Ignite Creation Date:
2025-12-25 @ 3:09 AM
Ignite Modification Date:
2025-12-26 @ 1:48 AM
Study NCT ID:
NCT02907905
Status:
COMPLETED
Last Update Posted:
2022-08-11
First Post:
2016-09-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Epidemiology of Viral Hepatitis Among Subjects in Precarious
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-08', 'completionDateStruct': {'date': '2019-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-08-10', 'studyFirstSubmitDate': '2016-09-12', 'studyFirstSubmitQcDate': '2016-09-19', 'lastUpdatePostDateStruct': {'date': '2022-08-11', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-09-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'serology HBV', 'timeFrame': '1 day', 'description': 'Study prevalence HBV in these precarious populations'}, {'measure': 'serology HCV', 'timeFrame': '1 day', 'description': 'Study prevalence HCV in these precarious populations'}, {'measure': 'serology HAV', 'timeFrame': '1 day', 'description': 'Study prevalence HAV in these precarious populations'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Social Insecurity']}, 'descriptionModule': {'briefSummary': 'Social insecurity is a significant cost in human terms (health and societal), it defines evil and can be identified as difficulties accessing health and especially water.\n\nWe chose to take stock of these populations defined by difficulties accessing water as precarious setting. Subjects homeless population fall into this by accident of life, a life "homeless" or migrant subjects often illegally having only transitory access (associative or charitable structures host) the conditions precarious sanitation including drinking water or toilet. Populations of slums in the same conditions or the presence rationed water (one tap for 150 people) restricts hygiene.', 'detailedDescription': 'Social insecurity is a significant cost in human terms (health and societal), it defines evil and can be identified as difficulties accessing health and especially water.\n\nWe chose to take stock of these populations defined by difficulties accessing water as precarious setting. Subjects homeless population fall into this by accident of life, a life "homeless" or migrant subjects often illegally having only transitory access (associative or charitable structures host) the conditions precarious sanitation including drinking water or toilet. Populations of slums in the same conditions or the presence rationed water (one tap for 150 people) restricts hygiene.\n\nThe sampling system as part of a consultation in routine care (will be in DBS (blotter) only alternative to invasive venous sample and requiring heavier care facility. The capillary sampling on filter will also detect a marker of malnutrition .\n\nThus in live in large social precariousness adult this study should show which interventions in public health and management proposals are most appropriate for this population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Population homeless (SDF)\n* Population living in slums.\n\nExclusion Criteria:\n\n* Pregnant or lactating women'}, 'identificationModule': {'nctId': 'NCT02907905', 'briefTitle': 'Epidemiology of Viral Hepatitis Among Subjects in Precarious', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Montpellier'}, 'officialTitle': 'Epidemiology of Hepatitis A,B and C Virus by Dried Blood Spot in Homeless Population', 'orgStudyIdInfo': {'id': '9609'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Population homeless or living in slum', 'description': 'Population homeless or living in slum realizing realizing a capillary sampling', 'interventionNames': ['Biological: capillary sampling']}], 'interventions': [{'name': 'capillary sampling', 'type': 'BIOLOGICAL', 'description': 'After elution in buffer (PBS-Tween azide and thiamol) eluate 200 microliter is processed on automated techniques (Siemens Centaur XL and Diasorin) after adjustment of the figures according to ISO 15189 scope B.\n\nThe results are qualitatively made and sent to the teams. The return of results, a proposal for appropriate care in the event of contact with virus (anti-HAV HCV HBV) through a rendering consultation results', 'armGroupLabels': ['Population homeless or living in slum']}]}, 'contactsLocationsModule': {'locations': [{'zip': '34295', 'city': 'Montpellier', 'country': 'France', 'facility': 'DUCOS', 'geoPoint': {'lat': 43.61093, 'lon': 3.87635}}], 'overallOfficials': [{'name': 'Jacques Ducos, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'University Hospital, Montpellier'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Montpellier', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}