Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers Pilot Study (SWIM)

This study has been completed.
Sponsor:
Collaborators:
University Teaching Hospital, Zambia
University of Zambia
Vestergaard Frandsen
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01116908
First received: May 4, 2010
Last updated: August 12, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Diarrhea
HIV Infection
Device: LifeStraw Family

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention

Resource links provided by NLM:


Further study details as provided by London School of Hygiene and Tropical Medicine:

Primary Outcome Measures:
  • Use of LifeStraw Family for children under 2 and all household members [ Time Frame: One year ] [ Designated as safety issue: No ]
    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


Secondary Outcome Measures:
  • Microbiological performance of LifeStraw Family [ Time Frame: One year ] [ Designated as safety issue: No ]
    Microbiological performance of LifeStraw Family, measured in terms of thermotolerant coliforms (TTC), a well-established WHO indicator organism for faecal contamination

  • Impact of LifeStraw Family on longitudinal prevalence of diarrhea [ Time Frame: One year ] [ Designated as safety issue: No ]
    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


Estimated Enrollment: 120
Study Start Date: April 2010
Study Completion Date: August 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Control
Active Comparator: LifeStraw Family Device: LifeStraw Family
LifeStraw Family is a household water treatment technology that will be implemented in the household to improve drinking water quality

Detailed Description:

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.

  Eligibility

Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Known HIV-status based on clinical testing
  • Have a child between 6-12 months at the initiation of the study
  • Within the catchment area of Kasisi or Ngwerere health clinics, Chongwe district, Lusaka

Exclusion Criteria:

  • Lived in the catchment area less than one year or planning to move
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01116908

Locations
Zambia
Ngwerere Health Clinic and Kasisi Health Clinic
Lusaka, Chongwe District, Lusaka Province, Zambia
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University Teaching Hospital, Zambia
University of Zambia
Vestergaard Frandsen
Investigators
Principal Investigator: Thomas Clasen, JD, PhD London School of Hygiene and Tropical Medicine
  More Information

No publications provided by London School of Hygiene and Tropical Medicine

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr. Thomas Clasen, London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier: NCT01116908     History of Changes
Other Study ID Numbers: QA270
Study First Received: May 4, 2010
Last Updated: August 12, 2011
Health Authority: United Kingdom: Research Ethics Committee
Zambia: Research Ethics Committee

Keywords provided by London School of Hygiene and Tropical Medicine:
Diarrhea
Water
Household Water Treatment
HIV
Infant Health

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
HIV Seropositivity
Diarrhea
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases
Signs and Symptoms, Digestive
Signs and Symptoms

ClinicalTrials.gov processed this record on September 18, 2014