Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI, Standard message.
- Who it may be relevant to
- Registry conditions: Cholera, Diarrhea. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Bangladesh
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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
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.
Interventions
- Behavioral Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) CATI
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. - Behavioral Standard message
Standard message given in the Democratic Republic of the Congo to diarrhea patients at health facility discharge on use of oral rehydration solution
Primary outcome measures
- Number of non-baseline cholera infections among individuals residing in a ring around cholera patients [Time frame: 1 month]
Secondary outcome measures (12)
- Diarrhea among individuals residing in a ring around cholera patients [Time frame: 12 months]
- Child development for children under 5 years of age as assessed by the Assessed by Extended Age and Stages Assessment Questionnaire (EASQ) [Time frame: 12 Months]
- Rate of Handwashing with soap at stool and food related events [Time frame: 12 Months]
- Free chlorine concentration (mg/L) in stored drinking water [Time frame: 12 months]
- Presence of Vibrio cholerae and E. coli in stored drinking water [Time frame: 12 months]
- Hand washing psychosocial risk factors as assessed by Water, Sanitation, and Hygiene (WASH) questionnaire [Time frame: 12 months]
- Height-for-age measurements among children under 2 years of age [Time frame: 12 months]
- Height-for-age measurements among children under 5 years of age [Time frame: 12 months]
- Weight-for-age measurements among children under 2 years of age [Time frame: 12 months]
- Weight-for-age measurements among children under 5 years of age [Time frame: 12 months]
- Weight-for-height measurements among children under 2 years of age [Time frame: 12 months]
- Weight-for-height measurements among children under 5 years of age [Time frame: 12 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Prevention
Study locations
Bangladesh · 2 centers
- International Centre for Diarrhoeal Disease Research, Bangladesh — Dhaka
- Research Training and Management International — Dhaka
Identifiers
NCT: NCT06003816 · IRB00009931 · 1R01AI148332-01