NCT05766826

Brief Summary

Guaranteeing access to safe drinking water is still a challenge in rural households in developing countries, and unsafe water sources are responsible for millions of deaths each year around the world. Coupons for free dilute chlorine solution are a cost-effective and effective way of ameliorating child health and reducing diarrhea incidence. It is still an empirical challenge, however, to see if the positive health effects will be maintained when the program is implemented at scale. In this study, investigators conduct a randomized controlled trial (RCT) at scale to study the impacts of a chlorine coupon program implemented at health clinics on child health, including self-reported diarrhea, fever, and cough incidence in the previous two weeks. Investigators further investigate the pathway of the impact, such as self-reported and objectively measured use of chlorine and frequency of visits to health clinics.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
3,468

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Feb 2023

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress89%
Feb 2023Oct 2026

First Submitted

Initial submission to the registry

February 2, 2023

Completed
19 days until next milestone

Study Start

First participant enrolled

February 21, 2023

Completed
20 days until next milestone

First Posted

Study publicly available on registry

March 13, 2023

Completed
3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2026

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2026

Expected
Last Updated

March 13, 2023

Status Verified

March 1, 2023

Enrollment Period

3 years

First QC Date

February 2, 2023

Last Update Submit

March 10, 2023

Conditions

Keywords

Child healthChild mortalityChlorineSafe waterTargetingCouponsRCTEast AfricaKenya

Outcome Measures

Primary Outcomes (6)

  • Verified chlorine usage - 6 months

    Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.

    The study will measure the presence of free chlorine residual in drinking water 6 months after the program launch.

  • Verified chlorine usage - 12 months

    Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.

    The study will measure the presence of free chlorine residual in drinking water 12 months after the program launch.

  • Verified chlorine usage - 18 months

    Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.

    The study will measure the presence of free chlorine residual in drinking water 18 months after the program launch.

  • Verified chlorine usage - 24 months

    Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.

    The study will measure the presence of free chlorine residual in drinking water 24 months after the program launch.

  • Verified chlorine usage - 30 months

    Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.

    The study will measure the presence of free chlorine residual in drinking water 30 months after the program launch.

  • Verified chlorine usage - 36 months

    Presence of free chlorine residual in the drinking water, as observed through water testing using chlorine test strips. Households with a non-zero concentration of residual chlorine are considered to have treated their water.

    The study will measure the presence of free chlorine residual in drinking water 36 months after the program launch.

Secondary Outcomes (12)

  • Child morbidity - 6 months

    The study assesses child morbidity 6 months after the program launch.

  • Child morbidity - 12 months

    The study assesses child morbidity 12 months after the program launch.

  • Child morbidity - 18 months

    The study assesses child morbidity 18 months after the program launch.

  • Child morbidity - 24 months

    The study assesses child morbidity 24 months after the program launch.

  • Child morbidity - 30 months

    The study assesses child morbidity 30 months after the program launch.

  • +7 more secondary outcomes

Study Arms (2)

Treatment Arm

EXPERIMENTAL

After enrollment over a phone call, they receive a SMS text message with an ID number to receive their coupons at the health facility. Those coupons can be used to redeem WaterGuard 150mL dilute chlorine. Participants in this group will receive a packet of coupons that ensure a monthly supply of a150ml bottle of dilute chlorine solution for at least the next 12 months. These coupons are redeemable in health facilities and other sites registered for the study.

Other: Coupons for safe water program: Treatment

Control Arm

EXPERIMENTAL

After enrollment over a phone call, they will not be contacted.

Other: Coupons for safe water program: Control

Interventions

Randomly selected women in the treatment group will receive coupons for free chlorine solutions to be redeemed at the health facility each month.

Treatment Arm

Randomly selected women in the treatment group will not receive coupons for free chlorine solutions after enrollment.

Control Arm

Eligibility Criteria

Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsThe recruitment takes place at health facility targeting women visiting health facilities for antenatal care, postnatal care, and other reasons. This study recruits currently pregnant women.
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Currently pregnant women
  • Women living inside Health and Demographic Surveillance Systems (HDSS) catchment areas.

You may not qualify if:

  • \- Women who do not consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Health and Demographic Surveillance System (HDSS sites)

Kisumu, Kenya

RECRUITING

Health and Demographic Surveillance System (HDSS) sites

Siaya, Kenya

RECRUITING

MeSH Terms

Conditions

DeathInfant DeathDiarrheaDiarrhea, InfantileWaterborne Diseases

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and SymptomsSigns and Symptoms, DigestiveSigns and SymptomsInfections

Study Officials

  • Michael Kremer, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR
  • Pascaline Dupas, PhD

    Stanford University

    PRINCIPAL INVESTIGATOR
  • Elisa M Maffioli, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Akito Kamei, PhD

    University of Chicago

    PRINCIPAL INVESTIGATOR
  • Sammy Khagayi, PhD

    Kenya Medical Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Akito Kamei, PhD

CONTACT

Elisa M Maffioli, PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: This study will conduct individual randomization, assigning half of the women to receive coupons and the other half to the control group as we enroll.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 2, 2023

First Posted

March 13, 2023

Study Start

February 21, 2023

Primary Completion

February 28, 2026

Study Completion (Estimated)

October 1, 2026

Last Updated

March 13, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will share

Once the analysis is complete, the de-identified data will be deposited in the public server for replicability of the research analysis.

Time Frame
After the completion of the whole study
Access Criteria
The de-identified data will be deposited in the public server

Locations