HYPER3: Human Papillomavirus in Young People Epidemiological Research 3

Sponsor

Monash University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05587725

Collaborator

The Alfred (Other), University of Melbourne (Other)

200

Enrollment

Anticipated Duration (Months)

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Human Papillomavirus Infection HPV HPV Infection Anal Cancer Cancer Men HPV 16 Infection

Study Design

Study Type:

Observational

Anticipated Enrollment :

200 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Anticipated Study Start Date :

Jan 1, 2023

Anticipated Primary Completion Date :

Dec 31, 2025

Anticipated Study Completion Date :

Dec 31, 2025

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 20 Years

Sexes Eligible for Study:

Male

Accepts Healthy Volunteers:

Yes

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