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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how to better implement screening and treatment for HIV, hepatitis C, and opioid use disorder in primary care clinics in West Virginia. The goal is to identify factors that help or hinder the effective use of these procedures. Clinics will receive special coaching and training (NIATx Coaching) to enhance their processes and determine if this leads to better patient health outcomes. The trial is open to primary care clinics in West Virginia that are federally recognized health centers or similar and provide care for adults. As an unphased trial, this study offers a unique opportunity to contribute to improving healthcare practices in the community.

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 prior data suggests that this intervention strategy is safe for primary care clinics?

Research shows that NIATx coaching safely and effectively improves healthcare services. Studies have found that it helps clinics manage treatments for issues like substance use and mental health disorders more effectively. This approach trains staff to enhance service delivery.

No reports of negative effects from NIATx coaching exist because it focuses on improving processes rather than introducing new drugs or medical procedures, resulting in a low safety risk for participants in the coaching process.

While specific data on side effects isn't available, this coaching method has successfully improved healthcare delivery in various settings. This suggests it is safe, particularly because it focuses on process improvement rather than direct patient treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about NIATx Coaching for managing HIV, Hepatitis C, and opioid use disorder because it takes a unique approach focused on improving healthcare delivery rather than directly targeting the disease. Unlike standard treatments that primarily rely on medications, this method uses a structured coaching and training technique to enhance clinic operations and patient care. By employing the Nominal Group Technique in a step-wedge design, it aims to identify and implement the most effective strategies for improving treatment access and adherence. This could lead to more consistent and effective management of these conditions, ultimately improving patient outcomes.

What evidence suggests that NIATx Coaching is effective for managing HIV, hepatitis C, and Opioid Use Disorder?

Research has shown that NIATx coaching, which participants in this trial will receive, improves the quality of care for various health issues, including HIV and opioid addiction. One study found that coaching was more effective than other methods, such as ECHO, in increasing the use of buprenorphine, a treatment for opioid addiction, in jails. Over 60 published studies support the effectiveness of the NIATx model in adopting proven healthcare practices. Additionally, two studies demonstrated that NIATx improves access to combined treatments for people with complex health needs. Overall, NIATx coaching has a strong history of enhancing healthcare practices and outcomes. ^{1 2 3 6 7}

Who Is on the Research Team?

Frederick L Altice, MD

Principal Investigator

Yale University

Natalie Kil, MPH

Principal Investigator

Yale University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5654706/

Evaluating Fidelity to a Modified NIATx Process ...

In a study aimed at improving the quality of HIV services for inmates, an organizational process improvement strategy using change teams was tested in 14 ...

2.

implementationscience.biomedcentral.com

implementationscience.biomedcentral.com/articles/10.1186/s13012-025-01419-6

Assessing the comparative effectiveness of ECHO and ...

Coaching emerged as a more effective implementation strategy than ECHO for increasing buprenorphine use in jail settings.

3.

niatx.wisc.edu

niatx.wisc.edu/niatx-as-an-evidence-based-practice/

NIATx as an Evidence-based Practice

Since then, more than 60 peer-reviewed publications support the effectiveness of the NIATx model. The model has expanded to include use in adopting evidence- ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5994046/

Using NIATx strategies to implement integrated services in ...

Two studies provide evidence for NIATx as an effective implementation strategy to improve access to integrated treatment for individuals with co ...

5.

researchgate.net

researchgate.net/publication/247496257_Teaching_the_NIATx_Model_of_Process_Improvement_as_an_Evidence-Based_Process

(PDF) Teaching the NIATx Model of Process Improvement ...

Emphasizing five phases of change, five key principles for change, and four revolving aims, NIATx has taught hundreds of addiction treatment ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03007940

Using NIATx Strategies to Implement Integrated Services in ...

The coach will help the staff identify ways to improve and integrate services for individuals with co-occurring substance use and mental health disorders.

7.

ajph.aphapublications.org

ajph.aphapublications.org/doi/full/10.2105/AJPH.2014.302035

Efficacy of a Process Improvement Intervention on Delivery of ...

Our results demonstrate that a modified NIATx process improvement model can effectively implement improved rates of delivery of some types of ...