Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7)

Johns Hopkins Bloomberg School of Public Health

Status: Completed

Conditions: Diarrhea; Cholera; Stunting

Treatments: Behavioral: CHoBI7 health facility program; Behavioral: CHoBI7 home visit program; Behavioral: CHoBI7 mHealth program

Study type: Interventional

Funder types: Other

Identifiers

NCT04008134

IRB00006785

PR-15133 (Other Identifier)

Details and patient eligibility

About

The Cholera Hospital Based Intervention for 7 Days (CHoBI7) randomized controlled trial for transition to scale aimed to: (1) Develop and evaluate scalable approaches to integrate the CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing with soap and water treatment behaviors and significant reductions in diarrheal disease over time.

Full description

The findings from the recent randomized controlled trial of The Cholera Hospital Based Intervention for 7 Days (CHoBI7) demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections in intervention households, and had significant sustained impacts on hand washing with soap behaviors and improved water quality 12 months post intervention. Next steps to transition to scale were: (1) Develop and evaluate scalable approaches to integrate the CHoBI7 intervention into the services provided for hospitalized diarrhea patients at health facilities in Bangladesh; and (2) Evaluate the ability of the CHoBI7 intervention to lead to a sustained uptake of the promoted hand washing with soap and water treatment behaviors and significant reductions in diarrheal disease over time.

Enrollment: 2,626 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

Diarrhea patients will be defined as patients having acute watery diarrhea three or more loose stools over a 24-hour period in the past three days. Diarrhea patients admitted to ICDDRB Dhaka Hospital or Mugda General Hospital will be eligible for the trial if:

1. have had 3 or more loose stools over the past 24 hours
2. plan to reside in Dhaka for the next 12 months
3. have no basin for running water in their home
4. have a child under five years of age in their household (including themselves) that produced a stool sample at baseline
5. have a working mobile phone in the household.

Household members of the diarrhea patient will be eligible for the trial if:

1. they have shared the same cooking pot and resided in the same home with the diarrhea patient for the last three days
2. plan to reside in their current household with the diarrhea patient for the next 12 months

Exclusion criteria

(1) Children in foster care will be excluded from all research study activities.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,626 participants in 3 patient groups

Standard recommendation (ORS)

No Intervention group

Description:

Participants received the standard recommendation on oral rehydration solution use

mHealth with no home visits

Experimental group

Description:

Participants received the health facility delivery of CHoBI7, plus bi-weekly mHealth (voice and text) reminders for 12 months

Treatment:

Behavioral: CHoBI7 health facility program

Behavioral: CHoBI7 mHealth program

mHealth with home visits

Experimental group

Description:

Participants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months

Treatment:

Behavioral: CHoBI7 home visit program

Behavioral: CHoBI7 health facility program

Behavioral: CHoBI7 mHealth program