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

NCT ID: NCT01116908

Last Updated: 2011-08-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-04-30

Study Completion Date

2011-08-31

Brief Summary

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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

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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.

Conditions

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Diarrhea HIV Infection

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Control

Group Type NO_INTERVENTION

No interventions assigned to this group

LifeStraw Family

Group Type ACTIVE_COMPARATOR

LifeStraw Family

Intervention Type DEVICE

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

Interventions

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LifeStraw Family

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

Intervention Type DEVICE

Eligibility Criteria

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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
Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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University Teaching Hospital, Lusaka, Zambia

OTHER

Sponsor Role collaborator

University of Zambia

OTHER

Sponsor Role collaborator

Vestergaard Frandsen

OTHER

Sponsor Role collaborator

London School of Hygiene and Tropical Medicine

OTHER

Sponsor Role lead

Responsible Party

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London School of Hygiene and Tropical Medicine

Principal Investigators

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Thomas Clasen, JD, PhD

Role: PRINCIPAL_INVESTIGATOR

London School of Hygiene and Tropical Medicine

Locations

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Ngwerere Health Clinic and Kasisi Health Clinic

Lusaka, Chongwe District, Lusaka Province, Zambia

Site Status

Countries

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Zambia

References

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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.

Reference Type DERIVED
PMID: 23082124 (View on PubMed)

Other Identifiers

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QA270

Identifier Type: -

Identifier Source: org_study_id

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