{"doc_desc":{"title":"Cohorte multicentrique de patients VIH positif","idno":"FRESH-PEF60080-fr","producers":[{"name":"Laurence MEYER","affiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60080-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60080"},{"agency":"FReSH","code":"FRESH-PEF60080"}]},"title":"Cohorte multicentrique de patients VIH positif","alternate_title":"ANRS CO2 SEROCO\/HEMOCO"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Laurence;MEYER","PILabo":"INSERM - Institut National de Sant\u00e9 et Recherche \/ U822","affiliationName":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ORCID","uri":"0000-0002-6113-936X","role":"pi id"},{"title":"IdRef","uri":"091570530","role":"pi id"},{"title":"SIREN","uri":"180036048","role":"organisation id"},{"title":"RNSR","uri":"199220513L","role":"labo id"}],"email":"laurence.meyer@inserm.fr","isContact":"Oui"}],"oth_id":[{"name":"Implication dans un r\u00e9seau de cohorte : - national : COHORTES AC7, HEPAVIH- international : COHERE, COHORTE EUROPEENNE D'USAGERS DE DROGUES INJECTABLES (M. PRINS, PAYS BAS), CASCADE Inclusion dans un projet europ\u00e9en : Cascade, Cohere","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (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"}]}]},"distribution_statement":{"contact":[{"name":"Laurence;MEYER","email":"laurence.meyer@inserm.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"}]}]},"study_info":{"keywords":[{"keyword":"stade Sida"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"morbidit\u00e9"},{"keyword":"mortalit\u00e9"}],"topics":[{"topic":"Infectiologie","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":"D\u00e9terminants comportementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux : Autres","vocab":"health determinant"},{"topic":"D\u00e9terminants socio-d\u00e9mographiques et \u00e9conomiques","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9 : Consommation des soins","vocab":"health determinant"},{"topic":"D\u00e9terminants environnementaux","vocab":"health determinant"},{"topic":"D\u00e9terminants li\u00e9s au syst\u00e8me de sant\u00e9","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : \u00e9tudier la progression spontan\u00e9e de la maladie VIH et de la r\u00e9ponse au traitement des sujets non h\u00e9mophiles (SEROCO) ou h\u00e9mophiles (HEMOCO). R\u00f4le pronostique des marqueurs, en particulier CD4, ARN-VIH, et ADN-VIH.","abstract":"","coll_dates":[{"start":"1988-01-01","end":"2009-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Ile-de-France','Provence - Alpes - C\u00f4te d\\'Azur']","analysis_unit":"Individus","universe":"{\n    \"level_sex_clusion_I\": [\n        {\n            \"value\": \"Masculin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008297\"\n            }\n        },\n        {\n            \"value\": \"F\u00e9minin\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D005260\"\n            }\n        }\n    ],\n    \"level_age_clusion_I\": [\n        {\n            \"value\": \"Adulte (19 \u00e0 24 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D055815\"\n            }\n        },\n        {\n            \"value\": \"Adulte (25 \u00e0 44 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000328\"\n            }\n        },\n        {\n            \"value\": \"Adulte (45 \u00e0 64 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D008875\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"SEROCO : Patients s\u00e9ropositifs pour le VIH-1 (test Elisa confirm\u00e9 par Western Blot), \u00e0 date de contamination connue ou dont la s\u00e9ropositivit\u00e9 est dat\u00e9e de moins d\u2019un an (d\u00e9lai entre la date du premier pr\u00e9l\u00e8vement positif et celle o\u00f9 le patient entre dans l\u2019enqu\u00eate) et non SIDA \u00e0 l\u2019inclusion ; consultant des m\u00e9decins des centres participant \u00e0 l\u2019enqu\u00eate, \u00e2ge sup\u00e9rieur ou \u00e9gal \u00e0 18 ans ; ayant donn\u00e9 leur consentement \u00e9clair\u00e9.  HEMOCO : H\u00e9mophiles s\u00e9ropositifs pour le VIH (test Elisa confirm\u00e9 par Western Blot) ; consultant des m\u00e9decins des centres participant \u00e0 l\u2019enqu\u00eate, \u00e2ge sup\u00e9rieur ou \u00e9gal \u00e0 3 ans et ayant donn\u00e9 leur consentement \u00e9clair\u00e9. Le consentement est sign\u00e9 par les titulaires de l\u2019autorit\u00e9 parentale pour les mineurs non \u00e9mancip\u00e9s ou par les organes tut\u00e9laires pour les mineurs sous tutelle.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Pr\u00e9sence d\\'une requ\u00eate de coh\u00e9rence apr\u00e8s la saisie des donn\u00e9es informatiques.Gestion des donn\u00e9es manquantes par retour au dossier source.Relance des m\u00e9decins pour r\u00e9aliser les visites de suivi.Les patients sont inform\u00e9s de l\\'utilisation de leur donn\u00e9es.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Ev\u00e9nements de sant\u00e9\/morbidit\u00e9\r\nEv\u00e9nements de sant\u00e9\/mortalit\u00e9\r\nConsommation de soins\/services de sant\u00e9"}]},"method":{"data_collection":{"time_method":"","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Questionnaire auto-administr\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"- 1551 (SEROCO) - 197 (HEMOCO)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]},{"subject":"observational study method","values":["Cohorte"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Acc\u00e8s r\u00e9serv\u00e9\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Utilisation possible des donn\u00e9es par des \u00e9quipes acad\u00e9miques Utilisation non possible des donn\u00e9es par des industriels","conditions":"","conf_dec":[{"txt":""}],"spec_perm":[{"txt":"","required":""}],"contact":[{"name":""}],"deposit_req":"","cit_req":""},"notes":""}},"additional":{"IsImport":true,"versionLang":"fr","originLang":"fr","autoTranslation":false,"status":"imported","creationDate":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"01-01-2019","isContributorPI":"Non","contributorName":"Laurence MEYER","contributorAffiliation":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/HAL-ANRS-CO2"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)"],"otherFundingAgentType":[""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Oui"},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Oui","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier Entretiens : saisie \u00e0 partir d\u2019un questionnaire papierExamens cliniques : \u00e9tape manuscrite Examens biologiques : \u00e9tape manuscrite","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"R\u00e9gions parisienne et PACA (21 centres)"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les 6 moisInformations recueillies lors de l'examen clinique : cliniques, virologiques, immunologiques, initiation et arr\u00eat des diff\u00e9rents antir\u00e9troviraux.","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : Sang","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}