HPV Vaccination in Women With Cystic Fibrosis

Completed

• Conditions: Human Papillomavirus Infection
• Interventions: Other: Self-report Written Questionnaire

• Registration Number: NCT03265743
• Lead Sponsor: Hospices Civils de Lyon

Brief Summary

The main risk factor for the development of cervical lesions is human papillomavirus (HPV) infection. Vaccination against human papillomavirus, which is offered to all girls aged 11 to 14, and catching up to girls aged 15 to 19, is an effective method of preventing cervical pathology. Despite this, human papillomavirus vaccination coverage remains low in France.

Some women with cystic fibrosis might need a transplantation, which is a factor associated with increased risk of human papillomavirus carriage and cervical pathology. An over-risk of cervical pathology would also be present in non-transplanted women with cystic fibrosis. Particular attention should therefore be paid to vaccination in this population.

The objective is to estimate the frequency of human papillomavirus vaccination in young patients with cystic fibrosis, and to evaluate the reasons for non-vaccination.

Detailed Description

Not available

Study Timeline

• Status Verified: 2017-07
• Study First Submitted: 2017-07-27
• Study First Submitted QC: 2017-08-28
• Study First Posted: 2017-08-29
• Study Start: 2017-09-25
• Primary Completion: 2017-12-15
• Study Completion: 2017-12-15
• Last Update Submitted: 2018-02-14
• Last Update Posted: 2018-02-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 74

Inclusion Criteria

• girls with Cystic Fibrosis
• followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA)
• aged 11 years or older

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Exclusion Criteria

• Refusal to respond to the questionnaire

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Patients with Cystic Fibrosis	Self-report Written Questionnaire	Patients with Cystic Fibrosis, followed in a pediatric or mixed Cystic Fibrosis center of the region Auvergne Rhône Alpes (AuRA), aged 11 years or older.

Primary Outcome Measures

Name	Time	Method
Realization of human papillomavirus vaccination	15 minutes	The main outcome is the prevalence of human papillomavirus vaccination in young women with Cystic fibrosis.; This data is collected using a questionnaire : HPV vaccination performed : yes/no

Secondary Outcome Measures

Name	Time	Method
Respect for the vaccinal plan	15 minutes	This data is collected using a questionnaire : number and dates of injections
Type of vaccine used	15 minutes	This data is collected using a questionnaire : bivalent (Cervarix®) or quadrivalent (Gardasil®)
Reasons for non-vaccination	15 minutes	In case of non-vaccination reasons are collected using a multiple choices questionnaire

Trial Locations

Locations (3)

CHU Grenoble; 🇫🇷 Grenoble, France

Nouvel Hôpital d'Estaing CRCM Mixte; 🇫🇷 Clermont-Ferrand, France

Cystic Fibrosis Reference Center, Hospices Civils de Lyon; 🇫🇷 Pierre-Bénite, France