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.
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
600
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
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia
Jullums Lismore Aboriginal Medical Service
Lismore, New South Wales, Australia
RECRUITINGWalhallow Aboriginal Corporation
Quirindi, New South Wales, Australia
RECRUITINGPangula Mannamurna Aboriginal Corporation
Mount Gambier, South Australia, Australia
Change in Hepatitis C prevalence
Change in the proportion of people with current HCV infection (HCV RNA positive)
Time frame: Week 0 to week 144
Change in Hepatitis C incidence
Change in HCV incidence will be calculated using person-time of observation.
Time frame: Week 0 to week 144
DAA uptake
Proportion with HCV infection initiating DAA therapy
Time frame: To week 144
Treatment response rate (SVR12 rate)
Overall SVR12 rate in those who commence treatment
Time frame: From week 0 to Week 144
HCV reinfection incidence post treatment
Participants will be assessed six monthly post end of treatment for HCV recurrence.
Time frame: 6 monthly from end of treatment until week 144
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Port Lincoln Aboriginal Health Service
Port Lincoln, South Australia, Australia
RECRUITING