NCT05264558

Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%

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
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 606 (actual)
• Sponsor: Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Hepatitis C

Interventions

Type	Name	Description
DEVICE	Xpert HCV Viral load finger stick point of care test (Cepheid)	Xpert HCV VL Fingerstick is an in vitro reverse transcription polymerase chain reaction (RT-PCR) assay for the detection and quantification of Hepatitis C Virus (HCV) RNA in human venous and capillary fingerstick EDTA whole blood. Appropriate pre and post testing counselling will be provided to participants.
DRUG	Epclusa 400Mg-100Mg Tablet	Same day HCV test and treatment
OTHER	Standard of care	Clinical services will receive additional education and have the option of providing incentives to attendees of service.

Timeline

• Start date: 2022-07-25
• Primary completion: 2023-08-31
• Completion: 2023-09-30
• First posted: 2022-03-03
• Last updated: 2023-11-13

Locations

1 site across 1 country: Australia

Regulatory

• FDA-regulated drug study
• FDA-regulated device study