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

HIV Infection Clinical Trial

— SWIM  

Official title:

Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01116908
• Other study ID #: QA270
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: August 12, 2011
• Start date: April 2010
• Est. completion date: August 2011

Study information

• Verified date: August 2011
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics CommitteeZambia: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention

Related Conditions & MeSH terms

• Diarrhea
• HIV Infection

Intervention

Device:
• LifeStraw Family
LifeStraw Family is a household water treatment technology that will be implemented in the household to improve drinking water quality

Locations

Country	Name	City	State
Zambia	Ngwerere Health Clinic and Kasisi Health Clinic	Lusaka	Chongwe District, Lusaka Province

Sponsors (4)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	University of Zambia, University Teaching Hospital, Lusaka, Zambia, Vestergaard Frandsen

Country where clinical trial is conducted

Zambia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	One year	No
Secondary	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	One year	No
Secondary	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	One year	No