DiarrheaNCT03021434
Trial of Low-cost Microbiological Water Test Kits
A study testing Community and household water safety education sessions, Household-specific water quality information and Low-cost microbiological water test kits in people with Diarrhea and E.Coli Infections, run by London School of Hygiene and Tropical Medicine.
Trial summary
The present study is a cluster randomized control trial of low-cost microbiological water test kits in rural and peri-urban communities in the Kanpur region of Uttar Pradesh, India. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, E.Coli Infections
- What is being tested?
- Community and household water safety education sessions, Household-specific water quality information and Low-cost microbiological water test kits
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 572 participants
- Where
- No sites listed yet
- Study dates
- Jan 2017to 25 May 2017
- 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
- Village located within the Kanpur district, within
- Village population between 100 and 1000 households.
- No chlorinated water sources available in the village.
- Consent to participate in the study
- Contain at least one child who is between 29 days and 60 months of age at the time of enrollment
Who cannot join
- Villages that receive chlorinated water from utility services
About this study
Official title: Cluster Randomized Trial of Low-cost Microbiological Water Test Kits
The present study is a cluster randomized control trial of low-cost microbiological water test kits in rural and peri-urban communities in the Kanpur region of Uttar Pradesh, India.
Read the detailed description
The proposed trial utilizes a cluster randomized controlled methodology, with clustering occurring at the village level. The intervention that will be tested in this cluster randomized controlled trial is informed by the development of a simple, low-cost water quality test kit developed and piloted by J. Brown and colleagues in Nagpur, Maharashtra.
There will be two intervention arms and one control/comparison arm. In all selected villages, the study team will work with local government to conduct a village-level information session on water quality and key water safety behaviours. Informational material on water safety behaviours will be distrubted to all houseohlds following this information session. In the control group, households will be visited to provide water safety informational cards and collect a drinking water sample to be analyzed in the lab. They will not receive the results of the analysis until the conclusion of the study. Households in Intervention Arm 1 (Standard Testing) will have their water sampled and analyzed in the lab, and results of the analysis will be delivered to the households. They will receive informational cards describing water purification strategies. Households in Intervention Arm 2 (Test Kits) will be provided with the materials and training needed to perform water quality testing in their own household using the newly developed testing kits. They will also receive informational cards describing water purification strategies.
Following the initial village-level information session, the study team will randomly sample households for participation in the trial. Participating households will complete a short survey on household demographics and water handling, storage, and use behaviours and a water sample will be taken and tested in the lab for fecal indicator bacteria. At an unannounced follow-up visit, roughly 1 - 2 months after enrollment, households will complete a short survey about changes in water handling, storage, and use behaviours and a second sample of household stored drinking water will be collected for laboratory analysis. The effect of the cluster randomized controlled trial on water quality will be determined by comparing arithmetic mean E. coli count from samples of household water and changes in water safety behaviours between baseline and endline.
Microbiological drinking water quality will be assessed at two time points: baseline and endline. At each visit, a 330 ml sample of household water will be collected for analysis; we will ask participants to fill the sample container as if it were a drinking cup for a child living in the household. Samples will be kept cold (on ice in a cooler) until delivery to the laboratory and thereafter stored at 4oC until processing, to begin within 8 hours of the sampling event.
- Conditions
- Diarrhea, E.Coli Infections
- Being tested
- Community and household water safety education sessions, Household-specific water quality information, Low-cost microbiological water test kits
- Keywords
- Water Supply/standards, Water microbiology, India, Hand disinfection, Escherichia coli Infections/prevention & control, Hygiene, Health behavior, Drinking water, Informational intervention
- Medical subject headings
- Diarrhea, Escherichia coli Infections, Health Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Community and household water safety education sessionsOther
Data collectors will give a short community presentation on water treatment, as well as safe water handling and storage. Then, data collectors will immediately visit households and review this information. Data collectors will return within 72 hours and review this information once more.
Household-specific water quality informationOther
Household specific water quality data will be provided in two ways. In the Standard Testing Arm, water quality data will be analyzed in a laboratory by standard methods and results will be delivered to households. In the Test Kit arm, water quality data will be analyzed in households using provided water test kits.
Low-cost microbiological water test kitsOther
Intervention component consists of low-cost, biodegradable that tests for the presence of E. coli in water samples. The test uses Aquatest broth medium with resorufin methyl ester chromogen. Presence of E. coli (positive test) imparts bright red color, making it easy to use/interpret at the household level with minimal training
| Study group | Role | What they receive |
|---|---|---|
| Standard Testing | Experimental | Households will participate in community and household water safety education sessions, during which they will be given generalized information on water quality and safe water handling. A water sample from these households will be collected for laboratory analysis. Household-specific water quality information will be delivered to households within 72 hours, and households will be informed whether their drinking water was found to be contaminated. A study team member will review the information from the laboratory tests with the household and review information covered in the informational materials on safe water handling, storage, and use behaviours. Receives: Other: Community and household water safety education sessions; Other: Household-specific water quality information |
| Test Kits | Experimental | Households will participate in community and household water safety education sessions, during which they will be given generalized information on water quality and safe water handling. Data collectors will demonstrate the use of the low-cost microbiological water test kits and test household stored drinking water. A study team member will return to the household within 72 hours and review the household-specific water quality information from the initial test with household members. Households will be given 10 water test kits to use at their discretion over the 1-2 month follow up period. They will be appropriately trained in how to both perform the test and interpret the results. Households will also review information on safe water handling, storage, and use behaviours. Receives: Other: Community and household water safety education sessions; Other: Household-specific water quality information; Other: Low-cost microbiological water test kits |
| Comparison | Active comparator | Households will participate in community and household water safety education sessions, during which they will be given generalized information on water quality and safe water handling. A water sample from these households will be collected for laboratory analysis. Results from this analysis will be returned to the household at project endline. A study team member will return to the household within 72 hours to review the information on safe water handling, storage, and use behaviours. Receives: Other: Community and household water safety education sessions |
What is being measured
The primary outcome is the main question the study is designed to answer.
Arithmetic mean E. coli count from sample of stored household drinking water
A sample of household drinking water will be collected and analyzed in a standard laboratory using membrane filtration.
Measured: 1-2 month follow up visit post initial household information session
Secondary outcomes (2)
Water storage, handling, and use behaviors
Self-reported water treatment practices, verifiable water treatment practices, water handling and water storage practices in the home, and changes in primary water source. This outcome is measured using baseline and follow up survey questionnaires, as well as direct observation of handwashing station and water storage containers
Measured: 1-2 month follow up visit post initial household information session
Intervention uptake/use
For households participating in the Test Kit Arm, intervention update will be assessed visual inspection of the number of test kits remaining in the household at end line (to determine utilization) as well as targeted survey question on the ease of use and perceived utility of the test kits.
Measured: 1-2 month follow up visit post initial household information session
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2017 (estimated)
- Study startJan 2017
- Primary completion25 May 2017
- Study completion25 May 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (19)Papers the sponsor has linked to this study.
- 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
- 572 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Indian Institute of Technology Kanpur
- Responsible party
- Sponsor
- Investigators
- Robert Dreibelbis, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03021434
- Sponsor's protocol ID
- 11920/RR/5743
- Status last verified
- Jan 2017
- First submitted
- 12 Jan 2017
- Last updated
- 29 Jun 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque AS, Zaidi AK, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O'Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013 Jul 20;382(9888):209-22. doi: 10.1016/S0140-6736(13)60844-2. Epub 2013 May 14.
PubMed 23680352Million Death Study Collaborators; Bassani DG, Kumar R, Awasthi S, Morris SK, Paul VK, Shet A, Ram U, Gaffey MF, Black RE, Jha P. Causes of neonatal and child mortality in India: a nationally representative mortality survey. Lancet. 2010 Nov 27;376(9755):1853-60. doi: 10.1016/S0140-6736(10)61461-4. Epub 2010 Nov 12.
PubMed 21075444Lakshminarayanan S, Jayalakshmy R. Diarrheal diseases among children in India: Current scenario and future perspectives. J Nat Sci Biol Med. 2015 Jan-Jun;6(1):24-8. doi: 10.4103/0976-9668.149073.
PubMed 25810630Hamoudi A, Jeuland M, Lombardo S, Patil S, Pattanayak SK, Rai S. The effect of water quality testing on household behavior: evidence from an experiment in rural India. Am J Trop Med Hyg. 2012 Jul;87(1):18-22. doi: 10.4269/ajtmh.2012.12-0051.
PubMed 22764286Davis J, Pickering AJ, Rogers K, Mamuya S, Boehm AB. The effects of informational interventions on household water management, hygiene behaviors, stored drinking water quality, and hand contamination in peri-urban Tanzania. Am J Trop Med Hyg. 2011 Feb;84(2):184-91. doi: 10.4269/ajtmh.2011.10-0126.
PubMed 21292883Dufour AP, Strickland ER, Cabelli VJ. Membrane filter method for enumerating Escherichia coli. Appl Environ Microbiol. 1981 May;41(5):1152-8. doi: 10.1128/aem.41.5.1152-1158.1981.
PubMed 7020592Brown J, Stauber C, Murphy JL, Khan A, Mu T, Elliott M, Sobsey MD. Ambient-temperature incubation for the field detection of Escherichia coli in drinking water. J Appl Microbiol. 2011 Apr;110(4):915-23. doi: 10.1111/j.1365-2672.2011.04940.x.
PubMed 21214694Bain RE, Woodall C, Elliott J, Arnold BF, Tung R, Morley R, du Preez M, Bartram JK, Davis AP, Gundry SW, Pedley S. Evaluation of an Inexpensive Growth Medium for Direct Detection of Escherichia coli in Temperate and Sub-Tropical Waters. PLoS One. 2015 Oct 23;10(10):e0140997. doi: 10.1371/journal.pone.0140997. eCollection 2015.
PubMed 26495983Magro G, Bain RE, Woodall CA, Matthews RL, Gundry SW, Davis AP. Synthesis and application of resorufin beta-D-glucuronide, a low-cost chromogenic substrate for detecting Escherichia coli in drinking water. Environ Sci Technol. 2014 Aug 19;48(16):9624-31. doi: 10.1021/es502319n. Epub 2014 Jul 29.
PubMed 25035967Creswell, J.W. and V.L. Plano Clark, Designing and conducting mixed methods research. 2011, Los Angeles: SAGE Publications.
Haas, C.N., How to average microbial densities to characterize risk. Water Research, 1996. 30(4): p. 1036-1038.
Moher D, Schulz KF, Altman DG; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. J Am Podiatr Med Assoc. 2001 Sep;91(8):437-42. doi: 10.7547/87507315-91-8-437.
PubMed 11574648Witte, K., Putting the fear back into fear appeals: The extended parallel process model. Communications Monographs, 1992. 59(4): p. 319-26.
Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. doi: 10.1093/ije/28.2.319.
PubMed 10342698Duflo, E., R. Glennerster, and M. Kremer, Using Randomization in Development Economics Research: A Toolkit, in T. Schultz and John Strauss, eds., Handbook of Development Economics. 2008, North Holland: Amsterdam and New York.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cluster Randomized Trial of Low-cost Microbiological Water Test Kits
- ClinicalTrials.gov ID
- NCT03021434
- Acronym / sponsor ID
- 11920/RR/5743
- Conditions
- Diarrhea, E.Coli Infections
- Keywords
- Water Supply/standards, Water microbiology, India, Hand disinfection, Escherichia coli Infections/prevention & control, Hygiene, Health behavior, Drinking water
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 572 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Indian Institute of Technology Kanpur
- Study start
- Jan 2017 (actual)
- Primary completion
- 25 May 2017 (actual)
- Study completion
- 25 May 2017 (actual)
- First posted
- 16 Jan 2017 (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.
The present study is a cluster randomized control trial of low-cost microbiological water test kits in rural and peri-urban communities in the Kanpur region of Uttar Pradesh, India.
Detailed description
The proposed trial utilizes a cluster randomized controlled methodology, with clustering occurring at the village level. The intervention that will be tested in this cluster randomized controlled trial is informed by the development of a simple, low-cost water quality test kit developed and piloted by J. Brown and colleagues in Nagpur, Maharashtra.
There will be two intervention arms and one control/comparison arm. In all selected villages, the study team will work with local government to conduct a village-level information session on water quality and key water safety behaviours. Informational material on water safety behaviours will be distrubted to all houseohlds following this information session. In the control group, households will be visited to provide water safety informational cards and collect a drinking water sample to be analyzed in the lab. They will not receive the results of the analysis until the conclusion of the study. Households in Intervention Arm 1 (Standard Testing) will have their water sampled and analyzed in the lab, and results of the analysis will be delivered to the households. They will receive informational cards describing water purification strategies. Households in Intervention Arm 2 (Test Kits) will be provided with the materials and training needed to perform water quality testing in their own household using the newly developed testing kits. They will also receive informational cards describing water purification strategies.
Following the initial village-level information session, the study team will randomly sample households for participation in the trial. Participating households will complete a short survey on household demographics and water handling, storage, and use behaviours and a water sample will be taken and tested in the lab for fecal indicator bacteria. At an unannounced follow-up visit, roughly 1 - 2 months after enrollment, households will complete a short survey about changes in water handling, storage, and use behaviours and a second sample of household stored drinking water will be collected for laboratory analysis. The effect of the cluster randomized controlled trial on water quality will be determined by comparing arithmetic mean E. coli count from samples of household water and changes in water safety behaviours between baseline and endline.
Microbiological drinking water quality will be assessed at two time points: baseline and endline. At each visit, a 330 ml sample of household water will be collected for analysis; we will ask participants to fill the sample container as if it were a drinking cup for a child living in the household. Samples will be kept cold (on ice in a cooler) until delivery to the laboratory and thereafter stored at 4oC until processing, to begin within 8 hours of the sampling event.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard Testing | Experimental | Other: Community and household water safety education sessions, Other: Household-specific water quality informationHouseholds will participate in community and household water safety education sessions, during which they will be given generalized information on water quality and safe water handling. A water sample from these households will be collected for laboratory analysis. Household-specific water quality information will be delivered to households within 72 hours, and households will be informed whether their drinking water was found to be contaminated. A study team member will review the information from the laboratory tests with the household and review information covered in the informational materials on safe water handling, storage, and use behaviours. |
| Test Kits | Experimental | Other: Community and household water safety education sessions, Other: Household-specific water quality information, Other: Low-cost microbiological water test kitsHouseholds will participate in community and household water safety education sessions, during which they will be given generalized information on water quality and safe water handling. Data collectors will demonstrate the use of the low-cost microbiological water test kits and test household stored drinking water. A study team member will return to the household within 72 hours and review the household-specific water quality information from the initial test with household members. Households will be given 10 water test kits to use at their discretion over the 1-2 month follow up period. They will be appropriately trained in how to both perform the test and interpret the results. Households will also review information on safe water handling, storage, and use behaviours. |
| Comparison | Active comparator | Other: Community and household water safety education sessionsHouseholds will participate in community and household water safety education sessions, during which they will be given generalized information on water quality and safe water handling. A water sample from these households will be collected for laboratory analysis. Results from this analysis will be returned to the household at project endline. A study team member will return to the household within 72 hours to review the information on safe water handling, storage, and use behaviours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Village located within the Kanpur district, within
- Village population between 100 and 1000 households.
- No chlorinated water sources available in the village.
- Consent to participate in the study
- Contain at least one child who is between 29 days and 60 months of age at the time of enrollment
Key exclusion criteria (1 listed)
- Villages that receive chlorinated water from utility services
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 |
|---|---|---|
| Community and household water safety education sessionsData collectors will give a short community presentation on water treatment, as well as safe water handling and storage. Then, data collectors will immediately visit households and review this information. Data collectors will return within 72 hours and review this information once more. | Other | Comparison, Standard Testing, Test Kits |
| Household-specific water quality informationHousehold specific water quality data will be provided in two ways. In the Standard Testing Arm, water quality data will be analyzed in a laboratory by standard methods and results will be delivered to households. In the Test Kit arm, water quality data will be analyzed in households using provided water test kits. | Other | Standard Testing, Test Kits |
| Low-cost microbiological water test kitsIntervention component consists of low-cost, biodegradable that tests for the presence of E. coli in water samples. The test uses Aquatest broth medium with resorufin methyl ester chromogen. Presence of E. coli (positive test) imparts bright red color, making it easy to use/interpret at the household level with minimal training | Other | Test Kits |
Primary outcome
Arithmetic mean E. coli count from sample of stored household drinking water
Time frame: 1-2 month follow up visit post initial household information session
A sample of household drinking water will be collected and analyzed in a standard laboratory using membrane filtration.
2 secondary outcomes
Water storage, handling, and use behaviors
Time frame: 1-2 month follow up visit post initial household information session
Intervention uptake/use
Time frame: 1-2 month follow up visit post initial household information session
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2017.
- Background: PubMed 23680352Kotloff KL, Nataro JP, Blackwelder WC, Nasrin D, Farag TH, Panchalingam S, Wu Y, Sow SO, Sur D, Breiman RF, Faruque AS, Zaidi AK, Saha D, Alonso PL, Tamboura B, Sanogo D, Onwuchekwa U, Manna B, Ramamurthy T, Kanungo S, Ochieng JB, Omore R, Oundo JO, Hossain A, Das SK, Ahmed S, Qureshi S, Quadri F, Adegbola RA, Antonio M, Hossain MJ, Akinsola A, Mandomando I, Nhampossa T, Acacio S, Biswas K, O'Reilly CE, Mintz ED, Berkeley LY, Muhsen K, Sommerfelt H, Robins-Browne RM, Levine MM. Burden and aetiology of diarrhoeal disease in infants and young children in developing countries (the Global Enteric Multicenter Study, GEMS): a prospective, case-control study. Lancet. 2013 Jul 20;382(9888):209-22. doi: 10.1016/S0140-6736(13)60844-2. Epub 2013 May 14.
- Background: PubMed 21075444Million Death Study Collaborators; Bassani DG, Kumar R, Awasthi S, Morris SK, Paul VK, Shet A, Ram U, Gaffey MF, Black RE, Jha P. Causes of neonatal and child mortality in India: a nationally representative mortality survey. Lancet. 2010 Nov 27;376(9755):1853-60. doi: 10.1016/S0140-6736(10)61461-4. Epub 2010 Nov 12.
- Background: PubMed 25810630Lakshminarayanan S, Jayalakshmy R. Diarrheal diseases among children in India: Current scenario and future perspectives. J Nat Sci Biol Med. 2015 Jan-Jun;6(1):24-8. doi: 10.4103/0976-9668.149073.
- Background: PubMed 22764286Hamoudi A, Jeuland M, Lombardo S, Patil S, Pattanayak SK, Rai S. The effect of water quality testing on household behavior: evidence from an experiment in rural India. Am J Trop Med Hyg. 2012 Jul;87(1):18-22. doi: 10.4269/ajtmh.2012.12-0051.
- Background: PubMed 21292883Davis J, Pickering AJ, Rogers K, Mamuya S, Boehm AB. The effects of informational interventions on household water management, hygiene behaviors, stored drinking water quality, and hand contamination in peri-urban Tanzania. Am J Trop Med Hyg. 2011 Feb;84(2):184-91. doi: 10.4269/ajtmh.2011.10-0126.
- Background: PubMed 7020592Dufour AP, Strickland ER, Cabelli VJ. Membrane filter method for enumerating Escherichia coli. Appl Environ Microbiol. 1981 May;41(5):1152-8. doi: 10.1128/aem.41.5.1152-1158.1981.
- Background: PubMed 21214694Brown J, Stauber C, Murphy JL, Khan A, Mu T, Elliott M, Sobsey MD. Ambient-temperature incubation for the field detection of Escherichia coli in drinking water. J Appl Microbiol. 2011 Apr;110(4):915-23. doi: 10.1111/j.1365-2672.2011.04940.x.
- Background: PubMed 26495983Bain RE, Woodall C, Elliott J, Arnold BF, Tung R, Morley R, du Preez M, Bartram JK, Davis AP, Gundry SW, Pedley S. Evaluation of an Inexpensive Growth Medium for Direct Detection of Escherichia coli in Temperate and Sub-Tropical Waters. PLoS One. 2015 Oct 23;10(10):e0140997. doi: 10.1371/journal.pone.0140997. eCollection 2015.
- Background: PubMed 25035967Magro G, Bain RE, Woodall CA, Matthews RL, Gundry SW, Davis AP. Synthesis and application of resorufin beta-D-glucuronide, a low-cost chromogenic substrate for detecting Escherichia coli in drinking water. Environ Sci Technol. 2014 Aug 19;48(16):9624-31. doi: 10.1021/es502319n. Epub 2014 Jul 29.
- BackgroundCreswell, J.W. and V.L. Plano Clark, Designing and conducting mixed methods research. 2011, Los Angeles: SAGE Publications.
- BackgroundHaas, C.N., How to average microbial densities to characterize risk. Water Research, 1996. 30(4): p. 1036-1038.
- Background: PubMed 11574648Moher D, Schulz KF, Altman DG; CONSORT Group (Consolidated Standards of Reporting Trials). The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. J Am Podiatr Med Assoc. 2001 Sep;91(8):437-42. doi: 10.7547/87507315-91-8-437.
- Individual participant dataSharing planned: No
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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.
Robert Dreibelbis, PhD principal investigator
London School of Hygiene and Tropical Medicine
Questions about this trial
What is this clinical trial studying?
A study testing Community and household water safety education sessions, Household-specific water quality information and Low-cost microbiological water test kits in people with Diarrhea and E.Coli Infections, run by London School of Hygiene and Tropical Medicine.
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 1 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: finished, as of the sponsor's last update on 29 Jun 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Arithmetic mean E. coli count from sample of stored household drinking water (time frame: 1-2 month follow up visit post initial household information session). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03021434, which also lists 19 linked publications.
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 29 Jun 2017.