Ignite Creation Date:
2025-12-26 @ 10:57 AM
Ignite Modification Date:
2025-12-26 @ 10:57 AM
Study NCT ID:
NCT01116908
Status:
COMPLETED
Last Update Posted:
2011-08-15
First Post:
2010-05-04
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers Pilot Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003967', 'term': 'Diarrhea'}, {'id': 'D015658', 'term': 'HIV Infections'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000086982', 'term': 'Blood-Borne Infections'}, {'id': 'D003141', 'term': 'Communicable Diseases'}, {'id': 'D007239', 'term': 'Infections'}, {'id': 'D015229', 'term': 'Sexually Transmitted Diseases, Viral'}, {'id': 'D012749', 'term': 'Sexually Transmitted Diseases'}, {'id': 'D016180', 'term': 'Lentivirus Infections'}, {'id': 'D012192', 'term': 'Retroviridae Infections'}, {'id': 'D012327', 'term': 'RNA Virus Infections'}, {'id': 'D014777', 'term': 'Virus Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D007153', 'term': 'Immunologic Deficiency Syndromes'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-08', 'completionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-08-12', 'studyFirstSubmitDate': '2010-05-04', 'studyFirstSubmitQcDate': '2010-05-04', 'lastUpdatePostDateStruct': {'date': '2011-08-15', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-05-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Use of LifeStraw Family for children under 2 and all household members', 'timeFrame': 'One year', 'description': 'Use, acceptability, and longevity of LifeStraw Family will be assessed for replacement and complementary feeds for children under 2 and for drinking water for all members of the household'}], 'secondaryOutcomes': [{'measure': 'Microbiological performance of LifeStraw Family', 'timeFrame': 'One year', 'description': 'Microbiological performance of LifeStraw Family, measured in terms of thermotolerant coliforms (TTC), a well-established WHO indicator organism for faecal contamination'}, {'measure': 'Impact of LifeStraw Family on longitudinal prevalence of diarrhea', 'timeFrame': 'One year', 'description': 'Impact of the intervention on longitudinal prevalence of diarrhoea among infants under 2 years and all household members, measured both as reported by the primary caretaker of the child and by their weight-for-age z-score (WAZ) as a proxy for diarrhoea'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diarrhea', 'Water', 'Household Water Treatment', 'HIV', 'Infant Health'], 'conditions': ['Diarrhea', 'HIV Infection']}, 'referencesModule': {'references': [{'pmid': '23082124', 'type': 'DERIVED', 'citation': 'Peletz R, Simunyama M, Sarenje K, Baisley K, Filteau S, Kelly P, Clasen T. Assessing water filtration and safe storage in households with young children of HIV-positive mothers: a randomized, controlled trial in Zambia. PLoS One. 2012;7(10):e46548. doi: 10.1371/journal.pone.0046548. Epub 2012 Oct 17.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess whether children under 2 years and other members of households in which HIV-positive mothers are providing replacement and complementary feeding would potentially benefit from the use of a filter designed to eliminate microbial pathogens from drinking water at the household level.', 'detailedDescription': 'Contaminated drinking water is a leading cause of morbidity and mortality in low-income settings. Safe drinking water is of particular concern for HIV-positive mothers since many HIV-infected Zambian women choose replacement feeding and early cessation of breastfeeding of infants to minimize the risk of transmission of the virus. This study builds upon preliminary baseline research which determined that HIV-positive mothers would potentially benefit from an intervention that encourages HIV-positive mothers to treat their water at the household level.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Known HIV-status based on clinical testing\n* Have a child between 6-12 months at the initiation of the study\n* Within the catchment area of Kasisi or Ngwerere health clinics, Chongwe district, Lusaka\n\nExclusion Criteria:\n\n* Lived in the catchment area less than one year or planning to move'}, 'identificationModule': {'nctId': 'NCT01116908', 'acronym': 'SWIM', 'briefTitle': 'Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers Pilot Study', 'organization': {'class': 'OTHER', 'fullName': 'London School of Hygiene and Tropical Medicine'}, 'officialTitle': 'Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention', 'orgStudyIdInfo': {'id': 'QA270'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'LifeStraw Family', 'interventionNames': ['Device: LifeStraw Family']}], 'interventions': [{'name': 'LifeStraw Family', 'type': 'DEVICE', 'description': 'LifeStraw Family is a household water treatment technology that will be implemented in the household to improve drinking water quality', 'armGroupLabels': ['LifeStraw Family']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lusaka', 'state': 'Chongwe District, Lusaka Province', 'country': 'Zambia', 'facility': 'Ngwerere Health Clinic and Kasisi Health Clinic', 'geoPoint': {'lat': -15.40669, 'lon': 28.28713}}], 'overallOfficials': [{'name': 'Thomas Clasen, JD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'London School of Hygiene and Tropical Medicine'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'London School of Hygiene and Tropical Medicine', 'class': 'OTHER'}, 'collaborators': [{'name': 'University Teaching Hospital, Lusaka, Zambia', 'class': 'OTHER'}, {'name': 'University of Zambia', 'class': 'OTHER'}, {'name': 'Vestergaard Frandsen', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Thomas Clasen', 'oldOrganization': 'London School of Hygiene and Tropical Medicine'}}}}