Human Papillomavirus in Young People Epidemiological Research 3 (HYPER3)

March 13, 2023 updated by: Eric Chow, Monash University

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

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.

Study Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Anticipated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Australia
    • Victoria
      • Melbourne, Victoria, Australia, 3053
        • Recruiting
        • Melbourne Sexual Health Centre
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 20 years (Child, Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Sampling Method

Non-Probability Sample

Study Population

Study participants will be recruited from sexual health clinics, community, gay community events, universities, social networking services, and peer-referral.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Prevalence of quadrivalent vaccine HPV types
Time Frame: Baseline
The oral, penile and anal prevalence of quadrivalent vaccine types (6, 11, 16 and 18)
Baseline
Prevalence of nonavalent vaccine HPV types
Time Frame: Baseline
The oral, penile and anal prevalence of nonavalent vaccine types (6, 11, 16, 18, 31,33, 45, 52 and 58)
Baseline
Prevalence of type-specific HPV types
Time Frame: Baseline
The oral, penile and anal prevalence of type-specific HPV types
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Monash University

Collaborators

The Alfred
University of Melbourne

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2023

Primary Completion (Anticipated)

December 31, 2025

Study Completion (Anticipated)

December 31, 2025

Study Registration Dates

First Submitted

October 17, 2022

First Submitted That Met QC Criteria

October 17, 2022

First Posted (Actual)

October 20, 2022

Study Record Updates

Last Update Posted (Actual)

March 15, 2023

Last Update Submitted That Met QC Criteria

March 13, 2023

Last Verified

March 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14/22

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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