Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT03186768
Status:
COMPLETED
Last Update Posted:
2018-05-17
First Post:
2017-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Soap on a Rope Trial
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'], 'maskingDescription': 'School group (intervention or control) will be blinded for data analysis.'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'School-randomized controlled trial'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2017-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-14', 'studyFirstSubmitDate': '2017-05-18', 'studyFirstSubmitQcDate': '2017-06-13', 'lastUpdatePostDateStruct': {'date': '2018-05-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-09-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in hand washing behavior', 'timeFrame': 'Handwashing behavior will be monitored at three time points: baseline, 3 weeks following the intervention, and 8 weeks following the intervention.', 'description': 'Students exiting the latrine will be monitored to determine if they wash their hands using soap and water.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hand Disinfection']}, 'descriptionModule': {'briefSummary': 'The soap on a rope behavioral trial is a school-randomized trial to determine if a disruptive cue (the soap on a rope hall pass) can influence hand washing behavior for students in Namwala District, Zambia.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Students in study schools who use the latrine on the day of observation\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT03186768', 'briefTitle': 'Soap on a Rope Trial', 'organization': {'class': 'OTHER', 'fullName': 'Syracuse University'}, 'officialTitle': 'Evaluation of Soap on a Rope Hall Pass Behavior Intervention: a School-randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'SoapRopetrial'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Intervention arm', 'description': 'Intervention arm receives a training of trainers on the soap on a rope hall pass intervention.', 'interventionNames': ['Behavioral: Soap on a rope hall pass intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control arm', 'description': 'Control arm delays the training of trainers on the soap on a rope hall pass intervention until endline hand washing data has been collected.'}], 'interventions': [{'name': 'Soap on a rope hall pass intervention', 'type': 'BEHAVIORAL', 'description': 'School health and nutrition coordinators will be trained on how to make and utilize the soap on a rope hall pass to improve hand washing behavior in schools.', 'armGroupLabels': ['Intervention arm']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Namwala', 'country': 'Zambia', 'facility': 'Namwala District', 'geoPoint': {'lat': -15.75042, 'lon': 26.43839}}], 'overallOfficials': [{'name': 'David A Larsen, PhD, MPH', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Syracuse University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'De-identified data will be shared upon reasonable request. Email Dr. David Larsen at dalarsen@syr.edu.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Syracuse University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'David Larsen', 'investigatorAffiliation': 'Syracuse University'}}}}