UHN Inpatient Hepatitis C & B Screening
Primary Purpose
Hepatitis C, Hepatitis B
Status
Unknown status
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Quality Improvement
Sponsored by
About this trial
This is an interventional screening trial for Hepatitis C focused on measuring Hepatitis C, Hepatitis B, Screening, Inpatient, Hospital
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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Conventional Serum Testing
Rapid Point-of-Care Testing
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
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.
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04620226
Brief Title
UHN Inpatient Hepatitis C & B Screening
Official Title
Screening for Hepatitis C and Hepatitis B in Inpatients: A Toronto Viral Hepatitis Care Network (VIRCAN) Collaboration
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Unknown status
Study Start Date
January 2021 (Anticipated)
Primary Completion Date
July 2022 (Anticipated)
Study Completion Date
July 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Jordan Feld
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hepatitis C, Hepatitis B
Keywords
Hepatitis C, Hepatitis B, Screening, Inpatient, Hospital
7. Study Design
Primary Purpose
Screening
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
2920 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Conventional Serum Testing
Arm Type
No Intervention
Arm Description
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.
Arm Title
Rapid Point-of-Care Testing
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Quality Improvement
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of HCV antibody positive participants who complete an HCV RNA PCR.
Description
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.
Time Frame
2 year
Title
Number of HCV RNA positive participants who attend their first hepatology appointment.
Description
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.
Time Frame
2 year
Title
Number of HCV RNA positive participants who achieve a Sustained Virological Response at 12 weeks (SVR12) after treatment completion.
Description
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.
Time Frame
2 year
Secondary Outcome Measure Information:
Title
Number of chronic hepatitis C and hepatitis B infection in the general internal medicine inpatient units.
Description
Proportion of screened participants who are positive and chronically infected in general internal medicine inpatient units.
Time Frame
1 year
Title
Number of patients willing to participate in hepatitis C and hepatitis B screening in general internal medicine inpatient units.
Description
To determine acceptability of implementing hepatitis C and hepatitis B screening in general internal medicine inpatient units.
Time Frame
1 year
Title
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.
Description
To determine the effect of hepatitis C and hepatitis B screening on hospital staff workflow in general internal medicine inpatient units.
Time Frame
1 year
Title
Proportion of Cepheid Xpert® HCV Viral Load test results matching test results from the standard commercial assay for HCV RNA PCR.
Description
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.
Time Frame
1 year
Title
Retrospective rates of HCV testing, HCV antibody positive results, and HCV RNA positive results in general internal medicine inpatient units.
Description
To determine the historical rate of HCV screening and chronic HCV infection in general internal medicine inpatient units.
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Brett Wolfson-Stofko, PhD
Phone
4163404800
Ext
8842
Email
brett.wolfson-stofko@uhnresearch.ca
First Name & Middle Initial & Last Name or Official Title & Degree
Camelia Capraru
Phone
4163404800
Ext
2926
Email
camelia.capraru@uhnresearch.ca
12. IPD Sharing Statement
Plan to Share IPD
No
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UHN Inpatient Hepatitis C & B Screening
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