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

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

About this trial

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). All participants who undergo HCV point-of-care testing at the study site will be included in the data collection. 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 criteria

This trial accepts healthy volunteers

Qualifiers

≥ 18 years of age.

Received point-of-care HCV testing.

Disqualifiers

Nil

Trial 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.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

  • Point-of-Care Testing

    Diagnostic test

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

Treatment groups

80,000 Participants
are divided into 1 treatment group
Group A: People at risk of HCV acquisition1 intervention

Trial outcomes

Primary outcomes

1

The proportion of HCV infected participants who initiate HCV treatment at 12 weeks

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.

Time frame
12 Weeks from enrolment

Secondary outcomes

1

The proportion of participants who accept point-of-care testing

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

Time frame
2 years from recruitment commencement
2

The prevalence of HCV infection amongst study participants tested

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

Time frame
2 years from recruitment commencement
3

To evaluate the time to HCV treatment uptake among HCV RNA positive participants

To evaluate the length of time participants take to initiate HCV treatment after diagnosis

Time frame
52 weeks
4

To evaluate proportion of HCV RNA positive participants who initiate HCV treatment

To evaluate the proportion of HCV RNA positive participants who initiate HCV treatment at 12 months (52 weeks) following finger-stick point-of-care HCV RNA testing.

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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