- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02928341
Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal Diseases in Uvira, Democratic Republic of Congo
August 23, 2022 updated by: London School of Hygiene and Tropical Medicine
Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal in Uvira, Democratic Republic of Congo
The aim of the study is to evaluate the impact of a large-scale urban water supply improvement intervention on cholera and other diarrhoeal diseases.
The study uses a step wedge cluster randomised controlled trial (SWcRCT) to measure the effect of the intervention on cholera centre admission rates and confirmed cholera cases.
A nested cohort study will examine changes in water-related practices following the intervention.
Study Overview
Study Type
Interventional
Enrollment (Actual)
4556
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Sud-Kivu
-
Uvira, Sud-Kivu, Congo, The Democratic Republic of the
- Centre de Traitement du Cholera, Hôpital General de Reference d'Uvira, Sud-Kivu, République Démocratique du Congo
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- ADULT
- OLDER_ADULT
- CHILD
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Uvira resident admitted to the Uvira Cholera Treatment Centre in Uvira
Exclusion Criteria:
- Any patients admitted during the period of intervention implementation in each cluster
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: FACTORIAL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: No intervention
Current water supply access
|
|
Experimental: Intervention
Received water supply improvement intervention designed to improve access to tap water, consisting of community managed public taps, improved tap water distribution network, refurbished tap connections and promotion of new household tap connections.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Admission rate to the Uvira Cholera Treatment Centre
Time Frame: 36 months
|
36 months
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Admission rate to the Uvira Cholera Treatment Centre of laboratory confirmed cholera cases
Time Frame: 36 months
|
36 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Karin Gallandat, PhD, London School of Hygiene and Tropical Medicine
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Gallandat K, Jeandron A, Ross I, Mufitini Saidi J, Bashige Rumedeka B, Lumami Kapepula V, Cousens S, Allen E, MacDougall A, Cumming O. The impact of improved water supply on cholera and diarrhoeal diseases in Uvira, Democratic Republic of the Congo: a protocol for a pragmatic stepped-wedge cluster randomised trial and economic evaluation. Trials. 2021 Jun 21;22(1):408. doi: 10.1186/s13063-021-05249-x.
- Williams C, Cumming O, Grignard L, Rumedeka BB, Saidi JM, Grint D, Drakeley C, Jeandron A. Prevalence and diversity of enteric pathogens among cholera treatment centre patients with acute diarrhea in Uvira, Democratic Republic of Congo. BMC Infect Dis. 2020 Oct 9;20(1):741. doi: 10.1186/s12879-020-05454-0.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
October 1, 2016
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
October 7, 2016
First Submitted That Met QC Criteria
October 7, 2016
First Posted (Estimate)
October 10, 2016
Study Record Updates
Last Update Posted (Actual)
August 26, 2022
Last Update Submitted That Met QC Criteria
August 23, 2022
Last Verified
August 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8913
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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