protocolSection identificationModule nctId: NCT06302725, orgStudyIdInfo id: APHP231514, secondaryIdInfos id: 2023-A02623-42, type: OTHER, domain: IDRCB, briefTitle: Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases, acronym: APOSY, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-03-12, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Assistance Publique - Hôpitaux de Paris, class: OTHER, descriptionModule briefSummary: Main objective: -To determine Human Papilloma Virus (HPV) prevalence in patients with immune-mediated inflammatory diseases (IMID) using vaginal self-sampling (VSS), one year after VSS was proposed Primary endpoint: - To determine the prevalence of HPV infection (yes/no) after VSS proposal Secondary objectives: - To describe the HPV typology and the rate of co-infection (with several high-risk HPV (HR-HPV)) in this population - To describe the factors associated with the presence of HPV infection - To determine the rate of HPV clearance after one year, during the second screening at 12 months- To determine the percentage of pre-cancerous cervical lesions and cervical cancer in the event of subsequent cervical smear - To determine the factors associated with persistence (or non-clearance ) of HPV infection - To determine the factors associated with the presence of pre-cancerous and cancerous cervical lesions - To determine the characteristics, tolerance and acceptability of VSS - To determine the rate of cervical cancer screening carried out following French Health Authorities guidelines -To determine the HPV vaccination coverage Secondary endpoints: 1/ HPV typology and presence of co-infection (Yes/No, type) or HPV multi-infection (more than 2 HPV, Yes/No) identified on samples at inclusion and at 1 year. 2/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: presence of HPV infection during follow-up. 3/ Characteristics, acceptability, obstacles and tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain). 4/ Up-to-date cervical cancer screening rate in accordance with HAS recommendations at 12 months post-procedure. 5/ Proportion of cervical cytological abnormalities and cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 6/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressants; variable to be explained: presence of cervical precancerous lesions and cervical cancer, authenticated on cervico-vaginal smear, if performed (histological confirmation if available) during follow-up. 7/ HPV vaccination coverage rate (measured on initial self-questionnaire) 8/ Prevalence of HR-HPV(s) at second screening at one year, in the case of initial positivity (Persistence of HPV infection (Yes/No). 9/ Explanatory variables: demographic, clinical, biological factors and treatments (corticoids, immunosuppressive treatments); variable to be explained: persistence of cervical HPV infection at one year (in the case of initial positivity)., conditionsModule conditions: HPV Infection, conditions: Systemic Disease, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 300, type: ESTIMATED, armsInterventionsModule interventions name: Vaginal self sampling detecting HPV, outcomesModule primaryOutcomes measure: prevalence of HPV infection (yes/no) after VSS proposal, secondaryOutcomes measure: the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population, secondaryOutcomes measure: The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population, otherOutcomes measure: Presence of HPV infection during follow-up (yes/no), otherOutcomes measure: description of demographic factor, otherOutcomes measure: description of clinical factor, otherOutcomes measure: description of biological factor, otherOutcomes measure: description of treatment (corticoids, immunosuppressive treatments), otherOutcomes measure: description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain)., otherOutcomes measure: description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain)., otherOutcomes measure: description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain)., otherOutcomes measure: description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain)., otherOutcomes measure: Up-to-date cervical cancer screening rate in accordance with HAS recommendations, otherOutcomes measure: Proportion of cervical cytological abnormalities if performed (histological confirmation if available), otherOutcomes measure: proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available), otherOutcomes measure: presence of cervical precancerous lesions and cervical cancer, otherOutcomes measure: HPV vaccination coverage rate, otherOutcomes measure: Persistence of HPV infection, eligibilityModule sex: FEMALE, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Service de Médecine Interne - Hôpital Bichat Claude Bernard, city: Paris, zip: 75018, country: France, contacts name: Tiphaine Goulenok, MD, role: CONTACT, phone: 00 33 1 40 25 72 89, email: tiphaine.goulenok@aphp.fr, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False