Buprenorphine Integration Research and Community Health

NCT05668780 | Active Not Recruiting

• 2 other identifiers: 2000034075R01DA054703
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Opioid Use Disorder; HIV Infections; Hepatitis C

Keywords

Implementation Science; HIV; Medication for Opioid Use Disorder; PrEP; Hepatitis C; Nominal Group Technique

Outcome Measures

Primary Outcomes (9)

• 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.

  Every 6 months for 24 months

• 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.

  24 months

• Number of patients screened for opioid use disorder (OUD)

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

  18 months

• Number of patients initiated on medications for OUD

  Prescription medication for OUD; prescription dates, medication type

  18 months

• Number of patients screened for HIV

  Lab ordered and result for HIV test entered in EHR

  18 months

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

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

  18 months

• Number of patients screened for Hepatitis C (HCV)

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

  18 months

• 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

  18 months

• Number of patients prescribed PrEP

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

  18 months

Secondary Outcomes (6)

• Number of patients with sustained viral response for HCV

  18 months

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

  6 months

• Number of patients retained on medication (ART) for HIV

  12 months

• Number of patients with Viral Suppression for HIV

  12 months

• Number of patients on PrEP to prevent HIV

  12 months

Study Arms (1)

Intervention - Nominal Group Technique, Training, Coaching

EXPERIMENTAL

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

Behavioral: NIATx Coaching

Interventions

NIATx Coaching 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

Intervention - Nominal Group Technique, Training, Coaching

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Yale University: lead
• National Institute on Drug Abuse (NIDA): collaborator
• West Virginia University: collaborator

Study Sites (1)

West Virginia University

Morgantown, West Virginia, 26506, United States

Location

MeSH Terms

Conditions

Opioid-Related Disorders; HIV Infections; Hepatitis C

Condition Hierarchy (Ancestors)

Narcotic-Related Disorders; Substance-Related Disorders; Chemically-Induced Disorders; Mental Disorders; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases; Hepatitis, Viral, Human; Flaviviridae Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Frederick L Altice, MD

  Yale University

  PRINCIPAL INVESTIGATOR

• Natalie Kil, MPH

  Yale University

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Using a step-wedge design with 20 PCCs, the investigators will conduct a Type 3 Hybrid implementation trial

Study Record Dates

• First Submitted: December 19, 2022
• First Posted: December 30, 2022
• Study Start: January 24, 2023
• Primary Completion (Estimated): May 31, 2027
• Study Completion (Estimated): May 31, 2027
• Last Updated: April 17, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)