CholeraCHoBI7NCT04008134
Cholera-Hospital-Based-Intervention-for-7-days
A study testing CHoBI7 health facility program, CHoBI7 mHealth program and CHoBI7 home visit program in people with Cholera and Diarrhea, run by Johns Hopkins Bloomberg School of Public Health.
Trial 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… Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- What is being tested?
- CHoBI7 health facility program, CHoBI7 mHealth program and CHoBI7 home visit program
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,626 participants
- Where
- No sites listed yet
- Study dates
- 4 Dec 2016to 26 Apr 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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
Who cannot join
- Children in foster care will be excluded from all research study activities.
About this study
Official title: CHoBI7 Trial: A Hospital Based Water, Sanitation and Hygiene Intervention for Households of Diarrheal Patients in Bangladesh
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.
Read the detailed 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.
- Being tested
- CHoBI7 health facility program, CHoBI7 mHealth program, CHoBI7 home visit program
- Keywords
- handwashing with soap, water treatment, behavior change, water, sanitation and hygiene
- Medical subject headings
- Cholera, Diarrhea, Growth Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CHoBI7 health facility programBehavioural
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 programBehavioural
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 programBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Behavioral: CHoBI7 health facility program; Behavioral: 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 Receives: Behavioral: CHoBI7 health facility program; Behavioral: CHoBI7 mHealth program; Behavioral: CHoBI7 home visit program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 12 months
Diarrhea prevalence among all household members
Diarrhea prevalence among all household members assessed by self report over a 12-month period
Measured: 12 months
Secondary outcomes (11)
Diarrhea prevalence among participants ages 5-9 years
Diarrhea prevalence among all household members ages 5-9 years assessed by self report over a 12-month period
Measured: 12 months
Diarrhea prevalence among participants ages 10-18 years
Diarrhea prevalence among all household members ages 10-18 years assessed by self report over a 12-month period
Measured: 12 months
Diarrhea prevalence among participants ages greater than 18 years
Diarrhea prevalence among all household members ages greater than 18 years assessed by self report over a 12-month period
Measured: 12 months
Handwashing with soap
Household members handwashing with soap at food and stool related events assessed by 5-hour structured observation over a 12-month period
Measured: 12 months
Household drinking water treatment
Households with stored drinking water samples without detectable E.coli (<1 colony forming units / 100 ml) assessed by unannounced household visits for sample collection of household stored drinking water over a 12-month period
Measured: 12 months
Height-for-age among children under 2 years of age
Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
Measured: 12 months
Height-for-age among children under 5 years of age
Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate height-for-age z-scores according to the World Health Organization child growth standards
Measured: 12 months
Weight-for-age among children under 2 years of age
Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
Measured: 12 months
Weight-for-age among children under 5 years of age
Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-age z-scores according to the World Health Organization child growth standards
Measured: 12 months
Weight-for-height among children under 2 years of age
Height, weight and age measurements among children under 2 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards
Measured: 12 months
Weight-for-height among children under 5 years of age
Height, weight and age measurements among children under 5 years of age assessed over a 12-month period were used to calculate weight-for-height z-scores according to the World Health Organization child growth standards
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jul 2019
- Study start4 Dec 2016
- Primary completion26 Apr 2019
- Study completion26 Apr 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for CholeraStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 2,626 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins Bloomberg School of Public Health
- Sponsor type
- University, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Responsible party
- Sponsor
- Investigators
- Christine Marie George, PhD, Principal investigator, Johns Hopkins Bloomberg School of Public Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04008134
- Sponsor's protocol ID
- IRB00006785
- Other IDs
- PR-15133
- Acronym
- CHoBI7
- Status last verified
- Jan 2022
- First submitted
- 2 Jul 2019
- Last updated
- 10 Feb 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 32761174George 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.
PubMed 33949243George 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.
PubMed 31366398Thomas 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.
PubMed 32487209Masud 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.
PubMed 32406989Islam 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.
PubMed 32406965Zohura 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.
PubMed 32406581George 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.
PubMed 35008045
Study at a glance
From the registry record, last updated by the sponsor on 10 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CHoBI7 Trial: A Hospital Based Water, Sanitation and Hygiene Intervention for Households of Diarrheal Patients in Bangladesh
- ClinicalTrials.gov ID
- NCT04008134
- Acronym / sponsor ID
- CHoBI7 / IRB00006785
- Keywords
- handwashing with soap, water treatment, behavior change, water, sanitation and hygiene
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,626 participants (actual)
- Lead sponsor
- Johns Hopkins Bloomberg School of Public HealthUniversity, hospital or other
- Collaborators
- International Centre for Diarrhoeal Disease Research, Bangladesh
- Study start
- 4 Dec 2016 (actual)
- Primary completion
- 26 Apr 2019 (actual)
- Study completion
- 26 Apr 2019 (actual)
- First posted
- 5 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Standard recommendation (ORS) | No intervention | –Participants received the standard recommendation on oral rehydration solution use |
| mHealth with no home visits | Experimental | Behavioral: CHoBI7 health facility program, Behavioral: CHoBI7 mHealth programParticipants received the health facility delivery of CHoBI7, plus bi-weekly mHealth (voice and text) reminders for 12 months |
| mHealth with home visits | Experimental | Behavioral: CHoBI7 health facility program, Behavioral: CHoBI7 mHealth program, Behavioral: CHoBI7 home visit programParticipants received the health facility delivery of CHoBI7, plus two home visits and bi-weekly mHealth (voice and text) reminders for 12 months |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (1 listed)
- Children in foster care will be excluded from all research study activities.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CHoBI7 health facility programThe 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. | Behavioural | mHealth with home visits, mHealth with no home visits |
| CHoBI7 mHealth programThe 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). | Behavioural | mHealth with home visits, mHealth with no home visits |
| CHoBI7 home visit programThe 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. | Behavioural | mHealth with home visits |
Primary outcome
Diarrhea prevalence among children under 2 years of age
Time frame: 12 months
Diarrhea prevalence among children under 2 years of age assessed by caregiver self report over a 12-month period
Diarrhea prevalence among children under 5 years of age
Time frame: 12 months
Diarrhea prevalence among children under 5 years of age assessed by caregiver self report over a 12-month period
Diarrhea prevalence among all household members
Time frame: 12 months
Diarrhea prevalence among all household members assessed by self report over a 12-month period
11 secondary outcomes
Diarrhea prevalence among participants ages 5-9 years
Time frame: 12 months
Diarrhea prevalence among participants ages 10-18 years
Time frame: 12 months
Diarrhea prevalence among participants ages greater than 18 years
Time frame: 12 months
Handwashing with soap
Time frame: 12 months
Household drinking water treatment
Time frame: 12 months
Height-for-age among children under 2 years of age
Time frame: 12 months
Height-for-age among children under 5 years of age
Time frame: 12 months
Weight-for-age among children under 2 years of age
Time frame: 12 months
Weight-for-age among children under 5 years of age
Time frame: 12 months
Weight-for-height among children under 2 years of age
Time frame: 12 months
Weight-for-height among children under 5 years of age
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Feb 2022.
- Results publication: PubMed 32761174George 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.
- Results publication: PubMed 33949243George 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.
- Results publication: PubMed 31366398George 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.
- Results publication: PubMed 32487209Thomas 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.
- Results publication: PubMed 32406989Masud 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.
- Results publication: PubMed 32406965Islam 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.
- Results publication: PubMed 32406581Zohura 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.
- Results publication: PubMed 35008045George 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Marie George, PhD principal investigator
Johns Hopkins Bloomberg School of Public Health
Questions about this trial
What is this clinical trial studying?
A study testing CHoBI7 health facility program, CHoBI7 mHealth program and CHoBI7 home visit program in people with Cholera and Diarrhea, run by Johns Hopkins Bloomberg School of Public Health.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Diarrhea prevalence among children under 2 years of age (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04008134, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Feb 2022; AzTrials last refreshed its copy on 30 Oct 2026.