Buprenorphine Integration Research and Community Health

NCT ID: NCT05668780

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-24
• Study Completion Date: 2027-05-31

Brief 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.

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.

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.

Conditions

Opioid Use Disorder; HIV Infections; Hepatitis C

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: NONE

Study Groups

Intervention - Nominal Group Technique, Training, Coaching

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

Group Type: EXPERIMENTAL

NIATx Coaching

Intervention Type: BEHAVIORAL

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

Interventions

NIATx Coaching

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

West Virginia University

OTHER

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Frederick L Altice, MD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Natalie Kil, MPH

Role: STUDY_DIRECTOR

Yale University

Locations

West Virginia University

Morgantown, West Virginia, United States

Countries

United States

Other Identifiers

R01DA054703

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000034075

Identifier Type: -

Identifier Source: org_study_id