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NCT05587738 Clinical Trial

Human Papillomavirus in Young People Epidemiological Research 4

Cancer Clinical Trial

— HYPER4  

Official title:
A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 21-25 Years in Australia

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05587738
Other study ID # 15/22
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date January 1, 2023
Est. completion date December 31, 2024

Study information
Verified date March 2023
Source Monash University
Contact Eric Chow, PhD
Phone +61393416233
Email eric.chow@monash.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

Anal cancer is overrepresented among gay, bisexual and other men who have sex with men (MSM), particularly those living with HIV. Australia was the first country to introduce a publicly funded national HPV vaccination program in 2007. This program was expanded to include schoolboys aged 12-13 years in 2013; with a 2-year catch-up for boys aged up to 15 years. The goal of the HYPER4 study is to determine the prevalence of anal, genital and oral HPV among 500 young gay and bisexual men aged 21-25 years who were eligible for the school-based gender-neutral quadrivalent vaccination program. Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.

Recruitment information / eligibility
Status Recruiting
Enrollment 500
Est. completion date December 31, 2024
Est. primary completion date December 31, 2024
Accepts healthy volunteers
Gender Male
Age group 21 Years to 25 Years
Eligibility Inclusion Criteria: - Men aged 21 to 25 years old in 2023-2024 - Same-sex attracted - Residing in Australia since 2013 Exclusion Criteria: - Unable to complete all study requirements in English

Study Design

Related Conditions & MeSH terms

Locations
Country Name City State
Australia Melbourne Sexual Health Centre Melbourne Victoria

Sponsors (3)
Lead Sponsor Collaborator
Monash University The Alfred, University of Melbourne

Country where clinical trial is conducted

Australia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Prevalence of quadrivalent vaccine HPV types The oral, penile and anal prevalence of quadrivalent vaccine types (6, 11, 16 and 18) Baseline
Primary Prevalence of type-specific HPV types The oral, penile and anal prevalence of type-specific HPV types Baseline
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