National program for point-of-care testing of Hepatitis C in Australia
Official title: 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
Run by Kirby Institute · NCT05042544 · Data updated 2026-11-12
This study is testing if quick finger-stick tests for Hepatitis C can help more people at risk get diagnosed and treated in places like drug clinics and prisons.
Quick facts
| Study type | Observational |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60000 (estimated) |
| Sponsor | Kirby Institute Government |
| Locations | 69 sites (Canberra, Australian Capital Territory and 68 other locations) |
| Status | Recruiting |
| Started | February 23, 2022 |
| Main results expected | June 30, 2029 |
| Study ends | June 30, 2029 |
| Registry record updated | September 28, 2026 |
| Trial ID | NCT05042544 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates include individuals aged 18 and older with risk factors for HCV infection or those attending services for at-risk populations.
✕Probably not a fit
Patients who do not have risk factors for HCV infection or are unwilling to provide informed consent may not benefit from this program.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This program aims to evaluate the effectiveness of finger-stick point-of-care testing for Hepatitis C (HCV) in increasing diagnosis and treatment rates among at-risk populations. Participants will be recruited from various settings, including drug treatment clinics and prisons, where they will undergo HCV RNA testing and complete a survey in a single visit. The study focuses on improving HCV treatment uptake to reduce the disease burden and aims to link those who test positive to standard care. The Kirby Institute, a leader in HCV research, will oversee the program.
Why it matters
Potential benefit: If successful, this program could significantly increase the diagnosis and treatment of Hepatitis C, contributing to its elimination in Australia by 2030.
How similar studies have gone: Previous studies have shown success with point-of-care testing interventions for Hepatitis C, indicating a promising approach for increasing diagnosis rates.
Who can join: the full rules
Show full inclusion / exclusion criteria
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.
Where it's running
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Hepatitis ACT
Canberra, Australian Capital Territory, Australia Recruiting -
Western NSW LHD
Bathurst, New South Wales, Australia Recruiting -
Central Coast LHD
Gosford, New South Wales, Australia Recruiting -
Nepean Blue Mountains LHD
Penrith, New South Wales, Australia Recruiting -
North and Mid North Coast LHD
Port Macquarie, New South Wales, Australia Recruiting -
Kirketon Road Centre
Sydney, New South Wales, Australia Recruiting
Show 44 more locations
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Nslhd
Sydney, New South Wales, Australia Recruiting -
WSLHD Drug Health
Sydney, New South Wales, Australia Recruiting -
Hepatitis NSW
Sydney, New South Wales, Australia Recruiting -
NSW Users and AIDS Association
Sydney, New South Wales, Australia Recruiting -
Prince of Wales Hospital
Sydney, New South Wales, Australia Recruiting -
SESLHD Community and Mental Health POCT Allicance (SCAMPA)
Sydney, New South Wales, Australia Recruiting -
SESLHD Drug Health
Sydney, New South Wales, Australia Recruiting -
Storr Liver Clinic (Westmead Hospital)
Sydney, New South Wales, Australia Recruiting -
Sydney Local Health District
Sydney, New South Wales, Australia Recruiting -
Murrumbidgee & Southern LHD
Wagga Wagga, New South Wales, Australia Recruiting -
Hunter New England LHD
Waratah, New South Wales, Australia Recruiting -
ISLHD Drug and Alcohol Service
Wollongong, New South Wales, Australia Recruiting -
ADSCA - Alice Springs Hospital
Alice Springs, Northern Territory, Australia Recruiting -
Clinic 34
Alice Springs, Northern Territory, Australia Recruiting -
Metro North HHS (Biala and Caboolture)
Brisbane, Queensland, Australia Recruiting -
IHWH Micah Projects
Brisbane, Queensland, Australia Recruiting -
Hepatitis QLD
Coorparoo, Queensland, Australia Recruiting -
Kombi Clinic
Inala, Queensland, Australia Recruiting -
Metro South Addiction Services - Inala AODS
Inala, Queensland, Australia Recruiting -
Ipswich AODS
Ipswich, Queensland, Australia Recruiting -
OneBridge
Maroochydore, Queensland, Australia Recruiting -
North West HHS - Mount Isa ATODS
Mount Isa, Queensland, Australia Recruiting -
Sunshine Coast HHS AODS
Nambour, Queensland, Australia Recruiting -
Ethnic Communities Council of Queensland
West End, Queensland, Australia Recruiting -
Clinic H
Adelaide, South Australia, Australia Recruiting -
The Queen Elizabeth Hospital, Central Adelaide LHN
Adelaide, South Australia, Australia Recruiting -
Drug and Alcohol Services South Australia
Adelaide, South Australia, Australia Recruiting -
Lyell McEwin Hospital, North Adelaide LHN
Adelaide, South Australia, Australia Recruiting -
Flinders Medical Centre, South Adelaide LHN
Adelaide, South Australia, Australia Recruiting -
Hepatitis SA
Hackney, South Australia, Australia Recruiting -
Tasmanian Sexual Health Service - Clinic 60
Hobart, Tasmania, Australia Recruiting -
Ballarat Community Health
Ballarat, Victoria, Australia Recruiting -
Harm Reduction Victoria
Brunswick, Victoria, Australia Recruiting -
Western Health
Footscray, Victoria, Australia Recruiting -
Eastern Health
Melbourne, Victoria, Australia Recruiting -
St Vincent's Hospital (Melbourne)
Melbourne, Victoria, Australia Recruiting -
Youth Projects - The Living Room
Melbourne, Victoria, Australia Recruiting -
Latrobe Community Health Service Liited
Morwell, Victoria, Australia Recruiting -
Goulburn Valley Community Health
Shepparton, Victoria, Australia Recruiting -
Primary Care Connect
Shepparton, Victoria, Australia Recruiting -
Peer Based Harm Reduction Bunbury
Bunbury, Western Australia, Australia Recruiting -
South Terrace Clinic - Fremantle Hospital
Fremantle, Western Australia, Australia Recruiting -
Pramana Medical Centre
Gosnells, Western Australia, Australia Recruiting -
Peer Based Harm Reduction - Perth
Perth, Western Australia, Australia Recruiting
+19 more sites. See ClinicalTrials.gov for the full list.
Study contacts
- Study coordinator: David C Silk, BSc
- Email: dsilk@kirby.unsw.edu.au
- Phone: +61293850900
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
-
Glecaprevir/pibrentasvir started during pregnancy for women with hepatitis C, with or without HIV
This trial will test whether taking glecaprevir/pibrentasvir during pregnancy is safe and how the drug is processed in pregnant women who have hepatitis C, including those who also have HIV, and will follow their infants for 10 weeks after birth.
-
Evaluating hepatitis C treatment during pregnancy
This study tests how well a new hepatitis C treatment works for pregnant adults with a history of drug use and looks at their experience during the treatment.
-
Decentralized treatment for hepatitis C in Brazil
This study is testing a new way to treat hepatitis C in Brazil using a medication called Epclusa to see if it helps more people get the care they need compared to traditional methods.
-
Helping young people who inject drugs start treatment for Hepatitis C
This study tests a new support program to help young adults who inject drugs start treatment for Hepatitis C and see if it works better than regular care.
-
Simplified hepatitis C testing with same-day treatment for people who inject drugs in Armenia, Georgia and Tanzania
This project will test whether a simplified pathway that starts hepatitis C treatment the same day after a quick antibody test helps people who inject drugs in Armenia, Georgia, and Tanzania get treated and cured faster than the usual antibody-plus-RNA pathway.
-
Point-of-care testing program for Hepatitis C screening
This study is testing if quick Hepatitis C tests done during a single visit can help more at-risk adults get diagnosed and start treatment faster.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.