ClinicalTrials.gg
CompletedNCT06998992Updated May 31, 2025

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 in Hepatitis B, Vaccination and Health Knowledge, Attitudes, Practice, sponsored by Centre Hospitalier de Saint-Denis. Completed at 1 site in France. Per ClinicalTrials.gov, last updated 2025-05-31.

Sponsored by Centre Hospitalier de Saint-Denis · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
200
Sex
All
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Study 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. 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.

02

Conditions studied

  • Hepatitis B
  • Vaccination
  • Health Knowledge, Attitudes, Practice
  • Serologic Tests
  • Ambulatory Care
  • Public Health
03

In context

Hepatitis B

1,662 studies on the registry are indexed under Hepatitis B; 192 are open to participants now.

This study's enrollment of 200 is below the median of 395 across 410 observational studies indexed under Hepatitis B.

Browse Hepatitis B studies →

Lead sponsor

Centre Hospitalier de Saint-Denis is the lead sponsor of 45 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Sampling method
Non-probability sample

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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Patients born in France.
  • Consulting at the CeGIDD of Delafontaine Hospital in Saint-Denis.
  • Requiring a hepatitis B serology test.

Exclusion criteria

Exclusion Criteria:

- Patients with a history of past hepatitis B infection.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
200 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. 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

07

Study locations

1 site
  • France
    Saint-Denis, France, France
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jul 2020 to primary completion in Oct 2020, 3 months.

Of 114 non-industry observational studies under Hepatitis B, half reached primary completion within 60 months of starting (the median), counting those still running; a quarter within 18 and three quarters within 109. This study's 3 months is below that.

Counting every sponsor, half of 133 studies reached it within 55 months; a quarter within 17 and three quarters within 108.

How these figures are worked out, and which studies are left out of them.

Registered
May 22, 2025
First posted
May 31, 2025
StartActual
Jul 1, 2020
Primary completionActual
Oct 1, 2020
CompletionActual
Oct 1, 2020
Last update
May 31, 2025
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 31, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06998992
Lead sponsor
Centre Hospitalier de Saint-Denis
Responsible party
Sponsor
First posted
May 31, 2025
Start date
Jul 1, 2020
Primary completion
Oct 1, 2020
Completion
Oct 1, 2020
Last update
May 31, 2025

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.

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Discussion

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