Trial of Safe Water Storage Among People Living With HIV
Randomized Controlled Trial of Safe Water Storage Among People Living With HIV
1 other identifier
interventional
1,600
1 country
1
Brief Summary
Environmental health-related pathogens include faecal-oral, diarrhoeagenic microbes that may be transmitted via drinking water and are related to sanitation and hygiene. Previous research has suggested that safeguarding household drinking water against recontamination may be a critical intervention that can reduce risks of diarrheal diseases and may be especially important for people living with HIV/AIDS (PLWHA) and other vulnerable populations (Clasen et al. 2007). The investigators propose here a randomised, controlled trial of a household safe storage container for drinking water in a well defined, HIV-impacted population in peri-urban Lusaka, Zambia. After a baseline data collection period (9 months) half of all households (150 households) will be given a safe water storage container specifically designed to prevent recontamination of water in household use. All households will be followed for an additional 9 months. Results of this study will help determine whether this promising water quality intervention can reduce diarrhoea and related outcomes in this and similar vulnerable populations.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Aug 2011
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
June 14, 2011
CompletedFirst Posted
Study publicly available on registry
June 20, 2011
CompletedStudy Start
First participant enrolled
August 1, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
August 1, 2013
CompletedJune 20, 2011
June 1, 2011
2 years
June 14, 2011
June 17, 2011
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Self-reported diarrheal disease
Self-reported diarrheal disease information will be collected from each study participant monthly. These data will be collected monthly with 24 hour, 48 hour, and 7-day recall. Data will be assessed at 18 months (change from baseline).
18 months
Secondary Outcomes (3)
Weight-for-age z-score
18 months
E. coli and total coliforms in household drinking water
18 months
Salivary antibody response
18 months
Study Arms (2)
Safe storage device
EXPERIMENTALThis arm will be assigned a safe water storage device.
Control
NO INTERVENTIONThis arm of the trial will receive nothing until the end of the trial.
Interventions
This device is a specially designed water storage container that is intended to reduce the likelihood of re-contamination of household stored drinking water.
Eligibility Criteria
You may qualify if:
- Resident of Misisi compound, Lusaka
- Willing to participate in the study
- Is able to give informed consent and does so
- Household has one or more children who are aged 48 months or less at the start of the trial
- The household stores drinking water in the home
You may not qualify if:
- Not a resident of Misisi compound, Lusaka
- Unwilling to participate in the study
- Unable to give informed consent or chooses not to participate
- Household does not have one or more children aged 48 months or less at the start of the trial
- The household does not store drinking water in the home
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine
Lusaka, Zambia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Joe Brown, PhD
London School of Hygiene and Tropical Medicine
Central Study Contacts
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
June 14, 2011
First Posted
June 20, 2011
Study Start
August 1, 2011
Primary Completion
August 1, 2013
Study Completion
August 1, 2013
Last Updated
June 20, 2011
Record last verified: 2011-06