NCT01116908

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

May 4, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 5, 2010

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2011

Completed
Last Updated

August 15, 2011

Status Verified

August 1, 2011

Enrollment Period

1.3 years

First QC Date

May 4, 2010

Last Update Submit

August 12, 2011

Conditions

Keywords

DiarrheaWaterHousehold Water TreatmentHIVInfant Health

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Microbiological performance of LifeStraw Family

    One year

  • Impact of LifeStraw Family on longitudinal prevalence of diarrhea

    One year

Study Arms (2)

Control

NO INTERVENTION

LifeStraw Family

ACTIVE COMPARATOR
Device: LifeStraw Family

Interventions

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

LifeStraw Family

Eligibility Criteria

Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Lived in the catchment area less than one year or planning to move

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ngwerere Health Clinic and Kasisi Health Clinic

Lusaka, Chongwe District, Lusaka Province, Zambia

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

DiarrheaHIV Infections

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsBlood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Officials

  • Thomas Clasen, JD, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 4, 2010

First Posted

May 5, 2010

Study Start

April 1, 2010

Primary Completion

August 1, 2011

Study Completion

August 1, 2011

Last Updated

August 15, 2011

Record last verified: 2011-08

Locations