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CompletedNCT04816552CHoBI7Updated May 2, 2024Results posted

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

An interventional study of CHoBI7 mHealth program Arm and general message on oral rehydration solution (ORS) in Cholera, sponsored by Johns Hopkins Bloomberg School of Public Health. Completed at 1 site in Bangladesh. Per ClinicalTrials.gov, last updated 2024-05-02.

Sponsored by Johns Hopkins Bloomberg School of Public Health · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
284
Allocation
Randomized
Sex
All
01

Study 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.

Read the 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.
02

Conditions studied

  • Cholera

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03

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
Yes

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

Exclusion Criteria:

  • Household has a tap or basin with running water inside their home.
04

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
284 participants (actual)

Study arms

  • 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 · Behavioral: 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)

Interventions

  • BehavioralCHoBI7 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.

  • Behavioralgeneral message on oral rehydration solution (ORS)

    general message on oral rehydration solution (ORS)

05

What researchers measure

Primary outcomes

  1. 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.

    Time frame: 1 month, 3 months

  2. Post Intervention Chlorine Concentration in Drinking Water

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

    Time frame: 7 Days after enrollment

Secondary outcomes

  1. 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.

    Time frame: Up to 3 months

06

Results

Posted May 2, 2024

Participant flow

Participant flow — Overall Study
MilestoneCHoBI7 mHealth Program ArmStandard Recommendation Arm
Started138146
Completed138146
Not completed00

Outcome measures

PrimaryNumber 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.

Time frame:
1 month, 3 months
Reported as:
Count of participants · Participants
Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events
ParticipantsCHoBI7 mHealth Program ArmStandard Recommendation Arm
1 month374
3 months2710
PrimaryPost Intervention Chlorine Concentration in Drinking Water

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

Time frame:
7 Days after enrollment
Reported as:
Number · Water samples with chlorine >0.2 mg/L
Post Intervention Chlorine Concentration in Drinking Water
Water samples with chlorine >0.2 mg/LCHoBI7 mHealth Program ArmStandard Recommendation Arm
Post Intervention Chlorine Concentration in Drinking Water230
SecondaryPercentage 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.

Time frame:
Up to 3 months
Reported as:
Mean · percentage of diarrheal events
Percentage of Diarrheal Events
percentage of diarrheal eventsCHoBI7 mHealth Program ArmStandard Recommendation Arm
Percentage of Diarrheal Events11 (6 to 17)4 (1 to 7)

Adverse events

Collected over 3 months. Non-serious events are listed at a 0% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
CHoBI7 mHealth Program Arm0/138 (0%)0/138 (0%)0/138 (0%)
Standard Recommendation Arm0/146 (0%)0/146 (0%)0/146 (0%)

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)CHoBI7 mHealth Program ArmStandard Recommendation ArmTotal
<=18 years6358121
Between 18 and 65 years7588163
>=65 years000
Age, Continuous
Age, Continuous(years)CHoBI7 mHealth Program ArmStandard Recommendation ArmTotal
Mean21 ± 1524 ± 17.521 ± 17
Sex: Female, Male
Sex: Female, Male(Participants)CHoBI7 mHealth Program ArmStandard Recommendation ArmTotal
Female7277149
Male6669135
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)CHoBI7 mHealth Program ArmStandard Recommendation ArmTotal
Hispanic or Latino000
Not Hispanic or Latino138146284
Unknown or Not Reported000
Region of Enrollment
Region of Enrollment(Participants)CHoBI7 mHealth Program ArmStandard Recommendation ArmTotal
Bangladesh138146284
07

Study locations

1 site
  • International Centre for Diarrhoeal Disease Research, Bangladesh
    Dhaka, Bangladesh
08

References and documents

Study documents

  • Protocol and statistical analysis plan · Jan 27, 2020

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: Undecided

09

Registry details

Key details

Study ID
NCT04816552
Lead sponsor
Johns Hopkins Bloomberg School of Public Health
Collaborators
National Institute of Allergy and Infectious Diseases (NIAID)
Responsible party
Sponsor
First posted
Mar 25, 2021
Start date
Mar 22, 2021
Primary completion
Nov 28, 2021
Completion
Nov 28, 2021
Results posted
May 2, 2024
Last update
May 2, 2024

Study contacts

Christine Marie George, PhD
principal investigator · Johns Hopkins Bloomberg School of Public Health

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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