HPV Prevalence in 16-20 Year Old Males

HPV Infection Clinical Trial

Official title:

Evaluation of the Impact of Quebec HPV Immunization Program: Prevalence of HPV Types in 16-20 Year Old Males

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04297670
• Other study ID #: HPV2020-5037
• Status: Recruiting
• Start date: February 20, 2020
• Est. completion date: December 31, 2020

Study information

• Verified date: March 2020
• Source: Laval University
• Contact: Chantal Sauvageau, MD, MSc
• Phone: 1 418 650 5115
• Email: chantal.sauvageau[@]inspq.qc.ca
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 681
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 20 Years

Eligibility

Inclusion Criteria:

• unvaccinated against HPV

• sexually active

Exclusion Criteria:

• received an HPV vaccine

• non sexually active

Related Conditions & MeSH terms

• HPV Infection
• Papillomavirus Infections

Intervention

Other:
• Measurement of HPV types prevalence
Self collected genital samples to be tested for the presence of different HPV types.

Locations

Country	Name	City	State
Canada	Laval University Research Hospital Center	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Laval University

Country where clinical trial is conducted

Canada, 

Outcome

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