CholeraNCT02928341
Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal Diseases in Uvira, Democratic Republic of Congo
A study testing Improved water supply in people with Cholera and Diarrhea, run by London School of Hygiene and Tropical Medicine at 1 site in Democratic Republic of the Congo.
Trial summary
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… Read more about this study
- Who is it for?
- Any age
- What is being tested?
- Improved water supply
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4,556 participants
- Where
- 1 siteDemocratic Republic of the Congo
- Study dates
- Oct 2016to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Uvira resident admitted to the Uvira Cholera Treatment Centre in Uvira
Who cannot join
- Any patients admitted during the period of intervention implementation in each cluster
Trial locations and contacts
1 site in 1 country.
Democratic Republic of the Congo1 site
Centre de Traitement du Cholera, Hôpital General de Reference d'Uvira, Sud-Kivu, République Démocratique du Congo
Uvira, South Kivu
About this study
Official title: 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.
- Being tested
- Improved water supply
- Medical subject headings
- Cholera, Diarrhea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Improved water supplyOther
| Study group | Role | What they receive |
|---|---|---|
| No intervention | No intervention | Current water supply access |
| Intervention | Experimental | 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. Receives: Other: Improved water supply |
What is being measured
The primary outcome is the main question the study is designed to answer.
Admission rate to the Uvira Cholera Treatment Centre
Measured: 36 months
Secondary outcomes (1)
Admission rate to the Uvira Cholera Treatment Centre of laboratory confirmed cholera cases
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2016 (estimated)
- Study startOct 2016
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 4,556 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Oliver Cumming, MSc, Principal investigator, London School of Hygiene and Tropical MedicineKarin Gallandat, PhD, Principal investigator, London School of Hygiene and Tropical Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02928341
- Sponsor's protocol ID
- 8913
- Status last verified
- Aug 2022
- First submitted
- 7 Oct 2016
- Last updated
- 26 Aug 2022
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Gallandat K, Macdougall A, Jeandron A, Mufitini Saidi J, Bashige Rumedeka B, Malembaka EB, Azman AS, Bompangue D, Cousens S, Allen E, Cumming O. Improved water supply infrastructure to reduce acute diarrhoeal diseases and cholera in Uvira, Democratic Republic of the Congo: Results and lessons learned from a pragmatic trial. PLoS Negl Trop Dis. 2024 Jul 3;18(7):e0012265. doi: 10.1371/journal.pntd.0012265. eCollection 2024 Jul.
PubMed 38959264Gallandat 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.
PubMed 34154636Williams 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.
PubMed 33036564
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact Evaluation of Urban Water Supply Improvements on Cholera and Other Diarrhoeal in Uvira, Democratic Republic of Congo
- ClinicalTrials.gov ID
- NCT02928341
- Acronym / sponsor ID
- 8913
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4,556 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 10 Oct 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| No intervention | No intervention | –Current water supply access |
| Intervention | Experimental | Other: Improved water supplyReceived 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. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Uvira resident admitted to the Uvira Cholera Treatment Centre in Uvira
Key exclusion criteria (1 listed)
- Any patients admitted during the period of intervention implementation in each cluster
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Improved water supply | Other | Intervention |
Primary outcome
Admission rate to the Uvira Cholera Treatment Centre
Time frame: 36 months
1 secondary outcome
Admission rate to the Uvira Cholera Treatment Centre of laboratory confirmed cholera cases
Time frame: 36 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2022.
- Derived from this study: PubMed 38959264Gallandat K, Macdougall A, Jeandron A, Mufitini Saidi J, Bashige Rumedeka B, Malembaka EB, Azman AS, Bompangue D, Cousens S, Allen E, Cumming O. Improved water supply infrastructure to reduce acute diarrhoeal diseases and cholera in Uvira, Democratic Republic of the Congo: Results and lessons learned from a pragmatic trial. PLoS Negl Trop Dis. 2024 Jul 3;18(7):e0012265. doi: 10.1371/journal.pntd.0012265. eCollection 2024 Jul.
- Derived from this study: PubMed 34154636Gallandat 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.
- Derived from this study: PubMed 33036564Williams 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.
- Individual participant dataSharing planned: No
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Diarrhea
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Oliver Cumming, MSc principal investigator
London School of Hygiene and Tropical Medicine
Karin Gallandat, PhD principal investigator
London School of Hygiene and Tropical Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Improved water supply in people with Cholera and Diarrhea, run by London School of Hygiene and Tropical Medicine at 1 site in Democratic Republic of the Congo.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Democratic Republic of the Congo. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Admission rate to the Uvira Cholera Treatment Centre (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02928341, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2022.