UHN Inpatient Hepatitis C & B Screening

NCT ID: NCT04620226

Last Updated: 2024-02-08

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 2920 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-02-01
• Study Completion Date: 2025-07-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

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.

Group Type: EXPERIMENTAL

Quality Improvement

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Jordan Feld

OTHER

Sponsor Role: lead

Responsible Party

Jordan Feld

Associate Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Toronto General Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Toronto Western Hospital

Toronto, Ontario, Canada

Site Status: RECRUITING

Countries

Canada

Central Contacts

Bethany Barber, RN

Role: CONTACT

Bethany.Barber@uhn.ca

4163404800 ext. 6569

Camelia Capraru

Role: CONTACT

camelia.capraru@uhnresearch.ca

4163404800 ext. 2926

Facility Contacts

Bethany Barber

Role: primary

Bethany Barber

Role: primary

Other Identifiers

UHN Inpatient HCV & HBV Screen

Identifier Type: -

Identifier Source: org_study_id