Human Papillomavirus in Young People Epidemiological Research 3

Cancer Clinical Trial

— HYPER3  

Official title:

A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 16-20 Years in Australia

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05587725
• Other study ID #: 14/22
• Status: Recruiting
• Start date: January 1, 2023
• Est. completion date: December 31, 2025

Study information

• Verified date: March 2023
• Source: Monash University
• Contact: Eric Chow, PhD
• Phone: +61393416233
• Email: eric.chow[@]monash.edu
• Is FDA regulated: No
• 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. In 2018, the 9-valent vaccine (covering genotypes 6/11/16/18/31/33/45/52/58) replaced the 4-valent vaccine in the national program. The goal of the HYPER3 study is to determine the prevalence of anal, genital and oral HPV among 200 young gay and bisexual men aged 16-20 years who were eligible for the school-based 9-valent vaccination. 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: 200
• Est. completion date: December 31, 2025
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 16 Years to 20 Years

Eligibility

Inclusion Criteria:

• Men aged 16 to 20 (i.e. men aged 16-18 years in 2023; men aged 16-19 years in 2024; and men aged 16-20 years in 2025 will be recruited. This is to ensure these men would have been eligible for the 9-valent school-based HPV program)
• Same-sex attracted
• Residing in Australia since 2018

Exclusion Criteria:

• Unable to complete all study requirements in English

Related Conditions & MeSH terms

• Anal Cancer
• Anus Neoplasms
• Cancer
• Communicable Diseases
• HPV
• HPV 16 Infection
• HPV Infection
• Human Papillomavirus Infection
• Infections
• Men
• Papillomavirus Infections

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 nonavalent vaccine HPV types	The oral, penile and anal prevalence of nonavalent vaccine types (6, 11, 16, 18, 31,33, 45, 52 and 58)	Baseline
Primary	Prevalence of type-specific HPV types	The oral, penile and anal prevalence of type-specific HPV types	Baseline