NCT06998992

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
200

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jul 2020

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2020

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

May 22, 2025

Completed
9 days until next milestone

First Posted

Study publicly available on registry

May 31, 2025

Completed
Last Updated

May 31, 2025

Status Verified

May 1, 2025

Enrollment Period

3 months

First QC Date

May 22, 2025

Last Update Submit

May 22, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • The percentage of patients who declared being vaccinated against hepatitis B and who are confirmed to be truly vaccinated by serology.

    July 2020 - October 2020

Eligibility Criteria

Sexall
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

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

You may not qualify if:

  • \- Patients with a history of past hepatitis B infection.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

France

Saint-Denis, France, France

Location

MeSH Terms

Conditions

Hepatitis BBehavior

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 22, 2025

First Posted

May 31, 2025

Study Start

July 1, 2020

Primary Completion

October 1, 2020

Study Completion

October 1, 2020

Last Updated

May 31, 2025

Record last verified: 2025-05

Locations