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Trial details imported from ClinicalTrials.gov

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




Registration number
NCT03000933
Ethics application status
Date submitted
19/12/2016
Date registered
22/12/2016
Date last updated
5/07/2019

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
Merck-54860
Universal Trial Number (UTN)
Trial acronym
HYPER2
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

Intervention/exposure
Study type
Observational
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

Outcomes
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
Baseline
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

Eligibility
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
Gender
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria
- Transgender male

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

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

Funding & Sponsors
Primary sponsor type
Other
Name
The Alfred
Address
Country
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

Summary
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
https://clinicaltrials.gov/show/NCT03000933
Trial related presentations / publications
Public notes

Contacts
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