NCT04871243

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started May 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

April 29, 2021

Completed
2 days until next milestone

Study Start

First participant enrolled

May 1, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 4, 2021

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 11, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 11, 2022

Completed
Last Updated

April 22, 2022

Status Verified

April 1, 2022

Enrollment Period

10 months

First QC Date

April 29, 2021

Last Update Submit

April 21, 2022

Conditions

Keywords

human papilloma virusvaccination

Outcome Measures

Primary Outcomes (1)

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

    4 months

Secondary Outcomes (1)

  • Concept identification to ameliorate the vaccination coverage by overcoming the obstacles

    4 months

Interventions

Individual semi-structured interviews

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients followed-up by a general practitioner that participate in the study

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CH Eure-Seine

Évreux, 27015, France

Location

MeSH Terms

Conditions

Vaccination Refusal

Condition Hierarchy (Ancestors)

Treatment RefusalTreatment Adherence and ComplianceHealth BehaviorBehavior

Study Design

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

Study Record Dates

First Submitted

April 29, 2021

First Posted

May 4, 2021

Study Start

May 1, 2021

Primary Completion

February 11, 2022

Study Completion

February 11, 2022

Last Updated

April 22, 2022

Record last verified: 2022-04

Locations