Clinical trial NCT05668780: Buprenorphine Integration Research and Community Health
Official title: Integrating Addiction and Infectious Diseases Services Into Primary Care in Rural Settings
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Opioid Use Disorder
HIV Infections
Hepatitis C
Keywords: Implementation Science
HIV
Medication for Opioid Use Disorder
PrEP
Hepatitis C
Nominal Group Technique
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
name: West Virginia University
First posted: 2022-12-30
Enrollment: 20
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Using a step-wedge design with 20 PCCs, the investigators will conduct a Type 3 Hybrid implementation trial
Primary purpose: HEALTH_SERVICES_RESEARCH

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.

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

Primary outcomes:
measure: Organizational Readiness and Staff Attitudes towards integration of OUD, HIV, HCV services into primary care clinics
timeFrame: Every 6 months for 24 months
measure: Integration of services
timeFrame: 24 months
measure: Number of patients screened for opioid use disorder (OUD)
timeFrame: 18 months
measure: Number of patients initiated on medications for OUD
timeFrame: 18 months
measure: Number of patients screened for HIV
timeFrame: 18 months
measure: Number of patients initiated on antiretroviral medication (ART) for HIV
timeFrame: 18 months
measure: Number of patients screened for Hepatitis C (HCV)
timeFrame: 18 months
measure: Number of patients initiated on medication for HCV
timeFrame: 18 months
measure: Number of patients prescribed PrEP
timeFrame: 18 months
Secondary outcomes:
measure: Number of patients with sustained viral response for HCV
timeFrame: 18 months
measure: Number of patients retained on medication for OUD for at least 6 months
timeFrame: 6 months
measure: Number of patients retained on medication (ART) for HIV
timeFrame: 12 months
measure: Number of patients with Viral Suppression for HIV
timeFrame: 12 months
measure: Number of patients on PrEP to prevent HIV
timeFrame: 12 months
measure: Quality Health Indicator (QHI) score for Primary Care screening variables
timeFrame: 18 months
Other outcomes:
Locations:
city: Morgantown
country: United States
facility: West Virginia University
state: West Virginia
Study officials:
affiliation: Yale University
name: Frederick L Altice, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Yale University
name: Natalie Kil, MPH
role: STUDY_DIRECTOR
References: