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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01116908
Recruitment Status : Completed
First Posted : May 5, 2010
Last Update Posted : August 15, 2011
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Study Description
Brief Summary:
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 or disease Intervention/treatment
Diarrhea HIV Infection Device: LifeStraw Family

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.

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : April 2010
Primary Completion Date : August 2011
Study Completion Date : August 2011

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U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :
  1. Use of LifeStraw Family for children under 2 and all household members [ Time Frame: One year ]
    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 :
  1. Microbiological performance of LifeStraw Family [ Time Frame: One year ]
    Microbiological performance of LifeStraw Family, measured in terms of thermotolerant coliforms (TTC), a well-established WHO indicator organism for faecal contamination

  2. Impact of LifeStraw Family on longitudinal prevalence of diarrhea [ Time Frame: One year ]
    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

Eligibility Criteria

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01116908

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, Lusaka, Zambia
University of Zambia
Vestergaard Frandsen
Principal Investigator: Thomas Clasen, JD, PhD London School of Hygiene and Tropical Medicine
More Information

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
First Posted: May 5, 2010    Key Record Dates
Last Update Posted: August 15, 2011
Last Verified: August 2011

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

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