Ignite Creation Date:
2025-12-24 @ 9:58 PM
Ignite Modification Date:
2026-01-05 @ 6:05 PM
Study NCT ID:
NCT03215732
Status:
COMPLETED
Last Update Posted:
2019-09-09
First Post:
2017-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B in the Rural Area of Niakhar, Senegal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019694', 'term': 'Hepatitis B, Chronic'}], 'ancestors': [{'id': 'D006509', 'term': 'Hepatitis B'}, {'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': 'D006521', 'term': 'Hepatitis, Chronic'}, {'id': 'D006505', 'term': 'Hepatitis'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 3119}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-09', 'completionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-09-06', 'studyFirstSubmitDate': '2017-07-10', 'studyFirstSubmitQcDate': '2017-07-11', 'lastUpdatePostDateStruct': {'date': '2019-09-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of chronic HBV infection', 'timeFrame': 'At baseline', 'description': 'HBs Ag positivity with a positive anti-HBc antibody and a negative anti-HBs antibody'}], 'secondaryOutcomes': [{'measure': "Prevalence of chronic HBV infection in age classes '0-15 years; 15-35 years, more than 35 years), and in women of childbearing age", 'timeFrame': 'At baseline', 'description': 'HBs Ag positivity'}, {'measure': 'HBV vaccine coverage (in children born after 2004, year of the introduction of the vaccine in the national program)', 'timeFrame': 'At baseline', 'description': 'HBs Ag negativity with a negative anti-HBc antibody and positive anti-HBs antibody'}, {'measure': 'HBV vaccine efficacy (in children born after 2004, year of the introduction of the vaccine in the national program)', 'timeFrame': 'At baseline', 'description': 'Titration of anti-HBs antibody \\> 10 UI/l among vaccinated participants'}, {'measure': 'Mortality associated with chronic HBV infection in the Niakhar area', 'timeFrame': '6 months', 'description': 'Rate of deaths in the area'}, {'measure': 'Morbidity associated with chronic HBV infection in the Niakhar area', 'timeFrame': '6 months', 'description': 'Rate of HBV-related hospitalizations/healthcare use in the area'}, {'measure': 'Quality of life and living conditions of HBV-infected individuals and of their households', 'timeFrame': '6 months', 'description': 'Comparison of quality of life scores and socio-economic characteristics between HBV-concerned and HBV not-concerned households'}, {'measure': 'HBV treatment needs in the Niakhar area and in the country', 'timeFrame': 'At baseline', 'description': 'Number of HBV-chronic individuals eligible to HBV treatment (according to WHO criteria) in the area, extrapolation to the needs in other areas of Senegal'}, {'measure': 'Number of quality-adjusted life years(QALYs) lost in the absence of HBV treatment', 'timeFrame': '6 months', 'description': 'Use of Markov simulation models'}, {'measure': 'Number of QALYs gained with different scenario of access to HBV treatment', 'timeFrame': '6 months', 'description': 'Use of Markov simulation models'}, {'measure': 'Total cost', 'timeFrame': '6 months', 'description': 'Use of Markov simulation models (with different scenarii of change in access to HBV treatment and amount of the financial contributions of populations, government and international programs)'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prevalence', 'vaccine coverage', 'risk factors', 'morbidity', 'mortality', 'quality of life', 'economic vulnerability', 'food security', 'treatment needs', 'decentralized care', 'health costs', 'caregivers training'], 'conditions': ['Chronic Hepatitis b']}, 'referencesModule': {'references': [{'pmid': '37143029', 'type': 'DERIVED', 'citation': 'Djaogol T, Perieres L, Marcellin F, Diouf A, Carrieri MP, Diallo A, Boyer S; ANRS 12356 AmBASS Study Group. Hepatitis B prevention and treatment needs in women in Senegal (ANRS 12356 AmBASS survey). BMC Public Health. 2023 May 5;23(1):825. doi: 10.1186/s12889-023-15710-y.'}, {'pmid': '31320358', 'type': 'DERIVED', 'citation': 'Coste M, De Seze M, Diallo A, Carrieri MP, Marcellin F, Boyer S; ANRS 12356 AmBASS Study Group. Burden and impacts of chronic hepatitis B infection in rural Senegal: study protocol of a cross-sectional survey in the area of Niakhar (AmBASS ANRS 12356). BMJ Open. 2019 Jul 17;9(7):e030211. doi: 10.1136/bmjopen-2019-030211.'}]}, 'descriptionModule': {'briefSummary': 'This study aims at estimating the prevalence of chronic hepatitis B virus (HBV) infection in rural Senegal (area of Niakhar) and at evaluating the associated burden in terms of both health-related and socio-economic consequences.', 'detailedDescription': "The prevalence of chronic HBV infection in Senegal is among the highest worldwide (10% to 17%) but available prevalence estimates relie on studies conducted in specific subgroups (such as military, pregnant women or blood donors).\n\nThe prevalence of HBV chronic infection remains undocumented in the general population of Senegal, and its health-related and socio-economic consequences need to be estimated.\n\nThis research is based on a cross-sectional survey conducted in the general population with collection of biological, socio-behavioral and economic data at two levels (at the participants' home and in healthcare centers) in the area of Niakhar (located at 135 kms at the East of Dakar).\n\nThe research includes three phases as follows:\n\n(i) Preliminary phase: information and communication about the research within the community, training of stakeholders and pilot survey\n\n(ii) Collection of data in the general population\n\n(iii) Communication of results on HBV status to participants and collection of additional data among HBV chronic individuals"}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '6 Months', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'The study population will include all individuals who live (even non-permanently) in the sampled households of the Niakhar area for at least 6 months, who are aged of at least 6 months, and who sign informed consent to participate in the survey.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n(i) Living in a household of the research zone (individuals living within participating households for at least 6 months, even non permanently: seasonal workers or individuals studying outside the Niakhar zone)\n\n(ii) Being aged of at least 6 months\n\n(iii) Giving informed consent to participate in the research\n\nExclusion Criteria:\n\n(i) Being an adult unable to sign informed consent\n\n(ii) Being a child whose parents or legal guardian is not present in the household at the time of the survey'}, 'identificationModule': {'nctId': 'NCT03215732', 'acronym': 'AMBASS', 'briefTitle': 'Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B in the Rural Area of Niakhar, Senegal', 'organization': {'class': 'OTHER_GOV', 'fullName': 'ANRS, Emerging Infectious Diseases'}, 'officialTitle': 'Cross Sectional Survey on the Burden and Impacts of Chronic Hepatitis B Virus Infection in the Rural Area of Niakhar, Senegal', 'orgStudyIdInfo': {'id': 'ANRS 12356 AMBASS'}}, 'armsInterventionsModule': {'interventions': [{'name': 'HBV testing with dried blood spots (DBS) technique', 'type': 'DIAGNOSTIC_TEST', 'description': 'Survey participants will be tested at home for chronic HBV infection using the DBS technique (collection of drops of whole blood dried onto filter paper).'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Niakhar', 'state': 'Fatick', 'country': 'Senegal', 'facility': 'At home', 'geoPoint': {'lat': 14.4817, 'lon': -16.39887}}], 'overallOfficials': [{'name': 'Sylvie BOYER, Dr', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Aix Marseille Univ, INSERM, IRD, SESSTIM, Sciences Economiques & Sociales de la Santé & Traitement de l'Information Médicale, Marseille, France"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ANRS, Emerging Infectious Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Institute of Research for Development, France', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}