Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination

NCT ID: NCT03776760

Last Updated: 2022-04-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-05-28

Study Completion Date

2022-08-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Hepatitis C Hepatitis Liver Diseases Hepatitis, Viral, Human RNA Virus Infections Digestive System Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Fingerstick Point of Care GeneXpert HCV Test

Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.

Fingerstick GeneXpert HCV RNA quantitative assay

Intervention Type DEVICE

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

sofosbuvir/velpatesvir

Intervention Type DRUG

Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

glecaprevir/pibrentasvir

Intervention Type DRUG

Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Treat - SOF/VEL

Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir

sofosbuvir/velpatesvir

Intervention Type DRUG

Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Treat - G/P

Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir

glecaprevir/pibrentasvir

Intervention Type DRUG

Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Interventions

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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

Intervention Type DEVICE

sofosbuvir/velpatesvir

Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Intervention Type DRUG

glecaprevir/pibrentasvir

Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Intervention Type DRUG

Other Intervention Names

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Epclusa Maviret

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* Pregnant women.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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South Australian Health and Medical Research Institute

OTHER

Sponsor Role collaborator

Flinders University

OTHER

Sponsor Role collaborator

Kirby Institute

OTHER_GOV

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Jullums Lismore Aboriginal Medical Service

Lismore, New South Wales, Australia

Site Status RECRUITING

Walhallow Aboriginal Corporation

Quirindi, New South Wales, Australia

Site Status RECRUITING

Pangula Mannamurna Aboriginal Corporation

Mount Gambier, South Australia, Australia

Site Status RECRUITING

Port Lincoln Aboriginal Health Service

Port Lincoln, South Australia, Australia

Site Status RECRUITING

Countries

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Australia

Central Contacts

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Gerard Estivill

Role: CONTACT

+612 9385 0900

Facility Contacts

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Peter Silberberg

Role: primary

+612 6621 4366

Suruchi Amarasena, MBBS

Role: primary

+612 6746 2001

Kellie Morello

Role: primary

+61 8 8724 7270

Sharon Bilney

Role: primary

+618 8683 0162

Other Identifiers

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VHCRP1802

Identifier Type: -

Identifier Source: org_study_id

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