Study setting and population
The WASH Benefits Bangladesh trial was a cluster randomized trial conducted in rural villages of four districts (Gazipur, Kishoreganj, Mymensingh, Tangail) in central Bangladesh (40, 46). The study population consisted of pregnant women in their first two trimesters of pregnancy and their children who were expected to be born within approximately 6 months of the survey conducted at baseline. The selection criteria were not based on their wealth. The enrollment began in May 2012 and the study enrolled a total of 5551 pregnant women in 720 geographic clusters.
WASH Benefits Intervention
The details of WASH Benefits study methods are described elsewhere(40, 46).WASH Benefits identified 8 mothers living in close proximity to each other, to form a cluster and then formed eight geographical clusters that were grouped to form a block. The study comprised of 90 blocks (720 clusters) in total (participants enrolment and retention summary details in supplementary table 1). The trial randomly allocated the group of eight geographically proximate clusters to one of the eight study arms that included two control and six intervention arms (Supplementary Table 2): water (W) arm, sanitation (S) arm, handwashing (H) arm, nutrition (N) arm, water, sanitation and handwashing combined arm (WSH) and water, sanitation handwashing and nutrition combined arm (WSHN). We established a buffer zone of a minimum of 15 min walking distance that separated two adjacent clusters so that the intervention would not spillover from cluster to another.
Household from the intervention arms received WASH technologies and nutrition supplements. Supplementary Table 1 details the technological supplies and key behavioral messages for intervention households in the WASH Benefits Trial. For the purposes of the current paper, we analyzed data from only the arms that had sanitation and handwashing interventions (single or combined). The details regarding water treatment and nutrition interventions are described elsewhere (40, 46). The technologies provided in the sanitation arm included hardware such as concrete ring-based dual pit latrines that had a slab, water seal and walls for privacy. The sanitation intervention also included a potty for young children and a sani-scoop for removal of child feces from the environment to safe disposal in the latrine. The handwashing intervention included the provision of a handwashing station, soapy water bottle and detergent—one station was provided for the latrine and another for the kitchen area. The intervention was implemented in phases over 24 months. In the control arm no intervention and behavioral change messages were delivered.
The intervention also included communication to promote adoption of the behavioral recommendations delivered with high fidelity, by local community health promoters (CHPs) (41). CHPs were nominated by community members from the same locality to enhance acceptability at household level. Each intervention cluster had its own CHP. Intensive training of CHPs was conducted at the beginning of the project followed by periodical refreshers training throughout the intervention period.
CHPs encouraged regular use of the hardware components through regular household visits, approximately twice a week. The behavioral recommendations were to treat drinking water for children aged <36 months, use latrines for defecation and the removal of human and animal feces from the compound, wash hands with soap at critical times around food preparation, defecation, and contact with feces.
Data collection
Hardware presence, functionality and behavioral uptake were measured as part of assessment at baseline (conducted immediately after the enrolment of the pregnant women), midline (end of the first year of intervention) and endline (end of the second year of intervention when the child age was about 21-30 month). Baseline data collection was conducted from May 2012 to July 2013, and endline data collection was conducted from November 2014 to November 2015. Assessment visits were unannounced prior to the individual household visits.
Assessment tools were designedbased on the project indicators which were developed, piloted and revised through substantial feedback, comments and discussions with national and international experts (41). The field workers collected data based on self-reports and objective observations.
Data analysis
We analysed three observed and one reported uptake indicators collected during baseline and compared with endline behaviours. First, the trained enumerators collected data on observed hand cleanliness of mothers since contaminated hands. Second, they collected data on presence of water and soap in the handwashing station. Third, they collected data on visible feces and lastly they collected self-reported data on whether the child defecated in a potty or latrine as a measure of potty-use.
For analyses of handwashing variables, we merged the data from all handwashing intervention arms (H, WSH, N+WSH) and for analyses of sanitation variables, we merged all sanitation arms (S, WSH, N+WSH). We generated descriptive summaries for socio-demographic characteristics of our respondents by study arms and wealth quintiles and education levels. We computed the wealth using principal component analysis (PCA) based on household characteristics and ownership of assets. Then we generated five wealth quintiles (Q1-Q5) where Q1 was the lowest and Q5 the wealthiest quintile. We compared observed and reported respondent practices between baseline and endline across wealth quintiles. We also compared observed and reported respondent practices between baseline and endline across education levels. We calculated difference in difference (DID) using generalized linear models (GLM) to compare changes from baseline to endline between households receiving interventions with the control group and adjusted for clustering using a clustered sandwich estimator. In addition, we conducted a three-way interaction between intervention, time and socio-demographic indicators using GLM to directly assess if the impact of the interventions were modified by maternal education and wealth quintiles.
Protection of study participants
Respondents in the enrolled households (children's mothers/caregivers) provided informed consent before interviews. The study protocol was reviewed and approved by human subject committees at the International Centre for Diarrhoeal Disease Research, Bangladesh (icddr,b), (PR#11063), University of California, Berkeley(2011-09-3652), and Stanford University (25863).