Hepatitis BNCT06998992
Assessing the Reliability of Self-Reported Hepatitis B Vaccination Status in Outpatients: Evaluation of Individuals Born in France and Consulting at the CeGIDD in Saint-Denis.
An observational study of Hepatitis B and Vaccination, run by Centre Hospitalier de Saint-Denis at 1 site in France.
Trial summary
This study aims to find out whether people accurately know their hepatitis B vaccination status. It focuses on individuals born in France who visit a sexual health clinic (CeGIDD) in Saint-Denis. During the consultation, each person is asked whether they think they are vaccinated against hepatitis B. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Hepatitis B, Vaccination, Health Knowledge, Attitudes, Practice
- How many people
- 200 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jul 2020to 1 Oct 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 Any age
- All sexes
- Child, Adult, Older adult
Study population: Participants will be adults born in France who attend the CeGIDD (sexual health clinic) at Delafontaine Hospital in Saint-Denis. These individuals are seeking care and require a hepatitis B serology test. The population includes people with diverse backgrounds in terms of age, sex, sexual orientation, and education level. Patients with a known history of past hepatitis B infection will be excluded. The study focuses on evaluating the reliability of their self-reported hepatitis B vaccination status compared to serological test results.
Who may be able to join
- Patients born in France.
- Consulting at the CeGIDD of Delafontaine Hospital in Saint-Denis.
- Requiring a hepatitis B serology test.
Who cannot join
- Patients with a history of past hepatitis B infection.
Trial locations and contacts
1 site in 1 country.
About this study
This study aims to find out whether people accurately know their hepatitis B vaccination status. It focuses on individuals born in France who visit a sexual health clinic (CeGIDD) in Saint-Denis. During the consultation, each person is asked whether they think they are vaccinated against hepatitis B. Then, a blood test is done to check if they really are. The goal is to see how often people's answers match their actual medical status. The study also looks at factors like age, gender, education level, and whether they have a regular doctor to understand who is more likely to be unsure or mistaken about their vaccination status. About 200 participants are expected to take part.
- Conditions
- Hepatitis B, Vaccination, Health Knowledge, Attitudes, Practice, Serologic Tests, Ambulatory Care, Public Health
- Medical subject headings
- Hepatitis B, Behavior
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage of patients who declared being vaccinated against hepatitis B and who are confirmed to be truly vaccinated by serology.
Measured: July 2020 - October 2020
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 May 2025
- Study start1 Jul 2020
- Primary completion1 Oct 2020
- Study completion1 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hepatitis BStudies 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
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier de Saint-Denis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06998992
- Sponsor's protocol ID
- 0006_SMIT
- Status last verified
- May 2025
- First submitted
- 22 May 2025
- Last updated
- 31 May 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Reliability of Self-Reported Hepatitis B Vaccination Status in Outpatients: Evaluation of Individuals Born in France and Consulting at the CeGIDD in Saint-Denis.
- ClinicalTrials.gov ID
- NCT06998992
- Acronym / sponsor ID
- 0006_SMIT
- Conditions
- Hepatitis B, Vaccination, Health Knowledge, Attitudes, Practice, Serologic Tests, Ambulatory Care, Public Health
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Centre Hospitalier de Saint-DenisUniversity, hospital or other
- Study start
- 1 Jul 2020 (actual)
- Primary completion
- 1 Oct 2020 (actual)
- Study completion
- 1 Oct 2020 (actual)
- First posted
- 31 May 2025 (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.
This study aims to find out whether people accurately know their hepatitis B vaccination status. It focuses on individuals born in France who visit a sexual health clinic (CeGIDD) in Saint-Denis. During the consultation, each person is asked whether they think they are vaccinated against hepatitis B. Then, a blood test is done to check if they really are. The goal is to see how often people's answers match their actual medical status. The study also looks at factors like age, gender, education level, and whether they have a regular doctor to understand who is more likely to be unsure or mistaken about their vaccination status. About 200 participants are expected to take part.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- Participants will be adults born in France who attend the CeGIDD (sexual health clinic) at Delafontaine Hospital in Saint-Denis. These individuals are seeking care and require a hepatitis B serology test. The population includes people with diverse backgrounds in terms of age, sex, sexual orientation, and education level. Patients with a known history of past hepatitis B infection will be excluded. The study focuses on evaluating the reliability of their self-reported hepatitis B vaccination status compared to serological test results.
Key inclusion criteria (3 listed)
- Patients born in France.
- Consulting at the CeGIDD of Delafontaine Hospital in Saint-Denis.
- Requiring a hepatitis B serology test.
Key exclusion criteria (1 listed)
- Patients with a history of past hepatitis B infection.
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
The percentage of patients who declared being vaccinated against hepatitis B and who are confirmed to be truly vaccinated by serology.
Time frame: July 2020 - October 2020
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 31 May 2025.
Related trials for Hepatitis B
Active, not recruitingPhase 2
A Study of Sequential Therapy With Daplusiran/Tomligisiran (DAP/TOM) Followed by Bepirovirsen in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B Virus Infection, Hepatitis B
RecruitingObservational study
Evaluation of Patients With Liver Disease
Hepatitis D, Hepatitis C
Active, not recruitingPhase 2
Study of Bepirovirsen in Participants Living With Human Immunodeficiency Virus and Chronic Hepatitis B Virus Infection (B-Focus)
Hepatitis B
Active, not recruitingPhase 2
Long-term Follow-up Study to Evaluate Durability of Treatment Response in Previous Bepirovirsen Study Participants (B-Sure)
Hepatitis B
Enrolling by invitationPhase 1
A Phase I Clinical Trial of CPU-YL01 Injection in Patients With Chronic Hepatitis B.
Chronic Hepatitis B
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 Hepatitis B and Vaccination, run by Centre Hospitalier de Saint-Denis 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 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 31 May 2025. 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?
The percentage of patients who declared being vaccinated against hepatitis B and who are confirmed to be truly vaccinated by serology. (time frame: July 2020 - October 2020). 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 31 May 2025.