UHN Inpatient Hepatitis C & B Screening

Hepatitis C Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04620226
• Other study ID #: UHN Inpatient HCV & HBV Screen
• Status: Recruiting
• Phase: Phase 4
• Start date: February 1, 2024
• Est. completion date: July 2025

Study information

• Verified date: February 2024
• Source: University Health Network, Toronto
• Contact: Bethany Barber, RN
• Phone: 4163404800
• Email: Bethany.Barber[@]uhn.ca
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 2920
• Est. completion date: July 2025
• Est. primary completion date: July 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hepatitis
• Hepatitis A
• Hepatitis B
• Hepatitis C

Intervention

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.

Locations

Country	Name	City	State
Canada	Toronto General Hospital	Toronto	Ontario
Canada	Toronto Western Hospital	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
Jordan Feld

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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