Clinical trial NCT04020965: Drinking Water Chlorination and Child Survival in Rural Kenya
Official title: Effect of Drinking Water Chlorination on Child Survival in Rural Kenya
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Death
Diarrhea
Child Development
Lead sponsor: Tufts University
Sponsor class: OTHER
Collaborators: name: University of Chicago
name: University of California, Berkeley
First posted: 2019-07-16
Enrollment: 46212
Sex: FEMALE
Maximum age (years): 50
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of the study is to estimate the effect of community-wide provision of water treatment (chlorine) solution on all-cause child mortality and on infectious disease related child mortality. We will also examine effects on the following secondary outcomes: 7-day diarrhea prevalence, all-cause under-2 mortality, diarrheal disease related child mortality, school attendance, and school enrollment. In addition, and for a subsample of children, we will examine effects on motor development, emergent language and literacy, emergent math/numeracy, and socio-emotional development.

Detailed description: The World Health Organization (WHO) estimates that in 2015 over 2 billion people consumed drinking water contaminated with feces and that approximately half a million people died from diarrheal disease associated with fecal contamination of water (1). Dilute chlorine solution is widely used to treat water as it is effective, safe, and low-cost. While nonexperimental studies suggest strong impacts of chlorine water treatment on child survival (2-4), there has been no previous randomized controlled trial of a water treatment intervention powered to evaluate effects on child survival.

We will examine the effect of community-wide provision of chlorine solution on child survival in rural Kenya, where a long-term village-wide chlorination randomized evaluation was implemented. The WASH Benefits Kenya trial was a randomized controlled trial of water treatment, sanitation, handwashing, and nutrition interventions in western Kenya. WASH Benefits Kenya enrolled pregnant women in their second or third gestational trimester between November 2012 and May 2014 and followed children for their first 2 years of life. In communities that were randomized to water treatment, chlorine solution dispensers were installed and refilled as needed. After the WASH Benefits Kenya trial ended, the NGO Evidence Action continued to refill most of the dispensers in the treatment villages.

We intend to re-visit all water treatment and control clusters in the trial approximately 6 years after the chlorination intervention was initiated to enroll all women 50 or younger, who had a child since January 1, 2008. We note that our target population includes both women (and children) who were and who were not "enrolled" in the original WASH Benefits Kenya study. The latter group is made up of women (and their children) who were pregnant before the study, women who were in their first trimester at the time of enrollment, and women who got pregnant after study enrollment. We expect to find approximately 22,000 such women. We will briefly survey these women to identify those that gave birth to a child who later died, and then conduct verbal autopsies to ascertain the cause of death. We will also perform free and total chlorine residual testing at households to assess current usage rates and collect GPS data on the location of houses and dispensers. We will estimate the intent-to-treat effect of the community-wide provision of chlorine solution on child survival by 1) comparing post-intervention mortality rates between water treatment and control areas; and 2) comparing changes in mortality rates (before and after the intervention) across treatment and control areas (a difference-in-difference analysis). The primary outcomes are all-cause child mortality and infectious disease related child mortality; secondary outcomes include: 7-day diarrhea prevalence, all-cause under-2 mortality, diarrheal disease related child mortality, school attendance, and school enrollment. In addition, for the subsample of children who were enrolled in the original WASH Benefits Kenya study, we will examine effects on motor development, emergent language and literacy, emergent math/numeracy, and socio-emotional development. Our findings will provide evidence on whether community-wide provision of chlorine reduces all-cause child mortality and infectious disease related child mortality.

Eligibility criteria: Inclusion Criteria:

1. Had one or more live births since January 1, 2008.
2. Live in a village which was randomized to water treatment or control arms during the WASH Benefits Kenya trial.

Primary outcomes:
measure: All-cause under-five child mortality
timeFrame: Measured 6 years after start of intervention (recall period from start of intervention to day of survey)
measure: Infectious disease related under-five child mortality
timeFrame: Measured 6 years after start of intervention (recall period from start of intervention to day of survey)
Secondary outcomes:
measure: 7-day under-five child diarrhea prevalence
timeFrame: Measured 6 years after intervention start
measure: All-cause under-two mortality
timeFrame: Measured 6 years after intervention (recall period from start of intervention to day of survey)
measure: Diarrheal disease related under-five child mortality
timeFrame: Measured 6 years after intervention (recall period from start of intervention to day of survey)
measure: School attendance
timeFrame: Measured 6 years after intervention start
measure: School enrollment
timeFrame: Measured 6 years after intervention start
measure: Motor development
timeFrame: Measured 6 years after intervention start
measure: Emergent language and literacy
timeFrame: Measured 6 years after intervention start
measure: Emergent math/numeracy
timeFrame: Measured 6 years after intervention start
measure: Socio-emotional development
timeFrame: Measured 6 years after intervention start
measure: All-cause under-six months mortality
timeFrame: Measured 6 years after intervention (recall period from start of intervention to day of survey)
measure: All-cause neonatal mortality
timeFrame: Measured 6 years after intervention (recall period from start of intervention to day of survey)
measure: Infectious disease related under-two mortality
timeFrame: Measured 6 years after start of intervention (recall period from start of intervention to day of survey)
Other outcomes:
Locations:
city: Kisumu
country: Kenya
facility: REMIT Kenya
Study officials:
References:
citation: World Health Organization. Drinking-water. Available at: https://www.who.int/news-room/fact-sheets/detail/drinking-water. (Accessed: 20th February 2019)
citation: Bhalotra, S. R., Díaz-Cayeros, A., Miller, G., Miranda, A. & Venkataramani, A. S. Urban Water Disinfection and Mortality Decline in Developing Countries.
citation: Galiani, S., Gertler, P. & Schargrodsky, E. Water for Life: The Impact of the Privatization of Water Services on Child Mortality. J. Polit. Econ. 113, 83-120 (2005).
citation: Cutler D, Miller G. The role of public health improvements in health advances: the twentieth-century United States. Demography. 2005 Feb;42(1):1-22. doi: 10.1353/dem.2005.0002.