Clinical trial NCT06003816: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)
Official title: Cholera-Hospital-Based-Intervention-for-7-Days (CHoBI7) Water, Sanitation, and Hygiene (WASH) Case Area Targeted Intervention (CATI)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cholera
Diarrhea
Keywords: randomized controlled trial
water
sanitation
hygiene
case area targeted intervention
Bangladesh
Lead sponsor: Johns Hopkins Bloomberg School of Public Health
Sponsor class: OTHER
Collaborators: name: Research Training and Management International (RTMI)
name: International Centre for Diarrhoeal Disease Research, Bangladesh
name: National Institute of Allergy and Infectious Diseases (NIAID)
First posted: 2023-08-22
Enrollment: 3140
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

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

Primary outcomes:
measure: Number of non-baseline cholera infections among individuals residing in a ring around cholera patients
timeFrame: 1 month
Secondary outcomes:
measure: Diarrhea among individuals residing in a ring around cholera patients
timeFrame: 12 months
measure: Child development for children under 5 years of age as assessed by the Assessed by Extended Age and Stages Assessment Questionnaire (EASQ)
timeFrame: 12 Months
measure: Rate of Handwashing with soap at stool and food related events
timeFrame: 12 Months
measure: Free chlorine concentration (mg/L) in stored drinking water
timeFrame: 12 months
measure: Presence of Vibrio cholerae and E. coli in stored drinking water
timeFrame: 12 months
measure: Hand washing psychosocial risk factors as assessed by Water, Sanitation, and Hygiene (WASH) questionnaire
timeFrame: 12 months
measure: Height-for-age measurements among children under 2 years of age
timeFrame: 12 months
measure: Height-for-age measurements among children under 5 years of age
timeFrame: 12 months
measure: Weight-for-age measurements among children under 2 years of age
timeFrame: 12 months
measure: Weight-for-age measurements among children under 5 years of age
timeFrame: 12 months
measure: Weight-for-height measurements among children under 2 years of age
timeFrame: 12 months
measure: Weight-for-height measurements among children under 5 years of age
timeFrame: 12 months
Other outcomes:
Locations:
city: Dhaka
country: Bangladesh
facility: International Centre for Diarrhoeal Disease Research, Bangladesh
city: Dhaka
country: Bangladesh
facility: Research Training and Management International
Study officials:
affiliation: Johns Hopkins Bloomberg School of Public Health
name: Christine Marie George, PhD
role: PRINCIPAL_INVESTIGATOR
References: