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

April 4, 2024 updated by: Johns Hopkins Bloomberg School of Public Health

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
284

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Bangladesh
      • Dhaka, Bangladesh
        • International Centre for Diarrhoeal Disease Research, Bangladesh

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: 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) .
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.
Behavioral: general message on oral rehydration solution (ORS)
general message on oral rehydration solution (ORS)
Active Comparator: Standard Recommendation Arm
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)
general message on oral rehydration solution (ORS)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events
Time Frame: 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.
1 month, 3 months
Post Intervention Chlorine Concentration in Drinking Water
Time Frame: 7 Days after enrollment
Free available chlorine in stored household drinking water >0.2 mg/L
7 Days after enrollment

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Percentage of Diarrheal Events
Time Frame: 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.
Up to 3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Johns Hopkins Bloomberg School of Public Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Christine Marie George, PhD, Johns Hopkins Bloomberg School of Public Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 22, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 28, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 28, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 24, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 24, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
March 25, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 2, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 4, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 9255
  • IRB00009255 (Other Identifier: JHSPH IRB)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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