{"doc_desc":{"title":"Natural history and sub-treatment of HIV infection","idno":"FRESH-PEF3620-en","producers":[{"name":"Val\u00e9rie GARCIA","affiliation":"UNIVERSITE DE BORDEAUX"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF3620-en","IDno":{"metadata_no":[{"agency":"PEF","code":"3620"},{"agency":"FReSH","code":"FRESH-PEF3620"}]},"title":"Natural history and sub-treatment of HIV infection","alternate_title":"ANRS CO3 AQUITAINE"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Fran\u00e7ois;DABIS","PILabo":"ISPED- Institut de Sant\u00e9 Publique d'Epid\u00e9miologie et de \/ \u00c9quipe INSERM, U897, VIH","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE MARSEILLE (AP-HM)","extlink":[{"title":"ORCID","uri":"0000-0002-1614-8857","role":"pi id"},{"title":"IdRef","uri":"031387012","role":"pi id"},{"title":"SIREN","uri":"261300081","role":"organisation id"},{"title":"RNSR","uri":"201320677Y","role":"labo id"}],"email":"francois.dabis@isped.u-bordeaux.fr","isContact":"Yes"}],"oth_id":[{"name":"Implication in a cohort network: EPAVIH, COPANA, AC7(COHORTES ANRS) Inclusion in a European project: CASCADE, DAD, ART-CC, EURO-SIDA, COHERE, HIV-TUBERCULOSIS","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"francois.dabis@isped.u-bordeaux.fr","type":"contact","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":"HIV infection"},{"keyword":"epidemiological surveillance"},{"keyword":"patient care"},{"keyword":"immunology"}],"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":"Behavioral determinants","vocab":"health determinant"}],"purpose":"Main objective: study the natural history and sub-treatment of the infection by the HIV. Secondary objectives: - Realize an epidemiological surveillance of the treatment of HIV infection - Analyze the progression of the infection and study the prognostic factors of this evolution - Evaluate the arrangements for patients caring - Study their impact on the disease progression","abstract":"","coll_dates":[{"start":"1987-01-01"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Nouvelle-Aquitaine']","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    \"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            \"value\": \"Aged, 80 and over (80 years and more)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D000369\"\n            }\n        }\n    ],\n    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"HIV-positive patients, at any clinical stage .Seen at least once in consultation or hospitalization .13 years or older at the time of the inclusion in the study .Freely consent\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Coherence request after computer data entry. Missing data checked back to the original file. Doctors remainders for follow-up visits. Internal and external quality audit reports every 2 years. Validation of deaths. Patients receive information about the use of their data.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality\r\nHealth care consumption and services"}]},"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\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}","{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"[1000-10000[ individuals","response_rate":"8677 (31\/12\/2012)"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"Data utilization possible for academic teams and for industrials.","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Access condition in agreement with the steering 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":"28-02-2014","isContributorPI":"No","contributorName":"Val\u00e9rie GARCIA","contributorAffiliation":"UNIVERSITE DE BORDEAUX","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/www.hal.inserm.fr\/ANRSCO3"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Private non-profit"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)","Public (France)"],"otherSponsorType":["",""]},"governance":{"committee":""},"collaborations":{"networkConsortium":"Yes"},"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":"Clinical examination: manual data entry Biological examination: manual data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"13 hospital departments in Aquitaine: Bordeaux, Libourne, Bayonne, Dax, Pau, P\u00e9rigueux, Villeneuve sur Lot, Mont de Marsan and Arcachon"},"dataTypes":{"clinicalDataDetails":"Clinical examination at inclusion and during the follow-up. Information collected through the clinical examination: - At inclusion, the record includes unique kind of variables: socio-demographic characteristics, risk factors for HIV infection, mode of transmission, date of first positive serology and diagnostic circumstances; eventually, date of the last negative serology, transfusion or risk exposure period. The inclusion record incorporates progressive variables: - Clinical examination data, specific pathologies diagnostics, classification according to the American centers for diseases control (CDC)(MMWR 1986;35:334-9) and the aids classification recognized by WHO\/CDC, taken over by the General Health Direction (DGS) in 1987 (bull epidemiol HEBD 1987; (51):201-3) and modified in 1993 (bull epidemiol HEBD 1993 ; (11) : 47-8); - Sexual practices and drug addiction, lifestyle, cardiovascular risk factors; - Hematological, virological, immunological, biochemical and serological check; prescribed therapeutics, treatment history; During each follow-up, the questionnaire will allow to collect again all the information concerning progressive variables.","biologicalDataDetails":"Virological markers, immunological","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}