In this study, we aim to estimate genital HPV prevalences in men aged 19-27 year in the general Dutch population. Also, we aim to link the hrHPV prevalences to the HPV vaccination status after completion of the catch-up campaign to compare theā¦
ID
Source
Brief title
Condition
- Ancillary infectious topics
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
The primary study outcomes are the prevalence of genital hrHPV *overall* and
types 16 and 18 and the HPV vaccination status after completion of the catch-up
campaign.
Secondary outcome
Secondary outcomes include the genital prevalences of HPV types other than
types 16 and 18 as well as the prevalence of hrHPV in urine to compare the
accuracy of hrHPV detection of self-collected first-void urine with
self-collected penile swabs.
Background summary
A persistent infection with a high-risk human papillomavirus (hrHPV) can cause
HPV-related cancer such as cervical, penile or anal cancer. In the Netherlands,
a girls-only vaccination (GOV) policy to prevent HPV-related cancer was
introduced in 2009. Since 2022, a gender-neutral vaccination (GNV) policy is
implemented in which boys and girls are invited for HPV vaccination in the year
they turn 10. Additionally, a catch-up campaign for persons aged 19-27 years
started in 2023. Such changes in HPV vaccination policy specifically require
monitoring and evaluation. While for women the effectiveness of the catch-up
campaign can be studied using information from the national population-based
cervical cancer screening, for men no such screening for HPV-related cancer and
(pre-)cancerous lesions exists yet. At this moment, only projections resulting
from e.g. modelling studies can provide insight into the future impact of the
catch-up campaign for men. Information on the prevalence of HPV in the general
population, especially for men, is limited but relevant for such modelling
studies. Also currently, studies evaluating the effectiveness of the GOV
programme focus mainly on vaccine effectiveness (VE), and HPV incidence,
prevalence and persistence among women and visitors of sexual health centres.
In these studies, the HPV occurrence is measured through genital self-swabs.
Considering the young age at which GNV is offered, using genital self-swabs may
be less suitable to evaluate the GNV programme. Therefore, alternatives are
explored and (first-void) urine is under consideration as a potential easily
accessible tool to measure HPV.
Study objective
In this study, we aim to estimate genital HPV prevalences in men aged 19-27
year in the general Dutch population. Also, we aim to link the hrHPV
prevalences to the HPV vaccination status after completion of the catch-up
campaign to compare the prevalences between men who received the HPV
vaccination during the catch-up campaign versus men who did not receive the
vaccination. Additionally, we aim to explore if HPV measured in urine can be
used as detection method to measure genital hrHPV prevalence in men and whether
it might be an applicable indicator of the impact of HPV vaccination in boys to
be used in future monitoring studies.
Study design
The study has a cross-sectional design in which participating men will be asked
to complete a baseline questionnaire containing questions about demographics
and about sexual preferences/behavior. Additionally, men will be asked to take
a penile swab and to collect urine (the latter one is optional). After
completion of the catch-up campaign, men receive a second short questionnaire
to retrieve information about whether they accepted the HPV vaccination during
the campaign.
Study burden and risks
Participation in the study is not associated with health risks and only
requires some time investment (approximately 35 minutes) from the participants
to complete the questionnaire and collect the self-sample(s).
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721MA
NL
Antonie van Leeuwenhoeklaan 9
Bilthoven 3721MA
NL
Listed location countries
Age
Inclusion criteria
- Male
- Born from 1996 up to and including 2003
- Provided informed consent
Exclusion criteria
not applicable
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL84202.041.23 |