NCT07601503

Brief Summary

This study evaluates the implementation and effectiveness of in-line chlorination (ILC) for improving drinking water quality in rural Nigeria. Unsafe drinking water remains a major contributor to diarrheal disease, particularly among children under five. Inline chlorination is a passive water treatment approach that automatically doses chlorine at community water systems without requiring electricity or daily user action. Two cluster randomized controlled trials will be conducted in Kano State (North-West Nigeria) and Cross River State (South-South Nigeria). Communities will be randomized to either receive in-line chlorination installed at eligible communal water systems or serve as controls with no chlorination. The unit of randomization is a community or a cluster of communities that share water system for drinking water. The primary objective is to estimate the causal impact of in-line chlorination on household drinking water quality. Outcomes include the prevalence of Escherichia coli contamination in tap water and stored household water as well as the presence of free chlorine residual. Secondary objectives assess water source usage and adoption of chlorinated sources, as well as reduction in diarrheal disease. Implementation fidelity and operational performance of chlorination devices will also be monitored.

Trial Health

63
Monitor

Trial Health Score

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

Enrollment
2,655

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started May 2026

Geographic Reach
1 country

2 active sites

Status
not yet 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

First Submitted

Initial submission to the registry

May 14, 2026

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 22, 2026

Completed
4 days until next milestone

Study Start

First participant enrolled

May 26, 2026

Expected
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

May 22, 2026

Status Verified

May 1, 2026

Enrollment Period

1.6 years

First QC Date

May 14, 2026

Last Update Submit

May 14, 2026

Conditions

Keywords

Inline Chlorination, Safe Water, Water Practices, Behavior, Diarrhea, Children

Outcome Measures

Primary Outcomes (3)

  • Proportion of water source samples with detectable free chlorine residual.

    Measured as \>0.1 ppm.

    About 4-, 8-, and 12-month follow ups after device installations

  • Proportion of household stored drinking water samples with detectable free chlorine residual.

    Measured as \>0.1 ppm.

    About 4-, 8-, and 12-month follow ups after device installations

  • Proportion of household stored drinking water samples positive for Escherichia coli.

    Measured as \>1 MPN/100 mL of water by culture-based assay

    About 4-, 8-, and 12-month follow ups after device installations

Secondary Outcomes (8)

  • Proportion of water source samples with detectable total chlorine residual.

    About 4-, 8-, and 12-month follow ups after device installations

  • Concentration of E. coli in water source samples

    About 4-, 8-, and 12-month follow ups after device installations

  • Concentration of E. coli in household stored water samples

    About 4-, 8-, and 12-month follow ups after device installations

  • Concentration of total coliform bacteria in water source samples

    About 4-, 8-, and 12-month follow ups after device installations

  • Concentration of total coliform bacteria in household stored water samples

    About 4-, 8-, and 12-month follow ups after device installations

  • +3 more secondary outcomes

Other Outcomes (4)

  • Proportion of households reporting an ILC-compatible water source as their primary drinking water source

    About 4-, 8-, and 12-month follow ups after device installations

  • Proportion of households switching away from ILC-treated water sources

    About 4-, 8-, and 12-month follow ups after device installations

  • Proportion of households reporting any household-level water treatment

    About 4-, 8-, and 12-month follow ups after device installations

  • +1 more other outcomes

Study Arms (2)

Arm 1: Inline Chlorination (ILC) with Behavioral Change Communication (BCC)

EXPERIMENTAL

Communities randomized to this arm will receive inline chlorination installed at eligible communal drinking water systems, such as boreholes or handpumps, and behavioral change communication.

Device: In-line Chlorination (ILC) with Behavioral Change Communication (BCC)

Arm 2: Control (No Chlorination)

NO INTERVENTION

Communities randomized to this arm will not receive inline chlorination during the study period and will continue their usual water collection and treatment practices.

Interventions

In-line chlorination devices will be installed on all compatible communal water systems within treatment communities. Devices automatically dose chlorine proportional to water flow without requiring electricity or daily user input. Technologies will include TuriTap liquid dosers installed at handpumps and CTI-8 tablet dosers installed at tanks or piped systems. Devices will be calibrated and routinely monitored to maintain chlorine residual within recommended ranges. In addition to device installation, communities will participate in behavior change communication (BCC) activities designed to support understanding and acceptance of chlorinated water. BCC activities will include community sensitization meetings conducted by the implementing partner. Meetings will provide information on the purpose of chlorination through the in-line chlorination devices, expected benefits and limitations, safe water handling practices, and guidance for addressing taste or odor concerns.

Arm 1: Inline Chlorination (ILC) with Behavioral Change Communication (BCC)

Eligibility Criteria

Age15 Years+
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Adult (18+) or emancipated minor (15+) pregnant women and women with children under 5 years old who do not plan to permanently move in the next 12 months.
  • Must be knowledgeable about the household's water collection and management practices

You may not qualify if:

  • Non-age-eligible women. Men and non-emancipated minors. Women who do not consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Yala LGA

Yala, Cross River State, Nigeria

Location

Makoda LGA

Makuda, Kano State, Nigeria

Location

Related Publications (2)

  • Pickering AJ, Crider Y, Sultana S, Swarthout J, Goddard FG, Anjerul Islam S, Sen S, Ayyagari R, Luby SP. Effect of in-line drinking water chlorination at the point of collection on child diarrhoea in urban Bangladesh: a double-blind, cluster-randomised controlled trial. Lancet Glob Health. 2019 Sep;7(9):e1247-e1256. doi: 10.1016/S2214-109X(19)30315-8.

    PMID: 31402005BACKGROUND
  • Lindmark M, Cherukumilli K, Crider YS, Marcenac P, Lozier M, Voth-Gaeddert L, Lantagne DS, Mihelcic JR, Zhang QM, Just C, Pickering AJ. Passive In-Line Chlorination for Drinking Water Disinfection: A Critical Review. Environ Sci Technol. 2022 Jul 5;56(13):9164-9181. doi: 10.1021/acs.est.1c08580. Epub 2022 Jun 14.

    PMID: 35700262BACKGROUND

MeSH Terms

Conditions

DiarrheaBehavior

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Amy J Pickering

    University of California, Berkeley

    PRINCIPAL INVESTIGATOR
  • Elisa M Maffioli

    University of Michigan

    PRINCIPAL INVESTIGATOR
  • Adamu I Tanko, PhD

    Bayero University Kano, Nigeria

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 14, 2026

First Posted

May 22, 2026

Study Start (Estimated)

May 26, 2026

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

May 22, 2026

Record last verified: 2026-05

Data Sharing

IPD Sharing
Will not share

Locations