- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07601503
Evaluating In-line Chlorination in Nigeria
14 maj 2026 uppdaterad 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.
Studieöversikt
Status
Har inte rekryterat ännu
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Beräknad)
2655
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Amy J Pickering
- Telefonnummer: +1.510.410.2666
- E-post: pickering@berkeley.edu
Studera Kontakt Backup
- Namn: Elisa M Maffioli
- Telefonnummer: +1.443.875.4930
- E-post: elisamaf@umich.edu
Studieorter
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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-post: 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-post: gadedayo@hanovialimited.com
-
-
Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Barn
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Ja
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Förebyggande
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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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Inget ingripande: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of water source samples with detectable free chlorine residual.
Tidsram: 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.
Tidsram: 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.
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of water source samples with detectable total chlorine residual.
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Andra resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Proportion of households reporting an ILC-compatible water source as their primary drinking water source
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- Huvudutredare: Amy J Pickering, University of California, Berkeley
- Huvudutredare: Elisa M Maffioli, University of Michigan
- Huvudutredare: Adamu I Tanko, PhD, Bayero University Kano, Nigeria
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Beräknad)
26 maj 2026
Primärt slutförande (Beräknad)
31 december 2027
Avslutad studie (Beräknad)
31 december 2027
Studieregistreringsdatum
Först inskickad
14 maj 2026
Först inskickad som uppfyllde QC-kriterierna
14 maj 2026
Första postat (Faktisk)
22 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
22 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
14 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 2025-08-18832
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
NEJ
Läkemedels- och apparatinformation, studiedokument
Studerar en amerikansk FDA-reglerad läkemedelsprodukt
Nej
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Nej
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