Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination

NCT ID: NCT02003508

Last Updated: 2020-03-06

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

345 participants

Study Classification

OBSERVATIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-12-29

Brief Summary

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This study will examine how common HPV infection is in teenage males in Australia before and after the introduction of universal school based vaccination of males in Australia.

Detailed Description

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Males aged 17 to 19 in Australia will be recruited from 2014. Men will undergo sampling from the penis for HPV. The prevalence of HPV infection will be determined in 2014-2015 and compared to the prevalence in 2016-2017.

Conditions

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Human Papillomavirus

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

PROSPECTIVE

Study Groups

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Pre-school based vaccination program (not vaccine eligible)

Young (17-19 years) men who were not eligible for school based vaccination due to their age at the time of the programs roll out.

No interventions assigned to this group

Post-school based vaccination program (vaccine eligible)

Young men (17-19 years) who were eligible for school based vaccination due to their age at the time of the programs roll out.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Male
* Aged 17 to 19
* Able to complete study requirements
* Residing in Australia from 12 years of age

Exclusion Criteria

-Males reporting sex with males in the past 12 months
Minimum Eligible Age

17 Years

Maximum Eligible Age

19 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

The Alfred

OTHER

Sponsor Role lead

Responsible Party

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Marcus Chen

Adjunct Associate Professor Central Clinical School and Medical Services Manager Melbourne Sexual Health Centre

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marcus Y Chen, PhD

Role: PRINCIPAL_INVESTIGATOR

Melbourne Sexual Health Centre Alfred Health and Central Clinical School Monash University

Locations

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Melbourne Sexual Health Centre

Melbourne, Victoria, Australia

Site Status

Countries

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Australia

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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IISP50939

Identifier Type: -

Identifier Source: org_study_id

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