Human Papillomavirus in Young People Epidemiological Research 3

Recruiting

• Conditions: Men; Human Papillomavirus Infection; HPV 16 Infection; HPV; Anal Cancer; Cancer; HPV Infection

• Registration Number: NCT05587725
• Lead Sponsor: Monash University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-10-17
• Study First Submitted QC: 2022-10-17
• Study First Posted: 2022-10-20
• Study Start: 2023-01-01
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-15
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Melbourne Sexual Health Centre; 🇦🇺 Melbourne, Victoria, Australia