Health TrialsbyHealthPanel

The Australian HCV Point-of-Care Testing Program

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). 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 criteria

This trial accepts healthy volunteers

Qualifiers

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).

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).

Disqualifiers

None

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

60,000 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 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 time to HCV treatment uptake among HCV RNA detectable participants following HCV RNA testing

Time to treatment

Time frame
52 weeks
4

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.

Initiation of 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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