Chronic Condition Clinical Trial
— MC-HPVOfficial title:
Evaluation of Human Papillomavirus Vaccine Coverage in Girls and Young Women With Chronic Disease
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.
| Status | Recruiting |
| Enrollment | 448 |
| Est. completion date | July 2024 |
| Est. primary completion date | July 2024 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 11 Years to 20 Years |
| Eligibility | 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) |
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Médical Spécialisé de l'Enfant et de l'Adolescent (CMSEA) | Paris | |
| France | Hôpital Necker-Enfants Malades | Paris |
| Lead Sponsor | Collaborator |
|---|---|
| Assistance Publique - Hôpitaux de Paris |
France,
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. — View 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. — View 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. — View Citation
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Immunization coverage rate for human papillomavirus vaccine | Percentage of patients with or without a chronic illness who have received HPV vaccination (complete vaccination schedule). | Day 1 | |
| Secondary | Intention of vaccination by human papillomavirus vaccine by the usual health professionals | Percentage of patients with or without a chronic illness who have been offered HPV vaccination. | Day 1 | |
| Secondary | Category of health professionals offering vaccination by human papillomavirus vaccine | 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. |
Day 1 | |
| Secondary | Reasons for non-vaccination by human papillomavirus vaccine | 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. |
Day 1 | |
| Secondary | Description of parameters that may impact vaccination coverage for human papillomavirus vaccine | 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. |
Day 1 |