Drinking Water Chlorination and Child Survival in Rural Kenya

NCT04020965 | Completed

• 1 other identifier: 1903034
• Study Type: interventional
• Target: 46,212
• Locations: 1 country
• Sites: 1

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.

Conditions

Death; Diarrhea; Child Development

Outcome Measures

Primary Outcomes (2)

• All-cause under-five child mortality

  All-cause mortality for children who died under the age of 5 years.

  Measured 6 years after start of intervention (recall period from start of intervention to day of survey)

• Infectious disease related under-five child mortality

  Mortality for children who died under the age of 5 years from infectious or parasitic diseases. Based on the 2016 WHO Verbal Autopsy instrument, the category of deaths by "infectious and parasitic diseases" include the following causes (ICD-10 codes in parenthesis): * Sepsis (A41) * Acute respiratory infection, including pneumonia (J22/J18) * HIV/AIDS related death (B24) * Diarrheal diseases (A09) * Malaria (B54) * Measles (B05) * Meningitis and encephalitis (G03; G04) * Tetanus, excluding neonatal tetanus (A35) * Pulmonary tuberculosis (A16) * Pertussis (A37) * Hemorrhagic fever (A99) * Dengue fever (A90; A91) * Unspecified infectious disease (B99)

  Measured 6 years after start of intervention (recall period from start of intervention to day of survey)

Secondary Outcomes (12)

• 7-day under-five child diarrhea prevalence

  Measured 6 years after intervention start

• All-cause under-two mortality

  Measured 6 years after intervention (recall period from start of intervention to day of survey)

• Diarrheal disease related under-five child mortality

  Measured 6 years after intervention (recall period from start of intervention to day of survey)

• School attendance

  Measured 6 years after intervention start

• School enrollment

  Measured 6 years after intervention start

Study Arms (2)

Control arm

NO INTERVENTION

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

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.

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

Interventions

Water Treatment BEHAVIORAL

Hardware: Chlorine dispensers provided for free at communal water sources, available to households in intervention arm who were and who were not enrolled in the WASH Benefits Kenya study. Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver behavior change messages that focused on the treatment of drinking water for all children living in the household. Compounds in intervention villages that were not enrolled in the WASH Benefits Kenya study did not receive such visits. After the completion of the WASH Benefits Kenya study, the NGO Evidence Action conducted educational campaigns to promote the use of dispensers.

Water Treatment

Sanitation BEHAVIORAL

Only households enrolled in the original WASH Benefits study and assigned to the combined WASH and combined WASH + nutrition arms received this intervention. Hardware: Free child potties, sani-scoop hoes to remove feces from household environments, and new or upgraded pit latrine for each household enrolled in the WASH Benefits Kenya study. Upgrades included structural improvements, plastic slabs, and superstructure improvements. Households in intervention villages not enrolled in the original trial did not receive any hardware. Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver behavior change messages that focused on handwashing with soap at critical times around food preparation, defecation, and contact with feces. Compounds in intervention villages that were not enrolled in the original trial did not receive such visits.

Water Treatment

Handwashing BEHAVIORAL

Only households enrolled in the original WASH Benefits study and assigned to the combined WASH and combined WASH + nutrition arms received this intervention. Hardware: Handwashing "dual tippy tap" stations, including jugs for clean and for soapy water, for each compound. Handwashing stations were stocked with soap for the duration of the WASH Benefits Kenya study. Compounds in intervention villages who were not enrolled in the WASH Benefits Kenya study did not receive any hardware. Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver behavior change messages that focused on the use of latrines for defecation and the removal of human and animal feces from the compound. Compounds in intervention villages that were not enrolled in the WASH Benefits Kenya study did not receive such visits.

Water Treatment

Nutrition DIETARY_SUPPLEMENT

Supplement: Lipid-based Nutrient Supplement (LNS) twice daily from ages 6 to 24 months, among children enrolled in the WASH Benefits Kenya study and for the duration of that study. Children in intervention villages who were not enrolled in the WASH Benefits Kenya study did not receive any supplements. Promotion: Local promoters visited compounds enrolled in the WASH Benefits Kenya study at least monthly during the first year and bi-monthly during the second (and last) year to deliver the following behavior change messages: (1) practice exclusive breastfeeding from birth to 6 months of age; (2) continue breast feeding with the introduction of LNS; (3) provide your child micronutrient-rich foods and vitamin A rich fruits and vegetables; and (4) feed your child at least 2-3 times per day when 6-8 months old and 3-4 times per day when 9-24 months old. Compounds in intervention villages that were not enrolled in the WASH Benefits Kenya study did not receive such visits.

Water Treatment

Eligibility Criteria

• Age: Up to 50 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

Sponsors & Collaborators

• Tufts University: lead
• University of Chicago: collaborator
• University of California, Berkeley: collaborator

Study Sites (1)

REMIT Kenya

Kisumu, Kenya

Location

Related Publications (4)

• World Health Organization. Drinking-water. Available at: https://www.who.int/news-room/fact-sheets/detail/drinking-water. (Accessed: 20th February 2019)

  BACKGROUND

• Bhalotra, S. R., Díaz-Cayeros, A., Miller, G., Miranda, A. & Venkataramani, A. S. Urban Water Disinfection and Mortality Decline in Developing Countries.

  BACKGROUND

• 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).

  BACKGROUND

• 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.

  PMID: 15782893 BACKGROUND

MeSH Terms

Conditions

Death; Diarrhea

Interventions

Water Purification; Sanitation; Hand Disinfection; Nutritional Status

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms, Digestive; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Waste Management; Sanitary Engineering; Communicable Disease Control; Public Health Practice; Public Health; Environment and Public Health; Hand Hygiene; Hygiene; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Outcome collectors were not informed of intervention status, but could have inferred status from observing intervention hardware during household visits.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: July 12, 2019
• First Posted: July 16, 2019
• Study Start: July 26, 2019
• Primary Completion: May 26, 2021
• Study Completion: May 26, 2021
• Last Updated: September 15, 2022

Record last verified: 2022-09

Locations

KE (1)