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

Sponsor
Kirby Institute
Study ID
NCT03776760
Status
Unknown

Conditions

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

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Accepted

Interventions

  • Fingerstick GeneXpert HCV RNA quantitative assay — 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 — DRUG
    Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
  • glecaprevir/pibrentasvir — DRUG
    Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Study Details

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.

Key Dates

Start date
May 28, 2019
Status verified
Apr 2022
Primary completion
Aug 31, 2022
Completion
Aug 31, 2022

Study Design

Enrollment
600 participants (estimated)

Arms

  • Arm: Fingerstick Point of Care GeneXpert HCV Test
    Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.
  • Arm: Treat - SOF/VEL
    Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir
  • Arm: Treat - G/P
    Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir

Primary Outcome Measure

Change in Hepatitis C prevalence [ Time Frame: Week 0 to week 144 ]

Central Contacts

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