RecruitingNCT05042544

The 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

Sponsor

Kirby Institute

Enrollment

60,000 participants

Start Date

Feb 22, 2022

Study Type

OBSERVATIONAL

Conditions

Hepatitis C

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This program is testing rapid point-of-care testing for hepatitis C (HCV) — a blood-borne virus that can damage the liver — at community locations across Australia that serve people at risk, so that infection can be detected and treated faster without needing a hospital visit. **You may be eligible if...** - You are 18 or older - You have at least one risk factor for hepatitis C, such as: ever injecting drugs, being incarcerated, having HIV, receiving blood products before 1990, having a tattoo or piercing in an unregulated setting, or a needle-stick injury - OR you are attending a service that supports people with these risk factors **You may NOT be eligible if...** - You are unable or unwilling to provide informed consent Talk to your doctor to see if this trial is right for you.

This is a simplified summary. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIAGNOSTIC_TESTPoint-of-Care Testing

Participants will be offered finger-stick point-of-care testing for HCV

Locations(69)

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

Asylum Seeker Centre

Newtown, 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