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| Name | Class |
|---|---|
| South Australian Health and Medical Research Institute | OTHER |
| Flinders University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Fingerstick Point of Care GeneXpert HCV Test | Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay. |
| |
| Treat - SOF/VEL | Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir |
| |
| Treat - G/P | Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hepatitis C prevalence | Change in the proportion of people with current HCV infection (HCV RNA positive) | Week 0 to week 144 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Hepatitis C incidence | Change in HCV incidence will be calculated using person-time of observation. | Week 0 to week 144 |
| DAA uptake | Proportion with HCV infection initiating DAA therapy |
| Measure | Description | Time Frame |
|---|---|---|
| HCV Transmission networks within the Aboriginal community | 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. | At screening for all participants |
Inclusion Criteria:
Exclusion Criteria:
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People attending Aboriginal health services will be invited to receive HCV RNA testing using the GeneXpert fingerstick HCV RNA assay. Those found to have active HCV infection will be offered treatment with one of two pan-genotypic direct acting antiviral therapies available in Australia (SOF/VEL or G/P)
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Gerard Estivill | Contact | +612 9385 0900 | gestivill@kirby.unsw.edu.au |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Jullums Lismore Aboriginal Medical Service | Recruiting | Lismore | New South Wales | 2480 | Australia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41250046 | Derived | Hosseini-Hooshyar S, Valerio H, Flynn E, Sexton C, Barzi F, Amarasena S, De Koster L, Sellen D, Winterfield N, Grebely J, Matthews GV, Boyd MA, Applegate TL, Petoumenos K, Lafferty L, Dore GJ, Treloar C, Martinello M, Ward J. A point-of-care testing intervention to improve hepatitis C diagnosis and treatment uptake among people attending Aboriginal community controlled health services: the SCALE-C study. BMC Infect Dis. 2025 Nov 17;25(1):1604. doi: 10.1186/s12879-025-12004-z. |
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Dried Blood Spot samples for HCV RNA viral load testing and viral genome sequencing
| 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 |
|
|
| To week 144 |
| Treatment response rate (SVR12 rate) | Overall SVR12 rate in those who commence treatment | From week 0 to Week 144 |
| HCV reinfection incidence post treatment | Participants will be assessed six monthly post end of treatment for HCV recurrence. | 6 monthly from end of treatment until week 144 |
| Walhallow Aboriginal Corporation | Recruiting | Quirindi | New South Wales | 2343 | Australia |
|
| Pangula Mannamurna Aboriginal Corporation | Recruiting | Mount Gambier | South Australia | 5290 | Australia |
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| Port Lincoln Aboriginal Health Service | Recruiting | Port Lincoln | South Australia | 5606 | Australia |
|
| ID | Term |
|---|---|
| D006526 | Hepatitis C |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D006525 | Hepatitis, Viral, Human |
| D012327 | RNA Virus Infections |
| D004066 | Digestive System Diseases |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D014777 | Virus Diseases |
| D018178 | Flaviviridae Infections |
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| ID | Term |
|---|---|
| D000069474 | Sofosbuvir |
| C000611331 | sofosbuvir-velpatasvir drug combination |
| C000654128 | glecaprevir and pibrentasvir |
| ID | Term |
|---|---|
| D014542 | Uridine Monophosphate |
| D014500 | Uracil Nucleotides |
| D011742 | Pyrimidine Nucleotides |
| D011743 | Pyrimidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D009711 | Nucleotides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012265 | Ribonucleotides |
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