Ignite Creation Date:
2025-12-24 @ 3:41 PM
Ignite Modification Date:
2025-12-25 @ 1:51 PM
Study NCT ID:
NCT04366492
Status:
COMPLETED
Last Update Posted:
2020-04-29
First Post:
2020-02-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
HBV/HCV/HIV in Belgian Prisons
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006526', 'term': 'Hepatitis C'}, {'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D015658', 'term': 'HIV Infections'}], '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'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3045}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-04', 'completionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-04-24', 'studyFirstSubmitDate': '2020-02-05', 'studyFirstSubmitQcDate': '2020-04-24', 'lastUpdatePostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-04-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants with HCV Ab+ (Hepatitis C Virus Antibody)', 'timeFrame': 'day 1', 'description': 'test using whole capillary blood (finger prick testing)'}, {'measure': 'Number of participants with HBsAg+ (Hepatitis B surface Antigen)', 'timeFrame': 'day 1', 'description': 'test using whole capillary blood (finger prick testing)'}, {'measure': 'Number of participants with HIV Ab+ (human immunodeficiency virus antibody)', 'timeFrame': 'day1', 'description': 'test using whole capillary blood (finger prick testing)'}], 'secondaryOutcomes': [{'measure': '.Prevalence of blood-borne viral infections in Belgian prisons', 'timeFrame': 'day 1', 'description': 'number of HCV Ab+/number of screened prisoners by finger prick\n\n* number of HBsAg+/number of screened prisoners by finger prick\n* number of HIV Ab+/number of screened prisoners by finger prick'}, {'measure': '5. Questionnaire to Identify risk factors associated with the aforementioned blood borne viral infections (hepatitis C, hepatitis B and HIV) in prison', 'timeFrame': 'day 1', 'description': 'i. Combine results from positive finger prick test with questionnaire regarding sociodemographic factors, migration, risk factors for blood born viruses (sexual contacts, incarceration, drug use)'}, {'measure': 'Analysis of uptake counselling by physician in prison', 'timeFrame': 'day 1', 'description': 'Percentage of patients with a positive finger prick test who attend a consultation by the prison physician in relation of total tested positive on finger prick'}, {'measure': 'Analysis of uptake of anti(retro)viral treatment', 'timeFrame': 'day 1', 'description': 'percentage of positive clients who started treatment in relation of total of positive clients needing treatment'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis C', 'Hepatitis B', 'HIV Infections']}, 'referencesModule': {'references': [{'pmid': '34315415', 'type': 'DERIVED', 'citation': 'Busschots D, Kremer C, Bielen R, Koc OM, Heyens L, Brixko C, Laukens P, Orlent H, Bilaey P, De Smet F, Hellemans G, Muyldermans G, Van Baelen L, Hens N, Van Vlierberghe H, Robaeys G. A multicentre interventional study to assess blood-borne viral infections in Belgian prisons. BMC Infect Dis. 2021 Jul 27;21(1):708. doi: 10.1186/s12879-021-06405-z.'}]}, 'descriptionModule': {'briefSummary': 'To assess the prevalence of blood-borne viral infections in prisons in Belgium, screening will be executed in several prisons in Flanders, Brussels and Wallonia to obtain a geographical representative distribution.\n\nUpon informed consent screening will be performed using whole capillary blood (finger prick testing) with three different tests for HCV Ab, HBsAg and HIV. Screening will be performed first. While awaiting the test result (15-20min), the participant can fill out a questionnaire (together with the study nurse), concerning risk factors for HCV, HBV and HIV infection. This questionnaire is filled out directly online, and will be immediately implemented in the encoded database. The database is set-up according to the rules of good clinical practice. (Castor EDC software). The results will be filled out immediately by the prison staff in this database after it is filled out by the participant, minimizing the risk of displacement of test results.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥ 18 years\n* Imprisoned in one of the predefined prisons in Flanders Brussels or Wallonia participating in this trial\n* Written informed consent obtained\n\nExclusion Criteria:\n\n* Written informed consent not possible: (language barrier, illiteracy)\n* Already participated in the study: re-entry within inclusion period in one of the prisons'}, 'identificationModule': {'nctId': 'NCT04366492', 'briefTitle': 'HBV/HCV/HIV in Belgian Prisons', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'Prevalence of Blood Borne Viral Infections (HBV/HCV/HIV) in the Belgian Prison System', 'orgStudyIdInfo': {'id': 'HBV-HCV-HIV-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'persons in prison', 'interventionNames': ['Other: Prevalence of blood borne viral infections (HBV/HCV/HIV)']}], 'interventions': [{'name': 'Prevalence of blood borne viral infections (HBV/HCV/HIV)', 'type': 'OTHER', 'description': 'rapid finger prick test for HCV Ab, HBsAg and HIV and a questionnaire', 'armGroupLabels': ['persons in prison']}]}, 'contactsLocationsModule': {'locations': [{'zip': '9000', 'city': 'Ghent', 'country': 'Belgium', 'facility': 'UZ Gent', 'geoPoint': {'lat': 51.05, 'lon': 3.71667}}, {'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Hasselt University', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Geert Robaeys, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasselt University'}, {'name': 'Dana Busschots, drs.', 'role': 'STUDY_CHAIR', 'affiliation': 'Hasselt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Ghent', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Geert Robaeys', 'investigatorAffiliation': 'Hasselt University'}}}}