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.

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

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.


+++++++++

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