- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT07601503
Evaluating In-line Chlorination in Nigeria
14. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Har ikke rekruttert ennå
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
2655
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Amy J Pickering
- Telefonnummer: +1.510.410.2666
- E-post: pickering@berkeley.edu
Studer Kontakt Backup
- Navn: Elisa M Maffioli
- Telefonnummer: +1.443.875.4930
- E-post: elisamaf@umich.edu
Studiesteder
-
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Cross River State
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Yala, Cross River State, Nigeria
- Yala LGA
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Ta kontakt med:
- Gbenga Adedayo
- Telefonnummer: +234.805.602.6845
- E-post: gadedayo@hanovialimited.com
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Kano State
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Makuda, Kano State, Nigeria
- Makoda LGA
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Ta kontakt med:
- Gbenga Adedayo
- Telefonnummer: +234.805.602.6845
- E-post: gadedayo@hanovialimited.com
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Ja
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Eksperimentell: 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.
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Ingen inngripen: 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.
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of water source samples with detectable free chlorine residual.
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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Measured as >0.1 ppm.
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About 4-, 8-, and 12-month follow ups after device installations
|
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Proportion of household stored drinking water samples with detectable free chlorine residual.
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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Measured as >0.1 ppm.
|
About 4-, 8-, and 12-month follow ups after device installations
|
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Proportion of household stored drinking water samples positive for Escherichia coli.
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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Measured as >1 MPN/100 mL of water by culture-based assay
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About 4-, 8-, and 12-month follow ups after device installations
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of water source samples with detectable total chlorine residual.
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
|
Measured as >0.1 ppm.
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About 4-, 8-, and 12-month follow ups after device installations
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Concentration of E. coli in water source samples
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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Concentration of E. coli (in log10 MPN/100ml) in water source samples by culture-based assay
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About 4-, 8-, and 12-month follow ups after device installations
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Concentration of E. coli in household stored water samples
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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Concentration of E. coli (in log10 MPN/100ml) in household stored water samples by culture-based assay
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About 4-, 8-, and 12-month follow ups after device installations
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Concentration of total coliform bacteria in water source samples
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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Concentration of total coliform bacteria (MPN/100mL) in water source samples
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About 4-, 8-, and 12-month follow ups after device installations
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Concentration of total coliform bacteria in household stored water samples
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
|
Concentration of total coliform bacteria (MPN/100mL) in household stored water samples
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About 4-, 8-, and 12-month follow ups after device installations
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Prevalence of caregiver-reported diarrhea among children under five years of age
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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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.
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About 4-, 8-, and 12-month follow ups after device installations
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Prevalence of caregiver-reported diarrhea among household members, any age
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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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.
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About 4-, 8-, and 12-month follow ups after device installations
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Prevalence of diarrhea among female caregivers
Tidsramme: Time frame - About 4-, 8-, and 12-month follow ups after device installations
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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.
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Time frame - About 4-, 8-, and 12-month follow ups after device installations
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Proportion of households reporting an ILC-compatible water source as their primary drinking water source
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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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)
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About 4-, 8-, and 12-month follow ups after device installations
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Proportion of households switching away from ILC-treated water sources
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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Measured as the percentage of households that discontinue use of a chlorinated water system for drinking water compared to baseline.
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About 4-, 8-, and 12-month follow ups after device installations
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Proportion of households reporting any household-level water treatment
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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Measured as the percentage of households reporting treatment of drinking water prior to consumption (e.g., boiling, filtration, manual chlorination).
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About 4-, 8-, and 12-month follow ups after device installations
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Time spent on household-level water treatment
Tidsramme: About 4-, 8-, and 12-month follow ups after device installations
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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
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Amy J Pickering, University of California, Berkeley
- Hovedetterforsker: Elisa M Maffioli, University of Michigan
- Hovedetterforsker: Adamu I Tanko, PhD, Bayero University Kano, Nigeria
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Antatt)
26. mai 2026
Primær fullføring (Antatt)
31. desember 2027
Studiet fullført (Antatt)
31. desember 2027
Datoer for studieregistrering
Først innsendt
14. mai 2026
Først innsendt som oppfylte QC-kriteriene
14. mai 2026
Først lagt ut (Faktiske)
22. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
22. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
14. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 2025-08-18832
Plan for individuelle deltakerdata (IPD)
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Nei
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