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

(BIRCH Trial)

Recruiting in Palo Alto (17 mi)

Overseen by Frederick L Altice, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Yale University

No Placebo Group

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.

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

Treatment Details

Interventions

• NIATx Coaching (Behavioral Intervention)

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+

Nancy J. Brown

Yale University

Chief Medical Officer since 2020

MD from Yale School of Medicine

Peter Salovey

Yale University

Chief Executive Officer since 2013

PhD in Psychology from Yale University

National Institute on Drug Abuse (NIDA)

Collaborator

Trials

2,658

Recruited

3,409,000+

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Executive Officer since 2003

MD from National Autonomous University of Mexico

Dr. Nora Volkow

National Institute on Drug Abuse (NIDA)

Chief Medical Officer since 2003

MD from National Autonomous University of Mexico

West Virginia University

Collaborator

Trials

192

Recruited

64,700+

Dr. William P. Petros

West Virginia University

Chief Medical Officer

PharmD from West Virginia University

Dr. Clay B. Marsh

West Virginia University

Chief Executive Officer since 2015

MD from West Virginia University, Bachelor’s in Biology from West Virginia University