NIATx Coaching for HIV, Hepatitis C, and Opioid Use Disorder Management

(BIRCH Trial)

Overseen By Adrienne Marable

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Yale University

Disqualifiers: Private clinics, Specialty clinics, others

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

Compensation: Varies

Number of Visits: Unknown

20 Participants Needed

Trial Summary

What is the purpose of this trial?

The goal of this clinical trial is to evaluate an intervention strategy in introducing screen/evaluate/treat (SET) procedures for HIV/ hepatitis C/ and Opioid Use Disorder in Primary Care Clinics in West Virginia. The main questions it aims to answer are: * What are the barriers and facilitators to integrating evidence based practices for screening and treatment of HIV, hepatitis C, and Opioid Use Disorder into primary care clinics in West Virginia? * To assess the extent to which our SET processes are achieved through enhanced EHR tools, NIATx (formerly known as Network for the Improvement of Addiction Treatment) facilitation and Extension for Community Healthcare Outcomes (ECHO)-supported collaborative learning? * Does implementing these services improve primary and secondary health outcomes for patients? Primary Care Clinics will participate in training and process improvement coaching to integrate these services. Using a step-wise design, 20 Primary Care Clinics will undergo the training and coaching in four groups of five clinics.

Will I have to stop taking my current medications?

The trial information does not specify whether participants need to stop taking their current medications.

What data supports the effectiveness of the NIATx Coaching treatment for managing HIV, Hepatitis C, and Opioid Use Disorder?

The NIATx Coaching treatment has been shown to improve access to and retention in care for alcohol and drug disorders by reducing the time to start treatment and increasing the number of patients who stay in treatment. These improvements suggest that similar strategies could be effective for managing HIV, Hepatitis C, and Opioid Use Disorder. ^{1 2 3 4 5}

Is NIATx Coaching safe for managing HIV, Hepatitis C, and Opioid Use Disorder?

NIATx Coaching focuses on improving the quality of care in addiction treatment programs, emphasizing safe, effective, and patient-centered approaches. While specific safety data for NIATx Coaching in managing HIV, Hepatitis C, and Opioid Use Disorder is not detailed, the framework is designed to enhance safety and quality in treatment settings. ^{1 2 4 6 7}

How is NIATx Coaching for HIV, Hepatitis C, and Opioid Use Disorder Management different from other treatments?

NIATx Coaching is unique because it integrates practice coaching to improve the implementation of on-site testing for HIV and Hepatitis C in opioid treatment programs, which is not commonly offered. This approach focuses on organizational change to enhance testing and linkage to care, making it different from traditional treatments that may not emphasize such comprehensive integration. ^{8 9 10 11 12}

Research Team

Frederick L Altice, MD

Principal Investigator

Yale University

Natalie Kil, MPH

Principal Investigator

Yale University

Eligibility Criteria

This trial is for Federally Qualified Health Centers and similar primary care clinics in West Virginia that provide adult care. It's not open to private or specialty clinics, or any clinic outside of West Virginia.

Inclusion Criteria

- Federally Qualified Health Centers (FQHCs) and Look-Alike FQHC Primary Care Clinics in West Virginia providing adult care

Exclusion Criteria

Clinics (private or specialty) or any clinics not in West Virginia

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Phase 1: Identification of Barriers and Facilitators

Nominal Group Technique focus groups and anonymous staff surveys at the 20 PCCs to identify barriers and facilitators to integrating evidence-based practices.

6 months

Focus groups and surveys

Phase 2: Implementation and Evaluation

Evaluation of deidentified reports from the PCCs Electronic Health Records and initiation of NIATx activities, including rapid-cycle Plan-Do-Study-Act (PDSA) activities.

18 months

Intensive coaching and collaborative learning sessions

Follow-up

Participants are monitored for sustainability of practice changes and effectiveness outcomes, including quality health indicators.

18 months

Treatment Details

Interventions

• NIATx Coaching

Trial Overview The study tests a strategy called NIATx Coaching to integrate screening, evaluation, and treatment procedures for HIV, hepatitis C, and Opioid Use Disorder into primary care. Clinics will receive training and coaching to adopt these practices.

Participant Groups

Group I: Intervention - Nominal Group Technique, Training, Coaching Experimental Treatment 1 Intervention

Each group of clinics will receive the same intervention in a step-wedge design, starting every 6-months.

Who Is Running the Clinical Trial?

Yale University

Lead Sponsor

Trials

1,963

Recruited

3,046,000+

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Findings from Research

Multidisciplinary care models that integrate treatment for opioid use disorder (OUD), hepatitis C (HCV), and HIV are essential for preventing the spread of these conditions, with 17 different models identified across various care settings.

Key components of effective care models include medication-assisted treatment for OUD, treatment for HIV and HCV, HIV pre-exposure prophylaxis, and behavioral health services, highlighting the importance of comprehensive approaches in managing these interconnected health issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Integrated Models of Care for Individuals with Opioid Use Disorder: How Do We Prevent HIV and HCV? Rich, KM., Bia, J., Altice, FL., et al.[2019]

A study involving 51 opioid treatment programs is testing two practice coaching interventions to improve on-site HIV and HCV testing, which is crucial for individuals with substance use disorders who are at high risk for HIV.

The research aims to enhance the implementation and sustainability of testing practices, potentially leading to better health outcomes and reduced rates of HIV and HCV infections among this vulnerable population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs. Frimpong, JA., Parish, C., Feaster, DJ., et al.[2023]

References

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

Improving care for the treatment of alcohol and drug disorders. [2021]

2. Ireland pubmed.ncbi.nlm.nih.gov

The Network for the Improvement of Addiction Treatment (NIATx): enhancing access and retention. [2019]

3. Ireland pubmed.ncbi.nlm.nih.gov

Replication and sustainability of improved access and retention within the Network for the Improvement of Addiction Treatment. [2021]

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

Adaptation of the Grasha Riechman Student Learning Style Survey and Teaching Style Inventory to assess individual teaching and learning styles in a quality improvement collaborative. [2019]

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

Improving quality of care in substance abuse treatment using five key process improvement principles. [2023]

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

Provision of hepatitis C education in a nationwide sample of drug treatment programs. [2022]

7. Canada pubmed.ncbi.nlm.nih.gov

Effect of an mHealth Intervention on Hepatitis C Testing Uptake Among People With Opioid Use Disorder: Randomized Controlled Trial. [2022]

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

Integrating services for injection drug users infected with hepatitis C virus with methadone maintenance treatment: challenges and opportunities. [2013]

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

Integrated Models of Care for Individuals with Opioid Use Disorder: How Do We Prevent HIV and HCV? [2019]

10. Netherlands pubmed.ncbi.nlm.nih.gov

Education by peers is the key to success. [2019]

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

A study protocol for Project I-Test: a cluster randomized controlled trial of a practice coaching intervention to increase HIV testing in substance use treatment programs. [2023]

12. Croatia pubmed.ncbi.nlm.nih.gov

[Prevention and treatment of hepatitis C in illicit drug users]. [2010]