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

Diarrhea Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06003816
• Other study ID #: IRB00009931
• Secondary ID: 1R01AI148332-01
• Status: Recruiting
• Phase: N/A
• Start date: October 18, 2023
• Est. completion date: November 2025

Study information

• Verified date: October 2023
• Source: Johns Hopkins Bloomberg School of Public Health
• Contact: Christine Marie George, PhD
• Phone: (202) 657-5798
• Email: cmgeorge[@]jhu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 3140
• Est. completion date: November 2025
• Est. primary completion date: November 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Cholera
• Diarrhea

Intervention

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.
• 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

Locations

Country	Name	City	State
Bangladesh	International Centre for Diarrhoeal Disease Research, Bangladesh	Dhaka
Bangladesh	Research Training and Management International	Dhaka

Sponsors (4)

Lead Sponsor	Collaborator
Johns Hopkins Bloomberg School of Public Health	International Centre for Diarrhoeal Disease Research, Bangladesh, National Institute of Allergy and Infectious Diseases (NIAID), Research Training and Management International (RTMI)

Country where clinical trial is conducted

Bangladesh, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Free chlorine concentration (mg/L) in stored drinking water	Free chlorine concentration (mg/L) in stored drinking water	12 months
Secondary	Presence of Vibrio cholerae and E. coli in stored drinking water	E.coli and Vibrio cholerae measured by bacterial culture	12 months
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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