Trial Outcomes & Findings for Water, Sanitation, and Hygiene Mobile Health Messages as an Innovative Tool to Facilitate Behavior Change (NCT NCT04816552)

Last Updated: 2024-05-02

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

284 participants

Primary outcome timeframe

1 month, 3 months

Results posted on

2024-05-02

Participant Flow

Unit of analysis: Households

Participant milestones

Participant milestones
Measure	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: The investigators 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. Participants will be provided a handwashing station, a covered water vessel, and chlorine tablets. Participants 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)	Standard Recommendation Arm The second arm participants will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS)
Overall Study STARTED	138 39	146 34
Overall Study COMPLETED	138 39	146 34
Overall Study NOT COMPLETED	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	CHoBI7 mHealth Program Arm n=138 Participants 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: 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)	Standard Recommendation Arm n=146 Participants The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS)	Total n=284 Participants Total of all reporting groups
Age, Categorical <=18 years	63 Participants n=99 Participants	58 Participants n=107 Participants	121 Participants n=206 Participants
Age, Categorical Between 18 and 65 years	75 Participants n=99 Participants	88 Participants n=107 Participants	163 Participants n=206 Participants
Age, Categorical >=65 years	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Age, Continuous	21 years STANDARD_DEVIATION 15 • n=99 Participants	24 years STANDARD_DEVIATION 17.5 • n=107 Participants	21 years STANDARD_DEVIATION 17 • n=206 Participants
Sex: Female, Male Female	72 Participants n=99 Participants	77 Participants n=107 Participants	149 Participants n=206 Participants
Sex: Female, Male Male	66 Participants n=99 Participants	69 Participants n=107 Participants	135 Participants n=206 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	138 Participants n=99 Participants	146 Participants n=107 Participants	284 Participants n=206 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=99 Participants	0 Participants n=107 Participants	0 Participants n=206 Participants
Region of Enrollment Bangladesh	138 Participants n=99 Participants	146 Participants n=107 Participants	284 Participants n=206 Participants

PRIMARY outcome

Timeframe: 1 month, 3 months

Population: Participants that were available are reported

Outcome measures

Outcome measures
Measure	CHoBI7 mHealth Program Arm n=138 Participants 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: 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)	Standard Recommendation Arm n=146 Participants The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS)
Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events 1 month	37 Participants	4 Participants
Number of Participants That Reported Handwashing With Soap at Stool and Food Related Events 3 months	27 Participants	10 Participants

PRIMARY outcome

Timeframe: 7 Days after enrollment

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

Outcome measures

Outcome measures
Measure	CHoBI7 mHealth Program Arm n=39 Household water samples 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: 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)	Standard Recommendation Arm n=34 Household water samples The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS)
Post Intervention Chlorine Concentration in Drinking Water	23 Water samples with chlorine >0.2 mg/L	0 Water samples with chlorine >0.2 mg/L

SECONDARY outcome

Timeframe: Up to 3 months

Population: Individuals with clinical surveillance data available from follow-up visits during the 3 month-surveillance period

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.

Outcome measures

Outcome measures
Measure	CHoBI7 mHealth Program Arm n=80 Participants 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: 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)	Standard Recommendation Arm n=76 Participants The second arm will serve as a Control Arm and only receive a general message on oral rehydration solution (ORS). general message on oral rehydration solution (ORS): general message on oral rehydration solution (ORS)
Percentage of Diarrheal Events	11 percentage of diarrheal events Interval 6.0 to 17.0	4 percentage of diarrheal events Interval 1.0 to 7.0

Adverse Events

CHoBI7 mHealth Program Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Standard Recommendation Arm

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Christine Marie George

Johns Hopkins School of Public Health

Phone: (202) 657-5798

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place