[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566548":3},{"organization":4,"outcomesModule":7,"designInfo":45,"detailedDescription":11,"studyPopulation":11,"armGroups":51,"interventions":57,"overallOfficials":11,"centralContacts":62,"locations":72,"responsibleParty":85,"collaborators":87,"id":97,"slug":11,"hasResults":98,"nctId":99,"briefTitle":100,"officialTitle":101,"acronym":102,"eligibilityCriteria":103,"healthyVolunteers":104,"sex":105,"minAge":106,"maxAge":107,"enrollmentInfo":108,"targetDuration":11,"studyType":111,"phases":112,"briefSummary":113,"conditions":114,"keywords":116,"overallStatus":121,"whyStopped":11,"lastUpdateSubmitDate":122,"lastUpdatePostDateStruct":123,"startDateStruct":126,"completionDateStruct":128,"leadSponsor":130,"locationsCount":131},{"fullName":5,"class":6},"Institut de Médecine et d'Epidémiologie Appliquée - Fondation Internationale Léon M'Ba","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":11},[9],{"measure":10,"description":11,"timeFrame":12},"Total number and proportion of eligible women (age 30 to 65, unscreened for cervical cancer for 3 to 5 years) who had an HPV PCR test on a self-collected vaginal sample when offered in a nonclinical setting by the Bus Santé de Seine-Saint-Denis",null,"Day 0",[14,16,18,20,22,24,26,28,30,32,34,36,38,40,42],{"measure":15,"description":11,"timeFrame":12},"Declined to participate: number and why",{"measure":17,"description":11,"timeFrame":12},"Description of the barriers to cervical cancer screening in the target population",{"measure":19,"description":11,"timeFrame":12},"Proportion of complete HPV-HR PCRs run onboard the Bus and proportion with same-day results available to the participants",{"measure":21,"description":11,"timeFrame":12},"Frequency of positive HPV-HR tests and of invalid HPV-HR tests using SCVS samples",{"measure":23,"description":11,"timeFrame":12},"Description of HPV types in the participant population",{"measure":25,"description":11,"timeFrame":12},"Comparison of HPV-HR negative and HPV-HR positive participants",{"measure":27,"description":11,"timeFrame":12},"Proportion of secondary pelvic examination and cervical PAP smears in HPV-positive participants ; in Step 1 (laboratory-based PCR) and Step 2 (PCR aboard the Bus with same-day results)",{"measure":29,"description":11,"timeFrame":12},"Proportion of Chlamydiae trachomatis and Neisseria gonorrhoea STIs",{"measure":31,"description":11,"timeFrame":12},"Number and frequency of cytological abnormalities and cervical lesions in participants who had a PAP smear following a positive HPV-HR test ; in Step 1 (laboratory-based PCR) and Step 2 (PCR aboard the Bus with same-day results)",{"measure":33,"description":11,"timeFrame":12},"Proportion of valid self-collected vaginal swabs (cellular density, valid HPV PCR)",{"measure":35,"description":11,"timeFrame":12},"Unavailability of point-of-care HPV-HR PCR: number of days and why (reagent shortage, instrument of power failure, environmental conditions, short-staffing…)",{"measure":37,"description":11,"timeFrame":12},"Reliability of vaginal self-sampling in a nonclinical setting: proportion of valid samples, types of non-conformity",{"measure":39,"description":11,"timeFrame":12},"Participant satisfaction with point-of-care self-sampling and HPV testing; proportion willing to recommend the intervention to their acquaintance",{"measure":41,"description":11,"timeFrame":12},"Staff satisfaction by self-questionnary",{"measure":43,"description":11,"timeFrame":44},"Adverse events; setbacks and adjustments over the study period","From day 0 to the last call (about month 2)",{"allocation":46,"interventionModel":47,"interventionModelDescription":11,"primaryPurpose":48,"observationalModel":11,"timePerspective":11,"maskingInfo":49},"NA","SINGLE_GROUP","SCREENING",{"masking":50,"maskingDescription":11,"whoMasked":11},"NONE",[52],{"label":53,"type":6,"description":54,"interventionNames":55},"prospective cervical cancer screening intervention","Evaluation of a cervical cancer screening outreach intervention using point-of-care High-Risk HPV (HPV-HR) tests on self-collected vaginal swabs",[56],"Other: HPV self sampling",[58],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":11},"HPV self sampling","Selected women will perform a vaginal self-sampling using a swab",[53],[63,68],{"name":64,"role":65,"phone":66,"phoneExt":11,"email":67},"KARINE AMAT","CONTACT","0140256352","karine.amat@fondation-imea.org",{"name":69,"role":65,"phone":70,"phoneExt":11,"email":71},"Aïda BENALYCHERIF","0140256365","aida.benalycherif@fondation-imea.org",[73],{"facility":74,"status":11,"city":75,"state":11,"zip":76,"country":77,"countryCode":78,"cosmosGeoPoint":79,"geoPoint":84,"contacts":11},"Hopital Avicenne","Bobigny","93000","France","FR",{"type":80,"coordinates":81},"Point",[82,83],2.45012,48.90982,{"lat":83,"lon":82},{"type":86,"investigatorFullName":11,"investigatorTitle":11,"investigatorAffiliation":11,"oldNameTitle":11,"oldOrganization":11},"SPONSOR",[88,90,93,95],{"name":89,"class":6},"Hospital Avicenne",{"name":91,"class":92},"National Cancer Institute, France","OTHER_GOV",{"name":94,"class":6},"INSERM UMR S 1136",{"name":96,"class":92},"Institut National de la Santé Et de la Recherche Médicale, France","100566548",false,"NCT06656611","Mobile Outreach Screening of High-Risk Human Papillomavirus Infection in Women with Limited Access to Health Services in Seine-Saint-Denis (greater Paris Area, France)","PAPMOBILE: Mobile Outreach Screening of High-Risk Human Papillomavirus Infection in Women with Limited Access to Health Services in Seine-Saint-Denis (greater Paris Area, France)","PAPMOBILE","Inclusion Criteria:\n\n* \\- Women from 30 to 65 years of age presenting to the \" Bus Santé \" nonclinical testing unit, eligible to cervical cancer screening by an HPV-HR test\n* Women affiliated to the French social security or immigrants benefiting from the state medical aid program for undocumented immigrants (Aide Médicale d'Etat). The inclusion of people not affiliated to a social security system is an exception and depends on the decision of the Personal Protection Committee, if it is based on an expected benefit for these people of a nature to justify the foreseeable risk incurred.\n* The intervention is designed for vulnerable women with limited access to healthcare, including but not limited to:\n\n  * Women living in shelters and hostels, women living in the streets, in squats, hot-bedding arrangements, emergency social housing;\n  * Recent immigrants, documented or undocumented;\n  * Young adults from priority neighbourhoods,\n  * Isolated or marginalized women\n* Free, informed, written consent, signed by the person and the investigator at the latest on the day of inclusion and before any sampling carried out as part of the trial (article L1122-1-1 of the Public Health Code)\n\nThe Bus will operate in underprivileged neighbourhoods in the greater Paris area (eastern Seine-Saint-Denis department.\n\nExclusion Criteria:\n\n* Screened for cervical cancer by a PAP smear in the last 3 years or by an HPV test in the last 5 years,\n* Women on their period (haemoglobin inhibits PCRs)\n* Pregnancy in the 2nd and 3rd trimesters\n* Total hysterectomy; absence of a vagina\n* Women under guardianship\u002Ftutelage",true,"FEMALE","30 Years","65 Years",{"count":109,"type":110},700,"ESTIMATED","INTERVENTIONAL",[46],"The study is a prospective cervical cancer screening intervention in the nonclinical setting of a mobile testing unit in a vehicle, using point-of-care HPV PCR tests with self-collected vaginal swabs.\n\nIt is designed for women with limited access to healthcare and prevention in underprivileged municipalities in the greater Paris area (Seine-Saint-Denis department, detailed in Annexe 3).\n\nHPV positive participants will receive counseiling and guidance to help them find a healthcare professional to take care of their needs",[115],"Women's Health: Cervical Neoplasm",[117,118,119,120],"HPV","cervical cancer","outreach intervention","vaginal self sampling","NOT_YET_RECRUITING","2024-10-23",{"date":124,"type":125},"2024-10-24","ACTUAL",{"date":127,"type":110},"2024-12-01",{"date":129,"type":110},"2026-07-30",{"name":5,"class":6},1]