Clinical trial NCT05769218: PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
Official title: PrEP and MOUD Rapid Access for Persons Who Inject Drugs: The CHORUS+ Study
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: 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)
Lead sponsor: Boston Medical Center
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: Victory Programs Mobile Prevention Services Van and Navigation Center
First posted: 2023-03-15
Enrollment: 284
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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
* Individuals who are pregnant at baseline
* Individuals who are already enrolled in an interventional study

Primary outcomes:
measure: Adherence to HIV PrEP at 6 months Adherence to HIV PrEP
timeFrame: 6 months
Secondary outcomes:
measure: Adherence to PrEP at 3 and 12 months
timeFrame: 3 months. 12 months
measure: Receipt of medication for opioid use disorder (MOUD)
timeFrame: 3 months, 6 months, and 12 months
measure: Test results for gonorrhea
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Test results for chlamydia
timeFrame: Baseline, 3 months, 6 months, and 12 months
measure: Test results for syphilis
timeFrame: Baseline, 3 months, 6 months, and 12 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center Faster Paths Bridge Clinic
state: Massachusetts
city: Boston
country: United States
facility: Victory Programs Mobile Prevention Services Van and Navigation Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center, Infectious Diseases
name: Sabrina A Assoumou, MD MPH
role: PRINCIPAL_INVESTIGATOR
References: