Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)

Completed

• Conditions: Human Papillomavirus; Human Papillomavirus Infection

• Registration Number: NCT03000933
• Lead Sponsor: The Alfred

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-12-19
• Study First Submitted QC: 2016-12-19
• Study First Posted: 2016-12-22
• Study Start: 2017-01-16
• Primary Completion: 2019-12-31
• Study Completion: 2019-12-31
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-02
• Last Update Posted: 2022-10-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 200

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Prevalence of quadrivalent vaccine HPV types	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 Outcome Measures

Name	Time	Method
Persistent HPV infection	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.

Trial Locations

Locations (1)

Melbourne Sexual Health Centre; 🇦🇺 Melbourne, Victoria, Australia