Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

60,000

participants targeted

Target at P75+ for all trials

Timeline

38mo left

Started Feb 2022

Longer than P75 for all trials

Geographic Reach

1 country

69 active sites

Status

recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

7.4 years study duration

Study Progress59%

Feb 2022Jun 2029

First Submitted

Initial submission to the registry

August 20, 2021

Completed

24 days until next milestone

First Posted

Study publicly available on registry

September 13, 2021

Completed

5 months until next milestone

Study Start

First participant enrolled

February 22, 2022

Completed

7.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2029

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2029

Last Updated

March 31, 2026

Status Verified

March 1, 2026

Enrollment Period

7.4 years

First QC Date

August 20, 2021

Last Update Submit

March 26, 2026

Conditions

Hepatitis C

Keywords

Hepatitis C Virus

Outcome Measures

Primary Outcomes (1)

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

Secondary Outcomes (8)

To evaluate the proportion of people who accept point-of-care testing among those offered testing.
Recruitment phase
To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.
Recruitment phase
To evaluate the time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing
52 weeks
To evaluate the proportion of HCV RNA detectable participants who initiate HCV treatment at 12 months (52 weeks) following detectable finger-stick point-of-care HCV RNA testing.
52 weeks
To evaluate the proportion of participants who complete HCV direct-acting antiviral (DAA) treatment.
52 weeks
+3 more secondary outcomes

Study Arms (1)

People at risk of HCV acquisition

This is an observational cohort study. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection. Participants will attend a single visit to receive point-of-care HCV testing and complete a self-administered survey. Testing will be performed using point-of-care HCV antibody testing (results within 1-20 minutes, depending on the test) and if positive, HCV RNA testing will be performed. Participants who have previously had HCV infection or previously received HCV treatment will be tested using point-of-care HCV RNA testing. Participants will not receive treatment as a part of this study. Participants who are HCV RNA detectable will be linked to standard of care for any other clinical assessments and treatment initiation.

Diagnostic Test: Point-of-Care Testing

Interventions

Point-of-Care TestingDIAGNOSTIC_TEST

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

People at risk of HCV acquisition

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodProbability Sample

Study Population

Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of HCV infection, including drug treatment clinics, needle and syringe programs, prisons, mobile outreach services, community health services, mental health services, homelessness services, and other appropriate settings nationally. It is anticipated approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.

You may qualify if:

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).

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Kirby Institutelead
Flinders Universitycollaborator

Study Sites (69)

Hepatitis ACT

Canberra, Australian Capital Territory, 2612, Australia

RECRUITING

Western NSW LHD

Bathurst, New South Wales, 2795, 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, 2250, 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, 2444, 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, 2010, Australia

RECRUITING

NSLHD

Sydney, New South Wales, 2065, Australia

RECRUITING

WSLHD Drug Health

Sydney, New South Wales, 2151, Australia

RECRUITING

South West Sydney LHD

Sydney, New South Wales, 2170, Australia

RECRUITING

Hepatitis NSW