Ignite Creation Date:
2025-12-25 @ 2:32 AM
Ignite Modification Date:
2026-01-01 @ 6:34 AM
Study NCT ID:
NCT04227834
Status:
UNKNOWN
Last Update Posted:
2020-01-14
First Post:
2020-01-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006373', 'term': 'Helminthiasis'}, {'id': 'D001196', 'term': 'Ascariasis'}, {'id': 'D014257', 'term': 'Trichuriasis'}, {'id': 'D006725', 'term': 'Hookworm Infections'}], 'ancestors': [{'id': 'D010272', 'term': 'Parasitic Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D017191', 'term': 'Ascaridida Infections'}, {'id': 'D017190', 'term': 'Secernentea Infections'}, {'id': 'D009349', 'term': 'Nematode Infections'}, {'id': 'D017189', 'term': 'Enoplida Infections'}, {'id': 'D017188', 'term': 'Adenophorea Infections'}, {'id': 'D017206', 'term': 'Strongylida Infections'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-03-01', 'size': 584698, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2020-01-09T09:40', 'hasProtocol': True}, {'date': '2019-03-01', 'size': 222666, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2020-01-10T00:54', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 432}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2019-03-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2020-03-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2020-01-10', 'studyFirstSubmitDate': '2020-01-04', 'studyFirstSubmitQcDate': '2020-01-10', 'lastUpdatePostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-01-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The effectiveness of repeated health hygiene education on the reinfection rates of STHs among school-aged children', 'timeFrame': '12 months', 'description': 'STH prevalence at 12 months'}], 'secondaryOutcomes': [{'measure': 'Prevalence of STHs among school-aged children prior to intervention', 'timeFrame': 'STH prevalence at month 0', 'description': 'Ascaris lumbricoides, Trichuris trichiura, hookworm infections at month 0'}, {'measure': 'Knowledge of STHs prevention measures among school-aged children before and after intervention', 'timeFrame': '12 months', 'description': 'A questionnaire used to evaluate the knowledge about STHs prevention'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Soil-transmitted helminth', 'School-aged children', 'Health hygiene', 'Education'], 'conditions': ['Helminthiasis', 'Ascaris Infection', 'Trichuris Infection', 'Hookworm Infections', 'Children, Only']}, 'descriptionModule': {'briefSummary': 'Soil-transmitted helminth (STH) infections caused by Ascaris lumbricoides, Trichuris trichiura, or hookworm, affect approximately 1.5 millions individuals primarily in tropical and subtropical regions. STHs infections have been associated with delay in growth and development in children. The prevalence in Indonesia varied from 45% to 65%, but in poor sanitation areas the prevalence can increased to 80%. World Health Organization currently recommends mass treatment with benzimidazoles and health hygiene education to control the disease. In this study we evaluated the effectiveness of single and four-monthly health hygiene education to STH reinfection rates among school-aged children in Mandailing Natal district, North Sumatera province, Indonesia.', 'detailedDescription': 'In this study we evaluate the prevalence of STH among school-aged children using Kato Katz examination prior to enrolment to the study. Two elementary schools in Mandailing Natal district, North Sumatera province, Indonesia have been selected and received either a single or repeated health hygiene education. Preliminary knowledge was also assessed using a questionnaire. Infected children received treatment of albendazole 400 mg for 3 days. Evaluation on reinfection status and STH knowledge is done at 4 month, 8 month and 12 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '15 Years', 'minimumAge': '6 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Children who are negative for STHs infection on Kato Katz examination following 3 days treatment of albendazole\n\nExclusion Criteria:\n\n* Parents who refused to participate in the study\n* Severe malnutrition\n* Co-infected with other helminth infections'}, 'identificationModule': {'nctId': 'NCT04227834', 'briefTitle': 'Soil-transmitted Helminth Reinfection Rates After Single and Repeated School Hygiene Education', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sumatera Utara'}, 'officialTitle': 'Re-infection Rates of Soil-transmitted Helminth Infections Among School-aged Children Following a Single or a 4-monthly Health Hygiene Education: an Open Label Clinical Trial', 'orgStudyIdInfo': {'id': 'STH032019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Single education', 'description': 'Single health hygiene education', 'interventionNames': ['Behavioral: Health hygiene education']}, {'type': 'EXPERIMENTAL', 'label': 'Repeated education', 'description': 'Four-monthly health hygiene education', 'interventionNames': ['Behavioral: Health hygiene education']}], 'interventions': [{'name': 'Health hygiene education', 'type': 'BEHAVIORAL', 'description': 'A cartoon video explaining the etiology, risk factors, clinical symptoms, treatment and prevention of helminthiasis were given to the school-aged children', 'armGroupLabels': ['Repeated education', 'Single education']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Panyabungan', 'state': 'North Sumatera', 'country': 'Indonesia', 'facility': 'Singkuang sub-district, Mandailing Natal district', 'geoPoint': {'lat': 1.93206, 'lon': 99.69113}}], 'overallOfficials': [{'name': 'Rizky KA Nasution, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitas Sumatera Utara'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Sumatera Utara', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Head of Tropical Medicine Master Programme', 'investigatorFullName': 'Inke Nadia Diniyanti Lubis', 'investigatorAffiliation': 'Universitas Sumatera Utara'}}}}