The Australian HCV Point-of-Care Testing Program

NCT05042544 · tracked via the Priya Life Science Australia tracker

Sponsor

Kirby Institute

Phase

Observational

Started

2022-02-23

Last updated

2026-09-28

Condition(s) studied

Hepatitis C

Investigational drug(s) / intervention(s)

Point-of-Care Testing

Point-of-Care Testing: Participants will be offered finger-stick point-of-care testing for HCV

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

Accepted

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.

Primary outcome measure(s)

To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following HCV RNA testing. — 12 Weeks from enrolment
HCV treatment

Trial sites (69)

Facility	City	Region	Status
Hepatitis ACT	Canberra	Australian Capital Territory	Recruiting
Western NSW LHD	Bathurst	New South Wales	Recruiting
Far West LHD	Broken Hill	New South Wales	Not Yet Recruiting
Maari Ma Health Aboriginal Corporation	Broken Hill	New South Wales	Completed
Galambila Aboriginal Health Service	Coffs Harbour	New South Wales	Completed
Central Coast LHD	Gosford	New South Wales	Recruiting
Armajun Health Service Aboriginal Corporation	Inverell	New South Wales	Completed
Rekindling the Spirit Health Service	Lismore	New South Wales	Completed
Asylum Seeker Centre	Newtown	New South Wales	Not Yet Recruiting
Nepean Blue Mountains LHD	Penrith	New South Wales	Recruiting
North and Mid North Coast LHD	Port Macquarie	New South Wales	Recruiting
Walhallow Aboriginal Corporation	Quirindi	New South Wales	Completed
Bulgarr Ngaru Medical Aboriginal Corporation	South Grafton	New South Wales	Completed
Kirketon Road Centre	Sydney	New South Wales	Recruiting
NSLHD	Sydney	New South Wales	Recruiting
WSLHD Drug Health	Sydney	New South Wales	Recruiting
South West Sydney LHD	Sydney	New South Wales	Completed
Hepatitis NSW	Sydney	New South Wales	Recruiting
NSW Users and AIDS Association	Sydney	New South Wales	Recruiting
Prince of Wales Hospital	Sydney	New South Wales	Recruiting
SESLHD Community and Mental Health POCT Allicance (SCAMPA)	Sydney	New South Wales	Recruiting
SESLHD Drug Health	Sydney	New South Wales	Recruiting
Storr Liver Clinic (Westmead Hospital)	Sydney	New South Wales	Recruiting
Sydney Local Health District	Sydney	New South Wales	Recruiting
Murrumbidgee & Southern LHD	Wagga Wagga	New South Wales	Recruiting
Hunter New England LHD	Waratah	New South Wales	Recruiting
ISLHD Drug and Alcohol Service	Wollongong	New South Wales	Recruiting
ADSCA - Alice Springs Hospital	Alice Springs	Northern Territory	Recruiting
Clinic 34	Alice Springs	Northern Territory	Recruiting
Metro North HHS (Biala and Caboolture)	Brisbane	Queensland	Recruiting
IHWH Micah Projects	Brisbane	Queensland	Recruiting
Cairns Sexual Health Service	Cairns	Queensland	Completed
Hepatitis QLD	Coorparoo	Queensland	Recruiting
Kombi Clinic	Inala	Queensland	Recruiting
Metro South Addiction Services - Inala AODS	Inala	Queensland	Recruiting
Ipswich AODS	Ipswich	Queensland	Recruiting
Ipswich Sexual Health and BBV Service, West Moreton Health	Ipswich	Queensland	Terminated
OneBridge	Maroochydore	Queensland	Recruiting
North West HHS - Mount Isa ATODS	Mount Isa	Queensland	Recruiting
Sunshine Coast HHS AODS	Nambour	Queensland	Recruiting

+ 29 more sites — see the full list on the official registry below.

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05042544 on ClinicalTrials.gov ↗ ← All trials in Australia