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

Not Applicable

Completed

• Conditions: Cholera
• Interventions: Behavioral: general message on oral rehydration solution (ORS); Behavioral: CHoBI7 mHealth program Arm

• Registration Number: NCT04816552
• Lead Sponsor: Johns Hopkins Bloomberg School of Public Health

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.

Detailed 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.

Study Timeline

• Study Start: 2021-03-22
• Study First Submitted: 2021-03-24
• Study First Submitted QC: 2021-03-24
• Study First Posted: 2021-03-25
• Primary Completion: 2021-11-28
• Study Completion: 2021-11-28
• Results First Submitted: 2023-03-22
• Status Verified: 2024-04
• Results First Submitted QC: 2024-04-04
• Last Update Submitted: 2024-04-04
• Results First Posted: 2024-05-02
• Last Update Posted: 2024-05-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 284

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard Recommendation Arm	general message on oral rehydration solution (ORS)	The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS).
CHoBI7 mHealth program Arm	CHoBI7 mHealth program Arm	The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) .
CHoBI7 mHealth program Arm	general message on oral rehydration solution (ORS)	The first arm will receive the CHoBI7 mHealth program and a general message on oral rehydration solution (ORS) (CHoBI7 mHealth program Arm) .

Primary Outcome Measures

Name	Time	Method
Post Intervention Chlorine Concentration in Drinking Water	7 Days after enrollment	Free available chlorine in stored household drinking water \>0.2 mg/L
Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events	1 month, 3 months	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.

Secondary Outcome Measures

Name	Time	Method
Percentage of Diarrheal Events	Up to 3 months	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.

Trial Locations

Locations (1)

International Centre for Diarrhoeal Disease Research, Bangladesh; 🇧🇩 Dhaka, Bangladesh