NCT04008134

Brief Summary

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
2,626

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Dec 2016

Typical duration for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 4, 2016

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 26, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 26, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 2, 2019

Completed
3 days until next milestone

First Posted

Study publicly available on registry

July 5, 2019

Completed
Last Updated

February 10, 2022

Status Verified

January 1, 2022

Enrollment Period

2.4 years

First QC Date

July 2, 2019

Last Update Submit

January 27, 2022

Conditions

CholeraDiarrheaStunting

Keywords

handwashing with soapwater treatmentbehavior changewater, sanitation and hygiene

Outcome Measures

Primary Outcomes (3)

  • Diarrhea prevalence among children under 2 years of age

    Diarrhea prevalence among children under 2 years of age assessed by caregiver self report over a 12-month period

    12 months

  • Diarrhea prevalence among children under 5 years of age

    Diarrhea prevalence among children under 5 years of age assessed by caregiver self report over a 12-month period

    12 months

  • Diarrhea prevalence among all household members

    Diarrhea prevalence among all household members assessed by self report over a 12-month period

    12 months

Secondary Outcomes (11)

  • Diarrhea prevalence among participants ages 5-9 years

    12 months

  • Diarrhea prevalence among participants ages 10-18 years

    12 months

  • Diarrhea prevalence among participants ages greater than 18 years

    12 months

  • Handwashing with soap

    12 months

  • Household drinking water treatment

    12 months

  • +6 more secondary outcomes

Study Arms (3)

Standard recommendation (ORS)

NO INTERVENTION

Participants received the standard recommendation on oral rehydration solution use

mHealth with no home visits

EXPERIMENTAL

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

Behavioral: CHoBI7 health facility programBehavioral: CHoBI7 mHealth program

mHealth with home visits

EXPERIMENTAL

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

Behavioral: CHoBI7 health facility programBehavioral: CHoBI7 mHealth programBehavioral: CHoBI7 home visit program

Interventions

CHoBI7 health facility programBEHAVIORAL

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.

mHealth with home visitsmHealth with no home visits
CHoBI7 mHealth programBEHAVIORAL

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 visitsmHealth with no home visits
CHoBI7 home visit programBEHAVIORAL

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.

mHealth with home visits

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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:
  • have had 3 or more loose stools over the past 24 hours
  • plan to reside in Dhaka for the next 12 months
  • have no basin for running water in their home
  • have a child under five years of age in their household (including themselves) that produced a stool sample at baseline
  • have a working mobile phone in the household.
  • Household members of the diarrhea patient will be eligible for the trial if:
  • they have shared the same cooking pot and resided in the same home with the diarrhea patient for the last three days
  • plan to reside in their current household with the diarrhea patient for the next 12 months

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (8)

  • George CM, Monira S, Zohura F, Thomas ED, Hasan MT, Parvin T, Hasan K, Rashid MU, Papri N, Islam A, Rahman Z, Rafique R, Islam Bhuyian MS, Saxton R, Labrique A, Alland K, Barman I, Jubyda FT, Afroze F, Sultana M, Johura FT, Khan MAH, Tahmina S, Munmun F, Sack DA, Perin J, Alam M. Effects of a Water, Sanitation, and Hygiene Mobile Health Program on Diarrhea and Child Growth in Bangladesh: A Cluster-randomized Controlled Trial of the Cholera Hospital-based Intervention for 7 Days (CHoBI7) Mobile Health Program. Clin Infect Dis. 2021 Nov 2;73(9):e2560-e2568. doi: 10.1093/cid/ciaa754.

    PMID: 32761174RESULT

  • George CM, Bhuyian MSI, Thomas ED, Parvin T, Monira S, Zohura F, Hasan MT, Tahmina S, Munmun F, Sack DA, Perin J, Alam M. Psychosocial Factors Mediating the Effect of the CHoBI7 Mobile Health Program on Handwashing With Soap and Household Stored Water Quality: A Randomized Controlled Trial. Health Educ Behav. 2022 Apr;49(2):326-339. doi: 10.1177/1090198120987134. Epub 2021 May 5.

    PMID: 33949243RESULT

  • George CM, Zohura F, Teman A, Thomas E, Hasan T, Rana S, Parvin T, Sack DA, Bhuyian SI, Labrique A, Masud J, Winch P, Leontsini E, Zeller K, Begum F, Khan AH, Tahmina S, Munum F, Monira S, Alam M. Formative research for the design of a scalable water, sanitation, and hygiene mobile health program: CHoBI7 mobile health program. BMC Public Health. 2019 Jul 31;19(1):1028. doi: 10.1186/s12889-019-7144-z.

    PMID: 31366398RESULT

  • Thomas ED, Zohura F, Hasan MT, Rana MS, Teman A, Parvin T, Masud J, Bhuyian MSI, Hossain MK, Hasan M, Tahmina S, Munmun F, Khan MAH, Monira S, Sack DA, Leontsini E, Winch PJ, Alam M, George CM. Formative research to scale up a handwashing with soap and water treatment intervention for household members of diarrhea patients in health facilities in Dhaka, Bangladesh (CHoBI7 program). BMC Public Health. 2020 Jun 1;20(1):831. doi: 10.1186/s12889-020-08727-0.

    PMID: 32487209RESULT

  • Masud J, Islam Bhuyian MS, Kumar Biswas S, Zohura F, Perin J, Papri N, Dil Farzana F, Parvin T, Monira S, Alam M, George CM. Diarrhoeal disease knowledge among diarrhoea patient housholds: findings from the randomised controlled trial of the Cholera-Hospital-Based-Intervention-for-7-days (CHoBI7) mobile health program. Trop Med Int Health. 2020 Aug;25(8):996-1007. doi: 10.1111/tmi.13415. Epub 2020 Jul 21.

    PMID: 32406989RESULT

  • Islam Bhuyian MS, Saxton R, Hasan K, Masud J, Zohura F, Monira S, Kumar Biswas S, Tasdik Hasan M, Parvin T, Minhaj I, Md Zillur Rahman K, Papri N, Rashid MU, Sharin L, Teman A, Thomas ED, Alland K, Labrique A, Sack DA, Perin J, Alam M, George CM. Process evaluation for the delivery of a water, sanitation and hygiene mobile health program: findings from the randomised controlled trial of the CHoBI7 mobile health program. Trop Med Int Health. 2020 Aug;25(8):985-995. doi: 10.1111/tmi.13414. Epub 2020 Jul 18.

    PMID: 32406965RESULT

  • Zohura F, Bhuyian MSI, Saxton RE, Parvin T, Monira S, Biswas SK, Masud J, Nuzhat S, Papri N, Hasan MT, Thomas ED, Sack D, Perin J, Alam M, George CM. Effect of a water, sanitation and hygiene program on handwashing with soap among household members of diarrhoea patients in healthcare facilities in Bangladesh: a cluster-randomised controlled trial of the CHoBI7 mobile health program. Trop Med Int Health. 2020 Aug;25(8):1008-1015. doi: 10.1111/tmi.13416. Epub 2020 Jul 14.

    PMID: 32406581RESULT

  • George CM, Perin J, Parvin T, Bhuyian S, Thomas ED, Monira S, Zohura F, Hasan T, Sack D, Alam M. Effects of a Water, Sanitation and Hygiene Mobile Health Program on Respiratory Illness in Bangladesh: A Cluster-Randomized Controlled Trial of the CHoBI7 Mobile Health Program. Am J Trop Med Hyg. 2022 Jan 10;106(3):979-984. doi: 10.4269/ajtmh.21-0679.

    PMID: 35008045RESULT

MeSH Terms

Conditions

CholeraDiarrheaGrowth Disorders

Condition Hierarchy (Ancestors)

Vibrio InfectionsGram-Negative Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfectionsSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsPathologic Processes

Study Officials

  • Christine Marie George, PhD

    Johns Hopkins Bloomberg School of Public Health

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Masking Details
Masking was not possible because the intervention included visible components including a handwashing station and a covered drinking water storage vessel.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 2, 2019

First Posted

July 5, 2019

Study Start

December 4, 2016

Primary Completion

April 26, 2019

Study Completion

April 26, 2019

Last Updated

February 10, 2022

Record last verified: 2022-01

Data Sharing

IPD Sharing
Will not share