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

The National Australian HCV Point-of-Care Testing Program will establish an observational cohort to evaluate whether scale-up of finger-stick point-of-care HCV testing increases diagnosis and treatment for HCV infection. Participants will be recruited from settings providing services to people with a risk factor for the acquisition of HCV infection (including drug treatment clinics, needle and syringe programs, homelessness settings, mental health services, prisons, and mobile outreach). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care.

Study Overview

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

Detailed Description

The advent of simple direct-acting antiviral hepatitis C (HCV) therapies with cure rates >95% is one of the greatest medical advances in decades, having led to a reversal in liver-related mortality. In Australia, treatment uptake has declined between 2016 (32,000 treated) and 2019/20 (2019: 11,500; 2020: 8,500).1 Progress towards HCV elimination has been impeded by COVID-19, affecting the delivery of national and state-based HCV strategies. Improving HCV treatment uptake to reduce disease burden is a key aim of global, national and state-based HCV strategies.2-4

Scale-up of HCV testing and treatment will be required to achieve elimination by 2030. Current diagnostic pathways require multiple visits to a practitioner reducing the proportion who receive a diagnosis. In Australia, 81% of people have had HCV antibody testing (indicates exposure), but only 47% have been HCV RNA tested (indicates active infection and the need for HCV treatment).5 Mathematical modelling suggests that HCV RNA testing needs to increase by at least 50% annually to achieve elimination in Australia by 2030.6

The Kirby Institute is an international leader in research evaluating the Xpert HCV assay (Grebely Lancet Gastro Hep 2017), having built a large network of Xpert platforms for HCV testing in needle and syringe programs, prisons, drug treatment clinics, tertiary hospitals, and Aboriginal Community Controlled Health Service. In Kirby-led research, point-of-care HCV testing interventions in needle and syringe programs and prisons have resulted in high HCV treatment uptake (70-90%). The Kirby Institute and Flinders University also have a strong track record of implementing point-of-care testing for STIs and COVID-19, providing an ideal foundation to scale-up Xpert HCV testing in Australia.

The Kirby Institute and Flinders University will establish the Australian National HCV Point-of-care Testing Program for the scale-up of point-of-care HCV RNA testing in services with high prevalence of HCV infection, including community health centres, drug treatment clinics, needle and syringe programs, and prisons. This program will include the development of standard operating procedures, logistics/deployment, initial set-up, an operator training program, and quality assurance and competency assessment program.

An observational cohort study will be established to evaluate HCV treatment uptake following scale-up of point-of-care HCV testing among people with a risk factor for acquisition of HCV infection or people attending a service caring for people with risk factors for the acquisition of HCV infection.

Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. All participants who undergo point-of-care HCV testing at the study site will be included in the data collection. Participants will not receive treatment as a part of this study. Participants who are HCV RNA positive will be linked to standard of care for any other clinical assessments and treatment initiation.

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

Contacts and Locations

• Study Contact: Name: Simon Comben, BSc, MN; Phone Number: +6193480777; Email: scomben@kirby.unsw.edu.au
• Study Contact Backup: Name: David Silk, BSc; Phone Number: +61293850900; Email: dsilk@kirby.unsw.edu.au

Study Locations

• Australia
  • New South Wales
    • Sydney, New South Wales, Australia
      • Not yet recruiting
      • Justice Health and Forensic Mental Health Network
      • Contact: Tracey Brown
  • Queensland
    • Cairns, Queensland, Australia
      • Recruiting
      • Lotus Glen Correctional Centre
      • Contact: Darren Russell
      • Principal Investigator: Darren Russell
    • Coorparoo, Queensland, Australia, 4151
      • Not yet recruiting
      • Hepatitis Queensland
      • Contact: Rachael Bryett
      • Principal Investigator: Rachael Bryett
    • Ipswich, Queensland, Australia
      • Recruiting
      • West Moreton Hospital and Health Service
      • Contact: Blake Ponting
      • Principal Investigator: Blake Ponting
    • Townsville, Queensland, Australia
      • Recruiting
      • Townsville Correctional Centre
      • Contact: John Morey
      • Principal Investigator: John Morey
    • Woodford, Queensland, Australia
      • Recruiting
      • Woodford Correctional Centre
      • Contact: Rajendra Prakash
      • Principal Investigator: Rajendra Prakash
  • South Australia
    • Marden, South Australia, Australia, 5070
      • Not yet recruiting
      • South Australian Prison Health Service
      • Contact: Tom Turnbull
      • Principal Investigator: Tom Turnbull
    • Mount Gambier, South Australia, Australia, 5290
      • Not yet recruiting
      • Mount Gambier Priosn
      • Contact: William Galloway
      • Principal Investigator: William Galloway
  • Victoria
    • Fitzroy, Victoria, Australia, 3065
      • Not yet recruiting
      • St Vincent's Correctional Health Services
      • Contact: Alex Thompson
      • Principal Investigator: Alex Thompson
    • Melbourne, Victoria, Australia, 3000
      • Not yet recruiting
      • Medically Supervised Injecting Room
      • Contact: Nathan Stam
      • Principal Investigator: Nathan Stam
    • Ravenhall, Victoria, Australia, 3023
      • Not yet recruiting
      • Geo Healthcare - The Geo Group Australia Pty Ltd
      • Contact: David Grace
      • Principal Investigator: David Grace

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 recruited 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 approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.

Description

Inclusion Criteria:

• ≥ 18 years of age.
• Received point-of-care HCV testing.

Exclusion Criteria:

• Nil

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

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.	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
The proportion of HCV infected participants who initiate HCV treatment at 12 weeks	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.	12 Weeks from enrolment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The proportion of participants who accept point-of-care testing	To evaluate the proportion of people who accept point-of-care testing among those offered testing.	2 years from recruitment commencement
The prevalence of HCV infection amongst study participants tested	To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.	2 years from recruitment commencement
To evaluate the time to HCV treatment uptake among HCV RNA positive participants	To evaluate the length of time participants take to initiate HCV treatment after diagnosis	52 weeks
To evaluate proportion of HCV RNA positive participants who initiate HCV treatment	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.	52 weeks
To evaluate the proportion of participants who complete HCV (DAA) treatment	To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.	52 weeks
To evaluate the proportion of participants who achieve an SVR	To evaluate the proportion of participants who achieve an SVR (defined as HCV RNA below the lower limit of quantitation at post treatment week 12).	12 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months	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.	52 weeks

Collaborators and Investigators

• Sponsor: Kirby Institute
• Collaborators: Flinders University

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: December 12, 2021
• First Submitted That Met QC Criteria: February 9, 2022
• First Posted (Actual): February 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 13, 2024
• Last Update Submitted That Met QC Criteria: June 11, 2024
• Last Verified: June 1, 2024

More Information

Terms related to this study

• Keywords: Hepatitis C Virus
• 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; Enterovirus Infections; Picornaviridae Infections; Hepatitis; Hepatitis A; Hepatitis C
• Other Study ID Numbers: VHCRP2104

Drug and device information, study documents

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