{"doc_desc":{"title":"Etude longitudinale sur des patients s\u00e9ropositifs : histoire naturelle et sous-traitement de l'infection par le VIH","idno":"FRESH-PEF3620-fr","producers":[{"name":"Val\u00e9rie GARCIA","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3620-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"3620"},{"agency":"FReSH","code":"FRESH-PEF3620"}]},"title":"Etude longitudinale sur des patients s\u00e9ropositifs : histoire naturelle et sous-traitement de l'infection par le VIH","alternate_title":"ANRS CO3 AQUITAINE"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Fran\u00e7ois;DABIS","firstname":"Fran\u00e7ois","lastname":"DABIS","type":"investigator","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/002cp4060","role":"organisation id"},{"title":"SIREN","uri":"261300081","role":"organisation id"}],"email":"francois.dabis@isped.u-bordeaux.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","PILabo":"ISPED- Institut de Sant\u00e9 Publique d'Epid\u00e9miologie et de \/ \u00c9quipe INSERM, U897, VIH","isContact":true}],"oth_id":[{"name":"Implication dans un r\u00e9seau de cohorte : HEPAVIH, COPANA, AC7(COHORTES ANRS) Inclusion dans un projet europ\u00e9en : CASCADE, DAD, ART-CC, EURO-SIDA, COHERE, HIV-TUBERCULOSIS","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"UNIVERSITE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/057qpr032","role":"sponsor id"},{"title":"SIREN","uri":"130018351","role":"sponsor id"}],"role":"sponsor"},{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE BORDEAUX","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/01hq89f96","role":"sponsor id"},{"title":"SIREN","uri":"263305823","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":"SIDACTION (ECS)","extlink":[{"title":"SIREN","uri":"398945543"}]}]},"distribution_statement":{"contact":[{"name":"Fran\u00e7ois;DABIS","lastname":"DABIS","firstname":"Fran\u00e7ois","type":"contact","email":"francois.dabis@isped.u-bordeaux.fr","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/002cp4060","role":"organisation id","title":"ROR"},{"uri":"261300081","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"Infection VIH"},{"keyword":"surveillance \u00e9pid\u00e9miologique"},{"keyword":"immunologie"},{"keyword":"prise en charge"}],"topics":[{"topic":"Immunologie m\u00e9dicale","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":"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"}],"purpose":"Objectif principal: \u00e9tudier l'histoire naturelle et sous traitement de l'infection par le VIH. Objectifs secondaires: - R\u00e9aliser une surveillance \u00e9pid\u00e9miologique de la prise en charge de l'infection par le VIH - Analyser la progression de l'infection et l'\u00e9tude des facteurs pronostiques de cette \u00e9volution - \u00c9valuer les modalit\u00e9s de prise en charge des patients - \u00c9tudier leur impact sur la progression de la maladie","abstract":"","coll_dates":[{"start":"1987-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine']","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\": \"Adolescence (13 \u00e0 18 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000293\"\n            }\n        },\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            \"value\": \"Personne \u00e2g\u00e9e (65 \u00e0 79 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000368\"\n            }\n        },\n        {\n            \"value\": \"Grand \u00e2ge (80 ans et plus)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"Patients s\u00e9ropositifs pour le VIH, quel que soit le stade clinique Vus au moins une fois en consultation ou en hospitalisation Age sup\u00e9rieur ou \u00e9gal \u00e0 13 ans au moment de l'inclusion Consentement libre\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','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. R\u00e9alisation d\\'audit qualit\u00e9 internes et externes tous les deux ans.Validation des d\u00e9c\u00e8s.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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}"],"research_instrument":"Acc\u00e8s restreint sur projet sp\u00e9cifique","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"8677 (31\/12\/2012)"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"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 possible des donn\u00e9es par des industriels","conditions":"Condition d'acc\u00e8s en accord avec les comit\u00e9s de pilotage","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":"09-05-2012","lastUpdatedAuto":null,"lastUpdatedManual":"28-02-2014","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/www.hal.inserm.fr\/ANRSCO3"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":true},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":true,"followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"Examens cliniques : saisie manuelleExamens biologiques : saisie manuelle","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"13 services hospitaliers en Aquitaine : Bordeaux, Libourne, Bayonne, Dax, Pau, P\u00e9rigueux, Villeneuve sur Lot, Mont de Marsan et Arcachon"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi Informations recueillies lors de l'examen clinique : - \u00e0 l\u2019inclusion, le dossier comprend des variables de type unique : caract\u00e9ristiques socio-d\u00e9mographiques, facteurs de risque de l\u2019infection par le VIH, mode de contamination, date de premi\u00e8re s\u00e9rologie positive et circonstances du diagnostic ; \u00e9ventuellement, date de derni\u00e8re s\u00e9rologie n\u00e9gative, de transfusion ou p\u00e9riode d\u2019exposition au risque. Le dossier d\u2019inclusion comprend aussi des variables \u00e9volutives :- donn\u00e9es d'examen clinique, diagnostic de pathologies sp\u00e9cifiques, classement selon la classification de l\u2019infection par les VIH des centers for diseases control americains (CDC) (MMWR 1986;35:334-9) et la classification du sida av\u00e9r\u00e9 de l\u2019OMS\/CDC reprise par la direction g\u00e9n\u00e9rale de la sant\u00e9 (DGS) en 1987 (bull epidemiol HEBD 1987; (51): 201-3) et modifi\u00e9e en 1993 (bull epidemiol HEBD 1993 ; (11) : 47-8) ;- pratiques sexuelles et de toxicomanie, habitudes de vie, facteurs de risque cardio-vasculaires ;- bilan h\u00e9matologique, virologique, immunologique, biochimique et s\u00e9rologique ;- th\u00e9rapeutiques prescrites, ant\u00e9c\u00e9dents th\u00e9rapeutiques ;Lors de chaque suivi, le questionnaire permet de recueillir \u00e0 nouveau l\u2019ensemble des informations concernant les variables \u00e9volutives.","biologicalDataDetails":"Marqueurs virologiques, immunologiques","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}