HPV Vaccination in Women With Cystic Fibrosis

NCT03265743 | Completed

• 1 other identifier: 69HCL17_0277
• Study Type: observational
• Target: 74
• Locations: 1 country
• Sites: 3

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.

Conditions

Human Papillomavirus Infection

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (3)

• Type of vaccine used

  15 minutes

• Respect for the vaccinal plan

  15 minutes

• Reasons for non-vaccination

  15 minutes

Study Arms (1)

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

Interventions

Self-report Written Questionnaire OTHER

Informations are gathered through a self-report written questionnaire, completed by the patients or their parents.

Patients with Cystic Fibrosis

Eligibility Criteria

• Age: 11 Years - 18 Years
• Sex: female
• Age Groups: Child (0-17), Adult (18-64)
• 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.

You may qualify if:

• 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

You may not qualify if:

• \- Refusal to respond to the questionnaire

Sponsors & Collaborators

• Hospices Civils de Lyon: lead

Study Sites (3)

Nouvel Hôpital d'Estaing CRCM Mixte

Clermont-Ferrand, 63003, France

Location

CHU Grenoble

Grenoble, 38043, France

Location

Cystic Fibrosis Reference Center, Hospices Civils de Lyon

Pierre-Bénite, 69495, France

Location

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Infections; DNA Virus Infections; Virus Diseases; Tumor Virus Infections; Genital Diseases; Urogenital Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 27, 2017
• First Posted: August 29, 2017
• Study Start: September 25, 2017
• Primary Completion: December 15, 2017
• Study Completion: December 15, 2017
• Last Updated: February 19, 2018

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

FR (3)