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Trial Title:
Human Papillomavirus in Young People Epidemiological Research 3
NCT ID:
NCT05587725
Condition:
Human Papillomavirus Infection
HPV
HPV Infection
Anal Cancer
Cancer
Men
HPV 16 Infection
Conditions: Official terms:
Infections
Communicable Diseases
Papillomavirus Infections
Anus Neoplasms
Conditions: Keywords:
Vaccination
Vaccine
Public health
Prevention
Men who have sex with men
Gay and bisexual men
Immunisation
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Cross-Sectional
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 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.
Criteria for eligibility:
Study pop:
Study participants will be recruited from sexual health clinics, community, gay community
events, universities, social networking services, and peer-referral.
Sampling method:
Non-Probability Sample
Criteria:
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
Gender:
Male
Gender based:
Yes
Minimum age:
16 Years
Maximum age:
20 Years
Healthy volunteers:
Accepts Healthy Volunteers
Locations:
Facility:
Name:
Melbourne Sexual Health Centre
Address:
City:
Melbourne
Zip:
3053
Country:
Australia
Status:
Recruiting
Contact:
Last name:
Eric PF Chow, PhD
Phone:
+61393416233
Email:
eric.chow@monash.edu
Start date:
January 1, 2023
Completion date:
December 31, 2025
Lead sponsor:
Agency:
Monash University
Agency class:
Other
Collaborator:
Agency:
The Alfred
Agency class:
Other
Collaborator:
Agency:
University of Melbourne
Agency class:
Other
Source:
Monash University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05587725
