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Completed

NCT Number: NCT04871243

Children Vaccination From 11 to 14 Years Old

The human papilloma virus infection is the most frequent sexually transmitted infection around the world. In the vast majority of cases, these are inapparent infections that disappear spontaneously. In some cases, the HPV infection persists and can generate anogenital warts or cancer.

In France, the papillomavirus is responsible for 6000 new cases of cancer/year with several possible localizations : cervical, anal, penile, oropharyngeal, vulvar or vaginal. Among them, 4580 new cases of cancer/year occur in women, and half of them are diagnosis of cervical cancer. A quarter of cancers caused by papillomavirus occur in men.

In France, the commercialization of anti-HPV vaccine in 2007 was addressed only to girls, in order to gain a group immunity that would therefore protect the boys. This vaccination did not achieve the cover immunization target that were announced: the objective was fixed at 60% of vaccination coverage and at the end of 2018, only 24% was achieved on the complete vaccination schedule. In December 2019, the French National Authority for Health recommended the anti-HPV vaccinations in girls and boys.

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Key information

Conditions

Vaccination Refusal Behavior Health Behavior Opinions Treatment Adherence and Compliance Treatment Refusal

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CH Eure-Seine

Évreux, 27015, France

About this study

This qualitative study evaluates parents' opinion regarding the vaccination and the HPV. Parent's eligible to participate in this study are those with boys between 11 and 14 years old.

The anti-HPV vaccination is perceived favorably in 38% of parents, but 42% of parents are undecided.

The investigators would like to evaluate qualitatively the opinions and the obstacles in this vaccination, using interviews in parents of boys aged between 11 and 14 years old.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • parents having boys between 11 and 14 years old, followed-up by a general practitioner that participate in the study
  • signed inform consent form

Exclusion criteria

  • language barrier that could prevent the understanding or formulation of opinions during the interview

Treatment and study plan

Qualitative interview

Other

Individual semi-structured interviews

Primary outcomes

  1. Evaluation of knowledge and understanding of papillomavirus and opinions related to anti-HPV vaccination

    Time frame: 4 months

Secondary outcomes

  1. Concept identification to ameliorate the vaccination coverage by overcoming the obstacles

    Time frame: 4 months

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Eure-Seine

Other

Registry information

Official study title

Qualitative Study Evaluating Opinions Regarding HPV Vaccinnation in Boys' Parents Aged From 11 to 14 Years Old

Acronym: QUALIOPIVAC

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
May 4, 2021
Registry last updated
Apr 22, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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