Please find below the description of a large grant by the Bill & Melinda Gates Foundation which I am leading here at the University of California, Berkeley, USA. If you have questions or comments, please put them into this thread.

Title of grant: Measuring the benefits of water quality, sanitation, handwashing and nutritional interventions for improving health and child development (WASH Benefits)

• Subtitle: The WASH Benefits Study: Cluster-randomised controlled trials of individual and combined water, sanitation, hygiene and nutritional interventions in rural Bangladesh and Kenya
• Name of lead organization: University of California, Berkeley
• Primary contact at lead organization: John M. Colford, Jr. MD PhD, Professor of Epidemiology, School of Public Health
• Grantee location: Berkeley, CA, USA
• Developing country where the research is being tested: Bangladesh (selected rural districts north of Dhaka), Kenya (rural parts of Bungoma, Kakamega, and Vihiga counties in Western Province)
• Start and end date: September 2009, March 2017 (possible extension to Sep 2017)
• Grant type: Other
• Grant size in USD: $28,996,341 (see here in BMGF grant database )

Short description of the project:

Enteric infections (e.g., diarrhea due to infectious causes) and growth faltering (also called stunting of children) are major burdens of disease among young children in low-income countries. Improvements in water, sanitation, and handwashing (WASH), together with improvements in nutrition, are thought to reduce these disease burdens. However, there have been few rigorous studies to measure the effects of WASH interventions on growth and the effects of combined interventions (e.g., WASH + Nutrition) compared with single interventions.

The WASH Benefits study includes two highly comparable randomized trials in rural communities -- one in Bangladesh, one in Kenya -- that will measure the effect of providing improved household compound-level WASH and nutritional interventions, alone and in combination, to a large birth cohort of children.

These are efficacy trials: measuring the effect of the interventions delivered by the research project and at no cost to participants (as opposed to delivered in a programmatic setting). Therefore, this project provides WASH hardware and behavior change activities to compounds in rural communities and measures health and child development outcomes among young children receiving these interventions. Child development as measured by communication, gross motor, and personal/social domains. The cost of the interventions is a small fraction of the total cost of the trial.

The trials were not originally designed to evaluate whether joint WASH, nutrition, and anthelminthic treatment (i.e., deworming) interventions affect child growth and development. One reason for this is that the trials measure outcomes among children 0-2 years old, and investigators did not expect sufficiently high enough levels of soil-transmitted helminth infection to justify measurement among this age group until the end of the trial. Thus, soil-transmitted helminth infection is measured at the end of the trials, and to maintain the standard of care in our study populations, all compound members will also be offered deworming at the end of the trials.

Methods and analysis:

WASH Benefits includes two cluster-randomised trials to assess improvements in water quality, sanitation, handwashing and child nutrition—alone and in combination—to rural households with pregnant women in Kenya and Bangladesh. Geographically matched clusters (groups of household compounds in Bangladesh and villages in Kenya) will be randomised to one of six intervention arms or control. Intervention arms include water quality, sanitation, handwashing, nutrition, combined water+sanitation+handwashing (WSH) and WSH+nutrition.

The studies will enrol newborn children (N=5760 in Bangladesh and N=8000 in Kenya) and measure outcomes at 12 and 24 months after intervention delivery. Primary outcomes include child length-for-age Z-scores and caregiver-reported diarrhoea. Secondary outcomes include stunting prevalence, markers of environmental enteropathy, intestinal parasite prevalence and infection intensity, and child development scores (verbal, motor and personal/social). We will estimate unadjusted and adjusted intention-to-treat effects using semiparametric estimators and permutation tests.

The Bangladesh trial will be conducted in selected districts north of Dhaka, the capital of Bangladesh. The study communities must meet the following study criteria:

• Rural communities
• Drinking water that has low levels of arsenic and iron, but sources are known to be frequently contaminated with fecal indicator bacteria
• Low levels of fully hygienic latrine coverage
• Levels of childhood stunting >30%
• No previous participation in other studies

The Kenya trial is being conducted in selected rural areas in Bungoma, Kakamega, and Vihiga counties in Kenya. The study communities must meet the following study criteria:

• The majority of village members collect their water from communal sources located in rural areas
• The majority of the community members relies on unimproved sanitation facilities
• There are at least 2 eligible target children in the village whose family owns their home and who have no plans to move away in the next 12 months (neighboring villages are then paired to create clusters with at least 8 eligible pregnant women, 6 of whom must be available for the baseline survey for the cluster to be enrolled in the study)
• The village cannot already have a chlorine dispenser installed
• Respondents can speak either English, Kiswahili or Luhya

Goal:
The goal of the WASH Benefits study is to generate rigorous evidence about the impacts of water quality, sanitation, handwashing and nutritional interventions on child health and development in the first two years of life. The specific objectives, below, outline more detail.

Objectives:

Primary scientific objectives:

• Measure the impact of sanitation, water quality, handwashing and nutrition interventions (see below for details) on child diarrhoea and linear growth after 2 years of exposure.
• Determine whether there are larger reductions in child diarrhoea when providing a combined water, sanitation and handwashing intervention compared to each component alone.
• Determine whether there are larger effects on child diarrhoea and linear growth from combining (A) a comprehensive child nutrition intervention with ( B ) a combined water, sanitation and handwashing intervention compared to A or B alone.

Information about the specific interventions:

Interventions planned for Bangladesh are listed here:
www.washbenefits.net/Bangladesh-Intervention-Descriptions

For example: a new or upgraded dual pit latrine for each household in the compound. The behavior change components of the intervention will emphasize the use of the latrine for defecation and the safe disposal of feces in the compound courtyard to prevent contact with young children.

Interventions planned for Kenya are listed here:
www.washbenefits.net/Kenya-Intervention-Descriptions

For example: a new or upgraded pit latrine for each household in the compound. If participants have a latrine, its structure will be improved if necessary. Plastic slabs will be installed to improve mud or wood floors, and the intervention delivery team will make sure that all latrine structures have walls, doors, roofs that ensure safety and privacy. The behavior change components of the intervention will emphasize the use of the latrine for defecation and the safe disposal of feces in the compound courtyard to prevent contact with young children.

Secondary scientific objectives:

• Measure the impact of a child nutritional intervention and household environmental interventions on environmental enteropathy biomarkers (e.g., lactulose, mannitol, myeloperoxidase, alpha-1 antitrypsin, neopterin, total IgG), and more clearly elucidate this potential pathway between environmental interventions and child growth and development.
• Measure the impact of sanitation, water quality, handwashing and nutritional interventions on intestinal parasitic infection prevalence and intensity by conducting Kato-Katz, PCR, and ELISA on stool samples.
• Measure the association between parasitic infection and other measures of enteric health, including acute diarrhoea and environmental enteropathy biomarkers.

Research or implementation partners:

• International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b): Implement study activities in Bangladesh, scientific oversight, ethical review, data collection, and laboratory analyses in Bangladesh
• Innovations for Poverty Action, Kenya (IPAK) : scientific oversight and data collection in Kenya
• Kenya Medical Research Institute (KEMRI): ethical review and laboratory analyses in Kenya
• Stanford University, USA: scientific oversight for both Bangladesh and Kenya
• Emory University, USA: scientific oversight in Kenya and input on design in both countries
• Johns Hopkins University, USA: guidance of intervention implementation and process evaluations in Bangladesh
• University at Buffalo, SUNY, USA: guidance on the handwashing intervention
• Wagner College, USA: laboratory analyses for a portion of the environmental enteropathy assessment
• University of California, Davis, USA: guidance on the nutrition intervention
• University of California, Berkeley, USA: scientific oversight, coordination between Bangladesh and Kenya, ethical review, and guidance on design and analysis
• The Ministries of Health in Bangladesh and Kenya are aware of the trials, but since these are efficacy trials they are not directly connected to Ministry activities.

Links, further readings – results to date:

• A detailed summary of the study design, rationale and protocol has been published open-access at: bmjopen.bmj.com/content/3/8/e003476.short
• The trials are registered at: www.clinicaltrials.gov (NCT01590095, NCT01704105)
• The study’s website includes an updated list of peer-reviewed publications from the trials and their pilot studies: www.washbenefits.net/Publications
• Presentations about this project: www.washbenefits.net/Presentations

Current state of affairs:

• The trials are currently conducting their final round of outcome measurement. We anticipate primary results in late 2016 (Bangladesh) and mid 2017 (Kenya).
• Although the trials are designed to provide highly comparable evidence, each trial is independently powered and the interventions differ slightly between countries to reflect cultural, demographic, and environmental differences between sites.
• The intervention programs have been refined over a two-year formative research period, and include hardware and behavior change components to improve water quality, sanitation, handwashing, and nutrition.

Biggest successes so far:

• Enrollment of 5,551 (Bangladesh) and 8,246 (Kenya) pregnant mothers and their newborns into the trials.
• Delivery of intensive interventions (e.g. improved latrines, sani-scoops, handwashing stations) to approximately 12,860 study compounds (there is approximately 1 compound per target child)

Main challenges / frustration:

The original timeline for the project included one year for piloting the study interventions, but it took a full two years to adequately develop hardware and software packages that our team was confident could sustain high uptake over the full duration of the study.


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Jack Colford, MD PhD
Professor of Epidemiology
UC Berkeley School of Public Health
101 Haviland, MC# 7358,
Berkeley, CA 94720-7358

Dear Dr. Jack,

That is a interesting research project. Just one minor query: What was the criteria for selecting Bangladesh and Kenya for conducting research?

Regards,

F H Mughal

Thanks for your interest in the project. The countries were chosen because these were locations where our team was already working with a network of collaborators in settings where the interventions were likely to have a potentially large and useful impact.

Thank you, Dr. Jack. I'm not sure, whether it would be possible for you, at this stage, to add a third country (e.g., Pakistan).

I believe, the final report(s) would be issued in Sep 2017. Perhaps, you may consider issuing interim reports.

Regards,

F H Mughal

Thanks for your interest in our project.

Unfortunately, adding a third country at this stage of the study isn't possible. Several years of preparation were required to conduct the study in Kenya and Bangladesh in order to pilot the appropriate interventions. Carrying out such work in another country would require time and support far above the current resources of the project.

The study is being carried out according to a pre-specified analysis plan. Interim reports are not part of the plan because we do not want to introduce any bias into the subsequent collection of data.

Thank you, Dr. Jack. I'll be looking forward to the final reports.

Regards,
F H Mughal

WASH Benefits Studies Published in 2016 – The WASH Benefits Study provides rigorous evidence on the health and developmental benefits of water quality, sanitation, handwashing, and nutritional interventions during the first years of life. The study includes two, cluster-randomized controlled trials to measure the impact of intervention among newborn infants in rural Bangladesh and Kenya. The studies are large in scope (> 5,000 newborns per country) and will measure primary outcomes after two years of intervention.

December 2016 – Adapting and Evaluating a Rapid, Low-Cost Method to Enumerate Flies in the Household Setting . Marlene K. Wolfe, Holly N. Dentz, Beryl Achando, MaryAnne Mureithi, Tim Wolfe, Clair Null, Amy J. Pickering. Am J Trop Med Hyg 2016 16-0162.

October 2016 – Occurrence of Host-Associated Fecal Markers on Child Hands, Household Soil, and Drinking Water in Rural Bangladeshi Households . Alexandria B. Boehm, Dan Wang, Ayse Ercumen, Meghan Shea, Angela R. Harris, Orin C. Shanks, Catherine Kelty, Alvee Ahmed, Zahid Hayat Mahmud, Benjamin F. Arnold, Claire Chase, Craig Kullmann, John M. Colford Jr., Stephen P. Luby, and Amy J. Pickering. Publication Date (Web): October 13, 2016. Environ. Sci. Technol. Lett. DOI: 10.1021/acs.estlett.6b00382.

June 2016 – Towards a Scalable and Sustainable Intervention for Complementary Food Safety . Rahman MJ, Nizame FA, Nuruzzaman M, Akand F, Islam MA, Parvez SM, Stewart CP, Unicomb L, Luby SP, Winch PJ. Food and Nutrition Bulletin. 2016 Jun;37(2):186-201.

June 2016 – Hygiene Practices During Food Preparation in Rural Bangladesh: Opportunities to Improve the Impact of Handwashing Interventions . Fosiul A. Nizame, Elli Leontsini, Stephen P. Luby, Md. Nuruzzaman, Shahana Parveen, Peter J. Winch, Pavani K. Ram, Leanne Unicomb. Published online June 13, 2016, doi: 10.4269/ajtmh.15-0377. Am J Trop Med Hyg 2016 vol. 95 no. 2 288-297.

June 2016 – Soil-Transmitted Helminth Eggs Are Present in Soil at Multiple Locations within Households in Rural Kenya . Lauren Steinbaum, Sammy M. Njenga, Jimmy Kihara, Alexandria B. Boehm, Jennifer Davis, Clair Null, Amy J. Pickering. PLOS ONE, Published: June 24, 2016.

June 2016 – Hand-and Object-Mouthing of Rural Bangladeshi Children 3–18 Months Old . Kwong LH, Ercumen A, Pickering AJ, Unicomb L, Davis J, Luby SP. Int J Environ Res Public Health. 2016 Jun 4;13(6).

May 2016 – Vitamin B-12 Concentrations in Breast Milk Are Low and Are Not Associated with Reported Household Hunger, Recent Animal-Source Food, or Vitamin B-12 Intake in Women in Rural Kenya . Williams AM, Chantry CJ, Young SL, Achando BS, Allen LH, Arnold BF, Colford JM Jr, Dentz HN, Hampel D, Kiprotich MC, Lin A, Null CA,Nyambane GM, Shahab-Ferdows S, Stewart CP. J Nutr. 2016 May;146(5):1125-31.

We would like to add the following list of recent publications in the WASH Benefits study to this thread about our WASH Benefits project.

The following articles related to WASH Benefits were published in 2016. Please check here: www.washbenefits.net/publications.html for an up-to-date list of all publications related to the study.


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Vitamin B-12 Concentrations in Breast Milk Are Low and Are Not Associated with Reported Household Hunger, Recent Animal-Source Food, or Vitamin B-12 Intake in Women in Rural Kenya. Williams AM, Chantry CJ, Young SL, Achando BS, Allen LH, Arnold BF, Colford JM Jr, Dentz HN, Hampel D, Kiprotich MC, Lin A, Null CA,Nyambane GM, Shahab-Ferdows S, Stewart CP. J Nutr. 2016 May;146(5):1125-31. www.ncbi.nlm.nih.gov/pubmed/27075905

Hand- and Object-Mouthing of Rural Bangladeshi Children 3-18 Months Old. Kwong LH, Ercumen A, Pickering AJ, Unicomb L, Davis J, Luby SP. Int J Environ Res Public Health. 2016 Jun 4;13(6). www.ncbi.nlm.nih.gov/pubmed/27271651 #1 (NCBI)
www.mdpi.com/1660-4601/13/6/563/htm #2 (MDPI)

Soil-Transmitted Helminth Eggs Are Present in Soil at Multiple Locations within Households in Rural Kenya. Lauren Steinbaum, Sammy M. Njenga, Jimmy Kihara, Alexandria B. Boehm, Jennifer Davis, Clair Null, Amy J. Pickering. PLOS. Published: June 24, 2016.

journals.plos.org/plosone/article?id=10....journal.pone.0157780

Hygiene Practices During Food Preparation in Rural Bangladesh: Opportunities to Improve the Impact of Handwashing Interventions. Fosiul A. Nizame, Elli Leontsini, Stephen P. Luby, Md. Nuruzzaman, Shahana Parveen, Peter J. Winch, Pavani K. Ram, Leanne Unicomb. Published online June 13, 2016, doi: 10.4269/ajtmh.15-0377. Am J Trop Med Hyg 2016 vol. 95 no. 2 288-297.

www.ajtmh.org/content/95/2/288.abstract?etoc

Towards a Scalable and Sustainable Intervention for Complementary Food Safety. Rahman MJ, Nizame FA, Nuruzzaman M, Akand F, Islam MA, Parvez SM, Stewart CP, Unicomb L, Luby SP, Winch PJ. - Food and Nutrition Bulletin. 2016 Jun;37(2):186-201.

fnb.sagepub.com/content/early/2016/03/03...72116631641.abstract

Occurrence of Host-Associated Fecal Markers on Child Hands, Household Soil, and Drinking Water in Rural Bangladeshi Households. Alexandria B. Boehm, Dan Wang, Ayse Ercumen, Meghan Shea, Angela R. Harris, Orin C. Shanks, Catherine Kelty, Alvee Ahmed, Zahid Hayat Mahmud, Benjamin F. Arnold, Claire Chase, Craig Kullmann, John M. ColfordJr., Stephen P. Luby, and Amy J. Pickering. Publication Date (Web): October 13, 2016. Environ. Sci. Technol. Lett. DOI: 10.1021/acs.estlett.6b00382.

pubs.acs.org/doi/pdf/10.1021/acs.estlett.6b00382

Adapting and Evaluating a Rapid, Low-Cost Method to Enumerate Flies in the Household Setting. Marlene K. Wolfe, Holly N. Dentz, Beryl Achando, MaryAnne Mureithi, Tim Wolfe, Clair Null, Amy J. Pickering. Am J Trop Med Hyg 2016 16-0162.

www.ajtmh.org/content/early/2016/12/08/ajtmh.16-0162

Nonrandomized Trial of Feasibility and Acceptability of Strategies for Promotion of Soapy Water as a Handwashing Agent in Rural Bangladesh. Sania Ashraf, Fosiul A. Nizame, Mahfuza Islam, Notan C. Dutta, Dahlia Yeasmin, Sadika Akhter, Jaynal Abedin, Peter J. Winch, Pavani K. Ram, Leanne Unicomb, Elli Leontsini, Stephen P. Luby. Am J Trop Med Hyg 2016 16-0304.

www.ajtmh.org/content/early/2016/12/22/ajtmh.16-0304.abstract

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Jade Benjamin-Chung, PhD
Epidemiologist
Colford Research Group
Division of Epidemiology
University of California, Berkeley

Dear Colleagues at WASH Benefits,

"The trials are currently conducting their final round of outcome measurement. We anticipate primary results in late 2016 (Bangladesh) and mid 2017 (Kenya)."

Are there any results to share for the Bangladesh study?

Very best
John Brogan
Terre des hommes

Hi John,

Thanks for your interest in WASH Benefits. The primary outcome results were recently presented at the 2016 meeting of the American Society of Tropical Medical and Hygiene. We are in the process of submitting manuscripts to peer-reviewed journals. We post all publications on our website as soon as they are available ( www.washbenefits.net ), and we will also update the SuSanA forum as well. Please check either for updates later this year.

thanks, Jack Colford

Does Improved Sanitation Helps in Preventing Stunted Growth in Children?

It is a generally-accepted belief that improved sanitation improves the hygiene in a community, which in turn, is helpful in preventing stunted growth in children. However, it appears, this view is not quite valid.

A recent paper by Stephen Luby, et al. tiled: Effects of water quality, sanitation, handwashing, and
nutritional interventions on diarrhoea and child growth in rural Bangladesh: a cluster randomised controlled trial; says somewhat otherwise. Stephen Luby worked for some time at Aga Khan hospital, Karachi.

Luby’s study found that children born into housing compounds with improvements in drinking water quality, sanitation and handwashing infrastructure were not measurably taller after two years compared to those born into compounds with more contamination – although children who received the interventions were significantly healthier overall. In a trial study, improving sanitation and hygiene in poor regions of Bangladesh helped children’s health but did not improve their growth and development.

This constitutes almost a breaking news! Forum users need to look at the study, available at: www.thelancet.com/journals/langlo/articl...(17)30490-4/fulltext , for more interesting details.

F H Mughal

Thanks, Mughal, for bringing this paper to our attention.
I have now moved it into this thread which deals with the research project from which this publication was produced.

Interesting finding - and counter-inuitive. But I guess another example of the "elusive effects of health benefits from sanitation". We know that the positive health effects should be there with better sanitation - but unless everything is perfect in the study design, it is very hard to prove!

I wonder if this aspect could explain the lower effect on health improvements than expected (I copy from their conclusions):

Because the sanitation intervention targeted compounds with pregnant women, these interventions only reached about 10% of residents in villages where interventions were implemented. If a higher threshold of sanitation coverage is necessary to achieve herd protection, then this study design would preclude the detection of this effect. We used compounds as the unit of intervention because they enabled us to deliver intensive interventions with high adherence for thousands of newborn children. In addition, we expected compound-level faecal contamination to represent the dominant source of exposure for index children because of the physical separation of compounds, and because children younger than 2 years of age in these communities spent nearly all of their time in their own compound.

The RCT trial which the paper is reporting on was funded by the Bill & Melinda Gates Foundation and is part of the project called:

Measuring the benefits of water quality, sanitation, handwashing and nutritional interventions for improving health and child development (WASH Benefits)
2009 - 2017 • University of California - Berkeley (UCB)
www.susana.org/en/knowledge-hub/projects/database/details/192

Regards,
Elisabeth