Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)

Australia was one of the countries to implement a universal school-based male vaccination program - in 2013. This research project will examine the prevalence of HPV among young men who have sex with men (MSM) who have been offered school-based HPV vaccination.

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Key information

Conditions

Human Papillomavirus Communicable Diseases DNA Virus Infections Disease Attributes Genital Diseases Human Papillomavirus Infection Infections Papillomavirus Infections Pathologic Processes Pathological Conditions, Signs and Symptoms Sexually Transmitted Diseases Sexually Transmitted Diseases, Viral Tumor Virus Infections Urogenital Diseases Virus Diseases

Age range

16 year–20 year

Sex eligibility

Male

Study type

Observational

Primary location

Melbourne Sexual Health Centre

Melbourne, Victoria, 3053, Australia

About this study

HYPER-2, will be a cross-section study, using the same recruitment and testing strategies used in HYPER 1, which determined the prevalence of anal, genital and oral HPV among men who have sex with men aged 16-20 years. Given the differing age groups that will have been offered vaccination over the 2 study period, men aged 16-19 will be recruited in the first year (2017) and men aged 16-20 will be recruited in the second year (2018) to ensure that the participants included in the HYPER-2 study would have been eligible for the free male HPV vaccine in Australia. A total of 200 men will be recruited over a 2-year period, and HPV vaccination status for each participant will be verified against the National HPV Vaccination Program Register.

This 2-year cross-sectional study will recruit men who report sex with men aged from 16 to 20 years.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Men aged 16 to 20 (Must be aged 16-19 years from 1 January 2017 to 31 December 2017, and aged 16-20 years from 1 January 2018 to 31 December 2018)
Report any previous type of sexual contact (including but not restricted to oral or anal sex) with at least one other man ever
Able to complete all study requirements including questionnaire in English and completion of 2 visits
Residing in Australia since 2013 (This is to ensure that males included in the study were present in Australia at the time HPV vaccination was offered)

Exclusion criteria

Transgender male

Treatment and study plan

Primary outcomes

Prevalence of quadrivalent vaccine HPV types

Time frame: Baseline

The primary outcome of interest will be the prevalence of quadrivalent vaccine types (6, 11, 16 and 18) among 16-20 year old MSM and comparison of these with non-quadrivalent vaccine HPV types which would be expected to remain high unless there is significant cross protection. Oral, penile, and anal HPV prevalence will be calculated.

Secondary outcomes

Persistent HPV infection

Time frame: Day 7

Detection of same HPV type at the same site at both visits (day 0 and 7). The objective of repeat sampling at day 7 is to investigate whether this might distinguish transient HPV detection from infection. A brief questionnaire will be self-completed by participants at day 7 to ascertain whether there has been any sexual re-exposure between day 0 and 7 that might explain repeat HPV positivity at day 7.

Sponsors and collaborators

Lead sponsor

The Alfred

Other

Collaborators

Merck Sharp & Dohme LLC

Registry information

Official study title

Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men Following Introduction of Universal Male HPV Vaccination Program in Australia

Acronym: HYPER2

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Dec 22, 2016
Registry last updated: Oct 5, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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