{"doc_desc":{"title":"Inter-cohort and clinical centers collaboration of subjects co-infected by human immunodeficiency virus and hepatitis C","idno":"FRESH-PEF3626-en","producers":[{"name":"Laure ESTERLE","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3626-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3626"},{"agency":"FReSH","code":"FRESH-PEF3626"}]},"title":"Inter-cohort and clinical centers collaboration of subjects co-infected by human immunodeficiency virus and hepatitis C","alternate_title":"ANRS C013 HEPAVIH"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Laure;ESTERLE","PILabo":"Inserm \/ INSERM, U1219, Centre de Recherche Inserm Bordeaux Publique Health, \u00e9quipe Morpheus, CMG-EC","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-1017-1327","role":"pi id"},{"title":"IdRef","uri":"144303140","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"201622170H","role":"labo id"}],"email":"","isContact":"No"},{"type":"investigator","name":"Dominique;SALMON","PILabo":"Assistance Publique des H\u00f4pitaux de Paris - H\u00f4pitaux Paris Centre, Universit\u00e9 Paris Descartes \/ Services des Maladies Infectieuses et Tropicales","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"19920814X","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"RNSR","uri":"201722478N","role":"labo id"}],"email":"dominique.salmon@aphp.fr","isContact":"Yes"},{"type":"investigator","name":"Philippe;SOGNI","PILabo":"Assistance Publique des H\u00f4pitaux de Paris - H\u00f4pitaux Paris Centre, Universit\u00e9 Paris Descarte, Inserm \/ Service d'H\u00e9patologie","affiliationName":"UNIVERSITE PARIS CITE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"076006824","role":"pi id"},{"title":"SIREN","uri":"130025737","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"philippe.sogni@aphp.fr","isContact":"Yes"}],"oth_id":[{"name":"","type":""},{"name":"","type":""}],"production_statement":{"prod_place":"Epidemiology France Portal (PEF)","producers":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76","role":"sponsor id"},{"title":"SIREN","uri":"180089385","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01kv58h76"},{"title":"SIREN","uri":"180089385"}]},{"name":"F. HOFFMANN-LA ROCHE AG","extlink":[{"title":"SIREN","uri":"775752140"}]},{"name":"GLAXOSMITHKLINE (FRANCE)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/00z1h3j87"},{"title":"SIREN","uri":"592052146"}]},{"name":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]},{"name":"JANSSEN CILAG (JANSSEN - JOHNSON & JOHNSON - JOHNSON & JOHNSON INNOVATIVE MEDICINE)","extlink":[{"title":"SIREN","uri":"562033068"}]},{"name":"MERCK SANTE","extlink":[{"title":"SIREN","uri":"572028033"}]}]},"distribution_statement":{"contact":[{"name":"Linda;WITTKOP","email":"linda.wittkop@u-bordeaux.fr","type":"contact","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/02vjkv261","role":"organisation id","title":"ROR"},{"uri":"180036048","role":"organisation id","title":"SIREN"}]},{"name":"Dominique;SALMON","email":"dominique.salmon@aphp.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]},{"name":"Philippe;SOGNI","email":"philippe.sogni@aphp.fr","type":"contact","affiliationName":"UNIVERSITE PARIS CITE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/05f82e368","role":"organisation id","title":"ROR"},{"uri":"130025737","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Adults"},{"keyword":"disease carriers"},{"keyword":"cured"},{"keyword":"treatment"},{"keyword":"co-infection"}],"topics":[{"topic":"Clinical immunology","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/7a3cf568-46ba-4840-be8f-f22fc030139f"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D000486"}]},{"topic":"Infectious disease medicine","vocab":"health theme","extLink":[{"title":"ESV","uri":"http:\/\/data.europa.eu\/8mn\/euroscivoc\/fa2ceeab-3b2f-45e9-9243-e5a8005b98de"},{"title":"MeSH","uri":"http:\/\/id.nlm.nih.gov\/mesh\/D055552"}]},{"topic":"HIV disease clinical stage 2 without mention of tuberculosis or malaria","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1575370503","title":"CIM-11"}]},{"topic":"Viral hepatitis","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/985510409","title":"CIM-11"}]},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"Short term: - Describe patient's characteristics - Analyze factors associated to a treatment of hepatitis C: beginning of the treatment, continuation or stop of the treatment. - Validate the field performance of not-invasive markers of hepatic fibrosis. Mid-term: - Realize an observational study of the evolution of hepatitis during an anti-VHC treatment, in an antiviral situation - Study the clinical and biological tolerance to the different treatments. - Study the impact of the observance of the treatment anti HIV and the life quality of patients. Long term: Study the natural history of chronic hepatitis, in particular at the stage of cirrhosis. - Analyze the factors associated to the evolution to fibrosis, to a decompensated hepatic disease or an hepatocellular carcinoma. - Evaluate the effects of antiretroviral agents on the evolution of not-treated hepatitis - Study the potential interactions between different virus of hepatitis","abstract":"","coll_dates":[{"start":"2005-01-01","end":"2018-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","analysis_unit":"Individuals","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Male\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"Female\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        },\n        {\n            \"value\": \"Other\",\n            \"concept\": {\n                \"vocab\": [],\n                \"vocabURI\": []\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Young Adult (19 to 24 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adult (25 to 44 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Middle Aged (45 to 64 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        },\n        {\n            \"value\": \"Aged (65 to 79 years)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Adults infected by HIV virus carriers of VHC or cured after anti-VHC treatment, or spontaneously healed without anti-VHC treatment or benefiting from an anti-VHC tritherapies.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Paraclinical data (non-biological) : Imaging']","quality_statement":{"standards":[{"name":"['---']","committee":"","governance":""}],"other_quality_statement":"['Data utilization possible for academic teams and for industrials. Temporary access condition : project accepted by the scientific committee']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health care consumption and services\r\nQuality of life\/health perception"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Other\"}']","sample_frame":{"frame_unit":{"unit_type":"['Through organizations (health services or institutions, schools, businesses, etc.)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"1849 in june 2018"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]},{"subject":"observational study method","values":["Cohort study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"Data utilization possible for academic teams and for industrials. Temporary access condition : project accepted by the scientific committee","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Temporary access condition : project accepted by the scientific committee","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"en","originLang":"en","autoTranslation":false,"status":"imported","creationDate":"09-05-2012","lastUpdatedAuto":null,"lastUpdatedManual":"07-08-2019","isContributorPI":"No","contributorName":"Dominique SALMON","contributorAffiliation":"UNIVERSITE PARIS CITE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Industry","Industry","Public (France)","Industry","Industry"],"otherFundingAgentType":["","","","","",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Yes","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Self-questionnaire: filled from a paper questionnaire. 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Information collected during the clinical examination: weigh, height, waist and hips circumference","biologicalDataDetails":"Blood check","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}