HPV Vaccination in Women With Cystic Fibrosis (VACCIN-HPV-MUC)

HPV (Papilloma Human Virus) Vaccination in Young Women With Cystic Fibrosis and Followed in the Auvergne Rhône-Alpes Region

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.

Study Overview

• Status: Completed
• Conditions: Human Papillomavirus Infection
• Intervention / Treatment: Other: Self-report Written Questionnaire

• Study Type: Observational
• Enrollment (Actual): 74

Contacts and Locations

Study Locations

• France
  • Clermont-Ferrand, France, 63003
    • Nouvel Hôpital d'Estaing CRCM Mixte
  • Grenoble, France, 38043
    • CHU Grenoble
  • Pierre-Bénite, France, 69495
    • Cystic Fibrosis Reference Center, Hospices Civils de Lyon

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 11 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

This study is intended for 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.

Description

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

Exclusion Criteria:

- Refusal to respond to the questionnaire

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with Cystic Fibrosis; 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.	Other: Self-report Written Questionnaire; Informations are gathered through a self-report written questionnaire, completed by the patients or their parents.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Realization of human papillomavirus vaccination	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	15 minutes

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Hospices Civils de Lyon

Study record dates

Study Major Dates

• Study Start (Actual): September 25, 2017
• Primary Completion (Actual): December 15, 2017
• Study Completion (Actual): December 15, 2017

Study Registration Dates

• First Submitted: July 27, 2017
• First Submitted That Met QC Criteria: August 28, 2017
• First Posted (Actual): August 29, 2017

Study Record Updates

• Last Update Posted (Actual): February 19, 2018
• Last Update Submitted That Met QC Criteria: February 14, 2018
• Last Verified: July 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Virus Diseases; Infections; Respiratory Tract Diseases; Lung Diseases; Infant, Newborn, Diseases; Genetic Diseases, Inborn; DNA Virus Infections; Tumor Virus Infections; Pancreatic Diseases; Cystic Fibrosis; Papillomavirus Infections
• Other Study ID Numbers: 69HCL17_0277

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No