Cholera-Hospital-Based-Intervention-for-7-days

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

2626 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-04

Study Completion Date

2019-04-26

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days (CHoBI7)

NCT06498817

Diarrhea Infectious Cholera

RECRUITING NA

Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)

NCT06003816

Cholera Diarrhea

RECRUITING NA

Introduction of Cholera Vaccine in Bangladesh

NCT01339845

Cholera

COMPLETED NA

Efficacy of iOWH032 in Dehydrating Cholera

NCT02111304

Secretory Diarrhea

WITHDRAWN PHASE2

To Determine the Safety and Immunogenicity of an Oral Whole Cell ShanChol Cholera Vaccine in Bangladesh

NCT01042951

Healthy

COMPLETED PHASE2

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Cholera Diarrhea Stunting

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Masking was not possible because the intervention included visible components including a handwashing station and a covered drinking water storage vessel.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Standard recommendation (ORS)

Participants received the standard recommendation on oral rehydration solution use

Group Type NO_INTERVENTION

No interventions assigned to this group

mHealth with no home visits

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

Group Type EXPERIMENTAL

CHoBI7 health facility program

Intervention Type BEHAVIORAL

The CHoBI7 health facility program focuses on promoting handwashing with soap and water treatment to diarrhea patients and their household members during the one-week period after the patient is admitted to the health facility, when their household is at highest risk for diarrheal diseases. The CHoBI7 program includes: (1) a WASH pictorial module delivered by a health worker bedside to diarrhea patient and their household members in a health facility on handwashing with soap, water treatment, and safe water storage; and (2) a diarrhea prevention package containing chlorine tablets for water treatment, a soapy water bottle (water and detergent powder), a handwashing station, and a water vessel with a lid and tap for safe drinking water storage. Households are instructed to boil their water once their supply of chlorine tablets is completed.

CHoBI7 mHealth program

Intervention Type BEHAVIORAL

The CHoBI7 mHealth (mobile health) program targets five key behaviors: (1) preparing soapy water using water and detergent powder; (2) handwashing with soap at food and stool related events; (3) treating household drinking water using chlorine tablets during the one week high risk period after the diarrhea patient in the household was admitted to the health facility; (4) safe drinking water storage in a water vessel with a lid and tap; and (5) heating of household drinking water until it reaches a rolling boil after the one week high risk period. Participant households receive bi-weekly voice and text messages from the CHoBI7 mHealth program over a 12-month period. These mobile messages are sent using the VIAMO platform (www.viamo.io).

mHealth with home visits

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

Group Type EXPERIMENTAL

CHoBI7 health facility program

Intervention Type BEHAVIORAL

The CHoBI7 health facility program focuses on promoting handwashing with soap and water treatment to diarrhea patients and their household members during the one-week period after the patient is admitted to the health facility, when their household is at highest risk for diarrheal diseases. The CHoBI7 program includes: (1) a WASH pictorial module delivered by a health worker bedside to diarrhea patient and their household members in a health facility on handwashing with soap, water treatment, and safe water storage; and (2) a diarrhea prevention package containing chlorine tablets for water treatment, a soapy water bottle (water and detergent powder), a handwashing station, and a water vessel with a lid and tap for safe drinking water storage. Households are instructed to boil their water once their supply of chlorine tablets is completed.

CHoBI7 mHealth program

Intervention Type BEHAVIORAL

The CHoBI7 mHealth (mobile health) program targets five key behaviors: (1) preparing soapy water using water and detergent powder; (2) handwashing with soap at food and stool related events; (3) treating household drinking water using chlorine tablets during the one week high risk period after the diarrhea patient in the household was admitted to the health facility; (4) safe drinking water storage in a water vessel with a lid and tap; and (5) heating of household drinking water until it reaches a rolling boil after the one week high risk period. Participant households receive bi-weekly voice and text messages from the CHoBI7 mHealth program over a 12-month period. These mobile messages are sent using the VIAMO platform (www.viamo.io).

CHoBI7 home visit program

Intervention Type BEHAVIORAL

The CHoBI7 home visit program involves two, 30-minute home visits conducted during the week after the index diarrhea patient was recruited at the health facility. A health worker reinforces the content of the CHoBI7 health facility program in the participant's home.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CHoBI7 health facility program

The CHoBI7 health facility program focuses on promoting handwashing with soap and water treatment to diarrhea patients and their household members during the one-week period after the patient is admitted to the health facility, when their household is at highest risk for diarrheal diseases. The CHoBI7 program includes: (1) a WASH pictorial module delivered by a health worker bedside to diarrhea patient and their household members in a health facility on handwashing with soap, water treatment, and safe water storage; and (2) a diarrhea prevention package containing chlorine tablets for water treatment, a soapy water bottle (water and detergent powder), a handwashing station, and a water vessel with a lid and tap for safe drinking water storage. Households are instructed to boil their water once their supply of chlorine tablets is completed.

Intervention Type BEHAVIORAL

CHoBI7 mHealth program

The CHoBI7 mHealth (mobile health) program targets five key behaviors: (1) preparing soapy water using water and detergent powder; (2) handwashing with soap at food and stool related events; (3) treating household drinking water using chlorine tablets during the one week high risk period after the diarrhea patient in the household was admitted to the health facility; (4) safe drinking water storage in a water vessel with a lid and tap; and (5) heating of household drinking water until it reaches a rolling boil after the one week high risk period. Participant households receive bi-weekly voice and text messages from the CHoBI7 mHealth program over a 12-month period. These mobile messages are sent using the VIAMO platform (www.viamo.io).

Intervention Type BEHAVIORAL

CHoBI7 home visit program

The CHoBI7 home visit program involves two, 30-minute home visits conducted during the week after the index diarrhea patient was recruited at the health facility. A health worker reinforces the content of the CHoBI7 health facility program in the participant's home.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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