Ignite Creation Date:
2025-12-25 @ 2:10 AM
Ignite Modification Date:
2026-01-07 @ 8:02 PM
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:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D018178', 'term': 'Flaviviridae Infections'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069474', 'term': 'Sofosbuvir'}, {'id': 'C000611331', 'term': 'sofosbuvir-velpatasvir drug combination'}, {'id': 'C000654128', 'term': 'glecaprevir and pibrentasvir'}], 'ancestors': [{'id': 'D014542', 'term': 'Uridine Monophosphate'}, {'id': 'D014500', 'term': 'Uracil Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'Dried Blood Spot samples for HCV RNA viral load testing and viral genome sequencing'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-05-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-04-13', 'studyFirstSubmitDate': '2018-11-21', 'studyFirstSubmitQcDate': '2018-12-12', 'lastUpdatePostDateStruct': {'date': '2022-04-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-12-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'HCV Transmission networks within the Aboriginal community', 'timeFrame': 'At screening for all participants', 'description': 'HCV viral genome for will be sequenced for all participants from their screening sample. The sequences ill be used for develop a phylogenetic tree which can be used to determine transmission networks within the study population.'}], 'primaryOutcomes': [{'measure': 'Change in Hepatitis C prevalence', 'timeFrame': 'Week 0 to week 144', 'description': 'Change in the proportion of people with current HCV infection (HCV RNA positive)'}], 'secondaryOutcomes': [{'measure': 'Change in Hepatitis C incidence', 'timeFrame': 'Week 0 to week 144', 'description': 'Change in HCV incidence will be calculated using person-time of observation.'}, {'measure': 'DAA uptake', 'timeFrame': 'To week 144', 'description': 'Proportion with HCV infection initiating DAA therapy'}, {'measure': 'Treatment response rate (SVR12 rate)', 'timeFrame': 'From week 0 to Week 144', 'description': 'Overall SVR12 rate in those who commence treatment'}, {'measure': 'HCV reinfection incidence post treatment', 'timeFrame': '6 monthly from end of treatment until week 144', 'description': 'Participants will be assessed six monthly post end of treatment for HCV recurrence.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C', 'Hepatitis', 'Liver Diseases', 'Hepatitis, Viral, Human', 'RNA Virus Infections', 'Digestive System Diseases']}, 'referencesModule': {'references': [{'pmid': '41250046', 'type': 'DERIVED', 'citation': 'Hosseini-Hooshyar S, Valerio H, Flynn E, Sexton C, Barzi F, Amarasena S, De Koster L, Sellen D, Winterfield N, Grebely J, Matthews GV, Boyd MA, Applegate TL, Petoumenos K, Lafferty L, Dore GJ, Treloar C, Martinello M, Ward J. A point-of-care testing intervention to improve hepatitis C diagnosis and treatment uptake among people attending Aboriginal community controlled health services: the SCALE-C study. BMC Infect Dis. 2025 Nov 17;25(1):1604. doi: 10.1186/s12879-025-12004-z.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'People attending Aboriginal health services will be invited to receive HCV RNA testing using the GeneXpert fingerstick HCV RNA assay. Those found to have active HCV infection will be offered treatment with one of two pan-genotypic direct acting antiviral therapies available in Australia (SOF/VEL or G/P)', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older;\n* voluntarily signed the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant women.'}, 'identificationModule': {'nctId': 'NCT03776760', 'acronym': 'SCALE-C', 'briefTitle': 'Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Kirby Institute'}, 'officialTitle': 'Strategies for Hepatitis C Testing and Treatment in Aboriginal Communities That Lead to Elimination', 'orgStudyIdInfo': {'id': 'VHCRP1802'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Fingerstick Point of Care GeneXpert HCV Test', 'description': 'Participants will have HCV testing using the finger-stick point of care GeneXpert quantitative HCV RNA assay.', 'interventionNames': ['Device: Fingerstick GeneXpert HCV RNA quantitative assay', 'Drug: sofosbuvir/velpatesvir', 'Drug: glecaprevir/pibrentasvir']}, {'label': 'Treat - SOF/VEL', 'description': 'Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - sofosbuvir/velpatesvir', 'interventionNames': ['Drug: sofosbuvir/velpatesvir']}, {'label': 'Treat - G/P', 'description': 'Participants with active HCV infection will be offered treatment with one of two pan-genoptyic regimens available in Australia - glecaprevir/pibrentasvir', 'interventionNames': ['Drug: glecaprevir/pibrentasvir']}], 'interventions': [{'name': 'Fingerstick GeneXpert HCV RNA quantitative assay', 'type': 'DEVICE', 'description': 'All participants at risk of HCV infection will receive HCV RNA testing using the GeneXpert finger-stick point-of-care HCV quantitative assay 6 monthly', 'armGroupLabels': ['Fingerstick Point of Care GeneXpert HCV Test']}, {'name': 'sofosbuvir/velpatesvir', 'type': 'DRUG', 'otherNames': ['Epclusa'], 'description': 'Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia', 'armGroupLabels': ['Fingerstick Point of Care GeneXpert HCV Test', 'Treat - SOF/VEL']}, {'name': 'glecaprevir/pibrentasvir', 'type': 'DRUG', 'otherNames': ['Maviret'], 'description': 'Participants with active HCV infection will be offered treatment with one of two pan-genotypic regimens available in Australia', 'armGroupLabels': ['Fingerstick Point of Care GeneXpert HCV Test', 'Treat - G/P']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2480', 'city': 'Lismore', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Peter Silberberg', 'role': 'CONTACT', 'email': 'peter@jullums.com', 'phone': '+612 6621 4366'}], 'facility': 'Jullums Lismore Aboriginal Medical Service', 'geoPoint': {'lat': -28.81354, 'lon': 153.2773}}, {'zip': '2343', 'city': 'Quirindi', 'state': 'New South Wales', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Suruchi Amarasena, MBBS', 'role': 'CONTACT', 'email': 'suruchiaaa@gmail.com', 'phone': '+612 6746 2001'}], 'facility': 'Walhallow Aboriginal Corporation', 'geoPoint': {'lat': -31.50763, 'lon': 150.67902}}, {'zip': '5290', 'city': 'Mount Gambier', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Kellie Morello', 'role': 'CONTACT', 'email': 'kellie.m@pangula.org.au', 'phone': '+61 8 8724 7270'}], 'facility': 'Pangula Mannamurna Aboriginal Corporation', 'geoPoint': {'lat': -37.8318, 'lon': 140.77919}}, {'zip': '5606', 'city': 'Port Lincoln', 'state': 'South Australia', 'status': 'RECRUITING', 'country': 'Australia', 'contacts': [{'name': 'Sharon Bilney', 'role': 'CONTACT', 'email': 'Sharon.Bilney@plahs.org.au', 'phone': '+618 8683 0162'}], 'facility': 'Port Lincoln Aboriginal Health Service', 'geoPoint': {'lat': -34.72625, 'lon': 135.87442}}], 'centralContacts': [{'name': 'Gerard Estivill', 'role': 'CONTACT', 'email': 'gestivill@kirby.unsw.edu.au', 'phone': '+612 9385 0900'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Kirby Institute', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'South Australian Health and Medical Research Institute', 'class': 'OTHER'}, {'name': 'Flinders University', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}