National program for point-of-care testing of Hepatitis C in Australia

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

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
• Enrollment: 60000 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Kirby Institute (Government)
• Locations: 69 sites (Canberra, Australian Capital Territory and 68 other locations)
• Trial ID: NCT05042544 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates include individuals aged 18 and older with risk factors for HCV infection or those attending services for at-risk populations.

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.

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 performed: Previous studies have shown success with point-of-care testing interventions for Hepatitis C, indicating a promising approach for increasing diagnosis rates.

Eligibility 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 this trial is running

Canberra, Australian Capital Territory and 68 other locations

• Hepatitis ACT — Canberra, Australian Capital Territory, Australia (Recruiting)
• Western NSW LHD — Bathurst, New South Wales, Australia (Recruiting)
• Far West LHD — Broken Hill, New South Wales, Australia (Not_yet_recruiting)
• Maari Ma Health Aboriginal Corporation — Broken Hill, New South Wales, Australia (Completed)
• Galambila Aboriginal Health Service — Coffs Harbour, New South Wales, Australia (Completed)
• Central Coast LHD — Gosford, New South Wales, Australia (Recruiting)
• Armajun Health Service Aboriginal Corporation — Inverell, New South Wales, Australia (Completed)
• Rekindling the Spirit Health Service — Lismore, New South Wales, Australia (Completed)
• Asylum Seeker Centre — Newtown, New South Wales, Australia (Not_yet_recruiting)
• Nepean Blue Mountains LHD — Penrith, New South Wales, Australia (Recruiting)
• North and Mid North Coast LHD — Port Macquarie, New South Wales, Australia (Recruiting)
• Walhallow Aboriginal Corporation — Quirindi, New South Wales, Australia (Completed)
• Bulgarr Ngaru Medical Aboriginal Corporation — South Grafton, New South Wales, Australia (Completed)
• Kirketon Road Centre — Sydney, New South Wales, Australia (Recruiting)
• Nslhd — Sydney, New South Wales, Australia (Recruiting)
• WSLHD Drug Health — Sydney, New South Wales, Australia (Recruiting)
• South West Sydney LHD — 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)
• Cairns Sexual Health Service — Cairns, Queensland, Australia (Completed)
• 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)
• Ipswich Sexual Health and BBV Service, West Moreton Health — Ipswich, Queensland, Australia (Terminated)
• 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)
• Pangula Mannamurna Aboriginal Corporation — Mount Gambier, South Australia, Australia (Completed)
• Tasmanian Sexual Health Service - Clinic 60 — Hobart, Tasmania, Australia (Recruiting)
• Moreton Group Rural Health — New Town, Tasmania, Australia (Withdrawn)

Study contacts

• Study coordinator: David C Silk, BSc

Conditions Hepatitis C; Hepatitis C Virus