Ignite Creation Date:
2025-12-25 @ 12:03 AM
Ignite Modification Date:
2025-12-25 @ 10:01 PM
Study NCT ID:
NCT05264558
Status:
COMPLETED
Last Update Posted:
2023-11-13
First Post:
2022-02-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%
Sponsor:
Macfarlane Burnet Institute for Medical Research and Public Health Ltd
Organization:
Study Overview
Official Title:
Preparing for the Final Phase of Hepatitis C Elimination in Cairns: An Implementation Trial of a Test and Treat Approach to Reach the Final 30%.
Status:
COMPLETED
Status Verified Date:
2023-11
Last Known Status:
None
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:
None
Brief Summary:
The study aims to assess the impact of models of HCV care on HCV testing, treatment uptake and cure within Cairns. Point of care testing for HCV , with test and treat strategies will be offered within a primary care service.
Detailed Description:
Available testing and treatment data will be explored pre and post the intervention period of the project within Cairns Hinterland health services that provide hepatitis C care.
Test and treat strategies of the project will include:
Part A: Same day test and treat clinical trial. The study will explore a 'same day test and treat' model to determine the impact on HCV treatment initiation and cure within a primary care service that recognises that they see people at risk of hepatitis C that are transient, and struggle to return to a care provider to engage in hepatitis C testing and care.
1. HCV RNA point of care (POC) testing
2. Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test.
Part B: Refresher and clinic in reach support work Primary care service/ General practitioner education and training \~1 hour in-person training for all clinic staff on hepatitis C testing, treatment, retention in HCV care cascade.
Part C: Services evaluation with incentive and peer intervention in HCV care cascade.
Test and treat strategies of the project will include:
Part A: Same day test and treat clinical trial. The study will explore a 'same day test and treat' model to determine the impact on HCV treatment initiation and cure within a primary care service that recognises that they see people at risk of hepatitis C that are transient, and struggle to return to a care provider to engage in hepatitis C testing and care.
1. HCV RNA point of care (POC) testing
2. Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test.
Part B: Refresher and clinic in reach support work Primary care service/ General practitioner education and training \~1 hour in-person training for all clinic staff on hepatitis C testing, treatment, retention in HCV care cascade.
Part C: Services evaluation with incentive and peer intervention in HCV care cascade.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?: