HPV InfectionNCT04297670
HPV Prevalence in 16-20 Year Old Males
An observational study of HPV Infection, run by Laval University at 1 site in Canada.
Trial summary
In Quebec, 18 birth cohorts of girls were vaccinated against HPV (aged 9 to 29 years in 2020). With an observed vaccination coverage of >80% an important herd effect might be expected. This study aim is to measure the HPV types prevalence in unvaccinated sexually active boys aged 16 to 20 years. 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
- HPV Infection
- What is being tested?
- Measurement of HPV types prevalence
- Type of treatment
- Vaccines
- How many people
- 681 participants
- Where
- 1 siteCanada
- Study dates
- 20 Feb 2020to 31 Dec 2020
- 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: Sexually active 16-20 years old boys studying at a professional school or college.
Who may be able to join
- unvaccinated against HPV
- sexually active
Who cannot join
- received an HPV vaccine
- non sexually active
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Laval University Research Hospital Center
Québec, G1E7G9
Chanta Sauvageau, MD, MSc, 418 650 5115 ext. 6368, chantal.sauvageau@inspq.qc.ca
Vladimir Gilca, MD, PhD, 4186667000 ext. 368, vladimir.gilca@inspq.qc.ca
About this study
Official title: Evaluation of the Impact of Quebec HPV Immunization Program: Prevalence of HPV Types in 16-20 Year Old Males
In Quebec, 18 birth cohorts of girls were vaccinated against HPV (aged 9 to 29 years in 2020). With an observed vaccination coverage of >80% an important herd effect might be expected. This study aim is to measure the HPV types prevalence in unvaccinated sexually active boys aged 16 to 20 years.
Read the detailed description
An HPV immunization program is in place in Quebec since 2008. By 2020 18 birth cohorts of girls were eligible for vaccination. Vaccine uptake with at least one dose of vaccine was >80%. With such a high vaccine uptake an important herd immunity might be expected. The main objective of this study is to measure the prevalence of different HPV types in unvaccinated sexually active boys aged 16 to 20 years. This is a cross sectional study which includes one visit for all participants. Self sampling technic is used. During this phase of the study a total of 681 boys will be recruited. An additional phase of the study will be conducted at the condition that the prevalence of HPV6/11/16/18/31/33/45/52 and 58 in unvaccinated boys will be at least 8.65%. The second phase of the study if conducted will measure the prevalence of the same HPV types in 681 vaccinated boys of the same age.
- Conditions
- HPV Infection
- Being tested
- Measurement of HPV types prevalence
- Keywords
- Prevalence, Boys
- Medical subject headings
- Papillomavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Measurement of HPV types prevalenceOther
Self collected genital samples to be tested for the presence of different HPV types.
| Study group | Role | What they receive |
|---|---|---|
| Unvaccinated against HPV boys | Sexually active unvaccinated against HPV 16-20 years old boys. Receives: Other: Measurement of HPV types prevalence |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prevalence of HPV 6/11/16/18/31/33/45/52 and 58
Unvaccinated sexually active 16-20 year old boys will be tested
Measured: Up to 18 months
Secondary outcomes (1)
Prevalence of 31 HPV types
Unvaccinated sexually active 16-20 year old boys will be tested
Measured: Up to 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2020
- Study start20 Feb 2020
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HPV InfectionStudies of the same condition, open and under way.
- More trials run by Laval UniversityThe sponsor's other registered studies.
- 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
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 681 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Laval University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04297670
- Sponsor's protocol ID
- HPV2020-5037
- Status last verified
- Mar 2020
- First submitted
- 3 Mar 2020
- Last updated
- 5 Mar 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with any researcher outside this study
Publications
Wolfe C, Ionescu IG, Mayrand MH, Coutlee F, Sauvageau C. Prevalence of Human Papillomavirus Genotypes in Unvaccinated 16- to 20-Year-Old Men in Quebec, Canada. J Infect Dis. 2025 Aug 14;232(2):e203-e212. doi: 10.1093/infdis/jiaf094.
PubMed 39982898
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Impact of Quebec HPV Immunization Program: Prevalence of HPV Types in 16-20 Year Old Males
- ClinicalTrials.gov ID
- NCT04297670
- Acronym / sponsor ID
- HPV2020-5037
- Conditions
- HPV Infection
- Keywords
- Prevalence, Boys
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 681 participants (estimated)
- Lead sponsor
- Laval UniversityUniversity, hospital or other
- Study start
- 20 Feb 2020 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 5 Mar 2020 (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.
In Quebec, 18 birth cohorts of girls were vaccinated against HPV (aged 9 to 29 years in 2020). With an observed vaccination coverage of >80% an important herd effect might be expected. This study aim is to measure the HPV types prevalence in unvaccinated sexually active boys aged 16 to 20 years.
Detailed description
An HPV immunization program is in place in Quebec since 2008. By 2020 18 birth cohorts of girls were eligible for vaccination. Vaccine uptake with at least one dose of vaccine was >80%. With such a high vaccine uptake an important herd immunity might be expected. The main objective of this study is to measure the prevalence of different HPV types in unvaccinated sexually active boys aged 16 to 20 years. This is a cross sectional study which includes one visit for all participants. Self sampling technic is used. During this phase of the study a total of 681 boys will be recruited. An additional phase of the study will be conducted at the condition that the prevalence of HPV6/11/16/18/31/33/45/52 and 58 in unvaccinated boys will be at least 8.65%. The second phase of the study if conducted will measure the prevalence of the same HPV types in 681 vaccinated boys of the same age.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Unvaccinated against HPV boys | – | Other: Measurement of HPV types prevalenceSexually active unvaccinated against HPV 16-20 years old boys. |
Who may qualify
- Ages
- 16 to 20 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- Sexually active 16-20 years old boys studying at a professional school or college.
Key inclusion criteria (2 listed)
- unvaccinated against HPV
- sexually active
Key exclusion criteria (2 listed)
- received an HPV vaccine
- non sexually active
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Measurement of HPV types prevalenceSelf collected genital samples to be tested for the presence of different HPV types. | Other | Unvaccinated against HPV boys |
Primary outcome
Prevalence of HPV 6/11/16/18/31/33/45/52 and 58
Time frame: Up to 18 months
Unvaccinated sexually active 16-20 year old boys will be tested
1 secondary outcome
Prevalence of 31 HPV types
Time frame: Up to 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2020.
- Derived from this study: PubMed 39982898Wolfe C, Ionescu IG, Mayrand MH, Coutlee F, Sauvageau C. Prevalence of Human Papillomavirus Genotypes in Unvaccinated 16- to 20-Year-Old Men in Quebec, Canada. J Infect Dis. 2025 Aug 14;232(2):e203-e212. doi: 10.1093/infdis/jiaf094.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with any researcher outside this study
Related trials for HPV Infection
Not yet recruitingPhase 1/2
Clinical Trial to Assess the Safety, Tolerability, Reactogenicity, and Immunogenicity of a 10 Valent Human Papillomavirus Virus (10vHPV) Vaccine
Human Papillomavirus Infection
Active, not recruitingPhase 4
Comparing Immune Response of 2 vs 3 HPV Doses (27-45 Years Old)
Immunization, HPV Infection
Not yet recruitingPhase 2
Combination Bevacizumab and PRGN-2012 in Adults With Recurrent Respiratory Papillomatosis (RRP)
Respiratory Recurrent Papillomatosis (RRP), Human Papillomavirus (HPV)
RecruitingPhase 2
A Study of the Preliminary Efficacy of DARE-HPV to Treat High-risk Persistent Human Papillomavirus (hrHPV)
Human Papilloma Virus (HPV), High-risk Human Papillomavirus Infection
RecruitingPhase 2
A Single Arm Phase II Trial in p16-positive Oropharynx Cancer of Selective Dose De-escalation of nodAl VolumEs at Minimal Risk and Primary Site Disease (SAVED)
Head and Neck Cancer, Head and Neck Squamous Cell Cancer
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 HPV Infection, run by Laval University at 1 site in Canada.
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 2 inclusion and 2 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 5 Mar 2020. 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 Canada. 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 Chantal Sauvageau, MD, MSc (1 418 650 5115 ext. 6368, chantal.sauvageau@inspq.qc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prevalence of HPV 6/11/16/18/31/33/45/52 and 58 (time frame: Up to 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04297670, which also lists 1 linked publication.
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 5 Mar 2020.