Cancer Clinical Trial
— HYPER3Official title:
A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 16-20 Years in Australia
NCT number | NCT05587725 |
Other study ID # | 14/22 |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | January 1, 2023 |
Est. completion date | December 31, 2025 |
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 2013Íž 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.
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 |
Country | Name | City | State |
---|---|---|---|
Australia | Melbourne Sexual Health Centre | Melbourne | Victoria |
Lead Sponsor | Collaborator |
---|---|
Monash University | The Alfred, University of Melbourne |
Australia,
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 |
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