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

Primary Purpose

Diarrhea, HIV Infection

Status
Completed
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
LifeStraw Family
Sponsored by
London School of Hygiene and Tropical Medicine
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Diarrhea focused on measuring Diarrhea, Water, Household Water Treatment, HIV, Infant Health

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Ngwerere Health Clinic and Kasisi Health Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Active Comparator

Arm Label

Control

LifeStraw Family

Arm Description

Outcomes

Primary Outcome Measures

Use of LifeStraw Family for children under 2 and all household members
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
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
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

Full Information

First Posted
May 4, 2010
Last Updated
August 12, 2011
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University Teaching Hospital, Lusaka, Zambia, University of Zambia, Vestergaard Frandsen
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1. Study Identification

Unique Protocol Identification Number
NCT01116908
Brief Title
Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers Pilot Study
Acronym
SWIM
Official Title
Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
August 2011 (Actual)
Study Completion Date
August 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University Teaching Hospital, Lusaka, Zambia, University of Zambia, Vestergaard Frandsen

4. Oversight

Data Monitoring Committee
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, HIV Infection
Keywords
Diarrhea, Water, Household Water Treatment, HIV, Infant Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
No Intervention
Arm Title
LifeStraw Family
Arm Type
Active Comparator
Intervention Type
Device
Intervention Name(s)
LifeStraw Family
Intervention Description
LifeStraw Family is a household water treatment technology that will be implemented in the household to improve drinking water quality
Primary Outcome Measure Information:
Title
Use of LifeStraw Family for children under 2 and all household members
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
Time Frame
One year
Secondary Outcome Measure Information:
Title
Microbiological performance of LifeStraw Family
Description
Microbiological performance of LifeStraw Family, measured in terms of thermotolerant coliforms (TTC), a well-established WHO indicator organism for faecal contamination
Time Frame
One year
Title
Impact of LifeStraw Family on longitudinal prevalence of diarrhea
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
Time Frame
One year

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Clasen, JD, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ngwerere Health Clinic and Kasisi Health Clinic
City
Lusaka
State/Province
Chongwe District, Lusaka Province
Country
Zambia

12. IPD Sharing Statement

Citations:
PubMed Identifier
23082124
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.
Results Reference
derived

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

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