- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07601503
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
Not yet recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Estimated)
2655
Phase
- 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
- Name: Amy J Pickering
- Phone Number: +1.510.410.2666
- Email: pickering@berkeley.edu
Study Contact Backup
- Name: Elisa M Maffioli
- Phone Number: +1.443.875.4930
- Email: elisamaf@umich.edu
Study Locations
-
-
Cross River State
-
Yala, Cross River State, Nigeria
- Yala LGA
-
Contact:
- Gbenga Adedayo
- Phone Number: +234.805.602.6845
- Email: gadedayo@hanovialimited.com
-
-
Kano State
-
Makuda, Kano State, Nigeria
- Makoda LGA
-
Contact:
- Gbenga Adedayo
- Phone Number: +234.805.602.6845
- Email: gadedayo@hanovialimited.com
-
-
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
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 |
Intervention / Treatment |
|---|---|
|
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.
|
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
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
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
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.
Investigators
- 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
- 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.
- 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.
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)
May 26, 2026
Primary Completion (Estimated)
December 31, 2027
Study Completion (Estimated)
December 31, 2027
Study Registration Dates
First Submitted
May 14, 2026
First Submitted That Met QC Criteria
May 14, 2026
First Posted (Actual)
May 22, 2026
Study Record Updates
Last Update Posted (Actual)
May 22, 2026
Last Update Submitted That Met QC Criteria
May 14, 2026
Last Verified
May 1, 2026
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID 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.
Clinical Trials on Diarrhea
-
Aboca Spa Societa' AgricolaUnknownDiarrhea | Diarrhea, Infantile | Chronic Diarrhea | Acute Diarrhea
-
Napo Pharmaceuticals, Inc.CompletedAdult Solid Tumor | Cancer Therapy-Related Diarrhea | Chemotherapy-related Diarrhea | Prophylaxis of Diarrhea | Symptomatic Relief of Diarrhea | Targeted Therapy-related DiarrheaUnited States, Taiwan, Georgia, Serbia, Argentina
-
Hospital San BartolomeInstituto de Investigacion de las Alteraciones del Crecimiento, Desarrollo...Unknown
-
South Shore HospitalWithdrawnAntibiotic Associated Diarrhea | Clostridium Difficile Associated Diarrhea
-
Cosmo Technologies LtdBausch Health Americas, Inc.CompletedTraveler's DiarrheaGuatemala, Mexico
-
Sana'a UniversityCompleted
-
PATHUniversity of Maryland; Center for Vaccine Development - MaliCompleted
-
Johns Hopkins Bloomberg School of Public HealthNaval Medical Research CenterCompletedTravelers' DiarrheaUnited States
-
Intercell USA, Inc.CompletedTraveler's DiarrheaUnited States
-
Augusta UniversityNRS Medical College, Kolkata, West Bengal, India; School of Tropical Medicine...Terminated
Clinical Trials on In-line Chlorination (ILC) with Behavioral Change Communication (BCC)
-
Shahjalal University of Science and TechnologyCompletedMenstrual Irregularity | Dysmenorrhea | Premenstrual Syndrome-PMSBangladesh
-
Thiruvananthapuram Medical CollegeCompletedType2 Diabetes Mellitus | Physical InactivityIndia
-
Umeå UniversityRecruiting
-
MAHAN TrustCaring Friends, Mumbai; Stitchting Geron, The Netherland; Mastek Foundation; Tribal...CompletedMortality Control Program for Economically Productive Age Group in Tribal Area of Melghat. (MCPEPAG)Pneumonia | Diarrhea | COPD | Diarrhea Chronic | Hypertension (HTN) | Malaria Fever | Asthma (Diagnosis)India