Drinking Water Chlorination and Child Survival in Rural Kenya

Tufts University

Status: Completed

Conditions: Death; Child Development; Diarrhea

Treatments: Dietary Supplement: Nutrition; Behavioral: Water Treatment; Behavioral: Sanitation; Behavioral: Handwashing

Study type: Interventional

Funder types: Other

Identifiers

NCT04020965

1903034

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46,212 patients

Sex: Female

Ages: Under 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46,212 participants in 2 patient groups

Control arm

No Intervention group

Description:

This arm includes all households in villages randomized to the active control arm (double-sized) or passive control arm of the original trial. Village-level promoter visited households enrolled in the WASH Benefits Kenya study active control arm and strictly engaged in recording the child's MUAC and referring children identified as malnourished (MUAC\<11.5 cm) to health clinics, for two years. These visits were also conducted in all active comparator arms. Households in active control and active comparator villages which were not enrolled in the original study did not receive such visits.

Water Treatment

Experimental group

Description:

This arm includes all households in villages randomized in the original WASH Benefits trial to the water treatment arm, combined water treatment with handwashing and sanitation (WASH) arm, and combined WASH + nutrition arm. Village-level promoter visited households enrolled in the original trial to promote the interventions for approximately two years.

Treatment:

Behavioral: Handwashing

Dietary Supplement: Nutrition

Behavioral: Sanitation

Behavioral: Water Treatment