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

Study Overview
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Brief Summary
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Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted water, sanitation, and hygiene (WASH) intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases.

Detailed Description
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Background: Worldwide there are estimated to be 2.9 million cholera cases annually. Effective targeted water, sanitation, and hygiene (WASH) interventions are urgently needed to reduce cholera globally. The investigators study in Bangladesh found that individuals living within 50 meters of a cholera patient were at 30 times higher risk of developing cholera than the general population during the first week after the index patient sought care at a health facility. However, there has been little work done to develop and evaluate interventions for this high risk population. Objective: The investigators objective is to develop and evaluate the effectiveness of a case area targeted WASH intervention in reducing cholera infections and increasing sustained WASH behaviors in transmission hotspots in a ring around cholera cases. Previous studies: The investigators research group developed the Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7), a WASH intervention delivered to cholera patients and the participants household members in a health facility. the investigators randomized controlled trial (RCT) in Bangladesh of CHoBI7 demonstrated this intervention was effective in significantly reducing cholera, and led to sustained increases in handwashing with soap and improved drinking water quality 12 months post-intervention in cholera patient households. This intervention, however, solely focused on cholera patients households. There are no studies to date that have evaluated the impact on reducing cholera of delivering a ring WASH intervention to households living near cholera patients. Design and Setting: The Director of Disease Control at the Bangladesh Ministry of Health and Family Welfare would like to take CHoBI7 to scale across Bangladesh, and has requested the investigators build evidence on scalable approaches for delivering CHoBI7 as a CATI in a ring around cholera patient households. This study will have 3 phases. During the formative research and planning phase the investigators will develop a scalable, theory and evidence based ring WASH intervention through in-depth interviews, focus group discussions, workshops, and a pilot. During the intervention implementation and evaluation phase the investigators will conduct a RCT to prospectively follow 3120 participants from 1040 households living in 40 rings around cholera cases to evaluate the effectiveness of the intervention in: (1) reducing cholera infections during the first week after the index patient in the ring seeks care at a health facility; and (2) increasing handwashing with soap and stored water quality over a 12 month period. The first arm will receive the standard recommendation given in Bangladesh during diarrhea outbreaks on oral rehydration solution use and a leaflet on WASH practices during a single visit. The second arm will receive this message and the ring WASH intervention which includes group sessions and home visits and mobile health messages. Whole genome sequencing will be performed on water and clinical Vibrio cholerae strains collected to investigate spatiotemporal transmission dynamics of V. cholerae in hotspots. During the dissemination and policy planning phase, the investigators will partner with the Director of Disease Control to disseminate study findings and inform cholera control policies. Significance: This will be the first RCT of a CATI WASH program to evaluate whether this intervention approach can reduce cholera.

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

Conditions
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Cholera, Diarrhea

Intervention / Treatment
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* Behavioral: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
* Behavioral: Standard message


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Index cholera patient have no running water inside of their home Exclusion Criteria: No one will be excluded because of age, sex, religion, or sexual preference
Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI<br>The CHoBI7 program is first delivered during group sessions by a health promoter to those residing in a ring around a cholera patient. The health promoter delivers a pictorial WASH module on how diarrhea can spread, and instructions on handwashing with soap, water treatment, and safe water storage. A cholera prevention package is provided containing: a one-month supply of chlorine tablets for water treatment, a soapy water bottle for handwashing, a handwashing station, and a water vessel with a lid and tap to ensure safe water storage. After the group session, households receive weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended WASH behaviors. | Behavioral: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI<br>* The CHoBI7 program is during group sessions by a health promoter to those residing in a ring around a cholera patient reinforced through weekly voice and text messages from the CHoBI7 mHealth program over 12 months on the recommended water, sanitation, and hygiene behaviors.<br>|
| Active Comparator: Standard Message Arm<br>Standard message given in the Bangladesh to diarrhea patients at health facility discharge on use of oral rehydration solution | Behavioral: Standard message<br>* Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of non-baseline cholera infections among individuals residing in a ring around cholera patients | cholera infection assessed by bacterial culture and/or vibriocidal antibody titer | 1 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Diarrhea among individuals residing in a ring around cholera patients | Self-reported or caregiver reported diarrhea (3 or more loose stools for a 24 hour period) | 12 months | 
| Child development for children under 5 years of age as assessed by the Assessed by Extended Age and Stages Assessment Questionnaire (EASQ) | Assessed by Extended Age and Stages Assessment Questionnaire (EASQ) | 12 Months | 
| Rate of Handwashing with soap at stool and food related events | Rate of patient household members handwashing with soap at stool and food related events | 12 Months | 
| Free chlorine concentration (mg/L) in stored drinking water | Free chlorine concentration (mg/L) in stored drinking water | 12 months | 
| Presence of Vibrio cholerae and E. coli in stored drinking water | E.coli and Vibrio cholerae measured by bacterial culture | 12 months | 
| Hand washing psychosocial risk factors as assessed by Water, Sanitation, and Hygiene (WASH) questionnaire | Water, Sanitation, and Hygiene (WASH) psychosocial risk factor questionnaire which involves both multiple choice questions and spot checks | 12 months | 
| Height-for-age measurements among children under 2 years of age | Height 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 | 12 months | 
| Height-for-age measurements among children under 5 years of age | Height 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 | 12 months | 
| Weight-for-age measurements among children under 2 years of age | 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 | 12 months | 
| Weight-for-age measurements among children under 5 years of age | 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 | 12 months | 
| Weight-for-height measurements 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 | 12 months | 
| Weight-for-height measurements 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 | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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randomized controlled trial, water, sanitation, hygiene, case area targeted intervention, Bangladesh