Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination (SCALE-C)

April 13, 2022 updated by: Kirby Institute
A community-based "test and treat" intervention integrating point-of-care HCV RNA testing, non-invasive liver disease assessment and linkage to care will lead to a reduction in HCV prevalence among people attending Aboriginal health services.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

SCALE-C is an interventional cohort study recruiting people with or at risk of HCV infection from Aboriginal health services in Australia. Participants will be screened for HCV infection using point-of-care testing (anti-HCV antibody and/or HCV RNA). People with current HCV infection (HCV RNA positive) will be offered treatment with eight or 12 weeks of pan-genotypic DAA therapy, glecaprevir/pibrentasvir or sofosbuvir/velpatasvir, as available on the PBS.

Study Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • New South Wales
      • Lismore, New South Wales, Australia, 2480
        • Recruiting
        • Jullums Lismore Aboriginal Medical Service
        • Contact:
      • Quirindi, New South Wales, Australia, 2343
        • Recruiting
        • Walhallow Aboriginal Corporation
        • Contact:
    • South Australia
      • Mount Gambier, South Australia, Australia, 5290
        • Recruiting
        • Pangula Mannamurna Aboriginal Corporation
        • Contact:
      • Port Lincoln, South Australia, Australia, 5606
        • Recruiting
        • Port Lincoln Aboriginal Health Service
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

People attending Aboriginal health services will be invited to receive HCV RNA testing using the GeneXpert fingerstick HCV RNA assay. Those found to have active HCV infection will be offered treatment with one of two pan-genotypic direct acting antiviral therapies available in Australia (SOF/VEL or G/P)

Description

Inclusion Criteria:

  • 18 years of age or older;
  • voluntarily signed the informed consent form.

Exclusion Criteria:

  • Pregnant women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Fingerstick Point of Care GeneXpert HCV Test
Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
Device: Fingerstick GeneXpert HCV RNA quantitative assay
All participants at risk of HCV infection will receive HCV RNA testing using the GeneXpert finger-stick point-of-care HCV quantitative assay 6 monthly
Drug: sofosbuvir/velpatesvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Other Names:
  • Epclusa
Drug: glecaprevir/pibrentasvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Other Names:
  • Maviret
Treat - SOF/VEL
Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir
Drug: sofosbuvir/velpatesvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Other Names:
  • Epclusa
Treat - G/P
Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir
Drug: glecaprevir/pibrentasvir
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Other Names:
  • Maviret

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hepatitis C prevalence
Time Frame: Week 0 to week 144
Change in the proportion of people with current HCV infection (HCV RNA positive)
Week 0 to week 144

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hepatitis C incidence
Time Frame: Week 0 to week 144
Change in HCV incidence will be calculated using person-time of observation.
Week 0 to week 144
DAA uptake
Time Frame: To week 144
Proportion with HCV infection initiating DAA therapy
To week 144
Treatment response rate (SVR12 rate)
Time Frame: From week 0 to Week 144
Overall SVR12 rate in those who commence treatment
From week 0 to Week 144
HCV reinfection incidence post treatment
Time Frame: 6 monthly from end of treatment until week 144
Participants will be assessed six monthly post end of treatment for HCV recurrence.
6 monthly from end of treatment until week 144

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
HCV Transmission networks within the Aboriginal community
Time Frame: At screening for all participants
HCV viral genome for will be sequenced for all participants from their screening sample. The sequences ill be used for develop a phylogenetic tree which can be used to determine transmission networks within the study population.
At screening for all participants

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kirby Institute

Collaborators

Flinders University
South Australian Health and Medical Research Institute

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

May 28, 2019

Primary Completion (ANTICIPATED)

August 1, 2022

Study Completion (ANTICIPATED)

August 1, 2022

Study Registration Dates

First Submitted

November 21, 2018

First Submitted That Met QC Criteria

December 12, 2018

First Posted (ACTUAL)

December 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

April 14, 2022

Last Update Submitted That Met QC Criteria

April 13, 2022

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • VHCRP1802

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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