Papilloma Viral InfectionHPVNCT05078554
HPV and Male Homosexuality in General Practice?
An observational study of Papilloma Viral Infection, run by University Hospital, Strasbourg, France at 1 site in France.
Trial summary
The main objective of this study is to find out whether young MSM (men who have sex with men) believe it is important for their GP to be informed of their sexual orientation, in order to improve their clinical, especially with HPV vaccination. Read more about this study
- Who is it for?
- Ages 18 to 26 years, men only
- Conditions the study is for
- Papilloma Viral Infection
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 27 May 2021to 27 Jan 2022
- 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 26 years
- Men only
- Adult
Study population: Subjetc aged between 18-26 years consulting at the HUS Cegidd as part of an STI screening
Who may be able to join
- Age: 18-26 years
- Consultation at the HUS Cegidd as part of an STI screening
- Subject who expressed no opposition to participating in the study
Who cannot join
- Refusal of the patient to participate in the study
- Subject who had already benefited from HPV vaccination (at least one dose)
- Inability to give informed consent
- Subject under safeguarde of justice
- Subject under guardianship or under curatorship
Trial locations and contacts
1 site in 1 country.
France1 site
Service du Trait d'Union - Hôpitaux Universitaires de Strasbourg
Strasbourg, 67091
About this study
Official title: HPV Vaccination (Human Papilloma Virus), or How to Address Male Homosexuality in General Practice in Alsace?
The main objective of this study is to find out whether young MSM (men who have sex with men) believe it is important for their GP to be informed of their sexual orientation, in order to improve their clinical, especially with HPV vaccination.
The secondary objective is to analyze the state of knowledge about the HPV vaccine and the value of HPV vaccine in this target population.
- Conditions
- Papilloma Viral Infection
- Keywords
- Papilloma Viral Infection, HPV, HPV vaccine
- Medical subject headings
- Papillomavirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
Retrospective descriptive study of vaccination against HPV (Human Papilloma Virus) in Alsace?
Measured: Files analysed retrospectively from April 27, 2021 to January 27, 2020 will be examined]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2021
- Study start27 May 2021
- Primary completion27 Jan 2022
- Study completion27 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Papilloma Viral InfectionStudies of the same condition, open and under way.
- More trials run by University Hospital, Strasbourg, FranceThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Strasbourg, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05078554
- Sponsor's protocol ID
- 8048
- Acronym
- HPV
- Status last verified
- Oct 2021
- First submitted
- 13 Oct 2021
- Last updated
- 10 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- HPV Vaccination (Human Papilloma Virus), or How to Address Male Homosexuality in General Practice in Alsace?
- ClinicalTrials.gov ID
- NCT05078554
- Acronym / sponsor ID
- HPV / 8048
- Conditions
- Papilloma Viral Infection
- Keywords
- Papilloma Viral Infection, HPV, HPV vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University Hospital, Strasbourg, FranceUniversity, hospital or other
- Study start
- 27 May 2021 (actual)
- Primary completion
- 27 Jan 2022 (actual)
- Study completion
- 27 Jan 2022 (actual)
- First posted
- 14 Oct 2021 (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.
The main objective of this study is to find out whether young MSM (men who have sex with men) believe it is important for their GP to be informed of their sexual orientation, in order to improve their clinical, especially with HPV vaccination.
The secondary objective is to analyze the state of knowledge about the HPV vaccine and the value of HPV vaccine in this target population.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 26 years
- Sex
- Male only
- Age groups
- Adult
- Study population
- Subjetc aged between 18-26 years consulting at the HUS Cegidd as part of an STI screening
Key inclusion criteria (3 listed)
- Age: 18-26 years
- Consultation at the HUS Cegidd as part of an STI screening
- Subject who expressed no opposition to participating in the study
Key exclusion criteria (5 listed)
- Refusal of the patient to participate in the study
- Subject who had already benefited from HPV vaccination (at least one dose)
- Inability to give informed consent
- Subject under safeguarde of justice
- Subject under guardianship or under curatorship
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
Retrospective descriptive study of vaccination against HPV (Human Papilloma Virus) in Alsace?
Time frame: Files analysed retrospectively from April 27, 2021 to January 27, 2020 will be examined]
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 10 Sep 2022.
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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.
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 Papilloma Viral Infection, run by University Hospital, Strasbourg, France at 1 site in France.
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 3 inclusion and 5 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 10 Sep 2022. 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 France. 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?
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?
Retrospective descriptive study of vaccination against HPV (Human Papilloma Virus) in Alsace? (time frame: Files analysed retrospectively from April 27, 2021 to January 27, 2020 will be examined]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 10 Sep 2022.