UHN Inpatient Hepatitis C & B Screening

NCT04620226 | Recruiting Phase 4 DMC

• 1 other identifier: UHN Inpatient HCV & HBV Screen
• Study Type: interventional
• Target: 2,920
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Hepatitis C; Hepatitis B

Keywords

Hepatitis C; Hepatitis B; Screening; Inpatient; Hospital

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (5)

• Number of chronic hepatitis C and hepatitis B infection in the 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.

  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.

  1 year

• Proportion of Cepheid Xpert® HCV Viral Load test results matching test results from 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.

  1 year

Study Arms (2)

Conventional Serum Testing

NO INTERVENTION

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.

Rapid Point-of-Care Testing

EXPERIMENTAL

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

Interventions

Quality Improvement OTHER

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.

Rapid Point-of-Care Testing

Eligibility Criteria

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

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Jordan Feld: lead

Study Sites (2)

Toronto General Hospital

Toronto, Ontario, M5G 2C4, Canada

RECRUITING

Toronto Western Hospital

Toronto, Ontario, M5T 2S8, Canada

RECRUITING

MeSH Terms

Conditions

Hepatitis C; Hepatitis B

Interventions

Quality Improvement

Condition Hierarchy (Ancestors)

Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases; Hepadnaviridae Infections; DNA Virus Infections

Intervention Hierarchy (Ancestors)

Engineering; Technology, Industry, and Agriculture; Quality of Health Care; Health Services Administration

Central Study Contacts

Bethany Barber, RN

CONTACT

4163404800; Bethany.Barber@uhn.ca

Camelia Capraru

CONTACT

4163404800; camelia.capraru@uhnresearch.ca

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: October 1, 2020
• First Posted: November 6, 2020
• Study Start: February 1, 2024
• Primary Completion: July 1, 2025
• Study Completion: July 1, 2025
• Last Updated: February 8, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (2)