Ignite Creation Date:
2025-12-24 @ 11:55 PM
Ignite Modification Date:
2026-02-26 @ 12:04 PM
Study NCT ID:
NCT02968251
Status:
UNKNOWN
Last Update Posted:
2017-05-09
First Post:
2016-10-11
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Designing and Evaluating a School-based Hand Washing Program in Malawi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 360}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-10', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-05-08', 'studyFirstSubmitDate': '2016-10-11', 'studyFirstSubmitQcDate': '2016-11-17', 'lastUpdatePostDateStruct': {'date': '2017-05-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-18', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proper hand washing', 'timeFrame': '9 month', 'description': 'This will be achieved by giving a score to the amount of fluorescents stain on the hand.'}], 'secondaryOutcomes': [{'measure': 'Knowledge gain', 'timeFrame': '9 month', 'description': 'A quiz will be administered to assess knowledge of school children.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['School-based, Hand-washing, Program, Malawi']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to design and evaluate a school-based hand washing program for children in Malawi, Sub-Saharan Africa, using a cluster randomized controlled trial (CRCT), so as to improve proper hand washing, increase knowledge level and also reduce school absenteeism.', 'detailedDescription': 'A cluster randomized controlled trial (CRCT) design with pre-, mid- and post-interventions and follow-up measures will be randomized into intervention or control groups. A simplified 5-steps hand washing program will be implemented in the intervention group while the control group will continue with their usual practice where schoolchildren do not follow any standard recommended handwashing technique.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '5 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schools that have piped tap water source situated in Mzuzu City,\n* Private primary schools,\n* Children in elementary one and six,\n* Written parental consent allowing their child to participate in the study.\n\nExclusion Criteria:\n\n* Schools without piped tap water source,\n* Government primary schools,\n* Children whose parents will not give consent.'}, 'identificationModule': {'nctId': 'NCT02968251', 'briefTitle': 'Designing and Evaluating a School-based Hand Washing Program in Malawi', 'organization': {'class': 'OTHER', 'fullName': 'The Hong Kong Polytechnic University'}, 'officialTitle': 'Designing and Evaluating a School-based Hand Washing Program in Malawi', 'orgStudyIdInfo': {'id': 'HSEARS20160619001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Hand Washing Program (HWP)', 'description': 'Clusters in this arm will be given a Hand Washing Program (HWP) which will consist of: integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week.', 'interventionNames': ['Behavioral: Hand Washing Program (HWP)']}, {'type': 'NO_INTERVENTION', 'label': 'No Hand Washing Program (NHWP)', 'description': 'Clusters in this arm will be allowed to continue with their usual practice regarding hand washing/hygiene'}], 'interventions': [{'name': 'Hand Washing Program (HWP)', 'type': 'BEHAVIORAL', 'description': 'HWP consists of integrating hand washing practice in the school health policy, setting up proper hand washing facilities in the intervention schools, training to school teachers, delivering of health talk to schoolchildren and their parents, developing reminders and posters of a simplified 5-step hand washing technique, peer briefing session, take home package (5-steps hand washing, commitment letter, poster, leaflet). The program will be delivered once every week.', 'armGroupLabels': ['Hand Washing Program (HWP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00000', 'city': 'Mzuzu', 'state': 'Northern Region', 'status': 'RECRUITING', 'country': 'Malawi', 'contacts': [{'name': 'Balwani M Chingatichifwe, MPH', 'role': 'CONTACT', 'email': 'balwani-mbakaya.chingatichifwe@connect.polyu.hk', 'phone': '(265) 888 159 286'}, {'name': 'Regina Lee, PhD', 'role': 'CONTACT', 'email': 'regina.Lee@polyu.edu.hk', 'phone': '(852) 2766 6388'}], 'facility': "St John's College of Nursing and Midwifery", 'geoPoint': {'lat': -11.46556, 'lon': 34.02071}}], 'centralContacts': [{'name': 'Balwani M Chingatichifwe, MPH', 'role': 'CONTACT', 'email': 'balwani-mbakaya.chingatichifwe@connect.polyu.hk', 'phone': '+265 888 159 286'}, {'name': 'Regina Lee, PhD', 'role': 'CONTACT', 'email': 'regina.Lee@polyu.edu.hk', 'phone': '(852) 2766 6388'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hong Kong Polytechnic University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}