Trial Review

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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT05587738




Registration number
NCT05587738
Ethics application status
Date submitted
17/10/2022
Date registered
20/10/2022
Date last updated
15/03/2023

Titles & IDs
Public title
Human Papillomavirus in Young People Epidemiological Research 4
Scientific title
A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 21-25 Years in Australia
Secondary ID [1] 0 0
15/22
Universal Trial Number (UTN)
Trial acronym
HYPER4
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Human Papillomavirus Infection 0 0
HPV 0 0
HPV Infection 0 0
Anal Cancer 0 0
Cancer 0 0
Men 0 0
HPV 16 Infection 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
Infection 0 0 0 0
Sexually transmitted infections
Cancer 0 0 0 0
Bowel - Anal

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
Prevalence of quadrivalent vaccine HPV types
Timepoint [1] 0 0
Baseline
Primary outcome [2] 0 0
Prevalence of type-specific HPV types
Timepoint [2] 0 0
Baseline

Eligibility
Key inclusion criteria
* Men aged 21 to 25 years old in 2023-2024
* Same-sex attracted
* Residing in Australia since 2013
Minimum age
21 Years
Maximum age
25 Years
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
* Unable to complete all study requirements in English

Study design
Purpose
Duration
Selection
Timing
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
1/01/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
31/12/2024
Actual
Sample size
Target
500
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
Monash University
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
The Alfred
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Melbourne
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
Brief summary
Anal cancer is overrepresented among gay, bisexual and other men who have sex with men (MSM), particularly those living with HIV. Australia was the first country to introduce a publicly funded national HPV vaccination program in 2007. This program was expanded to include schoolboys aged 12-13 years in 2013; with a 2-year catch-up for boys aged up to 15 years.

The goal of the HYPER4 study is to determine the prevalence of anal, genital and oral HPV among 500 young gay and bisexual men aged 21-25 years who were eligible for the school-based gender-neutral quadrivalent vaccination program.

Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.
Trial website
https://clinicaltrials.gov/study/NCT05587738
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
Eric Chow, PhD
Address 0 0
Country 0 0
Phone 0 0
+61393416233
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05587738