Recruiting

Hepatitis C & B

Sponsor:

Jordan Feld

Code:

NCT04620226

Conditions

Hepatitis C

Hepatitis B

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Quality Improvement

Study Details

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 ID

NCT04620226

Start date

Feb 1, 2024

Status verified date

Feb, 2024

Completion date

Jul, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

2920 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Screening

Interventions and Outcome Measures

Arms

no intervention: 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.

experimental: 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.

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.

Primary outcome measure

  • Number of HCV antibody positive participants who complete an HCV RNA PCR. [ Time Frame: 2 year ]
  • Number of HCV RNA positive participants who attend their first hepatology appointment. [ Time Frame: 2 year ]
  • Number of HCV RNA positive participants who achieve a Sustained Virological Response at 12 weeks (SVR12) after treatment completion. [ Time Frame: 2 year ]

Central Contacts and Locations

Central contacts

Locations

Toronto General Hospital

Recruiting

Toronto, Ontario, Canada, M5G 2C4

Toronto Western Hospital

Recruiting

Toronto, Ontario, Canada, M5T 2S8

More Information

Sponsor

Jordan Feld

Last update posted

Feb 8, 2024

Last verified

Feb, 2024

Keywords

  • Hepatitis C
  • Hepatitis B
  • Screening
  • Inpatient
  • Hospital

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Jordan Feld on 2024-02-08.