Trial of Low-cost Microbiological Water Test Kits

Diarrhea Clinical Trial

Official title:

Cluster Randomized Trial of Low-cost Microbiological Water Test Kits

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03021434
• Other study ID #: 11920/RR/5743
• Status: Completed
• Phase: N/A
• First received: January 12, 2017
• Last updated: June 28, 2017
• Start date: January 2017
• Est. completion date: May 25, 2017

Study information

• Verified date: January 2017
• Source: London School of Hygiene and Tropical Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 572
• Est. completion date: May 25, 2017
• Est. primary completion date: May 25, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria (for villages) :

• Village located within the Kanpur district, within

• Village population between 100 and 1000 households.

• No chlorinated water sources available in the village.

Inclusion Criteria (for households) :

• 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

Exclusion Criteria:

• Villages that receive chlorinated water from utility services

Related Conditions & MeSH terms

• Diarrhea
• E.Coli Infections
• Escherichia coli Infections

Intervention

Other:
• Community and household water safety education sessions
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 information
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 kits
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

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
London School of Hygiene and Tropical Medicine	Indian Institute of Technology Kanpur

References & Publications (19)

Bain 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. — View Citation

Brown 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. — View Citation

Burnard P. A method of analysing interview transcripts in qualitative research. Nurse Educ Today. 1991 Dec;11(6):461-6. — View Citation

Creswell, J.W. and V.L. Plano Clark, Designing and conducting mixed methods research. 2011, Los Angeles: SAGE Publications.

Davis 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. — View Citation

Duflo, 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.

Dufour AP, Strickland ER, Cabelli VJ. Membrane filter method for enumerating Escherichia coli. Appl Environ Microbiol. 1981 May;41(5):1152-8. — View Citation

Fleiss, J.L., Appendix: Sample-Size Determination, in The Design and Analysis of Clinical Experiments. 1999, John Wiley & Sons, Inc. p. 369-417.

Graneheim UH, Lundman B. Qualitative content analysis in nursing research: concepts, procedures and measures to achieve trustworthiness. Nurse Educ Today. 2004 Feb;24(2):105-12. Review. — View Citation

Haas, C.N., How to average microbial densities to characterize risk. Water Research, 1996. 30(4): p. 1036-1038.

Hamoudi 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. — View Citation

Hayes RJ, Bennett S. Simple sample size calculation for cluster-randomized trials. Int J Epidemiol. 1999 Apr;28(2):319-26. Review. — View Citation

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, Acácio 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. — View Citation

Lakshminarayanan 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. Review. — View Citation

Magro G, Bain RE, Woodall CA, Matthews RL, Gundry SW, Davis AP. Synthesis and application of resorufin ß-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. — View Citation

Million 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. — View Citation

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. — View Citation

Witte, K., Putting the fear back into fear appeals: The extended parallel process model. Communications Monographs, 1992. 59(4): p. 319-26.

Zhou H, Taber C, Arcona S, Li Y. Difference-in-Differences Method in Comparative Effectiveness Research: Utility with Unbalanced Groups. Appl Health Econ Health Policy. 2016 Aug;14(4):419-429. doi: 10.1007/s40258-016-0249-y. — View Citation

* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	1-2 month follow up visit post initial household information session
Secondary	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	1-2 month follow up visit post initial household information session
Secondary	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.	1-2 month follow up visit post initial household information session