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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04180228
Recruitment Status : Recruiting
First Posted : November 27, 2019
Last Update Posted : September 2, 2020
Sponsor:
Information provided by (Responsible Party):
Hospices Civils de Lyon

Tracking Information
First Submitted Date October 31, 2019
First Posted Date November 27, 2019
Last Update Posted Date September 2, 2020
Actual Study Start Date January 23, 2020
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: November 25, 2019)
Frequency of HPV vaccination (percentage of patients vaccinated). [ Time Frame: 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.
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Diseases.
Official Title Human Papilloma Virus Vaccination and Chronic Inflammatory Rheumatic Disease. A Cross-sectional Study of Vaccinal Coverage, Barriers and Motivations.
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.

Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Investigators study a French sample of young girls follow-up for systemic lupus erythematosus or idiopathic juvenile arthritis. It's a multicenter design.
Condition
  • Systemic Lupus Erythematosus
  • Idiopathic Juvenile Arthritis
  • Human Papilloma Virus
Intervention 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.
Study Groups/Cohorts
  • 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.
    Intervention: Other: self-administred questionnaire
  • 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.
    Intervention: Other: self-administred questionnaire
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: November 25, 2019)
150
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 2021
Estimated Primary Completion Date July 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: Female
Ages 11 Years to 19 Years   (Child, Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Emmanuelle DAVID 6 74 39 72 50 ext +33 emmanuelle.david01@chu-lyon.fr
Contact: Christine ROUSSET-JABLONSKI, MD 4 78 56 90 49 ext +33 christine.rousset-jablonski@chu-lyon.fr
Listed Location Countries France
Removed Location Countries  
 
Administrative Information
NCT Number NCT04180228
Other Study ID Numbers 69HCL19_0456
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Hospices Civils de Lyon
Study Sponsor Hospices Civils de Lyon
Collaborators Not Provided
Investigators Not Provided
PRS Account Hospices Civils de Lyon
Verification Date October 2019