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- Ensaio Clínico NCT07601503
Evaluating In-line Chlorination in Nigeria
14 de maio de 2026 atualizado por: 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.
Visão geral do estudo
Status
Ainda não está recrutando
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
2655
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Amy J Pickering
- Número de telefone: +1.510.410.2666
- E-mail: pickering@berkeley.edu
Estude backup de contato
- Nome: Elisa M Maffioli
- Número de telefone: +1.443.875.4930
- E-mail: elisamaf@umich.edu
Locais de estudo
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Cross River State
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Yala, Cross River State, Nigéria
- Yala LGA
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Contato:
- Gbenga Adedayo
- Número de telefone: +234.805.602.6845
- E-mail: gadedayo@hanovialimited.com
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Kano State
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Makuda, Kano State, Nigéria
- Makoda LGA
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Contato:
- Gbenga Adedayo
- Número de telefone: +234.805.602.6845
- E-mail: gadedayo@hanovialimited.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Sim
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Prevenção
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Nenhum (rótulo aberto)
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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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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Sem intervenção: 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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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of water source samples with detectable free chlorine residual.
Prazo: 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.
Prazo: 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.
Prazo: 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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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of water source samples with detectable total chlorine residual.
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Outras medidas de resultado
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Proportion of households reporting an ILC-compatible water source as their primary drinking water source
Prazo: 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
Prazo: 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
Prazo: 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
Prazo: 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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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Amy J Pickering, University of California, Berkeley
- Investigador principal: Elisa M Maffioli, University of Michigan
- Investigador principal: Adamu I Tanko, PhD, Bayero University Kano, Nigeria
Publicações e links úteis
A pessoa responsável por inserir informações sobre o estudo fornece voluntariamente essas publicações. Estes podem ser sobre qualquer coisa relacionada ao estudo.
Publicações Gerais
- 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.
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Estimado)
26 de maio de 2026
Conclusão Primária (Estimado)
31 de dezembro de 2027
Conclusão do estudo (Estimado)
31 de dezembro de 2027
Datas de inscrição no estudo
Enviado pela primeira vez
14 de maio de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de maio de 2026
Primeira postagem (Real)
22 de maio de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
22 de maio de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
14 de maio de 2026
Última verificação
1 de maio de 2026
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- 2025-08-18832
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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