UHN Inpatient Hepatitis C & B Screening

Screening for Hepatitis C and Hepatitis B in Inpatients: A Toronto Viral Hepatitis Care Network (VIRCAN) Collaboration

Currently, there is a lack of literature on programs evaluating rapid screening methods to traditional venipuncture methods for sample collection during screening for viral hepatitis. Due to the relatively low diagnosis and linkage to care rate, screening programs that provide same day results for viral hepatitis infection may improve both diagnosis and enable providers to engage patients shortly after diagnosis. This stands in contrast to the multi-visit, weeks long process that normally accompanies serum testing for hepatitis C virus (HCV) and hepatitis B virus (HBV). A few American studies have examined the implementation of HCV inpatient screening programs; however, they are focused specifically on high-risk patient populations, the barriers to accessing care experienced by study participants are not relevant to the Canadian healthcare system context, and do not use rapid testing. Furthermore, there are few, if any, data on HBV inpatient screening programs and the diagnosis rate remains low. This project will provide key data on a rapid inpatient screening and linkage to care strategy as well as the prevalence of these viruses across different age bands within the population. Finally, the study will help determine whether rapid inpatient screening is a feasible and acceptable approach for screening and linkage to care.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis B; Hepatitis C
• Intervention / Treatment: Other: Quality Improvement

• Study Type: Interventional
• Enrollment (Estimated): 2920
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Camelia Capraru; Phone Number: 2926 4163404800; Email: camelia.capraru@uhnresearch.ca
• Study Contact Backup: Name: Bethany Barber, RN; Phone Number: 6569 4163404800; Email: Bethany.Barber@uhn.ca

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5T 2S8
      • Recruiting
      • Toronto Western Hospital
      • Contact: Bethany Barber
    • Toronto, Ontario, Canada, M5G 2C4
      • Recruiting
      • Toronto General Hospital
      • Contact: Bethany Barber

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Adults aged 18 years or older at time of consent
• Patients admitted to GIMIUs at TGH or TWH

Exclusion Criteria:

• Patients whose end of life is expected to be less than 6 months
• Patients who are unable or decline to provide informed consent
• Patients with confirmed, active COVID-19 infections
• Patients with immediate life-threatening conditions where screening for chronic HCV and HBV infection may delay urgent care

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Screening
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Conventional Serum Testing; Participants will be screened by conventional HCV antibody (anti-HCV) serology and if screen positive, a second sample will be collected and tested for HCV RNA using a standard commercial assay.
Experimental: Rapid Point-of-Care Testing; Participants will be screened using the OraQuick® Rapid Anti-HCV Point-of-Care Test (OraSure) and if screen positive, an additional whole blood sample will be collected and tested for HCV RNA using Xpert® HCV RNA (Cepheid) point-of-care testing and confirmed using a standard commercial assay.	Other: Quality Improvement; Rapid Point-of-Care testing will provide participants with a HCV antibody and RNA result within 2 hours. If the participant is HCV RNA+, they will receive an inpatient consultation from a liver specialist prior to discharge. We hypothesize that this model will minimize losses in the continuum-of-care and improve linkages to care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of HCV antibody positive participants who complete an HCV RNA PCR.	To determine the proportion of HCV antibody positive participants who complete HCV RNA PCR in each arm. Participants will be contacted at 90 days and 1 year post-enrolment to self-report progress.	2 year
Number of HCV RNA positive participants who attend their first hepatology appointment.	To determine the proportion of HCV RNA positive participants successfully linked to care from each arm. Participants will be contacted at 90 days and 1 year post-enrolment to self-report.	2 year
Number of HCV RNA positive participants who achieve a Sustained Virological Response at 12 weeks (SVR12) after treatment completion.	To determine the proportion of HCV RNA positive participants who successfully achieved a sustained virological response at 12 weeks (SVR12) after treatment completion. Participants will be contacted at 90 days and 1 year post-enrolment to self-report.	2 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of chronic hepatitis C and hepatitis B infection in the general internal medicine inpatient units.	Proportion of screened participants who are positive and chronically infected in general internal medicine inpatient units.	1 year
Number of patients willing to participate in hepatitis C and hepatitis B screening in general internal medicine inpatient units.	To determine acceptability of implementing hepatitis C and hepatitis B screening in general internal medicine inpatient units.	1 year
Percentage of physicians, residents, and nurses who believe that hepatitis C and hepatitis B screening can be incorporated into the general internal medicine inpatient units' workflow.	To determine the effect of hepatitis C and hepatitis B screening on hospital staff workflow in general internal medicine inpatient units.	1 year
Proportion of Cepheid Xpert® HCV Viral Load test results matching test results from the standard commercial assay for HCV RNA PCR.	To determine whether results of the Cepheid Xpert® HCV Viral Load assay are valid when compared to the standard commercial assay for HCV RNA PCR.	1 year
Retrospective rates of HCV testing, HCV antibody positive results, and HCV RNA positive results in general internal medicine inpatient units.	To determine the historical rate of HCV screening and chronic HCV infection in general internal medicine inpatient units.	1 year

Collaborators and Investigators

• Sponsor: Jordan Feld

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Estimated): July 1, 2025
• Study Completion (Estimated): July 1, 2025

Study Registration Dates

• First Submitted: October 1, 2020
• First Submitted That Met QC Criteria: November 5, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): February 8, 2024
• Last Update Submitted That Met QC Criteria: February 6, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: Screening; Hospital; Hepatitis C; Hepatitis B; Inpatient
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepadnaviridae Infections; DNA Virus Infections; Enterovirus Infections; Picornaviridae Infections; Hepatitis B; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: UHN Inpatient HCV & HBV Screen

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No