Buprenorphine Integration Research and Community Health

HIV Infections Clinical Trial

— BIRCH  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05668780
• Other study ID #: 2000034075
• Secondary ID: R01DA054703
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 24, 2023
• Est. completion date: May 31, 2026

Study information

• Verified date: April 2024
• Source: Yale University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 20
• Est. completion date: May 31, 2026
• Est. primary completion date: May 31, 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis C
• HIV Infections
• Opioid Use Disorder
• Opioid-Related Disorders

Intervention

Behavioral:
• NIATx Coaching
The intervention will consist of: a Nominal Group Technique session to identify priorities in integrating HIV/HCV/MOUD rapid cycle improvement coaching sessions from a NIATx coach, using data dashboards and screening alerts to improve identification and treatment for HIV/HCV/OUD training for primary care providers

Locations

Country	Name	City	State
United States	West Virginia University	Morgantown	West Virginia

Sponsors (3)

Lead Sponsor	Collaborator
Yale University	National Institute on Drug Abuse (NIDA), West Virginia University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	Number of patients screened for opioid use disorder (OUD)	Screening result for opioid use disorder documented in electronic health record (EHR)	18 months
Primary	Number of patients initiated on medications for OUD	Prescription medication for OUD; prescription dates, medication type	18 months
Primary	Number of patients screened for HIV	Lab ordered and result for HIV test entered in EHR	18 months
Primary	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
Primary	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
Primary	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
Primary	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	Number of patients with sustained viral response for HCV	For those with HCV medication prescription; Viral load results in EHR after recommended treatment	18 months
Secondary	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	6 months
Secondary	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	12 months
Secondary	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	12 months
Secondary	Number of patients on PrEP to prevent HIV	Documentation of negative HIV labs in EHR every 3 months	12 months
Secondary	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.	18 months