HPV-CIR: Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.

Sponsor

Hospices Civils de Lyon (Other)

Overall Status

Completed

CT.gov ID

NCT04180228

Collaborator

(none)

Enrollment

Locations

15.3

Actual Duration (Months)

25.3

Patients Per Site

1.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with chronic inflammatory rheumatic disease (CIR) are at increased risk for infections. Vaccination is a powerful tool to prevent infections, even in immunocompromised patients. Low-risk types of Human papilloma virus (HPV) cause anogenital warts, while high risk types are strongly related to pre-malignant cervical abnormalities and cervical cancer. HPV vaccines have been developed to prevent these conditions. Human papillomavirus (HPV) infections are more prevalent in systemic lupus erythematosus (SLE) patients or other auto-immune diseases when compared to the healthy population. In France, despite a vaccination available since 2007, rate of vaccination remain low. Although little is known about HPV vaccination in SLE, few studies in patients with autoimmune rheumatic diseases (AIRDs) have shown that HPV vaccines are safe, and capable to induce an immunogenic response in this group of patients. To date, available data suggest that HPV vaccines can be given safely to SLE patients. Given the increased incidence of cervical abnormalities due to HPV in SLE patients, this vaccination should be encouraged.

The aim of this study was to assess the vaccination coverage rate in chronically ill girls with SLE or idiopathic juvenile arthritis who require a close pediatric specialized follow-up vaccination and to understand barriers or motivations for it.

Condition or Disease	Intervention/Treatment	Phase
Systemic Lupus Erythematosus Idiopathic Juvenile Arthritis Human Papilloma Virus	Other: self-administred questionnaire

Study Design

Study Type:

Observational

Actual Enrollment :

76 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Disease. A Cross-sectional Study of Vaccinal Coverage, Barriers and Motivations.

Actual Study Start Date :

Jan 23, 2020

Actual Primary Completion Date :

May 4, 2021

Actual Study Completion Date :

May 4, 2021

Arms and Interventions

Arm	Intervention/Treatment
Systemic lupus erythematosus Investigators include in this group all young girls between 11 to 19 years old who accepted to respond to the questionnaire with systemic lupus erythematosus.	Other: self-administred questionnaire On the occasion of a follow-up consultation with referent pediatrician, a self-administred questionnaire is distributed. It will take around ten minutes to the patient and her parents for completing the questionnaire. Questionnaire is anonymous. Participation is free and informed by an information notice. There is a list of items to complete by the patient and her parents. Most of questions are closed-ended. Clinical data are reported : age, level of education, principal disease (SLE or Juvenile arthritis), received treatments. In the questionnaire, it is asked if the patient is vaccinated or not for HPV, and reasons for it.
Idiopathic juvenile arthritis Investigators include in this group all young girls between 11 to 19 years old who accepted to respond to the questionnaire, with idiopathic juvenile arthritis.	Other: self-administred questionnaire On the occasion of a follow-up consultation with referent pediatrician, a self-administred questionnaire is distributed. It will take around ten minutes to the patient and her parents for completing the questionnaire. Questionnaire is anonymous. Participation is free and informed by an information notice. There is a list of items to complete by the patient and her parents. Most of questions are closed-ended. Clinical data are reported : age, level of education, principal disease (SLE or Juvenile arthritis), received treatments. In the questionnaire, it is asked if the patient is vaccinated or not for HPV, and reasons for it.

Arm

Intervention/Treatment

Systemic lupus erythematosus

Investigators include in this group all young girls between 11 to 19 years old who accepted to respond to the questionnaire with systemic lupus erythematosus.

Other: self-administred questionnaire

On the occasion of a follow-up consultation with referent pediatrician, a self-administred questionnaire is distributed. It will take around ten minutes to the patient and her parents for completing the questionnaire. Questionnaire is anonymous. Participation is free and informed by an information notice. There is a list of items to complete by the patient and her parents. Most of questions are closed-ended. Clinical data are reported : age, level of education, principal disease (SLE or Juvenile arthritis), received treatments. In the questionnaire, it is asked if the patient is vaccinated or not for HPV, and reasons for it.

Idiopathic juvenile arthritis

Investigators include in this group all young girls between 11 to 19 years old who accepted to respond to the questionnaire, with idiopathic juvenile arthritis.

Other: self-administred questionnaire

Outcome Measures

Primary Outcome Measures

Frequency of HPV vaccination (percentage of patients vaccinated). [Day 0, Time of intervention (questionnaire)]
We report this information with an item "vaccination for Human papilloma virus". The proposition of response is "Yes" or "No". We'll calculate the number of vaccination among the population including in the study.

Eligibility Criteria

Criteria

Ages Eligible for Study:

11 Years to 19 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Inclusion Criteria:

Young girls older than 11 years old until adult transition
Follow-up for systemic lupus erythematosus (American college of rheumatology classification) or idiopathic juvenile arthritis (International League of Associations for Rheumatology classification)
Follow-up in a Childen's hospital of Lyon (Hopital Femme Mère Enfant) and Paris (Hospital Necker-Enfants Malades, Hôpital Robert Debré)
With no parental opposition to participate

Exclusion Criteria:

Refusing to participate
Age < 11 years old

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	Hôpital Femme Mère Enfant	Bron	France	69677
2	Hôpital Necke -, Enfants Malades	Paris	France	75743
3	Service de médecine interne, Centre hospitalier Lyon Sud	Pierre-Bénite	France	69310