NCT04297670

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.

Trial Health

43
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Enrollment
681

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Feb 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Study Start

First participant enrolled

February 20, 2020

Completed
12 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2020

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 5, 2020

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

11 months

First QC Date

March 3, 2020

Last Update Submit

March 4, 2020

Conditions

Keywords

PrevalenceBoys

Outcome Measures

Primary Outcomes (1)

  • Prevalence of HPV 6/11/16/18/31/33/45/52 and 58

    Unvaccinated sexually active 16-20 year old boys will be tested

    Up to 18 months

Secondary Outcomes (1)

  • Prevalence of 31 HPV types

    Up to 18 months

Study Arms (1)

Unvaccinated against HPV boys

Sexually active unvaccinated against HPV 16-20 years old boys.

Other: Measurement of HPV types prevalence

Interventions

Self collected genital samples to be tested for the presence of different HPV types.

Unvaccinated against HPV boys

Eligibility Criteria

Age16 Years - 20 Years
Sexmale(Gender-based eligibility)
Gender Eligibility Detailsgender identity
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Sexually active 16-20 years old boys studying at a professional school or college.

You may qualify if:

  • unvaccinated against HPV
  • sexually active

You may not qualify if:

  • received an HPV vaccine
  • non sexually active

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Laval University Research Hospital Center

Québec, G1E7G9, Canada

RECRUITING

Related Publications (1)

  • Wolfe C, Ionescu IG, Mayrand MH, Coutlee F, Sauvageau C. Prevalence of Human Papillomavirus Genotypes in Unvaccinated 16- to 20-Year-Old Men in Quebec, Canada. J Infect Dis. 2025 Aug 14;232(2):e203-e212. doi: 10.1093/infdis/jiaf094.

Biospecimen

Retention: SAMPLES WITH DNA

Self collected genital sample.

MeSH Terms

Conditions

Papillomavirus Infections

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Chantal Sauvageau, MD, MSc

CONTACT

Vladimir Gilca, MD, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 3, 2020

First Posted

March 5, 2020

Study Start

February 20, 2020

Primary Completion

December 31, 2020

Study Completion

December 31, 2020

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Individual participant data will not be shared with any researcher outside this study

Locations