Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02003508
Recruitment Status : Completed
First Posted : December 6, 2013
Results First Posted : March 6, 2020
Last Update Posted : March 6, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Marcus Chen, The Alfred

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease
Human Papillomavirus

Detailed Description:
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.
Study Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Actual Enrollment : 345 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Prevalence of Genital HPV Infection in Males Following Introduction of Universal Male HPV Vaccination
Study Start Date : January 2014
Actual Primary Completion Date : December 29, 2017
Actual Study Completion Date : December 29, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
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.
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Prevalence of Penile HPV Genotypes [ Time Frame: Single study visit (one time point per participant) ]

    Prevalence of penile HPV genotypes among heterosexually active young men. Percentage of participants with specific genotypes on penile samples, as detected by Linear Array.

    Participants provided a single penile sample.



Biospecimen Retention:   Samples With DNA
Penile sampling for HPV DNA

Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   17 Years to 19 Years   (Child, Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Males aged 17-19 recruited from sexual health clinics and community sources
Criteria

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

Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02003508


Locations
Layout table for location information
Australia, Victoria
Melbourne Sexual Health Centre
Melbourne, Victoria, Australia, 3053
Sponsors and Collaborators
The Alfred
Merck Sharp & Dohme Corp.
Investigators
Layout table for investigator information
Principal Investigator: Marcus Y Chen, PhD Melbourne Sexual Health Centre Alfred Health and Central Clinical School Monash University
  Study Documents (Full-Text)

Documents provided by Marcus Chen, The Alfred:
Study Protocol and Statistical Analysis Plan  [PDF] April 21, 2015

More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
Layout table for additonal information
Responsible Party: Marcus Chen, Adjunct Associate Professor Central Clinical School and Medical Services Manager Melbourne Sexual Health Centre, The Alfred
ClinicalTrials.gov Identifier: NCT02003508    
Other Study ID Numbers: IISP50939
First Posted: December 6, 2013    Key Record Dates
Results First Posted: March 6, 2020
Last Update Posted: March 6, 2020
Last Verified: March 2020
Keywords provided by Marcus Chen, The Alfred:
Prevalence
HPV
Human papillomavirus
Vaccination
Additional relevant MeSH terms:
Layout table for MeSH terms
Papillomavirus Infections
Infections
DNA Virus Infections
Virus Diseases
Tumor Virus Infections