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

August 12, 2011 updated by: London School of Hygiene and Tropical Medicine

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

120

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zambia
    • Chongwe District, Lusaka Province
      • Lusaka, Chongwe District, Lusaka Province, Zambia
        • Ngwerere Health Clinic and Kasisi Health Clinic

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
One year
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
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

London School of Hygiene and Tropical Medicine

Collaborators

University of Zambia
University Teaching Hospital, Lusaka, Zambia
Vestergaard Frandsen

Investigators

  • Principal Investigator: Thomas Clasen, JD, PhD, London School of Hygiene and Tropical Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

August 1, 2011

Study Registration Dates

First Submitted

May 4, 2010

First Submitted That Met QC Criteria

May 4, 2010

First Posted (Estimate)

May 5, 2010

Study Record Updates

Last Update Posted (Estimate)

August 15, 2011

Last Update Submitted That Met QC Criteria

August 12, 2011

Last Verified

August 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • QA270

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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