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

May 4, 2010
August 12, 2011
April 2010
August 2011   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01116908 on ClinicalTrials.gov Archive Site
  • 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
Same as current
Not Provided
Not Provided
 
Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers Pilot Study
Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention

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.

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
  • Diarrhea
  • HIV Infection
Device: LifeStraw Family
LifeStraw Family is a household water treatment technology that will be implemented in the household to improve drinking water quality
  • No Intervention: Control
  • Active Comparator: LifeStraw Family
    Intervention: Device: LifeStraw Family
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
120
August 2011
August 2011   (final data collection date for primary outcome measure)

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
Female
Not Provided
No
Contact information is only displayed when the study is recruiting subjects
Zambia
 
NCT01116908
QA270
No
Dr. Thomas Clasen, London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
  • University Teaching Hospital, Zambia
  • University of Zambia
  • Vestergaard Frandsen
Principal Investigator: Thomas Clasen, JD, PhD London School of Hygiene and Tropical Medicine
London School of Hygiene and Tropical Medicine
August 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP