NCT02928341

Brief 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 cholera cases. A nested cohort study will examine changes in water-related practices following the intervention.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
4,556

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Oct 2016

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2016

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

October 7, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

October 10, 2016

Completed
5.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 26, 2022

Status Verified

August 1, 2022

Enrollment Period

5.3 years

First QC Date

October 7, 2016

Last Update Submit

August 23, 2022

Conditions

CholeraDiarrhea

Outcome Measures

Primary Outcomes (1)

  • Admission rate to the Uvira Cholera Treatment Centre

    36 months

Secondary Outcomes (1)

  • Admission rate to the Uvira Cholera Treatment Centre of laboratory confirmed cholera cases

    36 months

Study Arms (2)

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.

Other: Improved water supply

Interventions

Improved water supplyOTHER
Intervention

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Uvira resident admitted to the Uvira Cholera Treatment Centre in Uvira

You may not qualify if:

  • Any patients admitted during the period of intervention implementation in each cluster

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Centre de Traitement du Cholera, Hôpital General de Reference d'Uvira, Sud-Kivu, République Démocratique du Congo

Uvira, South Kivu, Democratic Republic of the Congo

Location

Related Publications (3)

  • 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.

    PMID: 38959264DERIVED

  • 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.

    PMID: 34154636DERIVED

  • 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.

    PMID: 33036564DERIVED

MeSH Terms

Conditions

CholeraDiarrhea

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Oliver Cumming, MSc

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

  • Karin Gallandat, PhD

    London School of Hygiene and Tropical Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
FACTORIAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 7, 2016

First Posted

October 10, 2016

Study Start

October 1, 2016

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 26, 2022

Record last verified: 2022-08

Data Sharing

IPD Sharing
Will not share

Locations

DE(1)