time Frame
3 months, 6 months, and 12 months
Title
Test results for gonorrhea
Description
Results will be assessed as negative or positive.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Test results for chlamydia
Description
Results will be assessed as negative or positive.
Time Frame
Baseline, 3 months, 6 months, and 12 months
Title
Test results for syphilis
Description
Results will be assessed as negative or positive.
Time Frame
Baseline, 3 months, 6 months, and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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 -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabrina A Assoumou, MD MPH
Phone
617-414-2896
Email
sabrina.assoumou@bmc.org
First Name & Middle Initial & Last Name or Official Title & Degree
Vanessa Bonilla
Email
haley.bonilla@bmc.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabrina A Assoumou, MD MPH
Organizational Affiliation
Boston Medical Center, Infectious Diseases
Official's Role
Principal Investigator
Facility Information:
Facility Name
Boston Medical Center Faster Paths Bridge Clinic
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States
Facility Name
Victory Programs Mobile Prevention Services Van and Navigation Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02118
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Comprehensive HIV, Hepatitis C, and Opioid Use Disorder Response to the Unaddressed Syndemic +

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