Ignite Creation Date:
2024-05-06 @ 7:26 PM
Last Modification Date:
2024-10-26 @ 3:06 PM
Study NCT ID:
NCT06003816
Status:
RECRUITING
Last Update Posted:
2023-10-23
First Post:
2023-08-16
Brief Title:
Cholera-Hospital-Based-Intervention-for-7-Days CHoBI7 Water Sanitation and Hygiene WASH Case Area Targeted Intervention CATI
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Cholera-Hospital-Based-Intervention-for-7-Days CHoBI7 Water Sanitation and Hygiene WASH Case Area Targeted Intervention CATI
Status:
RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 29 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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 1R01AI148332-01 | NIH | None | httpsreporternihgovquickSearch1R01AI148332-01 |