{"doc_desc":{"title":"Natural History of HIV-2-infected Adult Patients Living In France","idno":"FRESH-PEF60089-en","producers":[{"name":"Sophie MATHERON","affiliation":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60089-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60089"},{"agency":"FReSH","code":"FRESH-PEF60089"}]},"title":"Natural History of HIV-2-infected Adult Patients Living In France","alternate_title":"ANRS C05 VIH-2"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Sophie;MATHERON","PILabo":"APHP \/ MALADIES INFECTIEUSES ET TROPICALES, HOPITAL BICHAT-CLAUDE BERNARD","affiliationName":"ASSISTANCE PUBLIQUE HOPITAUX DE PARIS (AP-HP)","extlink":[{"title":"ORCID","uri":"0000-0001-7879-6553","role":"pi id"},{"title":"IdRef","uri":"181673061","role":"pi id"},{"title":"SIREN","uri":"267500452","role":"organisation id"},{"title":"RNSR","uri":"201722263E","role":"labo id"}],"email":"","isContact":"No"}],"oth_id":[{"name":"cohort network: ACHIEV2E (network of 14 European and 2 West African centers),","type":"collaboration"}],"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":"INSTITUT NATIONAL DE LA SANTE ET DE LA RECHERCHE MEDICALE (INSERM)","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/02vjkv261"},{"title":"SIREN","uri":"180036048"}]}]},"distribution_statement":{"contact":[{"name":"Julie;LONBOGARDI","email":"bph.cohorte_co5_vih-2@dif.credim.u-bordeaux.fr","type":"contact","affiliationName":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01kv58h76","role":"organisation id","title":"ROR"},{"uri":"180089385","role":"organisation id","title":"SIREN"}]},{"name":"Linda;WITTKOP","email":"linda.wittkop@inserm.fr","type":"contact","affiliationName":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/01kv58h76","role":"organisation id","title":"ROR"},{"uri":"180089385","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"HIV"},{"keyword":"HIV-2"},{"keyword":"natural history"},{"keyword":"AIDS"}],"topics":[{"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":"Certain infectious or parasitic diseases","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1435254666","title":"CIM-11"}]},{"topic":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Environmental determinants: Other","vocab":"health determinant"},{"topic":"Healthcare system determinants: Use of care","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"},{"topic":"Socio-demographic and economic determinants","vocab":"health determinant"},{"topic":"Environmental determinants","vocab":"health determinant"},{"topic":"Healthcare system determinants","vocab":"health determinant"}],"purpose":"Main objective To study HIV-2 infection in adult patients followed in France. Secondary objectives - To describe the epidemiological and clinical characteristics of participants infected with HIV-2, and the immuno-virological characteristics of the infection. - To study the clinical and immunological progression of HIV-2 infection and the prognostic factors for this progression. - To study the response (clinical, immuno-virological) to antiretroviral treatment and to contribute to the identification of antiretroviral strategies and combinations best suited to the particularities of the infection. - To allow an evaluation of the management practices of the participants - To provide a clinical and biological database and samples for basic science studies on HIV-2 infection.","abstract":"","coll_dates":[{"start":"1994-01-01"}],"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    \"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\": \"Inclusion Criteria : - HIV-2 infection only, diagnosed by ELISA, confirmed by Western-Blot, - Follow-up in one of the investigator centers, - Age greater than or equal to 18 years, - Extended follow-up possible, residence in France planned for at least one year, - Participant's consent to participate, - Possible ALD (Long Term Disorder) status for the participant, or state medical aid (SMA), or declaration of obtaining SMA at the time of inclusion.  Criteria for \",\n    \"clusion_E\": \"HIV-1 infection - double HIV-1 + HIV-2 seropositivity.\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data','Socio-demographic data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":"['Consistency checks after data entry. Remote and on-site monitoring: return to the source folder for data management and verification. Patients are informed about the use of their data.']"}},"study_development":{"development_activity":[{"activity_type":"primary evaluation","activity_description":"Health event\/morbidity\r\nHealth event\/mortality"}]},"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\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Converting or copying information into a structured record\"}"],"research_instrument":"Access on specific project only","sources":[{"sourceCitation":{"titlStmt":{"titl":""},"holdings":"","notes":{"subject":"source purpose","value":""}},"srcOrig":["Medico-administrative database"]}],"target_sample_size":"[1000-10000[ individuals","response_rate":"1185 participants, 540 under follow-up"},"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":"","status":"{\"value\":\"Restricted access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_16ec\"}]}"},"dataset_use":{"restrictions":"Possible use of the data by academic teams Possible use of the data by industrialists","conditions":"Time access requirements for academic research (collaborations for virological and immunological satellite studies, and therapeutic trials) Conditions of access possible industrial contractual collaborations (ANRS)","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"04-02-2021","isContributorPI":"No","contributorName":"Julie LONBOGARDI","contributorAffiliation":"AGENCE NATIONALE DE RECHERCHES SUR LE SIDA ET LES HEPATITES VIRALES (ANRS MIE)","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[]},"relatedDocument":[{"type":"","title":"List of publications in HAL","link":"http:\/\/tinyurl.com\/Hal-ANRS-CO5-HIV-2"}],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":["Public (France)","Public (France)"],"otherFundingAgentType":["",""]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Yes"},"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":"Interview: input from a paper questionnaire with double data entry Clinical examinations: handwritten with double data entry Biological analysis: handwritten with double data entry","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Yes"},"geographicalCoverage":{"geoDetail":"French Multicentric cohort (117 centres until 30\/10\/2019 then 34 centres)"},"dataTypes":{"clinicalDataDetails":"Clinical examination at baseline and at 6-month follow-up; information collected during clinical examination: weight, blood pressure, CDC stage B or C events, other clinical events, and, for women, pregnancy and menopause.","biologicalDataDetails":"Blood sample","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[""]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}