{"doc_desc":{"title":"Comparaison de strat\u00e9gies bas\u00e9es sur la RT-PCR ou le test antig\u00e9nique pour le d\u00e9pistage de l\u2019infection \u00e0 SARS-CoV-2 en population g\u00e9n\u00e9rale \u00e0 partir d\u2019auto-pr\u00e9l\u00e8vements.","idno":"FRESH-PEF73973-fr","producers":[{"name":"Amandine BAUDOT","affiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE"}]},"study_desc":{"title_statement":{"idno":"FRESH-PEF73973-fr","IDno":{"metadata_no":[{"agency":"PEF","code":"73973"},{"agency":"FReSH","code":"FRESH-PEF73973"}]},"title":"Comparaison de strat\u00e9gies bas\u00e9es sur la RT-PCR ou le test antig\u00e9nique pour le d\u00e9pistage de l\u2019infection \u00e0 SARS-CoV-2 en population g\u00e9n\u00e9rale \u00e0 partir d\u2019auto-pr\u00e9l\u00e8vements.","alternate_title":"AutoCoV"},"study_authorization":{"agency":[{"name":"CNIL"}]},"authoring_entity":[{"type":"investigator","name":"Julie;GAGNAIRE","PILabo":"CHU de Saint-Etienne","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"","uri":"","role":"pi id"},{"title":"IdRef","uri":"162520751","role":"pi id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"julie.gagnaire@chu-st-etienne.fr","isContact":"Oui"},{"type":"investigator","name":"Bruno;POZZETTO","PILabo":"CHU de Saint-Etienne","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ORCID","uri":"0000-0002-2603-8467","role":"pi id"},{"title":"IdRef","uri":"058490574","role":"pi id"},{"title":"SIREN","uri":"264200304","role":"organisation id"},{"title":"","uri":"","role":"labo id"}],"email":"bruno.pozzetto@chu-st-etienne.fr","isContact":"Oui"}],"oth_id":[{"name":""}],"production_statement":{"prod_place":"Portail Epid\u00e9miologie France (PEF)","producers":[{"name":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","extlink":[{"title":"ROR","uri":"https:\/\/ror.org\/04pn6vp43","role":"sponsor id"},{"title":"SIREN","uri":"264200304","role":"sponsor id"}],"role":"sponsor"}],"funding_agencies":[{"name":""}]},"distribution_statement":{"contact":[{"name":"Julie;GAGNAIRE","email":"julie.gagnaire@chu-st-etienne.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04pn6vp43","role":"organisation id","title":"ROR"},{"uri":"264200304","role":"organisation id","title":"SIREN"}]},{"name":"Bruno;POZZETTO","email":"bruno.pozzetto@chu-st-etienne.fr","type":"contact","affiliationName":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","contactPointLabo":"","extlink":[{"uri":"https:\/\/ror.org\/04pn6vp43","role":"organisation id","title":"ROR"},{"uri":"264200304","role":"organisation id","title":"SIREN"}]}]},"study_info":{"keywords":[],"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":"COVID-19","vocab":"cim-11","extLink":[{"uri":"http:\/\/id.who.int\/icd\/entity\/1730556128","title":"CIM-11"}]}],"purpose":"L'objectif principal est d\u2019\u00e9valuer, pour le d\u00e9pistage de l\u2019infection \u00e0 SARSCoV-2, les performances d\u2019une strat\u00e9gie qui combinerait 1) un autopr\u00e9l\u00e8vement salivaire associ\u00e9 \u00e0 un auto-pr\u00e9l\u00e8vement nasal ant\u00e9rieur et 2) un test diagnostique antig\u00e9nique directement r\u00e9alisable sur le terrain, en comparaison avec la technique de r\u00e9f\u00e9rence de RT-PCR sur pr\u00e9l\u00e8vement salivaire r\u00e9cemment valid\u00e9e par la HAS. Objectifs secondaires : - D\u00e9terminer la pr\u00e9valence de l\u2019infection \u00e0 SARS-CoV-2 dans la population test\u00e9e par le test de r\u00e9f\u00e9rence; - D\u00e9terminer la pr\u00e9valence de la circulation des diff\u00e9rents variants d\u2019int\u00e9r\u00eat de SARS-CoV-2 dans la population test\u00e9e; - Evaluer l\u2019acceptabilit\u00e9 des auto-pr\u00e9l\u00e8vements en fonction de l\u2019\u00e2ge et des cat\u00e9gories socio-professionnelles; - Evaluer la praticabilit\u00e9 des deux strat\u00e9gies de d\u00e9pistage; - Evaluer le rapport co\u00fbt-efficacit\u00e9 de la nouvelle strat\u00e9gie diagnostique par rapport \u00e0 la technique de r\u00e9f\u00e9rence (RT-PCR sur salive); - Renforcer l\u2019adh\u00e9sion aux gestes barri\u00e8res et aux consignes d\u2019isolement pr\u00e9coce des cas positifs par la r\u00e9alisation de tests rapides et par un accompagnement par des personnes sensibilis\u00e9es \u00e0 l\u2019approche motivationnelle; - Evaluer l\u2019accompagnement sanitaire des personnes \u00e0 l\u2019isolement; - Evaluer sur un \u00e9chantillon de sujets d\u00e9pist\u00e9s positifs ou n\u00e9gatifs, les connaissances relatives aux gestes barri\u00e8res et aux consignes d\u2019isolement par l\u2019utilisation des tests rapides et par l\u2019accompagnement des m\u00e9diateurs de lutte anti-COVID.","abstract":"","coll_dates":[{"start":"2021-01-01","end":"2021-12-31"}],"nation":[{"name":"France","abbreviation":"fr","extLink":{"vocab":"ISO","vocabURI":"fr"}}],"geog_coverage":"['Auvergne Rh\u00f4ne-Alpes']","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\": \"Enfance (6 \u00e0 12 ans)\",\n            \"concept\": {\n                \"vocab\": \"MeSH\",\n                \"vocabURI\": \"http:\\\/\\\/id.nlm.nih.gov\\\/mesh\\\/D002648\"\n            }\n        },\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\": \"Population g\u00e9n\u00e9rale\",\n    \"level_type_clusion_other\": \"\",\n    \"clusion_I\": \" Sujet adulte ou sujet de 10 ans ou plus susceptible de fournir un autopr\u00e9l\u00e8vement de salive et de nez ant\u00e9rieur - Sujet ou tuteur l\u00e9gal ne s\u2019opposant pas \u00e0 l\u2019auto-pr\u00e9l\u00e8vement et au recueil des donn\u00e9es anonymis\u00e9es dans le cadre de cette recherche - Patients affili\u00e9 ou ayant droit d'un r\u00e9gime de s\u00e9curit\u00e9 sociale\",\n    \"clusion_E\": \"\"\n}","data_kind":"['Donn\u00e9es rapport\u00e9es par le participant de l'\u00e9tude','Donn\u00e9es biologiques']","quality_statement":{"standards":[{"name":"","committee":"","governance":""}],"other_quality_statement":""}},"study_development":{"development_activity":[]},"method":{"data_collection":{"time_method":"Etude transversale r\u00e9p\u00e9t\u00e9e","frequency":"","sampling_procedure":"['{\"concept\":{\"vocabURI\":\"Other\",\"vocab\":\"CESSDA\"},\"value\":\"Autre\"}']","sample_frame":{"frame_unit":{"unit_type":"['Via les professionnels d'exercice lib\u00e9ral Via des structures (services ou \u00e9tablissements de sant\u00e9, \u00e9coles, entreprises\u2026)']"}},"coll_mode":["{\"concept\":{\"vocabURI\":\"Transcription\",\"vocab\":\"CESSDA\"},\"value\":\"Transcription et saisie d\u2019informations dans un enregistrement structur\u00e9\"}","{\"concept\":{\"vocabURI\":\"Interview\",\"vocab\":\"CESSDA\"},\"value\":\"Entretien avec le participant (dont clinique)\"}"],"research_instrument":"","sources":[],"target_sample_size":"[1000-10000[ individus","response_rate":"7100"},"method_notes":"Etude observationnelle","study_class":"Inconnu","notes":[{"subject":"research type","values":["Etude observationnelle"]}]},"data_access":{"dataset_availability":{"access_place":"","complete":"","status":"{\"value\":\"A d\u00e9finir\",\"extLink\":[]}"},"dataset_use":{"restrictions":"","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":"----","lastUpdatedAuto":null,"lastUpdatedManual":"07-05-2021","isContributorPI":"Non","contributorName":"Amandine BAUDOT","contributorAffiliation":"CENTRE HOSPITALIER UNIVERSITAIRE DE SAINT-ETIENNE","addTeamMember":"","obtainedAuthorization":{"otherAuthorizingAgency":[""]},"relatedDocument":[],"regulatoryRequirements":{"conformityDeclaration":""},"fundingAgent":{"fundingAgentType":[],"otherFundingAgentType":[]},"sponsor":{"sponsorType":["Public (France)"],"otherSponsorType":[""]},"governance":{"committee":"Oui"},"collaborations":{"networkConsortium":""},"theme":{"complementaryInformation":"","RareDiseases":""},"activeFollowUp":{"isActiveFollowUp":"Non","followUpModeOther":""},"interventionalStudy":{"researchPurpose":[],"trialPhase":[],"interventionalStudyModel":"","isClinicalTrial":"","otherResearchPurpose":""},"isInclusionGroups":"","allocation":{"allocationMode":"","allocationUnit":""},"masking":{"maskingType":"","blindedMaskingDetails":[]},"arms":[],"intervention":[],"inclusionGroups":[],"collectionProcess":{"collectionModeDetails":"","collectionModeOther":""},"dataCollection":{"inclusionStrategyOther":"","samplingModeOther":"","recruitmentSourceOther":"","otherDocumentation":""},"dataCollectionIntegration":{"isDataIntegration":"Non"},"geographicalCoverage":{"geoDetail":"Saint-Etienne m\u00e9trop\u00f4le"},"dataTypes":{"clinicalDataDetails":"","biologicalDataDetails":"Nombre et pourcentage de sujets test\u00e9s positifs par le test de RT-PCR dans la salive - Nombre et pourcentage de variants d\u2019int\u00e9r\u00eat de SARS-CoV-2 par rapport au nombre total de souches positives","isDataInBiobank":"Oui","biobankContent":[],"biobankContentOther":"","dataTypeOther":""},"variableDictionnary":{"variableDictionnaryAvailable":"","variableDictionnaryLink":""},"dataQuality":{"otherDocumentation":""},"mockSample":{"mockSampleAvailable":"","mockSampleLocation":""},"thirdPartySource":{"otherSourceType":[]},"isHealthTheme":"Oui","fileDscr":{"fileTxt":{"fileCitation":{"titlStmt":{"IDno":[]}}}}},"schematype":"survey"}