HPV Prevalence in 16-20 Year Old Males | NCT04297670

Studies
HPV Prevalence in 16-20 Year Old Males

NCT04297670

Sponsor

Laval University

Status

Unknown status

Last Update Posted

Mar 5, 2020Actual

Enrollment

681Estimated

Phase

Not provided

Conditions

HPV Infection

Interventions

Measurement of HPV types prevalence

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 20, 2020Actual

Primary Completion Date

Dec 31, 2020Estimated

Completion Date

Dec 31, 2020Estimated

First Submitted Date

Mar 3, 2020

First Submission Date that Met QC Criteria

Mar 4, 2020

First Posted Date

Mar 5, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 4, 2020

Last Update Posted Date

Mar 5, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

681Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Unvaccinated against HPV boys		Sexually active unvaccinated against HPV 16-20 years old boys.	Other: Measurement of HPV types prevalence

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Measurement of HPV types prevalence	Other	Self collected genital samples to be tested for the presence of different HPV types.	Unvaccinated against HPV boys

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

unvaccinated against HPV
sexually active

Exclusion Criteria:

received an HPV vaccine
non sexually active

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

gender identity

Minimum Age

16 Years

Maximum Age

20 Years

Standard Ages

ChildAdult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Chantal Sauvageau, MD, MSc	Contact	1 418 650 5115	6368	chantal.sauvageau@inspq.qc.ca
Vladimir Gilca, MD, PhD	Contact	1 418 650 5115	6510	vladimir.gilca@inspq.qc.ca

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Laval University Research Hospital Center	Recruiting	Québec		G1E7G9	Canada

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39982898	Derived	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.

ID	Term
D015229	Sexually Transmitted Diseases, Viral
D012749	Sexually Transmitted Diseases
D003141	Communicable Diseases
D007239	Infections