Ignite Creation Date:
2025-12-24 @ 3:36 PM
Ignite Modification Date:
2025-12-25 @ 4:38 PM
Study NCT ID:
NCT06998992
Status:
COMPLETED
Last Update Posted:
2025-05-31
First Post:
2025-05-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief 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.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'id': 'D001519', 'term': 'Behavior'}], 'ancestors': [{'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D018347', 'term': 'Hepadnaviridae Infections'}, {'id': 'D004266', 'term': 'DNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D006525', 'term': 'Hepatitis, Viral, Human'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2020-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-22', 'studyFirstSubmitDate': '2025-05-22', 'studyFirstSubmitQcDate': '2025-05-22', 'lastUpdatePostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-05-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The percentage of patients who declared being vaccinated against hepatitis B and who are confirmed to be truly vaccinated by serology.', 'timeFrame': 'July 2020 - October 2020'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hepatitis B', 'Vaccination', 'Health Knowledge, Attitudes, Practice', 'Serologic Tests', 'Ambulatory Care', 'Public Health']}, 'descriptionModule': {'briefSummary': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '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.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients born in France.\n* Consulting at the CeGIDD of Delafontaine Hospital in Saint-Denis.\n* Requiring a hepatitis B serology test.\n\nExclusion Criteria:\n\n\\- Patients with a history of past hepatitis B infection.'}, 'identificationModule': {'nctId': 'NCT06998992', 'briefTitle': '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.', 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier de Saint-Denis'}, 'officialTitle': '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.', 'orgStudyIdInfo': {'id': '0006_SMIT'}}, 'contactsLocationsModule': {'locations': [{'city': 'Saint-Denis', 'state': 'France', 'country': 'France', 'facility': 'France', 'geoPoint': {'lat': 48.93564, 'lon': 2.35387}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier de Saint-Denis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}