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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
Jordan Feld
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Hepatitis C focused on measuring Hepatitis C, Hepatitis B, Screening, Inpatient, Hospital

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

    First Posted
    October 1, 2020
    Last Updated
    November 5, 2020
    Sponsor
    Jordan Feld
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    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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