HPV Prevalence in 16-20 Year Old Males

• Conditions: HPV Infection
• Interventions: Other: Measurement of HPV types prevalence

• Registration Number: NCT04297670
• Lead Sponsor: Laval University

Brief Summary

In Quebec, 18 birth cohorts of girls were vaccinated against HPV (aged 9 to 29 years in 2020). With an observed vaccination coverage of \>80% an important herd effect might be expected. This study aim is to measure the HPV types prevalence in unvaccinated sexually active boys aged 16 to 20 years.

Detailed Description

An HPV immunization program is in place in Quebec since 2008. By 2020 18 birth cohorts of girls were eligible for vaccination. Vaccine uptake with at least one dose of vaccine was \>80%. With such a high vaccine uptake an important herd immunity might be expected. The main objective of this study is to measure the prevalence of different HPV types in unvaccinated sexually active boys aged 16 to 20 years. This is a cross sectional study which includes one visit for all participants. Self sampling technic is used. During this phase of the study a total of 681 boys will be recruited. An additional phase of the study will be conducted at the condition that the prevalence of HPV6/11/16/18/31/33/45/52 and 58 in unvaccinated boys will be at least 8.65%. The second phase of the study if conducted will measure the prevalence of the same HPV types in 681 vaccinated boys of the same age.

Study Timeline

• Study Start: 2020-02-20
• Status Verified: 2020-03
• Study First Submitted: 2020-03-03
• Study First Submitted QC: 2020-03-04
• Last Update Submitted: 2020-03-04
• Study First Posted: 2020-03-05
• Last Update Posted: 2020-03-05
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 681

Inclusion Criteria

• unvaccinated against HPV
• sexually active

Exclusion Criteria

• received an HPV vaccine
• non sexually active

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Unvaccinated against HPV boys	Measurement of HPV types prevalence	Sexually active unvaccinated against HPV 16-20 years old boys.

Primary Outcome Measures

Name	Time	Method
Prevalence of HPV 6/11/16/18/31/33/45/52 and 58	Up to 18 months	Unvaccinated sexually active 16-20 year old boys will be tested

Secondary Outcome Measures

Name	Time	Method
Prevalence of 31 HPV types	Up to 18 months	Unvaccinated sexually active 16-20 year old boys will be tested

Trial Locations

Locations (1)

Laval University Research Hospital Center; 🇨🇦 Quebec, Canada