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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT01422356




Registration number
NCT01422356
Ethics application status
Date submitted
16/08/2011
Date registered
24/08/2011
Date last updated
10/02/2014

Titles & IDs
Public title
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men
Scientific title
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men
Secondary ID [1] 0 0
MSHC-174/10
Universal Trial Number (UTN)
Trial acronym
HYPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus 0 0
Condition category
Condition code
Infection 0 0 0 0
Studies of infection and infectious agents
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
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
HPV Prevalence
Timepoint [1] 0 0
Baseline

Eligibility
Key inclusion criteria
- Men aged 16 to 20

- Same sex attracted

- Able to complete all study requirements including questionnaire in English and
completion of 4 visits
Minimum age
16 Years
Maximum age
20 Years
Sex
Males
Can healthy volunteers participate?
Yes
Key exclusion criteria

Study design
Purpose
Duration
Selection
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/09/2010
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
1/09/2013
Sample size
Target
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 0 0
Alfred Health (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 LLC
Address [1] 0 0
Country [1] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Studies indicate that men who have sex with men (MSM) have a high prevalence of anogenital
Human papillomavirus (HPV) infection and increased risk for HPV related anogenital lesions
including anogenital warts, anal intraepithelial neoplasia (the abnormal proliferation of
cells) and anal cancer. Currently in Australia, HPV vaccine for men is not covered by
programs. This study will explore the prevalence of HPV infection and sexual behaviours
associated with varying prevalence of HPV infection.

The investigators will survey 200 MSM aged 16-20 years who just started their sexual life.
The investigators will use a questionnaire to collect information of socio-demographic
characteristics, lifetime sexual experience, recent sexual experience, the most recent sexual
contact, sexually transmitted infections (STIs)/HIV history and testing history, HPV
knowledge and attitude, smoking/alcohol/drug/circumcision. The investigators will also
collect oral, penile and anal samples as well as blood samples to test for HPV DNA and
antibody.

The study will include four visits in the 12-month period. In each visit, participants will
be asked to fill a questionnaire and provide oral, penile and anal samples as well as blood
samples.
Trial website
https://clinicaltrials.gov/ct2/show/NCT01422356
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Christopher K Fairley, MB BS, Ph D
Address 0 0
The Alfred
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

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT01422356