Hepatitis C, Hepatitis, Liver Diseases, Hepatitis, Viral, Human, RNA Virus Infections, Digestive System Diseases
Conditions
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.
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.
Interventions
DEVICEFingerstick 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
DRUGsofosbuvir/velpatesvir
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
Sponsors
South Australian Health and Medical Research Institute
Flinders University
Kirby Institute
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
* 18 years of age or older; * voluntarily signed the informed consent form.
Exclusion criteria
* Pregnant women.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hepatitis C prevalence | Week 0 to week 144 | Change in the proportion of people with current HCV infection (HCV RNA positive) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Hepatitis C incidence | Week 0 to week 144 | Change in HCV incidence will be calculated using person-time of observation. |
| DAA uptake | To week 144 | Proportion with HCV infection initiating DAA therapy |
| Treatment response rate (SVR12 rate) | From week 0 to Week 144 | Overall SVR12 rate in those who commence treatment |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
Australia
Contacts
Primary ContactGerard Estivill
Outcome results
None listed