{"doc_desc":{"title":"Cohort of HIV-Seropositive Individuals Infected by Use of Intravenous drugs: Prospective Study in Marseille, Avignon, Nice and Ile-de-France","idno":"FRESH-PEF60063-en","producers":[{"name":"Maria Patrizia CARRIERI","affiliation":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF60063-en","IDno":{"metadata_no":[{"agency":"PEF","code":"60063"},{"agency":"FReSH","code":"FRESH-PEF60063"}]},"title":"Cohort of HIV-Seropositive Individuals Infected by Use of Intravenous drugs: Prospective Study in Marseille, Avignon, Nice and Ile-de-France","alternate_title":"MANIF-2000 FOLLOWED BY MANIF-2"},"study_authorization":{"agency":[]},"authoring_entity":[{"type":"investigator","name":"Maria Patrizia;CARRIERI","PILabo":"OBSERVATOIRE REGIONAL DE LA SANTE \/ ORS PACA - INSERM U912","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","extlink":[{"title":"ORCID","uri":"0000-0002-6794-4837","role":"pi id"},{"title":"IdRef","uri":"144323036","role":"pi id"},{"title":"SIREN","uri":"330065095","role":"organisation id"},{"title":"RNSR","uri":"200817366W","role":"labo id"}],"email":"maria-patrizia.carrieri@inserm.fr","isContact":"Yes"},{"type":"investigator","name":"Yolande;OBADIA","PILabo":"OBSERVATOIRE REGIONAL DE LA SANTE \/ ORS PACA","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"035252170","role":"pi id"},{"title":"SIREN","uri":"330065095","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"yolande.obadia@inserm.fr","isContact":"Yes"}],"oth_id":[{"name":"","type":"collaboration"}],"production_statement":{"prod_place":"Epidemiology France Portal (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","email":"maria-patrizia.carrieri@inserm.fr","type":"contact","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","contactPointLabo":"","extlink":[{"uri":"330065095","role":"organisation id","title":"SIREN"}]},{"name":"Yolande;OBADIA","email":"yolande.obadia@inserm.fr","type":"contact","affiliationName":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","contactPointLabo":"","extlink":[{"uri":"330065095","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[{"keyword":"related diseases"},{"keyword":"hepatic"},{"keyword":"psychiatric"},{"keyword":"genital and gynaecological"},{"keyword":"secondary side-effects from treatment"},{"keyword":"Health episodes"},{"keyword":"cardiovascular"},{"keyword":"neurological"},{"keyword":"infectious"},{"keyword":"prevention"}],"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":"Behavioral determinants: Addiction","vocab":"health determinant"},{"topic":"Behavioral determinants","vocab":"health determinant"}],"purpose":"General objective: MANIF 2000 is a cohort of HIV-1 seropositive patients that have been infected through intravenous drug use. Patients should have an initial CD4 count of > 300\/mm3. The initial aim of this study was to compare HIV progression according to whether patients were still active addicts, substituting or sober. This goal was revised in light of the changes in HIV history with the release of highly active combination therapy and the treatment of addicts with buprenorphine substitution. MANIF 2000 has become an observational cohort study focused on risk-related sexual behaviours associated with drug addiction, as well as adherence to therapy and interaction between substitution and treatment. Secondary objectives: - To determine the impact of depression and HIV treatment adherence on clinical progression; - to determine the impact of retention in substitution treatment on virological success.","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":"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    \"level_type_clusion_I\": \"Patients population\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \"HIV-1 or HIV-2 seropositive patients that have been infected through intravenous drug use with an initial CD4 count greater than 300\\\/mm3 and at clinical stage A or B.\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Clinical data','Participant-reported health data','Biological data']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"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\":\"SelfAdministeredQuestionnaire\",\"vocab\":\"CESSDA\"},\"value\":\"Self-administered questionnaire\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Interview with the participant (including clinical)\"}"],"research_instrument":"Access on specific project only","sources":[],"target_sample_size":"< 500 individuals","response_rate":"467"},"method_notes":"Observational Study","study_class":"Unknown","notes":[{"subject":"research type","values":["Observational Study"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"Metadata-only access\",\"extLink\":[{\"title\":\"COAR\",\"uri\":\"http:\/\/purl.org\/coar\/access_right\/c_14cb\"}]}"},"dataset_use":{"restrictions":"","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":"08-03-2013","lastUpdatedAuto":null,"lastUpdatedManual":"05-09-2017","isContributorPI":"No","contributorName":"Maria Patrizia CARRIERI","contributorAffiliation":"OBSERVATOIRE REGIONAL DE LA SANTE (ORS PACA)","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)","Private non-profit"],"otherFundingAgentType":["","",""]},"sponsor":{"sponsorType":["Private non-profit"],"otherSponsorType":[""]},"governance":{"committee":""},"collaborations":{"networkConsortium":""},"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":"Self-administered questionnaire: entry from a paper questionnaire Interviews: entry from a paper questionnaire Clinical examinations: handwritten.","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"No"},"geographicalCoverage":{"geoDetail":"Multicentric cohort throughout France (10 centres): Marseille, Avignon, Nice, Ile de France"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Type of samples taken: Haematology, chemistry, immunology, HIV serology, viral load, other serological tests such as Hepatitis B and C and freezing.","isDataInBiobank":"Yes","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Yes","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}