NCT06003816

Brief Summary

Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted water, sanitation, and hygiene (WASH) intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
3,140

participants targeted

Target at P75+ for not_applicable

Timeline
7mo left

Started Oct 2023

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
recruiting

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 Progress82%
Oct 2023Nov 2026

First Submitted

Initial submission to the registry

August 16, 2023

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 22, 2023

Completed
2 months until next milestone

Study Start

First participant enrolled

October 18, 2023

Completed
3.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2026

Last Updated

December 2, 2025

Status Verified

December 1, 2025

Enrollment Period

3.1 years

First QC Date

August 16, 2023

Last Update Submit

December 1, 2025

Conditions

CholeraDiarrhea

Keywords

randomized controlled trialwatersanitationhygienecase area targeted interventionBangladesh

Outcome Measures

Primary Outcomes (1)

  • Number of non-baseline cholera infections among individuals residing in a ring around cholera patients

    cholera infection assessed by bacterial culture and/or vibriocidal antibody titer

    1 month

Secondary Outcomes (12)

  • Diarrhea among individuals residing in a ring around cholera patients

    12 months

  • Child development for children under 5 years of age as assessed by the Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)

    12 Months

  • Rate of Handwashing with soap at stool and food related events

    12 Months

  • Free chlorine concentration (mg/L) in stored drinking water

    12 months

  • Presence of Vibrio cholerae and E. coli in stored drinking water

    12 months

  • +7 more secondary outcomes

Study Arms (2)

Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI

EXPERIMENTAL

The CHoBI7 program is first delivered during group sessions by a health promoter to those residing in a ring around a cholera patient. The health promoter delivers a pictorial WASH module on how diarrhea can spread, and instructions on handwashing with soap, water treatment, and safe water storage. A cholera prevention package is provided containing: a one-month supply of chlorine tablets for water treatment, a soapy water bottle for handwashing, a handwashing station, and a water vessel with a lid and tap to ensure safe water storage. After the group session, households receive weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended WASH behaviors.

Behavioral: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI

Standard Message Arm

ACTIVE COMPARATOR

Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution

Behavioral: Standard message

Interventions

Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATIBEHAVIORAL

The CHoBI7 program is during group sessions by a health promoter to those residing in a ring around a cholera patient reinforced through weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended water, sanitation, and hygiene behaviors.

Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
Standard messageBEHAVIORAL

Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution

Standard Message Arm

Eligibility Criteria

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

You may qualify if:

  • Index cholera patient have no running water inside of their home

You may not qualify if:

  • No one will be excluded because of age, sex, religion, or sexual preference

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

RECRUITING

Research Training and Management International

Dhaka, Bangladesh

RECRUITING

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

  • Christine Marie George, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Christine Marie George, PhD

CONTACT

(202) 657-5798cmgeorge@jhu.edu

Study Design

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

Study Record Dates

First Submitted

August 16, 2023

First Posted

August 22, 2023

Study Start

October 18, 2023

Primary Completion (Estimated)

November 30, 2026

Study Completion (Estimated)

November 30, 2026

Last Updated

December 2, 2025

Record last verified: 2025-12

Data Sharing

IPD Sharing
Will not share

All data will be de-identified and available to our collaborators

Locations

BA(2)