The National Australian HCV Point-of-Care Testing Program

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

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). Participants will attend a single visit to have their HCV RNA status tested and complete a self-administered survey. 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 that 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. This study will also include the linkage of survey data to a range of administrative datasets which will be used to evaluate the impact of HCV testing and treatment scale-up on a range of long-term health outcomes.

Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to receive point-of-care HCV testing and complete a self-administered survey. Testing will be performed using point-of-care HCV antibody testing (results within 1-20 minutes, depending on the test) and if positive, HCV RNA testing will be performed. Participants who have previously had HCV infection or previously received HCV treatment will be tested using point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA detectable 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: David C Silk, BSc; Phone Number: +61293850900; Email: dsilk@kirby.unsw.edu.au

Study Locations

• Australia
  • Australian Capital Territory
    • Canberra, Australian Capital Territory, Australia, 2612
      • Recruiting
      • Hepatitis ACT
      • Contact: Sarah Ahmed
  • New South Wales
    • Bathurst, New South Wales, Australia, 2795
      • Recruiting
      • Western NSW LHD
      • Contact: Katherine McQuillan
    • Broken Hill, New South Wales, Australia
      • Recruiting
      • Maari Ma Health Aboriginal Corporation
      • Contact: Regan Chesterfield
    • Broken Hill, New South Wales, Australia
      • Not yet recruiting
      • Far West LHD
      • Contact: Kendall Jackman
    • Coffs Harbour, New South Wales, Australia
      • Recruiting
      • Galambila Aboriginal Health Service
      • Contact: Robert Harris
    • Gosford, New South Wales, Australia, 2250
      • Not yet recruiting
      • Central Coast LHD
      • Contact: Amanda Burfitt
    • Inverell, New South Wales, Australia
      • Recruiting
      • Armajun Health Service Aboriginal Corporation
      • Contact: Debbie McCowen
    • Lismore, New South Wales, Australia
      • Recruiting
      • Jullums Lismore Aboriginal Service
      • Contact: Peter Silberberg
    • Penrith, New South Wales, Australia
      • Recruiting
      • Nepean Blue Mountains LHD
      • Contact: Julie Page
    • Port Macquarie, New South Wales, Australia, 2444
      • Recruiting
      • North and Mid North Coast LHD
      • Contact: Alexandra Wade
    • Quirindi, New South Wales, Australia
      • Recruiting
      • Walhallow Aboriginal Corporation
      • Contact: Suruchi Amarasena
    • South Grafton, New South Wales, Australia
      • Recruiting
      • Bulgarr Ngaru Medical Aboriginal Corporation
      • Contact: Marion Tait
    • Sydney, New South Wales, Australia
      • Recruiting
      • Prince of Wales Hospital
      • Contact: Marianne Martinello
    • Sydney, New South Wales, Australia, 2010
      • Recruiting
      • Kirketon Road Centre
      • Contact: Phillip Read
    • Sydney, New South Wales, Australia, 2151
      • Recruiting
      • WSLHD Drug Health
      • Contact: Thao Lam
    • Sydney, New South Wales, Australia, 2170
      • Recruiting
      • South West Sydney LHD
      • Contact: Gilbert Whitton
    • Sydney, New South Wales, Australia
      • Recruiting
      • NSW Users and AIDS Association
      • Contact: Charles Henderson
    • Sydney, New South Wales, Australia
      • Recruiting
      • SESLHD Community and Mental Health POCT Allicance (SCAMPA)
      • Contact: Amany Zekry
    • Sydney, New South Wales, Australia
      • Not yet recruiting
      • SESLHD Drug Health
      • Contact: Apo Demirkol
    • Sydney, New South Wales, Australia
      • Recruiting
      • Storr Liver Clinic (Westmead Hospital)
      • Contact: Jacob George
    • Sydney, New South Wales, Australia
      • Recruiting
      • Sydney Local Health District
      • Contact: Shih-Chi Kao
    • Sydney, New South Wales, Australia, 2065
      • Recruiting
      • NSLHD
      • Contact: Mark Montebello
    • Sydney, New South Wales, Australia
      • Not yet recruiting
      • Hepatitis NSW
      • Contact: Steven Drew
    • Wagga Wagga, New South Wales, Australia
      • Recruiting
      • Murrumbidgee & Southern LHD
      • Contact: Alison Nikitas
    • Waratah, New South Wales, Australia
      • Recruiting
      • Hunter New England LHD
      • Contact: Melanie Kingsland
    • Wollongong, New South Wales, Australia
      • Recruiting
      • ISLHD Drug and Alcohol Service
      • Contact: David Reid
  • Northern Territory
    • Alice Springs, Northern Territory, Australia
      • Recruiting
      • ADSCA - Alice Springs Hospital
      • Contact: Dan Wilson
  • Queensland
    • Brisbane, Queensland, Australia, 4000
      • Not yet recruiting
      • Metro North Hospital and Health Service
      • Contact: Jeremy Hayllar
    • Brisbane, Queensland, Australia, 4101
      • Recruiting
      • Micah Projects
      • Contact: Kim Rayner
    • Cairns, Queensland, Australia, 4870
      • Recruiting
      • Cairns Sexual Health Service
      • Contact: Carla Gorton
    • Coorparoo, Queensland, Australia
      • Recruiting
      • Hepatitis QLD
      • Contact: Rachael Bryett
    • Inala, Queensland, Australia, 4077
      • Recruiting
      • Kombi Clinic
      • Contact: Joss O'Loan
    • Inala, Queensland, Australia, 4077
      • Not yet recruiting
      • Metro South Addiction Services - Inala ADS
      • Contact: Holly McCormick
    • Ipswich, Queensland, Australia, 4305
      • Not yet recruiting
      • Ipswich AODS
      • Contact: Lorraine Barber
    • Ipswich, Queensland, Australia, 4305
      • Terminated
      • Ipswich Sexual Health and BBV Service, West Moreton Health
    • Maroochydore, Queensland, Australia, 4560
      • Not yet recruiting
      • OneBridge
      • Contact: Sonia Martin
  • South Australia
    • Adelaide, South Australia, Australia, 5000
      • Recruiting
      • Central Adelaide Local Health Network
      • Contact: Morgyn Warner
    • Adelaide, South Australia, Australia, 5112
      • Not yet recruiting
      • North Adelaide Local Health Network
      • Contact: Damien Harding
    • Adelaide, South Australia, Australia, 5168
      • Recruiting
      • South Adelaide Local Health Network
      • Contact: Alan Wigg
    • Adelaide, South Australia, Australia, 5069
      • Recruiting
      • Drug and Alcohol Services South Australia
      • Contact: Victoria Cock
    • Hackney, South Australia, Australia, 5069
      • Not yet recruiting
      • Hepatitis SA
      • Contact: Kerry Paterson
    • Mount Gambier, South Australia, Australia
      • Active, not recruiting
      • Pangula Mannamurna Aboriginal Corporation
    • Murray Bridge, South Australia, Australia
      • Withdrawn
      • Moorundi Aboriginal Community Controlled Aboriginal Health Service
  • Tasmania
    • Hobart, Tasmania, Australia
      • Recruiting
      • Clinic 60 (Sexual Health Services)
      • Contact: Megan Hughes
    • New Town, Tasmania, Australia
      • Terminated
      • Moreton Group Rural Health
  • Victoria
    • Footscray, Victoria, Australia, 3011
      • Not yet recruiting
      • Western Health
      • Contact: Thileepan Naren
    • Melbourne, Victoria, Australia
      • Recruiting
      • St Vincent's Hospital (Melbourne)
      • Contact: Jacinta Holmes
    • Melbourne, Victoria, Australia
      • Not yet recruiting
      • Youth Projects - The Living Room
      • Contact: Hayley Morgan
    • Melbourne, Victoria, Australia, 3128
      • Not yet recruiting
      • Eastern Health
      • Contact: Rohit Sawhney
    • Morwell, Victoria, Australia, 3840
      • Not yet recruiting
      • Latrobe Community Health Service Liited
      • Contact: Michelle Francis
  • Western Australia
    • Bunbury, Western Australia, Australia, 6230
      • Recruiting
      • Peer Based Harm Reduction Bunbury
      • Contact: Leanne Myers
    • Fremantle, Western Australia, Australia
      • Not yet recruiting
      • South Terrace Clinic - Fremantle Hospital
      • Contact: Joseph Cotter
    • Perth, Western Australia, Australia
      • Not yet recruiting
      • Next Step East Perth
      • Contact: Shuan Tan
    • Perth, Western Australia, Australia
      • Not yet recruiting
      • Next Step Fremantle
      • Contact: Michael Christmass
    • Perth, Western Australia, Australia
      • Not yet recruiting
      • Next Step Warwick
      • Contact: Wendy Lawrence
    • Perth, Western Australia, Australia, 6230
      • Recruiting
      • Peer Based Harm Reduction WA
      • Contact: Leanne Myers
    • Perth, Western Australia, Australia
      • Withdrawn
      • Busy Bee Pharmacy
    • Perth, Western Australia, Australia
      • Recruiting
      • Hepatitis WA
      • Contact: Brent Bell

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:

1. Provided informed consent.
2. ≥ 18 years of age.

3. Have a risk factor for the acquisition of HCV infection (including current or past injecting drug use, previous incarceration, HIV infection, receiving blood products prior to 1990, having a tattoo or piercing in an unregulated environment, a needle-stick injury, or a mother with HCV).

   OR:

4. Are attending a service caring for people with risk factors for the acquisition of HCV infection (e.g. drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, and homelessness services).

Exclusion Criteria:

a. Is unable or unwilling to provide informed consent or abide by the requirements of the study.

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; This is an observational cohort study. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to receive point-of-care HCV testing and complete a self-administered survey. Testing will be performed using point-of-care HCV antibody testing (results within 1-20 minutes, depending on the test) and if positive, HCV RNA testing will be performed. Participants who have previously had HCV infection or previously received HCV treatment will be tested using point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA detectable will be linked to standard of care for any other clinical assessments and treatment initiation.

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 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 time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing	Time to treatment	52 weeks
To evaluate the proportion of HCV RNA detectable participants who initiate HCV treatment at 12 months (52 weeks) following detectable 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.	Completion of treatment	52 weeks
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) following a detectable HCV RNA test result.	SVR	12 weeks
To evaluate the proportion of participants who are HCV RNA negative at 12 months (52 weeks) following a detectable HCV RNA test.	HCV negative	52 weeks
To evaluate the cost-effectiveness of different testing strategies	Cost-effectiveness	52 weeks

Collaborators and Investigators

• Sponsor: Kirby Institute

Study record dates

Study Major Dates

• Study Start (Actual): February 22, 2022
• Primary Completion (Estimated): December 31, 2024
• Study Completion (Estimated): December 31, 2025

Study Registration Dates

• First Submitted: August 20, 2021
• First Submitted That Met QC Criteria: September 6, 2021
• First Posted (Actual): September 13, 2021

Study Record Updates

• Last Update Posted (Estimated): February 28, 2024
• Last Update Submitted That Met QC Criteria: February 26, 2024
• Last Verified: February 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: VHCRP2101

Drug and device information, study documents

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