Human Papilloma Virus Vaccination in Girls With Cystic Fibrosis (VACCIN-HPV-MUC2)

Completed

• 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

Study Timeline

• Study First Submitted: 2018-08-29
• Study First Submitted QC: 2018-08-29
• Study First Posted: 2018-08-31
• Study Start: 2018-12-17
• Primary Completion: 2019-04-30
• Study Completion: 2019-04-30
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-17
• Last Update Posted: 2021-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 81

Inclusion Criteria

• 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

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Exclusion Criteria

-patients who refuse to answer to the self-administrated questionnaire

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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

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