HPV Prevalence in 16-20 Year Old Males

NCT ID: NCT04297670

Last Updated: 2020-03-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

681 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-02-20

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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HPV Infection

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Unvaccinated against HPV boys

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

Measurement of HPV types prevalence

Intervention Type OTHER

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

Interventions

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Measurement of HPV types prevalence

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

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* unvaccinated against HPV
* sexually active

Exclusion Criteria

* received an HPV vaccine
* non sexually active
Minimum Eligible Age

16 Years

Maximum Eligible Age

20 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Laval University Research Hospital Center

Québec, , Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Chantal Sauvageau, MD, MSc

Role: CONTACT

1 418 650 5115 ext. 6368

Vladimir Gilca, MD, PhD

Role: CONTACT

1 418 650 5115 ext. 6510

Facility Contacts

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Chanta Sauvageau, MD, MSc

Role: primary

418 650 5115 ext. 6368

Vladimir Gilca, MD, PhD

Role: backup

4186667000 ext. 368

References

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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.

Reference Type DERIVED
PMID: 39982898 (View on PubMed)

Other Identifiers

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HPV2020-5037

Identifier Type: -

Identifier Source: org_study_id

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