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Opioid Use DisorderBIRCHNCT05668780

Buprenorphine Integration Research and Community Health

A study testing NIATx Coaching in people with Opioid Use Disorder and HIV Infections, run by Yale University at 1 site in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Any age
Conditions the study is for
Opioid Use Disorder, HIV Infections, Hepatitis C
What is being tested?
NIATx Coaching
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
1 siteUnited States
Study dates
24 Jan 2023to 31 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Any age
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • West Virginia University

    Morgantown, West Virginia, 26506

Other trials in United States

About this study

Official title: Integrating Addiction and Infectious Diseases Services Into Primary Care in Rural Settings

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.
Read the detailed description

To integrate HIV/HCV/ OUD services into Primary Care Clinics (PCC), the investigators will introduce screen/evaluate/treat (SET) procedures for HIV/hepatitis C (HCV)/ Opioid Use Disorder (OUD) in PCCs in rural WV where ECHO and WV Hepatitis Academic Mentoring Partnership (WVHAMP) will support clinical skills for Primary Care Provider (PCPs) and where NIATx process improvement tools will be used to guide adoption and scale-up of SET procedures to achieve integration. Using a step-wedge design with 20 PCCs, the investigators will conduct a Type 3 Hybrid implementation trial and examine the extent to which our SET processes are achieved through enhanced electronic health record (EHR) tools, NIATx facilitation and ECHO and WVHAMP collaborative learning. Implementation outcomes include adoption of screening and treating with three distinct but linked evidence based practices (EBPs) for OUD, HIV and HCV in PCCs. Effectiveness outcomes will include quality health indicators (QHIs) for primary care, HIV, HCV and OUD.

This project is separated into two Phases. Phase 1 includes Nominal Group Technique focus groups and anonymous staff surveys at the 20 PCCs to identify barriers and facilitators to integrating these evidence based practices. Phase 2 is an evaluation of deidentified reports from the PCCs Electronic Health Records. In Phase 2, randomized sites will start NIATx activities, including a series of rapid-cycle Plan-Do-Study-Act (PDSA) activities. The first 6 months will include intensive coaching from a certified NIATx coach and enhanced by support from ECHO \& the WVHAMP to teach subspecialty clinical expertise. During an 18-month follow-up, the investigators will assess the sustainability of these practice changes. Effectiveness outcomes will include a set of nationally recommended quality health indicators (QHIs) to measure quality care. This project is a collaboration between Yale University, West Virginia University (WVU), and the West Virginia Primary Care Association.

Aim 1 (Phase 1):

Identify the barriers and facilitators for a diverse group of PCCs throughout WV, a mostly rural state that is profoundly impacted by OUD-associated HIV/HCV outbreaks, focusing on screening for and prescribing evidence-based treatment [medication for opioid use disorder (MOUD), Treatment as Prevention (TasP), pre-exposure prophylaxis (PrEP), and curative hepatitis C (HCV) treatment] for OUD, HIV and HCV.

Aim 2 (Phase 2):

Using a step-wedge design with 20 PCCs, the investigators will conduct a Type 3 hybrid implementation trial using the Integrated Promoting Action on Research Implementation in Health Services (iPARiHS) framework to assess the extent to which our SET processes are achieved through enhanced EHR tools, NIATx facilitation and ECHO-supported collaborative learning. Implementation outcomes include adoption of screening and implementation of three distinct but linked EBPs for OUD, HIV and HCV in PCCs. Effectiveness outcomes will include quality health indicators (QHIs) for primary care, HIV, HCV and OUD.

Being tested
NIATx Coaching
Keywords
Implementation Science, HIV, Medication for Opioid Use Disorder, PrEP, Hepatitis C, Nominal Group Technique
Medical subject headings
Opioid-Related Disorders, HIV Infections, Hepatitis C

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • NIATx CoachingBehavioural

    The intervention will consist of:

    1. a Nominal Group Technique session to identify priorities in integrating HIV/HCV/MOUD
    2. rapid cycle improvement coaching sessions from a NIATx coach, using data dashboards and screening alerts to improve identification and treatment for HIV/HCV/OUD
    3. training for primary care providers
Study groups in NCT05668780
Study groupRoleWhat they receive
Intervention - Nominal Group Technique, Training, CoachingExperimentalEach group of clinics will receive the same intervention in a step-wedge design, starting every 6-months.
Receives: Behavioral: NIATx Coaching

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Organizational Readiness and Staff Attitudes towards integration of OUD, HIV, HCV services into primary care clinics

    Staff survey results on organizational capacity, readiness to change, organizational functioning and social dominance orientation, and resistance to change.

    Measured: Every 6 months for 24 months

  2. Integration of services

    Adoption of screening and implementation of best evidence-based practices. Quality health indicators (QHIs) for primary care - OUD, HIV \& HCV documented in electronic health record data.

    Measured: 24 months

  3. Number of patients screened for opioid use disorder (OUD)

    Screening result for opioid use disorder documented in electronic health record (EHR)

    Measured: 18 months

  4. Number of patients initiated on medications for OUD

    Prescription medication for OUD; prescription dates, medication type

    Measured: 18 months

  5. Number of patients screened for HIV

    Lab ordered and result for HIV test entered in EHR

    Measured: 18 months

  6. Number of patients initiated on antiretroviral medication (ART) for HIV

    For those with a positive HIV test result, prescription medication for HIV; prescription dates

    Measured: 18 months

  7. Number of patients screened for Hepatitis C (HCV)

    Lab result ordered for HCV antibody / reflex polymerase chain reaction (PCR), result entered in EHR

    Measured: 18 months

  8. Number of patients initiated on medication for HCV

    For those with a positive HCV PCR test, documented in EHR prescription medication for HCV; prescription dates; fibrosis score

    Measured: 18 months

  9. Number of patients prescribed PrEP

    For those with a negative HIV result, prescription medication for PrEP; medication type; prescription dates; lab orders

    Measured: 18 months

Secondary outcomes (6)

  1. Number of patients with sustained viral response for HCV

    For those with HCV medication prescription; Viral load results in EHR after recommended treatment

    Measured: 18 months

  2. Number of patients retained on medication for OUD for at least 6 months

    For those with prescription for medication for OUD; documentation in EHR of repeated prescription orders

    Measured: 6 months

  3. Number of patients retained on medication (ART) for HIV

    For those with new prescription for medication for HIV; documentation in EHR of repeated prescriptions up to 6 and 12 months

    Measured: 12 months

  4. Number of patients with Viral Suppression for HIV

    For those with new HIV diagnosis; documentation in EHR of viral suppression defined as HIV RNA <200 copies/µl, at 6 and 12 months after prescription

    Measured: 12 months

  5. Number of patients on PrEP to prevent HIV

    Documentation of negative HIV labs in EHR every 3 months

    Measured: 12 months

  6. Quality Health Indicator (QHI) score for Primary Care screening variables

    QHI-PC score based on documentation of screening (limited age/sex) for hypertension, diabetes, hyperlipidemia, HIV, HCV, hepatitis B (HBV), syphilis, cervical cancer, breast cancers, prostate cancer, herpes simplex virus (HSV) serology, latent tuberculosis (TB), colorectal cancer, depression, chlamydia, gonorrhea.

    Measured: 18 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Dec 2022
  2. Study start24 Jan 2023
  3. Primary completion31 May 2027 (estimated)
  4. Study completion31 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Health services research
Allocation
Not applicable
Intervention model
Single group
Model description
Using a step-wedge design with 20 PCCs, the investigators will conduct a Type 3 Hybrid implementation trial
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05668780
Sponsor's protocol ID
2000034075
Other IDs
R01DA054703
Acronym
BIRCH
Status last verified
Sep 2026
First submitted
19 Dec 2022
Last updated
14 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing NIATx Coaching in people with Opioid Use Disorder and HIV Infections, run by Yale University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 14 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Organizational Readiness and Staff Attitudes towards integration of OUD, HIV, HCV services into primary care clinics (time frame: Every 6 months for 24 months). The study lists 9 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05668780.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2026.

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