- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT07601503
Evaluating In-line Chlorination in Nigeria
14. Mai 2026 aktualisiert von: 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.
Studienübersicht
Status
Noch keine Rekrutierung
Bedingungen
Intervention / Behandlung
Studientyp
Interventionell
Einschreibung (Geschätzt)
2655
Phase
- Unzutreffend
Kontakte und Standorte
Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.
Studienkontakt
- Name: Amy J Pickering
- Telefonnummer: +1.510.410.2666
- E-Mail: pickering@berkeley.edu
Studieren Sie die Kontaktsicherung
- Name: Elisa M Maffioli
- Telefonnummer: +1.443.875.4930
- E-Mail: elisamaf@umich.edu
Studienorte
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Cross River State
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Yala, Cross River State, Nigeria
- Yala LGA
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Kontakt:
- Gbenga Adedayo
- Telefonnummer: +234.805.602.6845
- E-Mail: gadedayo@hanovialimited.com
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Kano State
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Makuda, Kano State, Nigeria
- Makoda LGA
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Kontakt:
- Gbenga Adedayo
- Telefonnummer: +234.805.602.6845
- E-Mail: gadedayo@hanovialimited.com
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Teilnahmekriterien
Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
- Älterer Erwachsener
Akzeptiert gesunde Freiwillige
Ja
Beschreibung
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.
Studienplan
Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Verhütung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
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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.
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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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Kein Eingriff: 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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Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proportion of water source samples with detectable free chlorine residual.
Zeitfenster: 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.
Zeitfenster: 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 positive for Escherichia coli.
Zeitfenster: 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
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Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proportion of water source samples with detectable total chlorine residual.
Zeitfenster: 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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Concentration of E. coli in water source samples
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: About 4-, 8-, and 12-month follow ups after device installations
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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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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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Andere Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
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Proportion of households reporting an ILC-compatible water source as their primary drinking water source
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
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About 4-, 8-, and 12-month follow ups after device installations
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Mitarbeiter und Ermittler
Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.
Ermittler
- Hauptermittler: Amy J Pickering, University of California, Berkeley
- Hauptermittler: Elisa M Maffioli, University of Michigan
- Hauptermittler: Adamu I Tanko, PhD, Bayero University Kano, Nigeria
Publikationen und hilfreiche Links
Die Bereitstellung dieser Publikationen erfolgt freiwillig durch die für die Eingabe von Informationen über die Studie verantwortliche Person. Diese können sich auf alles beziehen, was mit dem Studium zu tun hat.
Allgemeine Veröffentlichungen
- 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.
Studienaufzeichnungsdaten
Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.
Haupttermine studieren
Studienbeginn (Geschätzt)
26. Mai 2026
Primärer Abschluss (Geschätzt)
31. Dezember 2027
Studienabschluss (Geschätzt)
31. Dezember 2027
Studienanmeldedaten
Zuerst eingereicht
14. Mai 2026
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
14. Mai 2026
Zuerst gepostet (Tatsächlich)
22. Mai 2026
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
22. Mai 2026
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
14. Mai 2026
Zuletzt verifiziert
1. Mai 2026
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 2025-08-18832
Plan für individuelle Teilnehmerdaten (IPD)
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Nein
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Nein
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