HPV - Anogenital Human Papilloma Virus InfectionNCT03474211
Prevalence of HPV Infection Using Self-sampling
An observational study of HPV - Anogenital Human Papilloma Virus Infection, run by University Hospital, Geneva.
Trial summary
Background: Currently prevalence of HPV infections for high risk strains among young women in Switzerland is unknown. In addition, since 2008 a vaccination program to prevent these infections has been implemented in a number of cantons, but its actual population impact is currently unknown. Read more about this study
- Who is it for?
- Ages 18 to 31 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- HPV - Anogenital Human Papilloma Virus Infection
- How many people
- 400 participants
- Where
- No sites listed yet
- Study dates
- Sep 2016to Sep 2017
- 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 18 to 31 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: It will take place in the health school of health and Faculty of Medicine at the University of Geneva. Trial information on the University website will be available; it will also contain a phone number for helpline. Cards to check eligibility, registration and scheduling will be available. The HPV self-collection kit will be directly distributed to participants at the end of their courses to School of Health and University of Geneva School of Medicine
Who may be able to join
- • Eligible women aged between 18-31 years attending of Haute Ecole de Santé - Genève and Faculty of Medicine at the University of Geneva.
- Understands study procedures and accepts voluntarily to participate by signing the informed consent form (ICF)
Who cannot join
- • History of hysterectomy or treatment on the cervix during the last 12 months
About this study
Official title: Prevalence of HPV Infection Using Self-sampling Screening and Monitoring the Earlier Impact of HPV-Vaccination Program in Switzerland
Background: Currently prevalence of HPV infections for high risk strains among young women in Switzerland is unknown. In addition, since 2008 a vaccination program to prevent these infections has been implemented in a number of cantons, but its actual population impact is currently unknown. For now, HPV screening in Switzerland is mainly performed by gynecologists or during gynecological consultation at hospital. This method is certainly effective, but expensive; population coverage of screening is still insufficient. A whole segment of the target population does not participate in this screening especially young people of foreign origin, for various reasons: economic cost, no gynecological, and for other reasons.
Several studies raise the effectiveness and efficiency of self-sampling to increase coverage of screening, and the rate of participation of non-participants. Through this study, the investigators evaluate effectiveness of this vaccination on the prevalence of HPV infections using HPV prevalence kit and assess evolution of infection and clearance of HPV virus during 5 years in a population of young unvaccinated and vaccinated women.
Read more
Method: During the study, each participants will perform a vaginal swab sampling by auto to research HPV. These samples will be sent to a laboratory where HPV typing is done by PCR using the Anyplex ™ II technology.
The study will focus on a sample of 400 young women. Participants must complete a questionnaire containing demographic questions and their HPV immunization status. Vaccination coverage expected in this population is about 50%. Depending on the state of vaccination, two different groups will be vaccinated vs unvaccinated (200 women per group). The cases of HPV infection are then calculated for each group and compared as a function of the status of vaccination. Statistical tests will be applied McNemar's test for comparison between the HPV prevalence rates between the 2 groups.
Expected Results: This study will allow us to confirm the possibility of using self-sampling as a method of screening and monitoring of HPV infections in the general population, it will also enable us to document the effectiveness of HPV vaccination by comparing prevalence rate of HPV infections among a group of young girls vaccinated and not vaccine and assess evolution of infection and clearance of HPV virus.
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| vaccinated | Not described | |
| non vaccinated | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the HPV prevalence of vaccine-type: 19 high-risk HPV types and 9 low-risk HPV types in a population of young unvaccinated and vaccinated women
Number of unvaccinated and vaccinated women infected by an HPV virus as assessed by using self sampling HPV kit.
Measured: 1.5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2018
- Study startSep 2016
- Primary completionJan 2017
- Study completionSep 2017
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 - Anogenital Human Papilloma Virus InfectionStudies of the same condition, open and under way.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 400 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeannot Emilien, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03474211
- Sponsor's protocol ID
- CER: 15-257
- Status last verified
- Mar 2018
- First submitted
- 21 Feb 2018
- Last updated
- 22 Mar 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Amadane M, de Pree C, Viviano M, Vassilakos P, Jeannot E, Petignat P. Characteristics of HPV-unvaccinated undergraduate health students in Switzerland, a cross sectional study. Arch Public Health. 2019 Jun 18;77:29. doi: 10.1186/s13690-019-0348-y. eCollection 2019.
PubMed 31236272
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevalence of HPV Infection Using Self-sampling Screening and Monitoring the Earlier Impact of HPV-Vaccination Program in Switzerland
- ClinicalTrials.gov ID
- NCT03474211
- Acronym / sponsor ID
- CER: 15-257
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- Sep 2016 (actual)
- Primary completion
- Jan 2017 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 22 Mar 2018 (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.
Background: Currently prevalence of HPV infections for high risk strains among young women in Switzerland is unknown. In addition, since 2008 a vaccination program to prevent these infections has been implemented in a number of cantons, but its actual population impact is currently unknown. For now, HPV screening in Switzerland is mainly performed by gynecologists or during gynecological consultation at hospital. This method is certainly effective, but expensive; population coverage of screening is still insufficient. A whole segment of the target population does not participate in this screening especially young people of foreign origin, for various reasons: economic cost, no gynecological, and for other reasons.
Several studies raise the effectiveness and efficiency of self-sampling to increase coverage of screening, and the rate of participation of non-participants. Through this study, the investigators evaluate effectiveness of this vaccination on the prevalence of HPV infections using HPV prevalence kit and assess evolution of infection and clearance of HPV virus during 5 years in a population of young unvaccinated and vaccinated women.
Method: During the study, each participants will perform a vaginal swab sampling by auto to research HPV. These samples will be sent to a laboratory where HPV typing is done by PCR using the Anyplex ™ II technology.
The study will focus on a sample of 400 young women. Participants must complete a questionnaire containing demographic questions and their HPV immunization status. Vaccination coverage expected in this population is about 50%. Depending on the state of vaccination, two different groups will be vaccinated vs unvaccinated (200 women per group). The cases of HPV infection are then calculated for each group and compared as a function of the status of vaccination. Statistical tests will be applied McNemar's test for comparison between the HPV prevalence rates between the 2 groups.
Expected Results: This study will allow us to confirm the possibility of using self-sampling as a method of screening and monitoring of HPV infections in the general population, it will also enable us to document the effectiveness of HPV vaccination by comparing prevalence rate of HPV infections among a group of young girls vaccinated and not vaccine and assess evolution of infection and clearance of HPV virus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| vaccinated | – | – |
| non vaccinated | – | – |
Who may qualify
- Ages
- 18 to 31 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- It will take place in the health school of health and Faculty of Medicine at the University of Geneva. Trial information on the University website will be available; it will also contain a phone number for helpline. Cards to check eligibility, registration and scheduling will be available. The HPV self-collection kit will be directly distributed to participants at the end of their courses to School of Health and University of Geneva School of Medicine
Key inclusion criteria (2 listed)
- • Eligible women aged between 18-31 years attending of Haute Ecole de Santé - Genève and Faculty of Medicine at the University of Geneva.
Key exclusion criteria (1 listed)
- • History of hysterectomy or treatment on the cervix during the last 12 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the HPV prevalence of vaccine-type: 19 high-risk HPV types and 9 low-risk HPV types in a population of young unvaccinated and vaccinated women
Time frame: 1.5 years
Number of unvaccinated and vaccinated women infected by an HPV virus as assessed by using self sampling HPV kit.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2018.
- Derived from this study: PubMed 31236272Amadane M, de Pree C, Viviano M, Vassilakos P, Jeannot E, Petignat P. Characteristics of HPV-unvaccinated undergraduate health students in Switzerland, a cross sectional study. Arch Public Health. 2019 Jun 18;77:29. doi: 10.1186/s13690-019-0348-y. eCollection 2019.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of HPV - Anogenital Human Papilloma Virus Infection, run by University Hospital, Geneva.
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 1 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: finished, as of the sponsor's last update on 22 Mar 2018. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To determine the HPV prevalence of vaccine-type: 19 high-risk HPV types and 9 low-risk HPV types in a population of young unvaccinated and vaccinated women (time frame: 1.5 years). 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 NCT03474211, 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 22 Mar 2018.