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

Sponsor
Kirby Institute (Other)
Overall Status
Recruiting
CT.gov ID
NCT03776760
Collaborator
South Australian Health and Medical Research Institute (Other), Flinders University (Other)
600
Enrollment
4
Locations
38.1
Anticipated Duration (Months)
150
Patients Per Site
3.9
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase

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 Design

Study Type:
Observational
Anticipated Enrollment :
600 participants
Observational Model:
Cohort
Time Perspective:
Prospective
Official Title:
Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
Actual Study Start Date :
May 28, 2019
Anticipated Primary Completion Date :
Aug 1, 2022
Anticipated Study Completion Date :
Aug 1, 2022

Arms and Interventions

Arm 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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Change in Hepatitis C prevalence [Week 0 to week 144]

      Change in the proportion of people with current HCV infection (HCV RNA positive)

    Secondary Outcome Measures

    1. Change in Hepatitis C incidence [Week 0 to week 144]

      Change in HCV incidence will be calculated using person-time of observation.

    2. DAA uptake [To week 144]

      Proportion with HCV infection initiating DAA therapy

    3. Treatment response rate (SVR12 rate) [From week 0 to Week 144]

      Overall SVR12 rate in those who commence treatment

    4. HCV reinfection incidence post treatment [6 monthly from end of treatment until week 144]

      Participants will be assessed six monthly post end of treatment for HCV recurrence.

    Other Outcome Measures

    1. HCV Transmission networks within the Aboriginal community [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.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:

    • 18 years of age or older;

    • voluntarily signed the informed consent form.

    Exclusion Criteria:
    • Pregnant women.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Jullums Lismore Aboriginal Medical Service Lismore New South Wales Australia 2480
    2 Walhallow Aboriginal Corporation Quirindi New South Wales Australia 2343
    3 Pangula Mannamurna Aboriginal Corporation Mount Gambier South Australia Australia 5290
    4 Port Lincoln Aboriginal Health Service Port Lincoln South Australia Australia 5606

    Sponsors and Collaborators

    • Kirby Institute
    • South Australian Health and Medical Research Institute
    • Flinders University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Kirby Institute
    ClinicalTrials.gov Identifier:
    NCT03776760
    Other Study ID Numbers:
    • VHCRP1802
    First Posted:
    Dec 17, 2018
    Last Update Posted:
    Apr 14, 2022
    Last Verified:
    Apr 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hepatitis A
    Hepatitis C
    RNA Virus Infections
    Hepatitis, Viral, Human
    Hepatitis
    Liver Diseases
    Digestive System Diseases
    Gastrointestinal Diseases
    Sofosbuvir

    Study Results

    No Results Posted as of Apr 14, 2022