Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change

Cholera Clinical Trial

— CHoBI7  

Official title:

Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change (CHoBI7 Program)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04816552
• Other study ID #: 9255
• Secondary ID: IRB00009255
• Status: Completed
• Phase: N/A
• Start date: March 22, 2021
• Est. completion date: November 28, 2021

Study information

• Verified date: April 2024
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

Aim 1. Develop an evidence and theory based WASH mHealth intervention for households in areas with confirmed cholera patients in Dhaka, Bangladesh through formative research

1. Conduct formative research through in-depth interviews, focus group discussions, and intervention planning workshops with caregivers and household members of young children, and government officials to identify perceptions of WASH behaviors and to inform the development of intervention materials.

2. Pilot the WASH mHealth intervention in a subset of households, and revise according to feedback.

Aim 2: Evaluate the effectiveness of the developed WASH mHealth intervention in increasing WASH behaviors and reducing fecal contamination on hands and in stored drinking water by conducting a RCT

1. Recruit and prospectively follow for 12 months 120 households (600 participants, 4 per household) with a child under five years of age assigned to one of two study arms (60 households per arm). The first arm will receive the CHoBI7 mHealth program (CHoBI7 mHealth program Arm) and the second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS).

2. Compare the 2 study arms using structured observation of handwashing with soap at stool and food related events, unannounced spot checks of the presence of soap in the cooking and latrine areas of the household, and fecal coliform counts on caregiver hands and in stored drinking water.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 284
• Est. completion date: November 28, 2021
• Est. primary completion date: November 28, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Cholera

Intervention

Behavioral:
• CHoBI7 mHealth program Arm
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.
• general message on oral rehydration solution (ORS)
general message on oral rehydration solution (ORS)

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka

Sponsors (2)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Post Intervention Chlorine Concentration in Drinking Water	Free available chlorine in stored household drinking water >0.2 mg/L	7 Days after enrollment
Secondary	Percentage of Diarrheal Events	Participants will be asked if they have had diarrhea in the past week at the follow-up visits during the 3 month surveillance visit. Percentage of diarrheal events is reported.	Up to 3 months