CHORUS+ Program for Opioid Use Disorder

(CHORUS+ Trial)

Recruiting at 1 trial location

Overseen By Sarah Miller

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Boston Medical Center

Must be taking: PrEP, MOUD

Disqualifiers: HIV, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 4

284 Participants Needed

Trial Summary

What is the purpose of this trial?

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).

Do I need to stop my current medications to join the trial?

The trial protocol does not specify whether you need to stop taking your current medications. However, it focuses on starting HIV PrEP and medication for opioid use disorder, so it's best to discuss your current medications with the trial team.

Is the CHORUS+ Program for Opioid Use Disorder safe for humans?

Buprenorphine treatment, which is part of opioid use disorder treatments, is considered safe and effective according to research. It has been used in various settings, including harm reduction agencies, to engage people in treatment without compromising safety. ^{1 2 3 4 5}

How is the CHORUS+ treatment for opioid use disorder different from other treatments?

The CHORUS+ treatment for opioid use disorder may involve a unique approach by integrating community partnerships and peer support to address barriers like stigma and improve treatment retention, which are not typically emphasized in standard medication treatments like methadone or buprenorphine. ^{6 7 8 9 10}

Research Team

Sabrina A Assoumou, MD MPH

Principal Investigator

Boston Medical Center, Infectious Diseases

Eligibility Criteria

This trial is for English-speaking individuals in the Boston area who have used opioids by injection within the last 6 months and plan to stay local for half a year. They must be willing to share contacts of two relatives or friends, sign medical records release forms, and not have HIV or intent to harm themselves or others.

Inclusion Criteria

Plans to reside in Boston area for the next 6 months

Ability to speak English

Injected opioids within the past 6 months (by self-report)

Exclusion Criteria

Individuals with HIV (self report)

Express desire to harm themselves or others

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Baseline and Motivational Interviewing

Baseline in-person session with motivational interviewing to encourage uptake of PrEP and MOUD

1 session

1 visit (in-person)

Treatment and Peer Recovery Coaching

Participants receive rapid initiation of PrEP and MOUD, with 6-month peer recovery coaching to support adherence

6 months

Multiple visits (in-person and virtual)

Follow-up

Participants are monitored for adherence to PrEP and MOUD, and for test results of various infections

12 months

Visits at 3, 6, and 12 months

Treatment Details

Interventions

• CHORUS+
• Standard of care

Trial Overview The CHORUS+ intervention is being tested against standard care. It includes peer-delivered support, mobile phone assistance, HIV self-testing, rapid start of PrEP (HIV prevention medication) and MOUD (medication for opioid use disorder), plus six months of coaching to stick with these treatments.

Participant Groups

Group I: CHORUS+ Experimental Treatment 1 Intervention

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.

Group II: Usual care- control Active Control 1 Intervention

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.

Who Is Running the Clinical Trial?

Boston Medical Center

Lead Sponsor

Trials

410

Recruited

890,000+

Victory Programs Mobile Prevention Services Van and Navigation Center

Collaborator

Trials

1

Recruited

280+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Findings from Research

Prison-based opioid substitution treatment (OST) significantly reduces the risk of death after release from prison, with a 75% reduction in all-cause mortality and an 85% reduction in drug-related poisoning deaths during the first month post-release, based on a study of 15,141 prisoners.

Participants receiving OST were also more likely to enter community drug misuse treatment within the first month after release, indicating that OST not only improves survival rates but also encourages engagement with treatment services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Does exposure to opioid substitution treatment in prison reduce the risk of death after release? A national prospective observational study in England. Marsden, J., Stillwell, G., Jones, H., et al.[2021]

The study aims to assess the effectiveness of initiating buprenorphine treatment directly at syringe services programs (SSPs) for 250 participants with opioid use disorder (OUD), hypothesizing that this approach will enhance treatment engagement without compromising safety or effectiveness.

Participants receiving onsite buprenorphine treatment will have more immediate access to care, with follow-up at a community health center, potentially improving overall treatment outcomes compared to those receiving only referrals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Onsite buprenorphine inductions at harm reduction agencies to increase treatment engagement and reduce HIV risk: Design and rationale. Perez-Correa, A., Abbas, B., Riback, L., et al.[2023]

In the first 15 months of California's Hub and Spoke Program, there was a remarkable 94.7% increase in new patients starting buprenorphine treatment across 118 clinics, indicating significant progress in expanding access to medications for opioid use disorders.

Despite the increase in providers authorized to prescribe buprenorphine, only 68.7% were actively prescribing, highlighting the need for improved support, mentorship, and training to overcome barriers such as provider confidence and stigma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Preliminary results of the evaluation of the California Hub and Spoke Program. Darfler, K., Sandoval, J., Pearce Antonini, V., et al.[2021]

A consensus was reached among a panel of 25 experts to establish a core outcomes set (OUD-COS) for evaluating treatments for opioid use disorder, which includes five key outcomes: global impression of improvement, incident non-fatal overdose, illicit/non-medical drug toxicology, duration of treatment, and fatal opioid poisoning.

This core outcomes set aims to standardize the evaluation of treatment efficacy and effectiveness in opioid use disorder, addressing the current heterogeneity in outcome measures used in clinical trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The opioid use disorder core outcomes set (OUD-COS) for treatment research: findings from a Delphi consensus study. Karnik, NS., Marsden, J., McCluskey, C., et al.[2023]

A systematic review of 88 studies found that people regularly inject buprenorphine, with daily doses ranging from less than 1 mg to 12 mg and injection frequencies between 0 to 10 times daily, indicating a widespread practice that could inform future treatment strategies.

Injecting buprenorphine may offer a feasible alternative to traditional injectable opioid agonist therapies, with potential safety benefits that could allow for take-home dosing, although the quality of the studies reviewed was generally low.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Patterns of use and adverse events reported among persons who regularly inject buprenorphine: a systematic review. Bozinoff, N., Tardelli, VS., Rubin-Kahana, DS., et al.[2022]

Long-term opioid agonist therapy with methadone and buprenorphine has been shown to be highly effective in treating opioid use disorder (OUD), significantly reducing the risk of relapse and saving lives.

Despite the effectiveness of these treatments, the delivery of prevention and treatment for OUD is often hindered by coexisting health issues, lack of support, and varying public opinions, highlighting the need for better scientific communication and evidence-based strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Opioid use disorder. Strang, J., Volkow, ND., Degenhardt, L., et al.[2021]

A community-partnered working group recommended using the Community Reinforcement and Family Treatment (CRAFT) approach to improve the uptake and adherence to Medications for Addiction Treatment (MAT) for opioid use disorders, indicating a promising strategy for enhancing treatment access.

To effectively compare the impacts of these interventions on abstinence and mortality rates, significantly larger sample sizes than those used in the original Community Partners in Care (CPIC) study would be necessary, highlighting the need for extensive multi-site trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Commentary: Applying the Community Partners in Care Approach to the Opioid Crisis. Wells, KB., Watkins, KE., Hurley, B., et al.[2023]

A patient-centered treatment program for opioid use disorder (OUD) in Iowa showed promising results, with a 92.5% retention rate over 3 months and significant improvements in recovery capital, as measured by the Assessment of Recovery Capital (ARC) score, which increased from 37 to 43 (p < 0.01).

Participants experienced a notable reduction in illegal drug use, with the median days of use dropping from 10 to 0 in the past month (p < 0.001), and cravings improved significantly, with 58.3% reporting no cravings at 3 months compared to 29.2% at intake (p < 0.001).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Three-month outcomes from a patient-centered program to treat opioid use disorder in Iowa, USA. Lynch, AC., Weber, AN., Hedden, S., et al.[2021]

The Washington State Hub and Spoke Model successfully integrated primary care and substance use treatment, providing medication treatment for opioid use disorders (OUD) to nearly 5000 individuals in the first 18 months, with 73% receiving buprenorphine.

This model emphasizes a flexible, community-based approach that ensures access to treatment regardless of entry point, demonstrating a significant step towards addressing the opioid crisis through improved care delivery and support services.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Washington State Hub and Spoke Model to increase access to medication treatment for opioid use disorders. Reif, S., Brolin, MF., Stewart, MT., et al.[2021]

Patients receiving methadone treatment reported experiencing various forms of stigma related to substance use and medication, which significantly hindered their retention in opioid use disorder treatment programs.

Peer recovery specialists (PRSs), who share similar experiences with substance use and recovery, have the potential to reduce stigma and improve retention in medication for opioid use disorder by leveraging their unique perspectives and support.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

"In their mind, they always felt less than": The role of peers in shifting stigma as a barrier to opioid use disorder treatment retention. Anvari, MS., Kleinman, MB., Massey, EC., et al.[2023]

References

1. England pubmed.ncbi.nlm.nih.gov

Does exposure to opioid substitution treatment in prison reduce the risk of death after release? A national prospective observational study in England. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Onsite buprenorphine inductions at harm reduction agencies to increase treatment engagement and reduce HIV risk: Design and rationale. [2023]

3. United States pubmed.ncbi.nlm.nih.gov

Preliminary results of the evaluation of the California Hub and Spoke Program. [2021]

4. England pubmed.ncbi.nlm.nih.gov

The opioid use disorder core outcomes set (OUD-COS) for treatment research: findings from a Delphi consensus study. [2023]

5. England pubmed.ncbi.nlm.nih.gov

Patterns of use and adverse events reported among persons who regularly inject buprenorphine: a systematic review. [2022]

6. England pubmed.ncbi.nlm.nih.gov

Opioid use disorder. [2021]

7. United States pubmed.ncbi.nlm.nih.gov

Commentary: Applying the Community Partners in Care Approach to the Opioid Crisis. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Three-month outcomes from a patient-centered program to treat opioid use disorder in Iowa, USA. [2021]

9. United States pubmed.ncbi.nlm.nih.gov

The Washington State Hub and Spoke Model to increase access to medication treatment for opioid use disorders. [2021]

10. United States pubmed.ncbi.nlm.nih.gov

"In their mind, they always felt less than": The role of peers in shifting stigma as a barrier to opioid use disorder treatment retention. [2023]