Human Papillomavirus
Conditions
Keywords
Prevalence, HPV, Human papillomavirus, Vaccination
Brief summary
This study will examine how common HPV infection is in teenage males in Australia before and after the introduction of universal school based vaccination of males in Australia.
Detailed description
Males aged 17 to 19 in Australia will be recruited from 2014. Men will undergo sampling from the penis for HPV. The prevalence of HPV infection will be determined in 2014-2015 and compared to the prevalence in 2016-2017.
Interventions
None listed
Sponsors
Merck Sharp & Dohme LLC
The Alfred
Study design
Observational model
ECOLOGIC_OR_COMMUNITY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
MALE
Age
17 Years to 19 Years
Healthy volunteers
Yes
Inclusion criteria
* Male * Aged 17 to 19 * Able to complete study requirements * Residing in Australia from 12 years of age
Exclusion criteria
-Males reporting sex with males in the past 12 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Prevalence of Penile HPV Genotypes | Single study visit (one time point per participant) | Prevalence of penile HPV genotypes among heterosexually active young men. Percentage of participants with specific genotypes on penile samples, as detected by Linear Array. Participants provided a single penile sample. |
Countries
Australia
Participant flow
Recruitment details
Participants were recruited from clinical and community sources across Australia over a period of four years (February 2014- December 2017), which represented two phases. Participants recruited in phase 1 (2014-2015) were ineligible for school-based HPV vaccination. Participants in Phase 2(2016-2017) were eligible for school-based HPV vaccination.
Participants by arm
| Arm | Count |
|---|---|
| Pre-vaccination Period Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2014-2015. This was a cohort preceding the introduction of the school-based male 4vHPV vaccination program. | 179 |
| Post-vaccination Period Heterosexual males aged 17-19 years, living in Australia since at least 2013. Recruited 2016-2017. This was a cohort were age-eligible for the school-based male 4vHPV vaccination program following its introduction | 166 |
| Total | 345 |
Baseline characteristics
| Characteristic | Pre-vaccination Period | Total | Post-vaccination Period |
|---|---|---|---|
| Age, Continuous | 18.5 years | 18.4 years | 18.3 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Australia | 179 participants | 345 participants | 166 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 179 Participants | 345 Participants | 166 Participants |
| Sexual contact in lifetime | 179 Participants | 345 Participants | 166 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 179 | 0 / 166 |
| other Total, other adverse events | 0 / 179 | 0 / 166 |
| serious Total, serious adverse events | 0 / 179 | 0 / 166 |
Outcome results
Primary
Prevalence of Penile HPV Genotypes
Prevalence of penile HPV genotypes among heterosexually active young men. Percentage of participants with specific genotypes on penile samples, as detected by Linear Array. Participants provided a single penile sample.
Time frame: Single study visit (one time point per participant)
Population: All participants in group one were ineligible for school-based vaccination. All participants in group two were eligible to receive 4vHPV vaccination. All participants had experienced sexual contact with a female (either oral or vaginal sex), no sexual contact (either oral or anal sex) with a male, and had assessable penile samples.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Phase 1 (2014-2015) | Prevalence of Penile HPV Genotypes | Any 4vHPV vaccine genotype | 2.6 percentage of participants |
| Phase 1 (2014-2015) | Prevalence of Penile HPV Genotypes | Any of 37 HPV genotypes | 21.7 percentage of participants |
| Phase 1 (2014-2015) | Prevalence of Penile HPV Genotypes | Any of 13 high-risk genotypes, other than 16 and 1 | 15.1 percentage of participants |
| Phase 2 (2016-2017) | Prevalence of Penile HPV Genotypes | Any 4vHPV vaccine genotype | 0.7 percentage of participants |
| Phase 2 (2016-2017) | Prevalence of Penile HPV Genotypes | Any of 37 HPV genotypes | 11.6 percentage of participants |
| Phase 2 (2016-2017) | Prevalence of Penile HPV Genotypes | Any of 13 high-risk genotypes, other than 16 and 1 | 7.5 percentage of participants |