The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset

The National Australian HCV Point-of-Care Testing Program: An Observational Cohort Study to Evaluate the Use of Finger-stick Point-of-care Hepatitis C Testing to Enhance Diagnosis and Treatment of HCV Infection - HCV Antibody Testing Minimal Dataset

The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is:

What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis?

Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit.

No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.

Study Overview

• Status: Recruiting
• Conditions: Hepatitis C
• Intervention / Treatment: Device: Diagnostic Test: Point-of-Care Testing

• Study Type: Observational
• Enrollment (Estimated): 40000

Contacts and Locations

• Study Contact: Name: Stephanie Davey, BSc; Phone Number: +61293481404; Email: sdavey@kirby.unsw.edu.au
• Study Contact Backup: Name: David Silk, BSc; Phone Number: +61293850900; Email: dsilk@kirby.unsw.edu.au

Study Locations

• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia
      • Not yet recruiting
      • ACT Justice Health
      • Contact: Alex Misev
      • Principal Investigator: Alex Misev, Dr
  • New South Wales
    • Sydney, New South Wales, Australia
      • Recruiting
      • Justice Health and Forensic Mental Health Network
      • Contact: Tracey Brown
  • Queensland
    • Bowen Hills, Queensland, Australia, 4006
      • Recruiting
      • Queensland Injectors Health Network Ltd
      • Contact: Nik Alexander
      • Principal Investigator: Nik Alexander
    • Brisbane, Queensland, Australia
      • Recruiting
      • West Moreton Hospital and Health Service
      • Contact: Blake Ponting
    • Cairns, Queensland, Australia
      • Recruiting
      • Lotus Glen Correctional Centre
      • Contact: Darren Russell
    • Townsville, Queensland, Australia, 4810
      • Not yet recruiting
      • Townsville Correctional Centre
      • Contact: John Morey
    • Woodford, Queensland, Australia
      • Recruiting
      • Woodford Correctional Centre
      • Contact: Rajendra Prakash
  • South Australia
    • Adelaide, South Australia, Australia
      • Not yet recruiting
      • South Australian Prison Health Service
      • Contact: Tom Turnbull
      • Principal Investigator: Tom Turnbull
    • Hackney, South Australia, Australia, 5069
      • Not yet recruiting
      • Hepatitis South Australia
      • Contact: Lisa Carter
  • Tasmania
    • Hobart, Tasmania, Australia
      • Not yet recruiting
      • Tasmanian Prison Service
      • Contact: Deborah Siddell
      • Principal Investigator: Meredith Stronach
  • Victoria
    • Melbourne, Victoria, Australia
      • Recruiting
      • St Vincent's Hospital (Melbourne)
      • Contact: Alex Thompson
      • Principal Investigator: Alex Thompson, Prof
  • Western Australia
    • Perth, Western Australia, Australia, 6000
      • Not yet recruiting
      • WA Department of Justice
      • Contact: Holly Beasley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Participants will be included from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated that approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.

Description

Inclusion Criteria:

• Provide informed consent
• ≥ 18 years of age.

Exclusion Criteria:

• Is unable or unwilling to provide informed consent

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
People at risk of HCV acquisition; Clinic staff will offer HCV point-of-care testing to participants as they access services. Testing will be performed using point-of-care HCV RNA testing	Device: Diagnostic Test: Point-of-Care Testing; Participants will be offered finger-stick point-of-care testing for HCV

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing.	HCV treatment	12 weeks from enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the proportion of people who accept point-of-care testing among those offered testing.	Accepting testing	Recruitment phase
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.	Prevalence	Recruitment phase
To evaluate the HCV antibody prevalence among people tested.	Prevalence	Recruitment phase
To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;	Time to treatment	52 weeks
To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.	Initiation of treatment	52 weeks
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;	Completion of treatment	52 weeks
To evaluate the proportion of participants who achieve an SVR following point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment	SVR	52 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.	HCV negative	52 weeks
To evaluate the cost of point-of-care HCV antibody testing prior to reflex HCV RNA testing compared to direct point-of-care HCV RNA testing and standard of care.	Cost-effectiveness	52 weeks

Collaborators and Investigators

• Sponsor: Kirby Institute
• Collaborators: Flinders University

Study record dates

Study Major Dates

• Study Start (Actual): January 25, 2023
• Primary Completion (Estimated): January 1, 2025
• Study Completion (Estimated): January 1, 2027

Study Registration Dates

• First Submitted: January 17, 2023
• First Submitted That Met QC Criteria: February 1, 2023
• First Posted (Actual): February 6, 2023

Study Record Updates

• Last Update Posted (Actual): July 3, 2024
• Last Update Submitted That Met QC Criteria: July 2, 2024
• Last Verified: July 1, 2024

More Information

Terms related to this study

• Keywords: HCV; Point-of-Care; Rapid Diagnostic Testing
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Blood-Borne Infections; Communicable Diseases; Liver Diseases; Flaviviridae Infections; Hepatitis, Viral, Human; Hepatitis; Hepatitis C
• Other Study ID Numbers: VHCRP2203

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No