Evaluating In-line Chlorination in Nigeria

May 14, 2026 updated by: Amy Janel Pickering, University of California, Berkeley

In-line Chlorination for Drinking Water Treatment in Nigeria

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
2655

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Arm 1: Inline Chlorination (ILC) with Behavioral Change Communication (BCC)
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)
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.
No Intervention: Arm 2: Control (No Chlorination)
Communities randomized to this arm will not receive inline chlorination during the study period and will continue their usual water collection and treatment practices.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of water source samples with detectable free chlorine residual.
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
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.
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
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.
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Measured as >1 MPN/100 mL of water by culture-based assay
About 4-, 8-, and 12-month follow ups after device installations

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of water source samples with detectable total chlorine residual.
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Measured as >0.1 ppm.
About 4-, 8-, and 12-month follow ups after device installations
Concentration of E. coli in water source samples
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Concentration of E. coli (in log10 MPN/100ml) in water source samples by culture-based assay
About 4-, 8-, and 12-month follow ups after device installations
Concentration of E. coli in household stored water samples
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Concentration of E. coli (in log10 MPN/100ml) in household stored water samples by culture-based assay
About 4-, 8-, and 12-month follow ups after device installations
Concentration of total coliform bacteria in water source samples
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Concentration of total coliform bacteria (MPN/100mL) 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
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Concentration of total coliform bacteria (MPN/100mL) in household stored water samples
About 4-, 8-, and 12-month follow ups after device installations
Prevalence of caregiver-reported diarrhea among children under five years of age
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Measured as the proportion of children under five reported by caregivers to have experienced diarrhea, defined as three or more loose or watery stools within a 24-hour period, during the 7 days preceding the survey.
About 4-, 8-, and 12-month follow ups after device installations
Prevalence of caregiver-reported diarrhea among household members, any age
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Measured as the proportion of individuals surveyed in the household that have experienced diarrhea, defined as three or more loose or watery stools within a 24-hour period, during the 7 days preceding the survey. Measured for subset of available respondents.
About 4-, 8-, and 12-month follow ups after device installations
Prevalence of diarrhea among female caregivers
Time Frame: Time frame - About 4-, 8-, and 12-month follow ups after device installations
Measured as the proportion of respondents that have experienced diarrhea, defined as three or more loose or watery stools within a 24-hour period, during the 7 days preceding the survey.
Time frame - About 4-, 8-, and 12-month follow ups after device installations

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Proportion of households reporting an ILC-compatible water source as their primary drinking water source
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Measured as the percentage of surveyed households identifying an ILC-compatible water system as their source of drinking water. ILC-compatible water systems (boreholes, piped systems, or handpumps have chlorinated water in treatment)
About 4-, 8-, and 12-month follow ups after device installations
Proportion of households switching away from ILC-treated water sources
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Measured as the percentage of households that discontinue use of a chlorinated water system for drinking water compared to baseline.
About 4-, 8-, and 12-month follow ups after device installations
Proportion of households reporting any household-level water treatment
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Measured as the percentage of households reporting treatment of drinking water prior to consumption (e.g., boiling, filtration, manual chlorination).
About 4-, 8-, and 12-month follow ups after device installations
Time spent on household-level water treatment
Time Frame: About 4-, 8-, and 12-month follow ups after device installations
Time (minutes) reported by households per day on making water safer to drink (gender stratified)
About 4-, 8-, and 12-month follow ups after device installations

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of California, Berkeley

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
University of Michigan
Bayero University Kano, Nigeria

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: 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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 26, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
December 31, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 22, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 22, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2025-08-18832

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

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