Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)
- Conditions
- Mucoviscidosis
- Interventions
- Other: Self administrated questionnaire
- Registration Number
- NCT03653377
- Lead Sponsor
- Hospices Civils de Lyon
- Brief Summary
Background The main risk factor for cervical cancer is the infection by human papillomavirus (HPV). Vaccination against HPV, offered to all girls aged 11 to 14 is an effective method of prevention against cervical pathology. Despite this, vaccination coverage against HPV remains low in France. A proportion of women with cystic fibrosis may be involved in transplantation, a factor associated with a higher risk of HPV carriage and cervical pathology. An over-risk of cervical pathology would also be present in women with non-transplanted cystic fibrosis. Particular attention to vaccination should therefore be included in this population.
Objectives of the study The main objective of the study is to estimate the frequency of HPV vaccination in young girls with CF over 9 years and followed in a pediatric CF center.
The secondary objectives are to know:
* The type of vaccine used (bivalent / quadrivalent / nonavalent)
* The proportion of vaccinated girls with respect of the vaccination schedule (number of injections / spacing between doses)
* Reasons for non-use of vaccination
Study design The study will last 12 months. It is a cross-sectional, non-interventional, multicenter conducted by self-administered questionnaire.
Population
* young girls aged 9 years or older with Cystic fibrosis
* Followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
* With parents who did not object to participation in the study
Number of subject: 62 patients
Expected results
* Knowledge of HPV vaccination coverage in young girls with CF.
* Sensitization of patients, their parents and health professionals to HPV vaccination. Understand the barriers and reasons for refusing vaccination to promote actions to improve immunization coverage.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 81
- young girls aged 9 years or older
- patients with Cystic Fibrosis
- patients followed in a pediatric or mixed CF center in the France (Rhone-Alpes Auvergne Region and Ile de France Region)
- patients with parents who did not object to participation in the study
-patients who refuse to answer to the self-administrated questionnaire
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Patients with self-administered questionnaire Self administrated questionnaire -
- Primary Outcome Measures
Name Time Method HPV vaccination Baseline The outcome measure is having HPV vaccination. This information is collected through a self-questionnaire, completed by the patients or their parents, during a visit to the CF center
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
CRCM, Institut Necker Enfants Malade
🇫🇷Paris, France
CRCM, Hôpital Robert Debré
🇫🇷Paris, France
Service Mucoviscidose, Pneumologie
🇫🇷Bron, France
Hôpital d'Estaing
🇫🇷Clermont-Ferrand, France
Centre de Ressources et de Compétences de la Mucoviscidose Adultes
🇫🇷Pierre-Bénite, France
CRCM, Hôpital Trousseau
🇫🇷Paris, France
Pôle Couple / Enfant
🇫🇷Grenoble, France