Human Papillomavirus InfectionHYPER3NCT05587725
Human Papillomavirus in Young People Epidemiological Research 3
An observational study of Human Papillomavirus Infection and HPV, run by Monash University at 1 site in Australia.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 20 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Human Papillomavirus Infection, HPV, HPV Infection
- How many people
- 200 participants
- Where
- 1 siteAustralia
- Study dates
- 1 Jan 2023to 31 Dec 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 20 years
- Men only
- Healthy volunteers accepted
- Child, Adult
Study population: Study participants will be recruited from sexual health clinics, community, gay community events, universities, social networking services, and peer-referral.
Who may be able to join
- Men aged 16 to 20 (i.e. men aged 16-18 years in 2023; men aged 16-19 years in 2024; and men aged 16-20 years in 2025 will be recruited. This is to ensure these men would have been eligible for the 9-valent school-based HPV program)
- Same-sex attracted
- Residing in Australia since 2018
Who cannot join
- Unable to complete all study requirements in English
Trial locations and contacts
1 site in 1 country.
Australia1 site, 1 recruiting
- Recruiting
Melbourne Sexual Health Centre
Melbourne, Victoria, 3053
Eric PF Chow, PhD, +61393416233, eric.chow@monash.edu
About this study
Official title: A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 16-20 Years in Australia
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. In 2018, the 9-valent vaccine (covering genotypes 6/11/16/18/31/33/45/52/58) replaced the 4-valent vaccine in the national program.
The goal of the HYPER3 study is to determine the prevalence of anal, genital and oral HPV among 200 young gay and bisexual men aged 16-20 years who were eligible for the school-based 9-valent vaccination.
Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.
- Conditions
- Human Papillomavirus Infection, HPV, HPV Infection, Anal Cancer, Cancer, Men
- Keywords
- Vaccination, Vaccine, Public health, Prevention, Men who have sex with men, Gay and bisexual men, Immunisation
- Medical subject headings
- Papillomavirus Infections, Anus Neoplasms, Neoplasms, Multiple Endocrine Neoplasia Type 1, Homosexuality
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of quadrivalent vaccine HPV types
The oral, penile and anal prevalence of quadrivalent vaccine types (6, 11, 16 and 18)
Measured: Baseline
Prevalence of nonavalent vaccine HPV types
The oral, penile and anal prevalence of nonavalent vaccine types (6, 11, 16, 18, 31,33, 45, 52 and 58)
Measured: Baseline
Prevalence of type-specific HPV types
The oral, penile and anal prevalence of type-specific HPV types
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2022
- Study start1 Jan 2023
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papillomavirus InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Monash University
- Sponsor type
- University, hospital or other
- Collaborators
- The Alfred, University of Melbourne
- Responsible party
- Principal investigator, Eric Chow, Monash University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05587725
- Sponsor's protocol ID
- 14/22
- Acronym
- HYPER3
- Status last verified
- Mar 2023
- First submitted
- 17 Oct 2022
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Cross-sectional Study to Evaluate the Prevalence of HPV in Gay and Bisexual Men Aged 16-20 Years in Australia
- ClinicalTrials.gov ID
- NCT05587725
- Acronym / sponsor ID
- HYPER3 / 14/22
- Conditions
- Human Papillomavirus Infection, HPV, HPV Infection, Anal Cancer, Cancer, Men
- Keywords
- Vaccination, Vaccine, Public health, Prevention, Men who have sex with men, Gay and bisexual men, Immunisation
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Monash UniversityUniversity, hospital or other
- Collaborators
- The Alfred, University of Melbourne
- Study start
- 1 Jan 2023 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 20 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. In 2018, the 9-valent vaccine (covering genotypes 6/11/16/18/31/33/45/52/58) replaced the 4-valent vaccine in the national program.
The goal of the HYPER3 study is to determine the prevalence of anal, genital and oral HPV among 200 young gay and bisexual men aged 16-20 years who were eligible for the school-based 9-valent vaccination.
Participants will be required to complete a questionnaire and provide samples for HPV testing. No follow-up visits will be required.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Study participants will be recruited from sexual health clinics, community, gay community events, universities, social networking services, and peer-referral.
Key inclusion criteria (3 listed)
- Men aged 16 to 20 (i.e. men aged 16-18 years in 2023; men aged 16-19 years in 2024; and men aged 16-20 years in 2025 will be recruited. This is to ensure these men would have been eligible for the 9-valent school-based HPV program)
- Same-sex attracted
- Residing in Australia since 2018
Key exclusion criteria (1 listed)
- Unable to complete all study requirements in English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Prevalence of quadrivalent vaccine HPV types
Time frame: Baseline
The oral, penile and anal prevalence of quadrivalent vaccine types (6, 11, 16 and 18)
Prevalence of nonavalent vaccine HPV types
Time frame: Baseline
The oral, penile and anal prevalence of nonavalent vaccine types (6, 11, 16, 18, 31,33, 45, 52 and 58)
Prevalence of type-specific HPV types
Time frame: Baseline
The oral, penile and anal prevalence of type-specific HPV types
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Human Papillomavirus Infection and HPV, run by Monash University at 1 site in Australia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Eric Chow, PhD (+61393416233, eric.chow@monash.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of quadrivalent vaccine HPV types (time frame: Baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2023.