DiarrheaNCT07601503
Evaluating In-line Chlorination in Nigeria
A study testing In-line Chlorination (ILC) with Behavioral Change Communication (BCC) in people with Diarrhea and Water Quality, run by University of California, Berkeley at 2 sites in Nigeria.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and olderHealthy volunteers can take part
- Conditions the study is for
- Diarrhea, Water Quality, Adoption
- What is being tested?
- In-line Chlorination (ILC) with Behavioral Change Communication (BCC)
- Type of treatment
- Pill or oral medicine, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,655 participants
- Where
- 2 sitesNigeria
- Study dates
- 26 May 2026to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Non-age-eligible women. Men and non-emancipated minors. Women who do not consent.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Nigeria2 sites
Makoda LGA
Makuda, Kano State
Gbenga Adedayo, +234.805.602.6845, gadedayo@hanovialimited.com
Yala LGA
Yala, Cross River State
Gbenga Adedayo, +234.805.602.6845, gadedayo@hanovialimited.com
About this study
Official title: 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.
- Conditions
- Diarrhea, Water Quality, Adoption
- Being tested
- In-line Chlorination (ILC) with Behavioral Change Communication (BCC)
- Keywords
- Inline Chlorination, Safe Water, Water Practices, Behavior, Diarrhea, Children
- Medical subject headings
- Diarrhea, Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
In-line Chlorination (ILC) with Behavioral Change Communication (BCC)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of water source samples with detectable free chlorine residual.
Measured as >0.1 ppm.
Measured: 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.
Measured: 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
Measured: About 4-, 8-, and 12-month follow ups after device installations
Secondary outcomes (8)
Proportion of water source samples with detectable total chlorine residual.
Measured as >0.1 ppm.
Measured: About 4-, 8-, and 12-month follow ups after device installations
Concentration of E. coli in water source samples
Concentration of E. coli (in log10 MPN/100ml) in water source samples by culture-based assay
Measured: About 4-, 8-, and 12-month follow ups after device installations
Concentration of E. coli in household stored water samples
Concentration of E. coli (in log10 MPN/100ml) in household stored water samples by culture-based assay
Measured: About 4-, 8-, and 12-month follow ups after device installations
Concentration of total coliform bacteria in water source samples
Concentration of total coliform bacteria (MPN/100mL) in water source samples
Measured: About 4-, 8-, and 12-month follow ups after device installations
Concentration of total coliform bacteria in household stored water samples
Concentration of total coliform bacteria (MPN/100mL) in household stored water samples
Measured: About 4-, 8-, and 12-month follow ups after device installations
Prevalence of caregiver-reported diarrhea among children under five years of age
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.
Measured: About 4-, 8-, and 12-month follow ups after device installations
Prevalence of caregiver-reported diarrhea among household members, any age
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.
Measured: About 4-, 8-, and 12-month follow ups after device installations
Prevalence of diarrhea among female caregivers
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.
Measured: Time frame - About 4-, 8-, and 12-month follow ups after device installations
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start26 May 2026 (estimated)
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DiarrheaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,655 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Berkeley
- Sponsor type
- University, hospital or other
- Collaborators
- University of Michigan, Bayero University Kano, Nigeria
- Responsible party
- Principal investigator, Amy Janel Pickering, University of California, Berkeley
- Investigators
- Amy J Pickering, Principal investigator, University of California, BerkeleyElisa M Maffioli, Principal investigator, University of MichiganAdamu I Tanko, PhD, Principal investigator, Bayero University Kano, Nigeria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07601503
- Sponsor's protocol ID
- 2025-08-18832
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31402005Lindmark 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.
PubMed 35700262
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- In-line Chlorination for Drinking Water Treatment in Nigeria
- ClinicalTrials.gov ID
- NCT07601503
- Acronym / sponsor ID
- 2025-08-18832
- Conditions
- Diarrhea, Water Quality, Adoption
- Keywords
- Inline Chlorination, Safe Water, Water Practices, Behavior, Diarrhea, Children
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 2,655 participants (estimated)
- Lead sponsor
- University of California, BerkeleyUniversity, hospital or other
- Collaborators
- University of Michigan, Bayero University Kano, Nigeria
- Study start
- 26 May 2026 (estimated)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 22 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1: Inline Chlorination (ILC) with Behavioral Change Communication (BCC) | Experimental | Device: In-line 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. |
| 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. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (1 listed)
- Non-age-eligible women. Men and non-emancipated minors. Women who do not consent.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | Arm 1: Inline Chlorination (ILC) with Behavioral Change Communication (BCC) |
Primary outcome
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.
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.
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
8 secondary outcomes
Proportion of water source samples with detectable total chlorine residual.
Time frame: 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 household stored water samples
Time frame: 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 in household stored water samples
Time frame: 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
Prevalence of caregiver-reported diarrhea among household members, any age
Time frame: 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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
- Background: PubMed 31402005Pickering 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.
- Background: PubMed 35700262Lindmark 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Amy J Pickering principal investigator
University of California, Berkeley
Elisa M Maffioli principal investigator
University of Michigan
Adamu I Tanko, PhD principal investigator
Bayero University Kano, Nigeria
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing In-line Chlorination (ILC) with Behavioral Change Communication (BCC) in people with Diarrhea and Water Quality, run by University of California, Berkeley at 2 sites in Nigeria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Nigeria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amy J Pickering (+1.510.410.2666, pickering@berkeley.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of water source samples with detectable free chlorine residual. (time frame: About 4-, 8-, and 12-month follow ups after device installations). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07601503, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.