Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-03-09 @ 6:58 AM
Study NCT ID:
NCT03972618
Status:
COMPLETED
Last Update Posted:
2019-06-03
First Post:
2019-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 698}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-05', 'completionDateStruct': {'date': '2019-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-05-31', 'studyFirstSubmitDate': '2019-05-31', 'studyFirstSubmitQcDate': '2019-05-31', 'lastUpdatePostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-06-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diarrhea', 'timeFrame': '2-weeks', 'description': 'self-report of diarrhea'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diarrhea']}, 'referencesModule': {'references': [{'pmid': '33397511', 'type': 'DERIVED', 'citation': 'Tintle N, Van De Griend K, Ulrich R, Wade RD, Baar TM, Boven E, Cooper CEA, Couch O, Eekhoff L, Fry B, Goszkowicz GK, Hecksel MA, Heynen A, Laughlin JA, Les SM, Lombard TR, Munson BD, Peterson JM, Schumann E, Settecerri DJ, Spry JE, Summerfield MJ, Sunder M, Wade DR, Zonnefeld CG, Brokus SA, Moen FS, Slater AD, Peterson JW, Pikaart MJ, Krueger BP, Best AA. Diarrhea prevalence in a randomized, controlled prospective trial of point-of-use water filters in homes and schools in the Dominican Republic. Trop Med Health. 2021 Jan 4;49(1):1. doi: 10.1186/s41182-020-00291-y.'}]}, 'descriptionModule': {'briefSummary': 'Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. The distribution of the water filters will begin in September 2018 to Child Hope schools in 4 different countries (Dominican Republic, Guatemala, Honduras, and Nicaragua). In order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms including schools, homes, simultaneous home/school and a control group', 'detailedDescription': 'Nathan Tintle, in conjunction with others at Dordt College including Dr. Kristin Van De Griend and undergraduate student research assistants, have agreed to collaborate with Hope College and Sawyer Products, Inc. to analyze the impact of different water filter deployment strategies in schools and villages on diarrhea and other medical and economic outcomes. The distribution of the water filters will begin in September 2018 to Child Hope schools in 4 different countries (Dominican Republic, Guatemala, Honduras, and Nicaragua). In order to evaluate efficacy of alternative filter deployment strategies, filters will be distributed in 4 separate treatment arms:\n\nArm 1: Simultaneous installation of filters in schools and the villages sending children to the school Arm 2: Initial installation of the water filters in a school, with later installation in the corresponding village Arm 3: Instillation of the water filters in villages, with later installation in the corresponding school Arm 4: Control arm. No filter installation initially but, ultimately, installation of filters in both the schools and villages.\n\nSelf-reported information on filter usage and health outcomes will be collected through surveys administered to parents (in the households in the villages), teachers (in the schools) and school administrators. Data collection will occur at baseline (when filters are installed), at 2 and 8 weeks post installation. The major goal of this project is to better understand the different health impacts of each different deployment strategy on child and family wellbeing. Better understanding of these filter installation strategies will help guide us as we make filter deployment decisions to provide access to clean drinking water.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Lives in selected villages and has children that attend the local school\n\nExclusion Criteria:\n\n* No children attending the local school'}, 'identificationModule': {'nctId': 'NCT03972618', 'briefTitle': 'Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic', 'organization': {'class': 'OTHER', 'fullName': 'Dordt University'}, 'officialTitle': 'Evaluation of the Efficacy of Sawyer Point One Filters in Schools and Homes in the Dominican Republic', 'orgStudyIdInfo': {'id': 'DR001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'School and village', 'description': 'Simultaneous installation of filters in schools and the village', 'interventionNames': ['Behavioral: Installation of water filtration system for filtering existing water source']}, {'type': 'EXPERIMENTAL', 'label': 'School only', 'description': 'Initial installation in school only', 'interventionNames': ['Behavioral: Installation of water filtration system for filtering existing water source']}, {'type': 'EXPERIMENTAL', 'label': 'Village only', 'description': 'Initial installation in village only', 'interventionNames': ['Behavioral: Installation of water filtration system for filtering existing water source']}, {'type': 'NO_INTERVENTION', 'label': 'Control', 'description': 'Control group. No filter installation initially.'}], 'interventions': [{'name': 'Installation of water filtration system for filtering existing water source', 'type': 'BEHAVIORAL', 'description': 'Installation of water filtration system and education on hand washing.', 'armGroupLabels': ['School and village', 'School only', 'Village only']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Santo Domingo', 'country': 'Dominican Republic', 'facility': 'Child Hope Network', 'geoPoint': {'lat': 18.47186, 'lon': -69.89232}}], 'overallOfficials': [{'name': 'Nathan Tintle, Ph.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Dordt College'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Available upon reasonable request'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Dordt University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}