Recruiting

PrEP & MOUD

Sponsor:

Boston Medical Center

Code:

NCT05769218

Conditions

Opioid Use Disorder

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

CHORUS+

Standard of care

Study Details

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).

Conditions

Opioid Use Disorder

Study ID

NCT05769218

Start date

Dec 19, 2024

Status verified date

Mar, 2026

Completion date

Jun 30, 2028

Anticipated

Primary completion date

Jul 1, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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 Design

Enrollment

284 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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.

Standard of care

Normal protocols for care of participants who inject opioids will be followed.

Primary outcome measure

  • Adherence to HIV PrEP at 6 months Adherence to HIV PrEP [ Time Frame: 6 months ]

Central Contacts and Locations

Central contacts

Locations

Boston Medical Center Faster Paths Bridge Clinic

Recruiting

Boston, Massachusetts, United States, 02118

Victory Programs Mobile Prevention Services Van and Navigation Center

Recruiting

Boston, Massachusetts, United States, 02118

More Information

Sponsor

Boston Medical Center

Last update posted

Apr 6, 2026

Last verified

Mar, 2026

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)

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Boston Medical Center on 2026-04-06.