Trial of Safe Water Storage Among People Living With HIV
Primary Purpose
Diarrhea, Waterborne Disease, HIV
Status
Unknown status
Phase
Not Applicable
Locations
Zambia
Study Type
Interventional
Intervention
Safe storage device
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea focused on measuring environmental health, diarrhea, water, HIV
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Safe storage device
Control
Arm Description
This arm will be assigned a safe water storage device.
This arm of the trial will receive nothing until the end of the trial.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
Weight-for-age z-score
Weight-for-age z-scores will be taken for all children who are aged less than 48 months ("under 5s") at the start of the trial and monthly during the trial. These data are useful in tracking short-term wasting, associated with diarrheal disease events. Data will be assessed at 18 months (change from baseline).
E. coli and total coliforms in household drinking water
Microbiological indicators of fecal contamination of drinking water at the household level. Samples will be taken from all households monthly. Data will be assessed at 18 months (change from baseline).
Salivary antibody response
We will collect salivary samples from all consenting individuals (an additional consent form is required) to gather information on IgG and IgA response to specific diarrheal pathogens using a multiplex assay. This measure provides useful information on both outcomes of interest (diarrheal disease) and exposure to diarrheagenic pathogens. Samples will be taken at three time points: the beginning, midpoint, and end of the trial. Data will be assessed at 18 months (change from baseline).
Full Information
NCT ID
NCT01376336
First Posted
June 14, 2011
Last Updated
June 17, 2011
Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Zambia
1. Study Identification
Unique Protocol Identification Number
NCT01376336
Brief Title
Trial of Safe Water Storage Among People Living With HIV
Official Title
Randomized Controlled Trial of Safe Water Storage Among People Living With HIV
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Unknown status
Study Start Date
August 2011 (undefined)
Primary Completion Date
August 2013 (Anticipated)
Study Completion Date
August 2013 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
London School of Hygiene and Tropical Medicine
Collaborators
University of Zambia
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Specific Aim #1: To assess environmental health-related risk and outcomes in a low income peri-urban area of Zambia with a high percentage of people living with HIV/AIDS (PLWHA) (longitudinal observational cohort study and baseline) (Year 1). We will assemble a rich dataset on environmental health-related risk factors in a well defined population, with a focus on household drinking water quality and other water, sanitation, and hygiene (WSH) exposures.
Specific Aim #2: To quantify the WSH-related disease burden among PLWHA, compared with those without HIV/AIDS (individual and household level stratification) (conclusion of baseline). After nine months of data collection, we will perform an initial analysis to determine WSH-related risk by HIV status.
Specific Aim #3: To assess the impact of a water quality intervention on the longitudinal prevalence of Highly Credible Gastrointestinal Illness (HCGI) among PLWHA (randomized controlled trial, year 2). We will conduct a randomised, controlled trial of a safe water storage intervention. We will assess the health impacts of this intervention, with particular focus on the high-risk groups of PLWHA and children under 5 years of age.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea, Waterborne Disease, HIV
Keywords
environmental health, diarrhea, water, HIV
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1600 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Safe storage device
Arm Type
Experimental
Arm Description
This arm will be assigned a safe water storage device.
Arm Title
Control
Arm Type
No Intervention
Arm Description
This arm of the trial will receive nothing until the end of the trial.
Intervention Type
Device
Intervention Name(s)
Safe storage device
Intervention Description
This device is a specially designed water storage container that is intended to reduce the likelihood of re-contamination of household stored drinking water.
Primary Outcome Measure Information:
Title
Self-reported diarrheal disease
Description
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).
Time Frame
18 months
Secondary Outcome Measure Information:
Title
Weight-for-age z-score
Description
Weight-for-age z-scores will be taken for all children who are aged less than 48 months ("under 5s") at the start of the trial and monthly during the trial. These data are useful in tracking short-term wasting, associated with diarrheal disease events. Data will be assessed at 18 months (change from baseline).
Time Frame
18 months
Title
E. coli and total coliforms in household drinking water
Description
Microbiological indicators of fecal contamination of drinking water at the household level. Samples will be taken from all households monthly. Data will be assessed at 18 months (change from baseline).
Time Frame
18 months
Title
Salivary antibody response
Description
We will collect salivary samples from all consenting individuals (an additional consent form is required) to gather information on IgG and IgA response to specific diarrheal pathogens using a multiplex assay. This measure provides useful information on both outcomes of interest (diarrheal disease) and exposure to diarrheagenic pathogens. Samples will be taken at three time points: the beginning, midpoint, and end of the trial. Data will be assessed at 18 months (change from baseline).
Time Frame
18 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Joe Brown, PhD
Phone
+1 919 360 8752
Email
joe.brown@lshtm.ac.uk
First Name & Middle Initial & Last Name or Official Title & Degree
Paul Kelly, MD
Phone
+44 20 7882 2643
Email
m.p.kelly@qmul.ac.uk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joe Brown, PhD
Organizational Affiliation
London School of Hygiene and Tropical Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine
City
Lusaka
Country
Zambia
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul Kelly, MD
First Name & Middle Initial & Last Name & Degree
Michelo Simuyandi, MSc
12. IPD Sharing Statement
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Trial of Safe Water Storage Among People Living With HIV
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