NCT04816552

Brief Summary

Develop a scalable approach for delivering water, sanitation, and hygiene (WASH) messages to households in areas with confirmed cholera patients in Dhaka, Bangladesh. This will be done by conducting formative research through in-depth interviews, focus group discussions, and intervention planning workshops with households in areas with confirmed cholera patients and government officials to identify perceptions of WASH behaviors and to inform the development of a mobile health intervention (mHealth) for this population. This intervention approach will then be piloted in a subset of households, and revised according to feedback. Then the investigators will conduct a randomized controlled of the refined mHealth intervention.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
284

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Mar 2021

Shorter than P25 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 22, 2021

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 24, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 28, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 28, 2021

Completed
2.4 years until next milestone

Results Posted

Study results publicly available

May 2, 2024

Completed
Last Updated

May 2, 2024

Status Verified

April 1, 2024

Enrollment Period

8 months

First QC Date

March 24, 2021

Results QC Date

March 22, 2023

Last Update Submit

April 4, 2024

Conditions

Outcome Measures

Primary Outcomes (2)

  • Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events

    Handwashing with soap measured by 5-hour structured at the following food and stool related events in the household: (1) after using the toilet; (2) after cleaning a child's anus; (3) before eating; (4) before feeding a child; and (5) before preparing food.

    1 month, 3 months

  • Post Intervention Chlorine Concentration in Drinking Water

    Free available chlorine in stored household drinking water \>0.2 mg/L

    7 Days after enrollment

Secondary Outcomes (1)

  • Percentage of Diarrheal Events

    Up to 3 months

Study Arms (2)

CHoBI7 mHealth program Arm

EXPERIMENTAL

The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) .

Behavioral: CHoBI7 mHealth program ArmBehavioral: general message on oral rehydration solution (ORS)

Standard Recommendation Arm

ACTIVE COMPARATOR

The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS).

Behavioral: general message on oral rehydration solution (ORS)

Interventions

We will start delivery of this intervention with a pictorial module delivered in the home during two 30 minute visits on cholera transmission and prevention after enrollment. Households will be provided a handwashing station, a covered water vessel, and chlorine tablets. Households will then receive the CHoBI7 WASH mHealth program voice and text messages on handwashing with soap and water treatment bi-weekly.

CHoBI7 mHealth program Arm

general message on oral rehydration solution (ORS)

CHoBI7 mHealth program ArmStandard Recommendation Arm

Eligibility Criteria

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

You may qualify if:

  • At least one household member must report ownership of an active mobile phone in their possession on the day of enrollment

You may not qualify if:

  • Household has a tap or basin with running water inside their home.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

International Centre for Diarrhoeal Disease Research, Bangladesh

Dhaka, Bangladesh

Location

MeSH Terms

Conditions

Cholera

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Results Point of Contact

Title
Dr. Christine Marie George
Organization
Johns Hopkins School of Public Health

Study Officials

  • Christine Marie George, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

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

March 24, 2021

First Posted

March 25, 2021

Study Start

March 22, 2021

Primary Completion

November 28, 2021

Study Completion

November 28, 2021

Last Updated

May 2, 2024

Results First Posted

May 2, 2024

Record last verified: 2024-04

Locations