Clinical trial · Observational
Human Papillomavirus in Young People Epidemiological Research 2 (HYPER2)
Human Papillomavirus (HPV) Infection in Young Men Who Have Sex With Men Following Introduction of Universal Male HPV Vaccination Program in Australia
NCT03000933CI-TRIAL-00061252HYPER2completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Australia was one of the countries to implement a universal school-based male vaccination program - in 2013. This research project will examine the prevalence of HPV among young men who have sex with men (MSM) who have been offered school-based HPV vaccination.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Human Papillomavirus | — | UNRESOLVED | — |
| Human Papillomavirus Infection | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (1)
- label
- Young same-sex attracted men
- description
- Same-sex attracted men aged 16 to 20
Primary outcomes (1)
- measure
- Prevalence of quadrivalent vaccine HPV types
- timeFrame
- Baseline
- description
- The primary outcome of interest will be the prevalence of quadrivalent vaccine types (6, 11, 16 and 18) among 16-20 year old MSM and comparison of these with non-quadrivalent vaccine HPV types which would be expected to remain high unless there is significant cross protection. Oral, penile, and anal HPV prevalence will be calculated.
Secondary outcomes (1)
- measure
- Persistent HPV infection
- timeFrame
- Day 7
- description
- Detection of same HPV type at the same site at both visits (day 0 and 7). The objective of repeat sampling at day 7 is to investigate whether this might distinguish transient HPV detection from infection. A brief questionnaire will be self-completed by participants at day 7 to ascertain whether there has been any sexual re-exposure between day 0 and 7 that might explain repeat HPV positivity at day 7.
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 16 Years
- Maximum age
- 20 Years
Show eligibility criteria text
Inclusion Criteria: * Men aged 16 to 20 (Must be aged 16-19 years from 1 January 2017 to 31 December 2017, and aged 16-20 years from 1 January 2018 to 31 December 2018) * Report any previous type of sexual contact (including but not restricted to oral or anal sex) with at least one other man ever * Able to complete all study requirements including questionnaire in English and completion of 2 visits * Residing in Australia since 2013 (This is to ensure that males included in the study were present in Australia at the time HPV vaccination was offered) Exclusion Criteria: * Transgender male
References
Publications (2)
- RESULTChow 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. PMID 34043963
- RESULTChow 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. PMID 34971362