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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000611331', 'term': 'sofosbuvir-velpatasvir drug combination'}, {'id': 'D059039', 'term': 'Standard of Care'}], 'ancestors': [{'id': 'D019984', 'term': 'Quality Indicators, Health Care'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D006298', 'term': 'Health Services Administration'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'The model will permit all interventions to be explored for their impact on testing and treatment numbers in the HCV care cascade'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 606}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-09-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-11-09', 'studyFirstSubmitDate': '2022-02-20', 'studyFirstSubmitQcDate': '2022-03-02', 'lastUpdatePostDateStruct': {'date': '2023-11-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-03-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'HCV testing', 'timeFrame': '12 months', 'description': 'The number of participants who receive HCV testing in each of the arms'}, {'measure': 'HCV treatment', 'timeFrame': '12 months', 'description': 'The number of participants who start HCV treatment in each of the arms'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'conditions': ['Hepatitis C']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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.\n\nTest and treat strategies of the project will include:\n\nPart 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.\n\n1. HCV RNA point of care (POC) testing\n2. Epclusa (Sofosbuvir/Velpatasvir 400mg/100mg) course initiated at same day of visit following a +ve HCV RNA result from the POC test.\n\nPart 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.\n\nPart C: Services evaluation with incentive and peer intervention in HCV care cascade."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* attending primary health care service of CHHS aged 18 years or over\n\nExclusion Criteria: only for intervention arm test and treat\n\n* Known to have hepatitis B or HIV infection\n* Known to have cirrhosis\n* Previous treatment with direct acting antivirals\n* Previously received interferon-based hepatitis C treatment that did not work\n* Women that are pregnant or breastfeeding\n* Already receiving hepatitis C treatment.'}, 'identificationModule': {'nctId': 'NCT05264558', 'briefTitle': 'Preparing for the Final Phase of Hepatitis C Elimination. Cairns Final 30%', 'organization': {'class': 'OTHER', 'fullName': 'Macfarlane Burnet Institute for Medical Research and Public Health Ltd'}, 'officialTitle': '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%.', 'orgStudyIdInfo': {'id': '16112020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test and treat', 'description': '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.', 'interventionNames': ['Device: Xpert HCV Viral load finger stick point of care test (Cepheid)', 'Drug: Epclusa 400Mg-100Mg Tablet']}, {'type': 'OTHER', 'label': 'General Practitioner Refresher and Clinic in reach', 'description': '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', 'interventionNames': ['Other: Standard of care']}, {'type': 'OTHER', 'label': 'Incentive and Peer intervention in HCV care cascade', 'description': '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', 'interventionNames': ['Other: Standard of care']}], 'interventions': [{'name': 'Xpert HCV Viral load finger stick point of care test (Cepheid)', 'type': 'DEVICE', 'description': '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.', 'armGroupLabels': ['Test and treat']}, {'name': 'Epclusa 400Mg-100Mg Tablet', 'type': 'DRUG', 'description': 'Same day HCV test and treatment', 'armGroupLabels': ['Test and treat']}, {'name': 'Standard of care', 'type': 'OTHER', 'description': 'Clinical services will receive additional education and have the option of providing incentives to attendees of service.', 'armGroupLabels': ['General Practitioner Refresher and Clinic in reach', 'Incentive and Peer intervention in HCV care cascade']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4870', 'city': 'Cairns', 'state': 'Queensland', 'country': 'Australia', 'facility': 'Cairns and Hinterland Hospital and Health Service', 'geoPoint': {'lat': -16.92366, 'lon': 145.76613}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Macfarlane Burnet Institute for Medical Research and Public Health Ltd', 'class': 'OTHER'}, 'collaborators': [{'name': 'Cairns Hinterland Health Hospital and Health Services', 'class': 'UNKNOWN'}, {'name': 'The University of Queensland', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}