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

Not Applicable

Completed

• Conditions: Diarrhea; HIV Infection
• Interventions: Device: LifeStraw Family

• Registration Number: NCT01116908
• Lead Sponsor: London School of Hygiene and Tropical Medicine

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.

Study Timeline

• Study Start: 2010-04
• Study First Submitted: 2010-05-04
• Study First Submitted QC: 2010-05-04
• Study First Posted: 2010-05-05
• Status Verified: 2011-08
• Primary Completion: 2011-08
• Study Completion: 2011-08
• Last Update Submitted: 2011-08-12
• Last Update Posted: 2011-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
LifeStraw Family	LifeStraw Family	-

Primary Outcome Measures

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

Name	Time	Method
Microbiological performance of LifeStraw Family	One year	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	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

Trial Locations

Locations (1)

Ngwerere Health Clinic and Kasisi Health Clinic; 🇿🇲 Lusaka, Chongwe District, Lusaka Province, Zambia