Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease

Recruiting

• Conditions: Human Papillomavirus Vaccine; Chronic Condition
• Interventions: Other: Questionnaire

• Registration Number: NCT06158802
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief Summary

The main objective of the study is to determine the vaccination coverage rate for human papillomavirus in adolescents aged 11 to 20 with chronic disease and treated at the Necker-Enfants Malades Hospital, compared to a population witnessed adolescent girls aged 11 to 20 years without chronic disease.

Detailed Description

Girls and young women with chronic condition are at higher risk for infections that can be prevented by vaccination. Human papillomavirus infection is very common, one of the three most common in the general population. A vaccine exists to significantly prevent this infection and its complications.

In France, it is advisable to vaccinate girls and boys from the age of 9 years and as soon as possible in the case of acquired immunodeficiency since these patients are more likely to be suffering from cancer induced by the human papillomavirus.

In France, the overall rate of vaccination coverage for girls is 21%, which is significantly lower than in several other industrialized countries.

The vaccination coverage rate for human papillomavirus in patients with chronic diseases may be even lower.

The main objective of the study is to determine the vaccination coverage rate for human papillomavirus in adolescents aged 11 to 20 with chronic condition and treated at the Necker-Enfants Malades Hospital, compared to a population witnessed adolescent girls aged 11 to 20 years without chronic disease.

Study Timeline

• Study First Submitted: 2023-11-24
• Study First Submitted QC: 2023-12-05
• Study First Posted: 2023-12-06
• Study Start: 2024-01-23
• Status Verified: 2024-07
• Last Update Submitted: 2024-07-04
• Last Update Posted: 2024-07-08
• Primary Completion: 2025-01
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 448

Inclusion Criteria

• Information and non-opposition of major patients and holders of parental authority of minor patients and minor patients

• Girls and young women aged 11 to 20

• To be followed at the Necker-Enfants Malades Hospital ("chronic condition" group)

• To be followed at the Specialized Medical Center for Children and Adolescents ("control" group)

• Have a chronic condition ("chronic condition" group) :

  • Diabetes type 1
  • Metabolic diseases
  • Patients followed in immuno-hematology
  • Cystic Fibrosis
  • Sickle
  • Kidney transplant
  • Heart Disease
  • Inflammatory bowel diseases
  • Rare anorectal and pelvic anomalies

• Live in France

• Comprehension of the French language (oral and written)

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Exclusion Criteria

• Have a contraindication to the HPV vaccine - Gardasil 9 (Vidal Hoptimal, 2018)
• Have a contraindication to the HPV vaccine - Gardasil (Vidal Hopitmal, 2018)
• Have a contraindication to HPV vaccine - Cervarix (Vidal Hoptimal, 2018)

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Control	Questionnaire	Girls and young women between the ages of 11 and 20 in good health
Chronic condition	Questionnaire	Girls and young women between the ages of 11 and 20 suffering from chronic condition

Primary Outcome Measures

Name	Time	Method
Immunization coverage rate for human papillomavirus vaccine	Day 1	Percentage of patients with or without a chronic illness who have received HPV vaccination (complete vaccination schedule).

Secondary Outcome Measures

Name	Time	Method
Description of parameters that may impact vaccination coverage for human papillomavirus vaccine	Day 1	Description of patients with or without a chronic illness and vaccinated or not against HPV; * Average age of patients at the time of inclusion,; * Socio-professional category of parents (father's and mother's profession),; * Average age at menarche,; * Assessment of risk behaviors (percentage of patients who smoke, percentage of patients who consume alcohol),; * Percentage of patients who have started their sexual life,; * Average age at first sexual intercourse,; * Percentage of patients followed by a pediatrician,; * Percentage of patients followed by a general practitioner,; * Percentage of patients followed by a gynecologist.
Intention of vaccination by human papillomavirus vaccine by the usual health professionals	Day 1	Percentage of patients with or without a chronic illness who have been offered HPV vaccination.
Reasons for non-vaccination by human papillomavirus vaccine	Day 1	Patients suffering from a chronic illness or not and not vaccinated: * Percentage of patients not vaccinated due to fear/apprehension,; * Percentage of patients not vaccinated because they did not know this vaccine,; * Percentage of patients not vaccinated because they are against vaccination,; * Percentage of patients not vaccinated due to lack of time.
Category of health professionals offering vaccination by human papillomavirus vaccine	Day 1	Patients with or without a chronic illness to whom vaccination has been offered/prescribed : * Percentage of vaccination offered/prescribed by the general practitioner; * Vaccination percentage proposed/prescribed by the pediatrician,; * Vaccination percentage proposed/prescribed by the gynecologist,; * Percentage of vaccination proposed/prescribed by the specialist doctor,; * Percentage of vaccination offered/prescribed by another healthcare professional.

Trial Locations

Locations (2)

Centre Médical Spécialisé de l'Enfant et de l'Adolescent (CMSEA); 🇫🇷 Paris, France

Hôpital Necker-Enfants Malades; 🇫🇷 Paris, France