The National Australian HCV Point-of-Care Testing Program
NCT ID: NCT05042544
Last Updated: 2024-06-13
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
40000 participants
OBSERVATIONAL
2022-02-22
2026-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
The National Australian HCV Point-of-Care Testing Program - Minimal Dataset
NCT05248555
The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset
NCT05713136
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
NCT03776760
Control and Elimination Within Australia of Hepatitis C From People Living With HIV
NCT02102451
Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%
NCT05264558
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
COHORT
PROSPECTIVE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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.
Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Point-of-Care Testing
Participants will be offered finger-stick point-of-care testing for HCV
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Flinders University
OTHER
Kirby Institute
OTHER_GOV
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Hepatitis ACT
Canberra, Australian Capital Territory, Australia
Western NSW LHD
Bathurst, New South Wales, Australia
Far West LHD
Broken Hill, New South Wales, Australia
Maari Ma Health Aboriginal Corporation
Broken Hill, New South Wales, Australia
Galambila Aboriginal Health Service
Coffs Harbour, New South Wales, Australia
Central Coast LHD
Gosford, New South Wales, Australia
Armajun Health Service Aboriginal Corporation
Inverell, New South Wales, Australia
Rekindling the Spirit Health Service
Lismore, New South Wales, Australia
Nepean Blue Mountains LHD
Penrith, New South Wales, Australia
North and Mid North Coast LHD
Port Macquarie, New South Wales, Australia
Walhallow Aboriginal Corporation
Quirindi, New South Wales, Australia
Bulgarr Ngaru Medical Aboriginal Corporation
South Grafton, New South Wales, Australia
Kirketon Road Centre
Sydney, New South Wales, Australia
NSLHD
Sydney, New South Wales, Australia
WSLHD Drug Health
Sydney, New South Wales, Australia
South West Sydney LHD
Sydney, New South Wales, Australia
Hepatitis NSW
Sydney, New South Wales, Australia
NSW Users and AIDS Association
Sydney, New South Wales, Australia
Prince of Wales Hospital
Sydney, New South Wales, Australia
SESLHD Community and Mental Health POCT Allicance (SCAMPA)
Sydney, New South Wales, Australia
SESLHD Drug Health
Sydney, New South Wales, Australia
Storr Liver Clinic (Westmead Hospital)
Sydney, New South Wales, Australia
Sydney Local Health District
Sydney, New South Wales, Australia
Murrumbidgee & Southern LHD
Wagga Wagga, New South Wales, Australia
Hunter New England LHD
Waratah, New South Wales, Australia
ISLHD Drug and Alcohol Service
Wollongong, New South Wales, Australia
ADSCA - Alice Springs Hospital
Alice Springs, Northern Territory, Australia
Alcohol and Harm Reduction Biala
Brisbane, Queensland, Australia
Micah Projects
Brisbane, Queensland, Australia
Cairns Sexual Health Service
Cairns, Queensland, Australia
Hepatitis QLD
Coorparoo, Queensland, Australia
Kombi Clinic
Inala, Queensland, Australia
Metro South Addiction Services - Inala ADS
Inala, Queensland, Australia
Ipswich AODS
Ipswich, Queensland, Australia
Ipswich Sexual Health and BBV Service, West Moreton Health
Ipswich, Queensland, Australia
OneBridge
Maroochydore, Queensland, Australia
Central Adelaide Local Health Network
Adelaide, South Australia, Australia
Drug and Alcohol Services South Australia
Adelaide, South Australia, Australia
North Adelaide Local Health Network
Adelaide, South Australia, Australia
South Adelaide Local Health Network
Adelaide, South Australia, Australia
Hepatitis SA
Hackney, South Australia, Australia
Pangula Mannamurna Aboriginal Corporation
Mount Gambier, South Australia, Australia
Clinic 60 (Sexual Health Services)
Hobart, Tasmania, Australia
Moreton Group Rural Health
New Town, Tasmania, Australia
Western Health
Footscray, Victoria, Australia
Eastern Health
Melbourne, Victoria, Australia
St Vincent's Hospital (Melbourne)
Melbourne, Victoria, Australia
Youth Projects - The Living Room
Melbourne, Victoria, Australia
Latrobe Community Health Service Liited
Morwell, Victoria, Australia
Peer Based Harm Reduction Bunbury
Bunbury, Western Australia, Australia
South Terrace Clinic - Fremantle Hospital
Fremantle, Western Australia, Australia
Peer Based Harm Reduction WA
Perth, Western Australia, Australia
Hepatitis WA
Perth, Western Australia, Australia
Next Step East Perth
Perth, Western Australia, Australia
Next Step Fremantle
Perth, Western Australia, Australia
Next Step Warwick
Perth, Western Australia, Australia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Sarah Ahmed
Role: primary
Katherine McQuillan
Role: primary
Kendall Jackman
Role: primary
Regan Chesterfield
Role: primary
Amanda Burfitt
Role: primary
Peter Silberberg
Role: primary
Julie Page
Role: primary
Alexandra Wade
Role: primary
Suruchi Amarasena
Role: primary
Marion Tait
Role: primary
Phillip Read
Role: primary
Mark Montebello
Role: primary
Thao Lam
Role: primary
Gilbert Whitton
Role: primary
Steven Drew
Role: primary
Charles Henderson
Role: primary
Marianne Martinello
Role: primary
Amany Zekry
Role: primary
Apo Demirkol
Role: primary
Jacob George
Role: primary
Shih-Chi Kao
Role: primary
Alison Nikitas
Role: primary
Melanie Kingsland
Role: primary
David Reid
Role: primary
Dan Wilson
Role: primary
Jeremy Hayllar
Role: primary
Kim Rayner
Role: primary
Rachael Bryett
Role: primary
Joss O'Loan
Role: primary
Holly McCormick
Role: primary
Lorraine Barber
Role: primary
Sonia Martin
Role: primary
Morgyn Warner
Role: primary
Victoria Cock
Role: primary
Damien Harding
Role: primary
Alan Wigg
Role: primary
Kerry Paterson
Role: primary
Megan Hughes
Role: primary
Thileepan Naren
Role: primary
Rohit Sawhney
Role: primary
Jacinta Holmes
Role: primary
Hayley Morgan
Role: primary
Michelle Francis
Role: primary
Leanne Myers
Role: primary
Joseph Cotter
Role: primary
Leanne Myers
Role: primary
Brent Bell
Role: primary
Shuan Tan
Role: primary
Michael Christmass
Role: primary
Wendy Lawrence
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VHCRP2101
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.