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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05587725
Registration number
NCT05587725
Ethics application status
Date submitted
17/10/2022
Date registered
20/10/2022
Date last updated
15/03/2023
Titles & IDs
Public title
Human Papillomavirus in Young People Epidemiological Research 3
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Scientific title
A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 16-20 Years in Australia
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Secondary ID [1]
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14/22
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Universal Trial Number (UTN)
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Trial acronym
HYPER3
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus Infection
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HPV
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HPV Infection
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Anal Cancer
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Cancer
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Men
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HPV 16 Infection
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Infection
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Sexually transmitted infections
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Cancer
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Bowel - Anal
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Prevalence of quadrivalent vaccine HPV types
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Assessment method [1]
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The oral, penile and anal prevalence of quadrivalent vaccine types (6, 11, 16 and 18)
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Timepoint [1]
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Baseline
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Primary outcome [2]
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Prevalence of nonavalent vaccine HPV types
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Assessment method [2]
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The oral, penile and anal prevalence of nonavalent vaccine types (6, 11, 16, 18, 31,33, 45, 52 and 58)
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Timepoint [2]
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Baseline
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Primary outcome [3]
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Prevalence of type-specific HPV types
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Assessment method [3]
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The oral, penile and anal prevalence of type-specific HPV types
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Timepoint [3]
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Baseline
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Eligibility
Key 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
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Minimum age
16
Years
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Maximum age
20
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
* Unable to complete all study requirements in English
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Study design
Purpose
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Duration
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Selection
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Timing
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/01/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
31/12/2025
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Actual
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Sample size
Target
200
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Melbourne Sexual Health Centre - Melbourne
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Recruitment postcode(s) [1]
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3053 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
Monash University
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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The Alfred
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Melbourne
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05587725
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Eric Chow, PhD
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Address
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Country
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Phone
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+61393416233
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Fax
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Email
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[email protected]
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05587725
Download to PDF