We are experiencing 4 week turn-around time in review of submissions and resubmissions. We recommend commencing this process concurrently with your ethics submission and allowing at least 8 weeks for registration to be completed from date of first submission. We currently do not have the capacity to expedite reviews.

Note also there are delays to review of updates. We appreciate your patience.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT03000933

Registration number
Ethics application status
Date submitted
Date registered
Date last updated

Titles & IDs
Public title
Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)
Scientific title
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men Following Introduction of Universal Male HPV Vaccination Program in Australia
Secondary ID [1] 0 0
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus 0 0
Human Papillomavirus Infection 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases

Study type
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Young same-sex attracted men - Same-sex attracted men aged 16 to 20

Comparator / control treatment
Control group

Primary outcome [1] 0 0
Prevalence of quadrivalent vaccine HPV types - 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.
Timepoint [1] 0 0
Secondary outcome [1] 0 0
Persistent HPV infection - 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.
Timepoint [1] 0 0
Day 7

Key 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)
Minimum age
16 Years
Maximum age
20 Years
Can healthy volunteers participate?
Key exclusion criteria
- Transgender male

Study design
Statistical methods / analysis

Recruitment status
Active, not recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Date of last participant enrolment
Date of last data collection
Sample size
Accrual to date
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Melbourne Sexual Health Centre - Melbourne
Recruitment postcode(s) [1] 0 0
3053 - Melbourne

Funding & Sponsors
Primary sponsor type
The Alfred
Other collaborator category [1] 0 0
Commercial sector/Industry
Name [1] 0 0
Merck Sharp & Dohme Corp.
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

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.
Trial website
Trial related presentations / publications
Public notes

Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications