Trial Review

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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 registered on ANZCTR


Registration number
ACTRN12611000857909
Ethics application status
Approved
Date submitted
28/07/2011
Date registered
12/08/2011
Date last updated
22/11/2019
Date data sharing statement initially provided
22/11/2019
Date results information initially provided
22/11/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
Human Papillomavirus (HPV) infection in young men who have sex with men
Scientific title
HPV infection in young men who have sex with men
Secondary ID [1] 262735 0
NIL
Universal Trial Number (UTN)
NA
Trial acronym
HYPER
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human papillomavirus infection 270443 0
Condition category
Condition code
Infection 270590 270590 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
Cohort study of HPV infection over a 12 month period. Each participant will have a three samples taken for HPV DNA (genital, throat, and anal) and serology taken for HPV DNA antibodies. These samples (HPV DNA and serology) will be taken at base line, 3 months, 6 months, and 12 months (4 time periods).
Intervention code [1] 267081 0
Not applicable
Comparator / control treatment
NIL
Control group
Uncontrolled

Outcomes
Primary outcome [1] 269331 0
HPV DNA detected at throat or genital or anus during any of the observation periods
Timepoint [1] 269331 0
at t=0, t=3 months, t=6 months, t=12 months
Secondary outcome [1] 279396 0
HPV positive serology or HPV RNA detction
Timepoint [1] 279396 0
at t=0, t=3 months, t=6 months, t=12 months

Eligibility
Key inclusion criteria
Men aged 16 to 20
Report previous sexual contact (any type of sexual contact) with at least one other man ever
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
NIL

Study design
Purpose
Natural history
Duration
Longitudinal
Selection
Convenience sample
Timing
Prospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
20/09/2010
Actual
20/09/2010
Date of last participant enrolment
Anticipated
Actual
24/08/2011
Date of last data collection
Anticipated
Actual
24/08/2012
Sample size
Target
200
Accrual to date
Final
200
Recruitment in Australia
Recruitment state(s)
VIC

Funding & Sponsors
Funding source category [1] 267551 0
Government body
Name [1] 267551 0
National Health and Medical Research Council (NHMRC)
Country [1] 267551 0
Australia
Funding source category [2] 267552 0
Commercial sector/Industry
Name [2] 267552 0
Merck
Country [2] 267552 0
Australia
Primary sponsor type
Hospital
Name
Alfred Hospital
Address
The Alfred

P.O Box 315
Prahran. Vic. 3181.
Country
Australia
Secondary sponsor category [1] 266590 0
None
Name [1] 266590 0
Address [1] 266590 0
Country [1] 266590 0
Other collaborator category [1] 252158 0
Commercial sector/Industry
Name [1] 252158 0
Merck
Address [1] 252158 0
MSD
Level 4, 66 Waterloo Rd,
North Ryde, NSW 2113
Australia
Country [1] 252158 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269514 0
Alfred Ethics committee
Ethics committee address [1] 269514 0
The Alfred

P.O Box 315
Prahran. Vic. 3181.
Ethics committee country [1] 269514 0
Australia
Date submitted for ethics approval [1] 269514 0
Approval date [1] 269514 0
27/07/2010
Ethics approval number [1] 269514 0
1/10/0174

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 persistent HPV infection, distinguishing this from transient HPV infection and sexual behaviours associated with varying prevalence of HPV infection.
We will survey 200 MSM aged 16-20 who just started their sexual life. We will use a questionnaire to collect information of socio-demographic characteristics, lifetime sexual experience, recent sexual experience, the most recent sexual contact, STIs/HIV history and testing history, HPV knowledge and attitude, smoking/alcohol/drug/circumcision. We will also collect oral, penile and anal samples as well as blood samples to test for HPV DNA, mRNA 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.

Each participant will receive $25 at each visit as compensation for their time. All participants will be offered free HPV vaccine at the end of the study.
Trial website
http://www.hyper.org.au/index.htm
Trial related presentations / publications
Zou HC, Tabrizi SN, Grulich AE, Garland SM, Hocking JS, Bradshaw CS, Morrow A, Prestage G, Cornall AM, Fairley CK and Chen MY. Early acquisition of anogenital human papillomavirus among teenage men who have sex with men. JID 2014; 209: 642-51.
Public notes

Contacts
Principal investigator
Name 32950 0
Prof Christopher Fairley
Address 32950 0
Melbourne Sexual Health Centre
580 Swanston Street Carlton Victoria 3053
Country 32950 0
Australia
Phone 32950 0
+61 3 9341 6200
Fax 32950 0
Email 32950 0
[email protected]
Contact person for public queries
Name 16197 0
Christopher Fairley
Address 16197 0
Alfred Health
Melbourne Sexual Health Centre
580 Swanston Street Carlton Vic 3053
Country 16197 0
Australia
Phone 16197 0
61 3 9341 6241
Fax 16197 0
61 3 9347 6757
Email 16197 0
[email protected]
Contact person for scientific queries
Name 7125 0
christopher Fairley
Address 7125 0
Alfred Health
Melbourne Sexual Health Centre
580 Swanston Street Carlton Vic 3053
Country 7125 0
Australia
Phone 7125 0
61 3 9341 6241
Fax 7125 0
61 3 9347 6757
Email 7125 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We do not have ethical approval for this.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually

Documents added automatically
No additional documents have been identified.