RecruitingNCT05042544

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

Sponsor

Kirby Institute

Enrollment

40,000 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

Inclusion Criteria5

Provided informed consent.
≥ 18 years of age.
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:
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 Criteria1

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

Interventions

DIAGNOSTIC_TESTPoint-of-Care Testing

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

Locations(56)

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