Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers Pilot Study (SWIM)
This study has been completed.
Sponsor:
London School of Hygiene and Tropical Medicine
Collaborators:
University Teaching Hospital, Zambia
University of Zambia
Vestergaard Frandsen
Information provided by:
London School of Hygiene and Tropical Medicine
ClinicalTrials.gov Identifier:
NCT01116908
First received: May 4, 2010
Last updated: August 12, 2011
Last verified: August 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Diarrhea HIV Infection |
Device: LifeStraw Family |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Prevention |
| Official Title: | Safe Drinking Water For Households With Infants Born to HIV-Positive Mothers in Zambia: Piloting a Household Water Treatment Intervention |
Resource links provided by NLM:
Further study details as provided by London School of Hygiene and Tropical Medicine:
Primary Outcome Measures:
- Use of LifeStraw Family for children under 2 and all household members [ Time Frame: One year ] [ Designated as safety issue: No ]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:
- Microbiological performance of LifeStraw Family [ Time Frame: One year ] [ Designated as safety issue: No ]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 [ Time Frame: One year ] [ Designated as safety issue: No ]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
| Estimated Enrollment: | 120 |
| Study Start Date: | April 2010 |
| Study Completion Date: | August 2011 |
| Primary Completion Date: | August 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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
|
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.
Eligibility| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Criteria
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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01116908
Locations
| Zambia | |
| Ngwerere Health Clinic and Kasisi Health Clinic | |
| Lusaka, Chongwe District, Lusaka Province, Zambia | |
Sponsors and Collaborators
London School of Hygiene and Tropical Medicine
University Teaching Hospital, Zambia
University of Zambia
Vestergaard Frandsen
Investigators
| Principal Investigator: | Thomas Clasen, JD, PhD | London School of Hygiene and Tropical Medicine |
More Information
No publications provided by London School of Hygiene and Tropical Medicine
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Dr. Thomas Clasen, London School of Hygiene and Tropical Medicine |
| ClinicalTrials.gov Identifier: | NCT01116908 History of Changes |
| Other Study ID Numbers: | QA270 |
| Study First Received: | May 4, 2010 |
| Last Updated: | August 12, 2011 |
| Health Authority: | United Kingdom: Research Ethics Committee Zambia: Research Ethics Committee |
Keywords provided by London School of Hygiene and Tropical Medicine:
|
Diarrhea Water Household Water Treatment HIV Infant Health |
Additional relevant MeSH terms:
|
HIV Infections Acquired Immunodeficiency Syndrome Diarrhea HIV Seropositivity Lentivirus Infections Retroviridae Infections RNA Virus Infections Virus Diseases |
Sexually Transmitted Diseases, Viral Sexually Transmitted Diseases Immunologic Deficiency Syndromes Immune System Diseases Slow Virus Diseases Signs and Symptoms, Digestive Signs and Symptoms |
ClinicalTrials.gov processed this record on May 19, 2013