NCT05587725

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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2023

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 17, 2022

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 20, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

January 1, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

March 15, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

October 17, 2022

Last Update Submit

March 13, 2023

Conditions

Human Papillomavirus InfectionHPVHPV InfectionAnal CancerCancerMenHPV 16 Infection

Keywords

VaccinationVaccinePublic healthPreventionMen who have sex with menGay and bisexual menImmunisation

Outcome Measures

Primary Outcomes (3)

  • Prevalence of quadrivalent vaccine HPV types

    The oral, penile and anal prevalence of quadrivalent vaccine types (6, 11, 16 and 18)

    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)

    Baseline

  • Prevalence of type-specific HPV types

    The oral, penile and anal prevalence of type-specific HPV types

    Baseline

Eligibility Criteria

Age16 Years - 20 Years
Sexmale(Gender-based eligibility)
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be recruited from sexual health clinics, community, gay community events, universities, social networking services, and peer-referral.

You may qualify if:

  • 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

You may not qualify if:

  • Unable to complete all study requirements in English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Melbourne Sexual Health Centre

Melbourne, Victoria, 3053, Australia

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

1. Self-collected oral rinse sample for HPV testing 2. Self-collected penile swab for HPV testing 3. Clinician-collected anal swab for HPV testing

MeSH Terms

Conditions

Papillomavirus InfectionsAnus NeoplasmsNeoplasmsMultiple Endocrine Neoplasia Type 1Homosexuality

Condition Hierarchy (Ancestors)

Sexually Transmitted Diseases, ViralSexually Transmitted DiseasesCommunicable DiseasesInfectionsDNA Virus InfectionsVirus DiseasesTumor Virus InfectionsGenital DiseasesUrogenital DiseasesDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsRectal NeoplasmsColorectal NeoplasmsIntestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesGastrointestinal DiseasesIntestinal DiseasesAnus DiseasesRectal DiseasesMultiple Endocrine NeoplasiaEndocrine Gland NeoplasmsNeoplasms, Multiple PrimaryNeoplastic Syndromes, HereditaryGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesEndocrine System DiseasesSexualitySexual BehaviorBehavior

Central Study Contacts

Eric Chow, PhD

CONTACT

+61393416233eric.chow@monash.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

October 17, 2022

First Posted

October 20, 2022

Study Start

January 1, 2023

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

March 15, 2023

Record last verified: 2023-03

Locations

AU(1)