NCT03776760

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

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 600 (estimated)
• Sponsor: Kirby Institute · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

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

Interventions

Type	Name	Description
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
DRUG	glecaprevir/pibrentasvir	Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia

Timeline

• Start date: 2019-05-28
• Primary completion: 2022-08-01
• Completion: 2022-08-01
• First posted: 2018-12-17
• Last updated: 2022-04-14

Locations

4 sites across 1 country: Australia