Viewing Study NCT03776760


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Study NCT ID: NCT03776760
Status: UNKNOWN
Last Update Posted: 2022-04-14
First Post: 2018-11-21
Is NOT Gene Therapy: True
Has Adverse Events: False

Brief Title: Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
Sponsor: Kirby Institute
Organization:

Study Overview

Official Title: Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination
Status: UNKNOWN
Status Verified Date: 2022-04
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: SCALE-C
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.

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: False
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: