Clinical trial NCT06158802: Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease
Official title: Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Human Papillomavirus Vaccine
Chronic Condition
Keywords: Human papillomavirus vaccine
Young women with chronic condition
Vaccination coverage rate
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2023-12-06
Enrollment: 448
Sex: FEMALE
Minimum age (years): 11
Maximum age (years): 20
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients aged from 11 to 20 to cover the recommended age window for HPV vaccination, ie between 11 and 14 years old, with the possibility of catching up between 15 and 19 years of age (Public Health France, 2019).

"Chronic condition" group: type 1 diabetes, metabolic diseases, immuno-hematological diseases, cystic fibrosis, sickle cell disease, kidney transplant, heart disease and inflammatory bowel disease, rare anorectal and pelvic malformations. Recruitment at the Necker-Enfants Malades Hospital and at the Specialized Medical Center for Children and Adolescents in Paris.

"Control" group: patients in good health. Recruitment at the Specialized Medical Center for Children and Adolescents in 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.

Eligibility criteria: 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)

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)

Primary outcomes:
measure: Immunization coverage rate for human papillomavirus vaccine
timeFrame: Day 1
Secondary outcomes:
measure: Intention of vaccination by human papillomavirus vaccine by the usual health professionals
timeFrame: Day 1
measure: Category of health professionals offering vaccination by human papillomavirus vaccine
timeFrame: Day 1
measure: Reasons for non-vaccination by human papillomavirus vaccine
timeFrame: Day 1
measure: Description of parameters that may impact vaccination coverage for human papillomavirus vaccine
timeFrame: Day 1
Other outcomes:
Locations:
city: Paris
country: France
facility: Centre Médical Spécialisé de l'Enfant et de l'Adolescent (CMSEA)
city: Paris
country: France
facility: Hôpital Necker-Enfants Malades
Study officials:
affiliation: Assistance Publique - Hôpitaux de Paris
name: Sabrina DA COSTA, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Assistance Publique - Hôpitaux de Paris
name: Alaa CHEIKHELARD, MD
role: STUDY_DIRECTOR
References:
citation: Hofstetter AM, Camargo S, Natarajan K, Rosenthal SL, Stockwell MS. Vaccination Coverage of Adolescents With Chronic Medical Conditions. Am J Prev Med. 2017 Nov;53(5):680-688. doi: 10.1016/j.amepre.2017.07.017. Epub 2017 Sep 18.
citation: Gras-Le Guen C, Legrand A, Caquard M, Micaelli X, Picherot G, Lacroix S, Volteau C, Launay E. Chronically ill adolescents are also incompletely vaccinated: A cross-sectional study in France. Vaccine. 2017 Aug 24;35(36):4707-4712. doi: 10.1016/j.vaccine.2017.07.042. Epub 2017 Jul 29.
citation: Hoffman L, Okcu MF, Dreyer ZE, Suzawa H, Bryant R, Middleman AB. Human papillomavirus vaccination in female pediatric cancer survivors. J Pediatr Adolesc Gynecol. 2012 Oct;25(5):305-7. doi: 10.1016/j.jpag.2012.05.004. Epub 2012 Jul 24.