A Phase 4 interventional study of Xpert HCV Viral load finger stick point of care test (Cepheid) and Epclusa 400Mg-100Mg Tablet in Hepatitis C, sponsored by Macfarlane Burnet Institute for Medical Research and Public Health Ltd. Completed at 1 site in Australia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-11-13.
Sponsored by Macfarlane Burnet Institute for Medical Research and Public Health Ltd · Phase 4, Interventional, and Treatment
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.
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.
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.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 606 is above the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Macfarlane Burnet Institute for Medical Research and Public Health Ltd is the lead sponsor of 13 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Exclusion Criteria: only for intervention arm test and treat
This group will receive POC HCV viral load testing via a fingerstick using the Xpert HCV Viral load finger stick point of care test (Cepheid) in addition to the standard of care whole blood conventional laboratory based HCV PCR viral load testing. Participants who return a positive POC HCV viral load result will be provided with Epclusa on the same day as result. Follow up management will be determined by results received from standard of care blood. Service level data will be investigated to estimate HCV targeted treatment numbers prior to intervention arms implementation. Service level data will be measured post intervention periods.
Device: Xpert HCV Viral load finger stick point of care test (Cepheid) · Drug: Epclusa 400Mg-100Mg Tablet
Perform hepatitis C education for GP and clinic staff at primary health services; on hepatitis testing and treatment at a service level will offer the opportunity to tailor education to the requirements of the clinic and staffing needs.Service level data will be investigated to estimate HCV targeted treatment numbers prior to intervention arms implementation. Service level data will be measured post intervention period
Other: Standard of care
Assess the effectiveness in primary health services of engaging people in hepatitis C testing, and retention throughout the care cascade whilst employing innovative techniques including incentives and peer recruitment.Service level data will be investigated to estimate HCV targeted treatment numbers prior to intervention arms implementation. Service level data will be measured post intervention period
Other: Standard of care
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.
Same day HCV test and treatment
Clinical services will receive additional education and have the option of providing incentives to attendees of service.
HCV testing
The number of participants who receive HCV testing in each of the arms
Time frame: 12 months
HCV treatment
The number of participants who start HCV treatment in each of the arms
Time frame: 12 months
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2023. You cannot join it, but the record below documents what was studied.
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Macfarlane Burnet Institute for Medical Research and Public Health Ltd