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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/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
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Scientific title
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men
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Secondary ID [1]
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MSHC-174/10
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Universal Trial Number (UTN)
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Trial acronym
HYPER
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus
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Condition category
Condition code
Infection
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Studies of infection and infectious agents
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Infection
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Other infectious diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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HPV Prevalence
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Assessment method [1]
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Prevalence of anal HPV of any type at baseline
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Timepoint [1]
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Baseline
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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
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Minimum age
16
Years
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Maximum age
20
Years
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Sex
Males
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Can healthy volunteers participate?
Yes
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Key exclusion criteria
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Study design
Purpose
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Duration
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Selection
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Timing
Prospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
1/09/2010
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
1/09/2013
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Sample size
Target
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Accrual to date
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Final
200
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Recruitment in Australia
Recruitment state(s)
VIC
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Recruitment hospital [1]
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Alfred Health (Melbourne Sexual Health Centre) - Melbourne
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Recruitment postcode(s) [1]
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3053 - Melbourne
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Funding & Sponsors
Primary sponsor type
Other
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Name
The Alfred
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Address
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Country
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Other collaborator category [1]
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Commercial sector/industry
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Name [1]
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Merck Sharp & Dohme LLC
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Address [1]
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Country [1]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/study/NCT01422356
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Trial related presentations / publications
Chow EPF, Fairley CK, Zou H, Wigan R, Garland SM, Cornall AM, Atchison S, Tabrizi SN, Chen MY. Human Papillomavirus Antibody Levels Following Vaccination or Natural Infection Among Young Men Who Have Sex With Men. Clin Infect Dis. 2022 Aug 25;75(2):323-329. doi: 10.1093/cid/ciab1052. Erratum In: Clin Infect Dis. 2022 Aug 25;75(2):362. doi: 10.1093/cid/ciac245. Chow EPF, Tabrizi SN, Fairley CK, Wigan R, Machalek DA, Garland SM, Cornall AM, Atchison S, Hocking JS, Bradshaw CS, Balgovind P, Murray GL, Chen MY. Prevalence of human papillomavirus in young men who have sex with men after the implementation of gender-neutral HPV vaccination: a repeated cross-sectional study. Lancet Infect Dis. 2021 Oct;21(10):1448-1457. doi: 10.1016/S1473-3099(20)30687-3. Epub 2021 May 24. Zou H, Tabrizi SN, Grulich AE, Hocking JS, Bradshaw CS, Cornall AM, Morrow A, Prestage G, Law MG, Garland SM, Chen MY, Fairley CK. Site-specific human papillomavirus infection in adolescent men who have sex with men (HYPER): an observational cohort study. Lancet Infect Dis. 2015 Jan;15(1):65-73. doi: 10.1016/S1473-3099(14)70994-6. Epub 2014 Nov 28.
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Public notes
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Contacts
Principal investigator
Name
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Christopher K Fairley, MB BS, Ph D
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Address
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The Alfred
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results are available at
https://clinicaltrials.gov/study/NCT01422356
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