vaginal self-sampling for detecting high-risk human papillomavirus cervical infection in patients with immune-mediated inflammatory diseases

Conditions: HPV Infection; Systemic Disease

Summary: 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).


Eligibility criteria:
inclusion criteria: * women aged 30 to 65 years old * presenting with msia, msia includes systemic lupus erythematosus sjögren's syndrome systemic scleroderma mixed connective tissue disease inflammatory myositis systemic sarcoidosis systemic vasculitis behçet's disease adult-onset still's disease igg4-related disease autoimmune cytopenia (autoimmune hemolytic anemia, immune thrombocytopenic purpura, evans syndrome) susac syndrome * followed in the internal medicine department of bichat hospital, paris * at least 1 scheduled visit between december 2023 and december 2025 * not up to date with gynecological follow-up (i.e., cervical cancer screening more than one year old or undatable) exclusion criteria: * patient under legal protection, guardianship, or trusteeship * history of colpohysterectomy * not affiliated with a social security scheme (general or cmu) * absence of informed and written consent

Keywords: hpv systemic disease cervical cancer screening vaginal self sampling