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

NCT02003508 | Completed Results

• 1 other identifier: IISP50939
• Study Type: observational
• Target: 345
• Locations: 1 country
• Sites: 1

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.

Conditions

Human Papillomavirus

Keywords

Prevalence; HPV; Human papillomavirus; Vaccination

Outcome Measures

Primary Outcomes (1)

• Prevalence of Penile HPV Genotypes

  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.

  Single study visit (one time point per participant)

Study Arms (2)

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.

Eligibility Criteria

• Age: 17 Years - 19 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Males aged 17-19 recruited from sexual health clinics and community sources

You may qualify if:

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

You may not qualify if:

• Males reporting sex with males in the past 12 months

Sponsors & Collaborators

• The Alfred: lead
• Merck Sharp & Dohme LLC: collaborator

Study Sites (1)

Melbourne Sexual Health Centre

Melbourne, Victoria, 3053, Australia

Location

Biospecimen

Retention: SAMPLES WITH DNA

Penile sampling for HPV DNA

Results Point of Contact

• Title: A/Prof Marcus Chen
• Organization: Melbourne Sexual Health Centre

mchen@mshc.org.au

+613 93416260

Study Officials

• Marcus Y Chen, PhD

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: ECOLOGIC OR COMMUNITY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Adjunct Associate Professor Central Clinical School and Medical Services Manager Melbourne Sexual Health Centre

Study Record Dates

• First Submitted: December 2, 2013
• First Posted: December 6, 2013
• Study Start: January 1, 2014
• Primary Completion: December 29, 2017
• Study Completion: December 29, 2017
• Last Updated: March 6, 2020
• Results First Posted: March 6, 2020

Record last verified: 2020-03

Locations

AU (1)