Vaginal Self-sampling for Detecting High-risk Human Papillomavirus Cervical Infection in Patients With Immune-mediated Inflammatory Diseases (APOSY)

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).

Study Overview

• Status: Active, not recruiting
• Conditions: HPV Infection; Systemic Disease
• Intervention / Treatment: Procedure: Vaginal self sampling detecting HPV

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Paris, France, 75018
    • Service de Médecine Interne - Hôpital Bichat Claude Bernard

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

Prospective and retrospective patient

• 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
• Not up to date with gynecological follow-up (i.e., Pap smear more than one year old or undatable) (for retrospective patients: at the time of initial screening)

Retrospective patient

- Patient who underwent Pap smear screening less than one year before the start of the study

Exclusion Criteria:

Prospective and retrospective patient

• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Vaginal self sampling detecting HPV

Procedure: Vaginal self sampling detecting HPV; IMIDs patients who are not up to date with CCS be included into the study to perform a vaginal self-screening (VSS) A positive VSS will be confirmed by a standard HPV test and management of the results of standard HPV test or VSS will be performed as planned following HAS guidelines. For women with a positive VSS, follow-up results (HPV test and cytology, biopsy, etc.) will be collected according to the usual procedures of the screening facility and in accordance with the recommendations of the Health authorities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
prevalence of HPV infection (yes/no) after VSS proposal	at one year

Secondary Outcome Measures

Outcome Measure	Time Frame
the HPV typology of co-infection (with several high-risk HPV (HR-HPV)) in this population	at inclusion and at one year after inclusion
The rate of co-infection (with several high-risk HPV (HR-HPV)) in this population	at inclusion and at one year after inclusion

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Presence of HPV infection during follow-up (yes/no)		at inclusion and at one year
description of demographic factor		at inclusion and at one year
description of clinical factor		at inclusion and at one year
description of biological factor		at inclusion and at one year
description of treatment (corticoids, immunosuppressive treatments)		at inclusion and at one year
description of characteristics of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).		at inclusion and at one year
description of acceptability of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).		at inclusion and at one year
description of tolerance of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).		at inclusion and at one year
description obstacles of VPA reported by self-questionnaire (including procedure failures, bleeding and pain).		at inclusion and at one year
Up-to-date cervical cancer screening rate in accordance with HAS recommendations		at 12 months post-inclusion.
Proportion of cervical cytological abnormalities if performed (histological confirmation if available)		during 1 year of follow-up
proportion of cervical cancer authenticated on cervico-vaginal smear, if performed (histological confirmation if available)		during 1 year of follow-up
presence of cervical precancerous lesions and cervical cancer	authenticated on cervico-vaginal smear, if performed (histological confirmation if available)	during 1 year of follow-up
HPV vaccination coverage rate	(measured on initial self-questionnaire)	at inclusion
Persistence of HPV infection	Prevalence of HR-HPV(s) at second screening , in the case of initial positivity	at one year

Collaborators and Investigators

• Sponsor: Assistance Publique - Hôpitaux de Paris
• Investigators: Principal Investigator: Tiphaine Goulenok, MD, Assistance Publique - Hopitaux de Paris

Publications and helpful links

General Publications

• Goulenok T, Sacre K. HPV Infection and Prevention in Patients With Immune-Mediated Inflammatory Diseases: A Scoping Review. J Clin Rheumatol. 2024 Oct 1;30(7S Suppl 1):S34-S41. doi: 10.1097/RHU.0000000000002122.

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): March 1, 2027

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 4, 2024
• First Posted (Actual): March 12, 2024

Study Record Updates

• Last Update Posted (Actual): January 15, 2026
• Last Update Submitted That Met QC Criteria: January 13, 2026
• Last Verified: January 1, 2026

More Information

Terms related to this study

• Keywords: HPV; cervical cancer screening; systemic disease; vaginal self sampling
• Additional Relevant MeSH Terms: Urogenital Diseases; Genital Diseases; Pathologic Processes; Disease Attributes; Infections; Virus Diseases; Communicable Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; DNA Virus Infections; Tumor Virus Infections; Pathological Conditions, Signs and Symptoms; Papillomavirus Infections
• Other Study ID Numbers: APHP231514; 2023-A02623-42 (Other Identifier: IDRCB)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No