DiarrheaNCT01376336
Trial of Safe Water Storage Among People Living With HIV
A study testing Safe storage device in people with Diarrhea and Waterborne Disease, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Waterborne Disease, HIV
- What is being tested?
- Safe storage device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,600 participants
- Where
- 1 siteZambia
- Study dates
- Aug 2011to Aug 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Zambia1 site
Tropical Gastroenterology and Nutrition Group (TROPGAN), University of Zambia School of Medicine
Lusaka
Paul Kelly, MD
Michelo Simuyandi, MSc
About this study
Official title: Randomized Controlled Trial of Safe Water Storage Among People Living With HIV
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.
Read the 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.
- Conditions
- Diarrhea, Waterborne Disease, HIV
- Being tested
- Safe storage device
- Keywords
- environmental health, diarrhea, water, HIV
- Medical subject headings
- Diarrhea, Waterborne Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Safe storage deviceDevice
This device is a specially designed water storage container that is intended to reduce the likelihood of re-contamination of household stored drinking water.
| Study group | Role | What they receive |
|---|---|---|
| Safe storage device | Experimental | This arm will be assigned a safe water storage device. Receives: Device: Safe storage device |
| Control | No intervention | This arm of the trial will receive nothing until the end of the trial. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 18 months
Secondary outcomes (3)
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).
Measured: 18 months
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).
Measured: 18 months
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).
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zambia
- Investigators
- Joe Brown, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01376336
- Sponsor's protocol ID
- QA308
- Status last verified
- Jun 2011
- First submitted
- 14 Jun 2011
- Last updated
- 20 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of Safe Water Storage Among People Living With HIV
- ClinicalTrials.gov ID
- NCT01376336
- Acronym / sponsor ID
- QA308
- Conditions
- Diarrhea, Waterborne Disease, HIV
- Keywords
- environmental health, diarrhea, water, HIV
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 1,600 participants (estimated)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- University of Zambia
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 20 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Safe storage device | Experimental | Device: Safe storage deviceThis arm will be assigned a safe water storage device. |
| Control | No intervention | –This arm of the trial will receive nothing until the end of the trial. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Safe storage deviceThis device is a specially designed water storage container that is intended to reduce the likelihood of re-contamination of household stored drinking water. | Device | Safe storage device |
Primary outcome
Self-reported diarrheal disease
Time frame: 18 months
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).
3 secondary outcomes
Weight-for-age z-score
Time frame: 18 months
E. coli and total coliforms in household drinking water
Time frame: 18 months
Salivary antibody response
Time frame: 18 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2011.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Joe Brown, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Safe storage device in people with Diarrhea and Waterborne Disease, run by London School of Hygiene and Tropical Medicine at 1 site in Zambia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Zambia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Joe Brown, PhD (+1 919 360 8752, joe.brown@lshtm.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Self-reported diarrheal disease (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2011.