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The National Australian HCV Point-of-Care Testing Program - HCV Antibody Testing Minimal Dataset

ConditionHepatitis C
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorKirby Institute

About this trial

The goal of this observational study is to learn if offering a point-of-care screening test for exposure to the Hepatitis C virus, before providing a diagnostic test for Hepatitis C infection can increase testing, diagnosis and treatment in Adults. Participants will be recruited from settings that provide services to people with a risk factor for the acquisition of Hepatitis C viral infection. The main question it aims to answer is:

What proportion of the participants that have been diagnosed with HCV infection have started treatment when their records are reviewed 12 weeks after diagnosis?

Participants will have one in-person visit where they will provide informed consent and receive a finger-prick rapid result test for Hepatitis C infection. Participants with no previous Hepatitis C infection will have a screening test to see if they have an immune reaction to Hepatitis C. Participants who know they have been infected with Hepatitis C in the past, and all participants with a positive screening test result will then be given a Hepatitis C diagnostic test at this visit.

No treatment is provided as a part of this study, participants who are diagnosed with Hepatitis C infection will be referred to testing locations standard of care for any additional clinical assessments and treatment initiation. A review of the participant's records will be made 12 weeks after their Hepatitis C result and their treatment data are gathered.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Provide informed consent

≥ 18 years of age.

Disqualifiers

Is unable or unwilling to provide informed consent

Trial population

Participants will be included 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 that approximately 40,000 participants will be screened for HCV infection using point-of-care HCV testing.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Diagnostic Test: Point-of-Care Testing

    Device

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

Treatment groups

40,000 Participants
are divided into 1 treatment group
Group A: People at risk of HCV acquisition1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the proportion of HCV infected (HCV RNA quantifiable) participants who initiate HCV treatment at 12 weeks following finger-stick point-of-care HCV RNA testing.

HCV treatment

Time frame
12 weeks from enrolment

Secondary outcomes

1

To evaluate the proportion of people who accept point-of-care testing among those offered testing.

Accepting testing

Time frame
Recruitment phase
2

To evaluate the prevalence of current HCV infection (HCV RNA quantifiable) among people tested.

Prevalence

Time frame
Recruitment phase
3

To evaluate the HCV antibody prevalence among people tested.

Prevalence

Time frame
Recruitment phase
4

To evaluate the time to treatment uptake among people receiving point-of-care HCV antibody testing with reflex HCV RNA testing in those who are HCV antibody detectable who received HCV treatment;

Time to treatment

Time frame
52 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Kirby Institute

Lead sponsor

Flinders University

Collaborator

Source ClinicalTrials.gov
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