{"doc_desc":{"title":"Etude longitudinale de personnes s\u00e9ropositives pour le VIH contamin\u00e9es par usage de drogues intraveineuses : \u00e9tude prospective \u00e0 Marseille, Avignon, Nice et en Ile-de-France","idno":"FRESH-PEF60063-fr","producers":[{"name":"Maria Patrizia CARRIERI","affiliation":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60063-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"60063"},{"agency":"FReSH","code":"FRESH-PEF60063"}]},"title":"Etude longitudinale de personnes s\u00e9ropositives pour le VIH contamin\u00e9es par usage de drogues intraveineuses : \u00e9tude prospective \u00e0 Marseille, Avignon, Nice et en Ile-de-France","alternate_title":"MANIF-2000 PUIS MANIF-2"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"name":"Maria Patrizia;CARRIERI","firstname":"Maria Patrizia","lastname":"CARRIERI","type":"investigator","extlink":[{"title":"SIREN","uri":"330065095","role":"organisation id"}],"email":"maria-patrizia.carrieri@inserm.fr","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","PILabo":"OBSERVATOIRE REGIONAL DE LA SANTE \/ ORS PACA - INSERM U912","isContact":true},{"name":"Yolande;OBADIA","firstname":"Yolande","lastname":"OBADIA","type":"investigator","extlink":[{"title":"SIREN","uri":"330065095","role":"organisation id"}],"email":"yolande.obadia@inserm.fr","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","PILabo":"OBSERVATOIRE REGIONAL DE LA SANTE \/ ORS PACA","isContact":true}],"oth_id":[{"name":"Implication dans un r\u00e9seau de cohorte : collaborations internationales (survey among hiv cohorts on serious non aids conditions avec B. LEDERGERBER et age\/sex-specific death rates in art na\u00efve patients with CD4 count above 350\/MM3 compared with the general population avec R LODWIICK)","type":"collaboration"}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","extlink":[{"title":"SIREN","uri":"330065095","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":"DEPARTEMENT DES BOUCHES DU RHONE","extlink":[{"title":"SIREN","uri":"221300015"}]},{"name":"SIDACTION (ECS)","extlink":[{"title":"SIREN","uri":"398945543"}]}]},"distribution_statement":{"contact":[{"name":"Maria Patrizia;CARRIERI","lastname":"CARRIERI","firstname":"Maria Patrizia","type":"contact","email":"maria-patrizia.carrieri@inserm.fr","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","contactPointLabo":"","extlink":[{"uri":"330065095","role":"organisation id","title":"SIREN"}]},{"name":"Yolande;OBADIA","lastname":"OBADIA","firstname":"Yolande","type":"contact","email":"yolande.obadia@inserm.fr","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","contactPointLabo":"","extlink":[{"uri":"330065095","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"pathologies li\u00e9es"},{"keyword":"h\u00e9patiques"},{"keyword":"neurologiques"},{"keyword":"psychiatriques"},{"keyword":"gyn\u00e9cologiques et g\u00e9nitales"},{"keyword":"infectieuses"},{"keyword":"effets secondaires ind\u00e9sirables des traitements"},{"keyword":"\u00e9v\u00e9nements de sant\u00e9"},{"keyword":"cardiovasculaires"},{"keyword":"pr\u00e9vention"}],"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 : Addictions","vocab":"health determinant"},{"topic":"D\u00e9terminants comportementaux","vocab":"health determinant"}],"purpose":"Objectif g\u00e9n\u00e9ral : MANIF 2000 est une cohorte compos\u00e9e de patients s\u00e9ropositifs pour le VIH-1 qui ont tous \u00e9t\u00e9 contamin\u00e9s par le biais d'une toxicomanie intraveineuse. Les patients devaient disposer d'un taux de CD4 initial sup\u00e9rieur \u00e0 300\/mm3. Le but initial de cette \u00e9tude \u00e9tait de comparer l'\u00e9volution de la maladie VIH selon que les patients \u00e9taient des toxicomanes toujours actifs, substitues ou abstinents. Les modifications intervenues dans l'histoire de la maladie VIH avec la diffusion des combinaisons th\u00e9rapeutiques hautement actives et dans la prise en charge des toxicomanes avec la diffusion de la substitution par bupr\u00e9norphine, ont amen\u00e9 \u00e0 revoir cet objectif. MANIF 2000 est devenue une cohorte d'observation des comportements s'int\u00e9ressant notamment aux risques sexuels et li\u00e9s a la toxicomanie, mais aussi \u00e0 l'observance th\u00e9rapeutique et \u00e0 l'int\u00e9raction entre substitution et traitement. Objectifs secondaires : - D\u00e9terminer l'impact de la d\u00e9pression et de l'observance au traitement VIH sur la progression clinique ; - D\u00e9terminer l'impact de la r\u00e9tention du traitement de substitution sur le succ\u00e8s virologique.","abstract":"","coll_dates":[{"start":"1995-01-01","end":"2006-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"","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\": \"Patients s\u00e9ropositifs pour le VIH-1 ou VIH-2 contamin\u00e9s par le biais de toxicomanie intraveineuse ayant des CD4 initiaux sup\u00e9rieurs \u00e0 300\\\/mm3 et en stade clinique A ou B.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es cliniques','Donn\u00e9es rapport\u00e9es par le participant de l&#x27;\u00e9tude','Donn\u00e9es paracliniques','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']"}},"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":"< 500 individus","response_rate":"467"},"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 aux seules m\u00e9tadonn\u00e9es\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"Utilisation non 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":"05-09-2017","isContributorPI":false,"contributorName":"","contributorAffiliation":"","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[{"type":"","title":"Liste des publications dans HAL","link":"http:\/\/tinyurl.com\/Hal-MANIF-2000"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)","Priv\u00e9 \u00e0 but non lucratif"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Priv\u00e9 \u00e0 but non lucratif"],"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":"Auto-questionnaire : saisie \u00e0 partir d\u2019un questionnaire papier Entretiens : saisie \u00e0 partir d\u2019un questionnaire papier Examens cliniques : \u00e9tape manuscrite","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":false},"geographicalCoverage":{"geoDetail":"Cohorte multicentrique (10 centres) fran\u00e7aise : Marseille, Avignon, Nice, Ile de France"},"dataTypes":{"clinicalDataDetails":"Examen clinique \u00e0 l\u2019inclusion et au cours du suivi tous les deux ans.Informations recueillies lors de l'examen clinique : Pathologies, examens para-cliniques et traitements suivis","biologicalDataDetails":"Type de pr\u00e9l\u00e8vements r\u00e9alis\u00e9s : H\u00e9matologie, chimie, immunologie, s\u00e9rologie VIH, charge virale, autres s\u00e9rologies telles que H\u00e9patites B et C et cong\u00e9lation.","isDataInBiobank":true,"biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":true,"fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}