Ignite Creation Date:
2024-07-17 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 3:34 PM
Study NCT ID:
NCT06498817
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-01
Brief Title:
Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days CHoBI7
Sponsor:
Johns Hopkins Bloomberg School of Public Health
Organization:
Johns Hopkins Bloomberg School of Public Health
Study Overview
Official Title:
Testing a Scalable Model of the Cholera Hospital-Based Intervention for 7 Days CHoBI7
Status:
RECRUITING
Status Verified Date:
2024-08
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:
CHoBI7
Brief Summary:
The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days CHoBI7 demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections diarrheal disease and stunting among young children in intervention households and had significant sustained impacts on handwashing with soap behaviors and improved water quality 12 months post intervention Therefore the investigators next step in the transition to scale is to 1 To tailor the CHoBI7 program for delivery in rural health facilities and market test the CHoBI7 Program to determine the feasibility of providing a modified water sanitation and hygiene WASH package with only a soapy water bottle and chlorine tablets in both urban and rural settings through formative research and engagement of key stakeholders Formative Research Phase and 2 To evaluate the effectiveness of delivering the CHoBI7 program in district hospitals and sub-district health complexes in rural areas in terms of increases in WASH behaviors and decreases in diarrheal disease by conducting a randomized controlled trial RCT Intervention Implementation and Evaluation Phase
Detailed Description:
Diarrhea is the second leading cause of death in children under 5 years of age globally causing an estimated 800000 deaths annually Previous studies have identified lack of caregiver hand washing with soap and treatment of household drinking water poor water storage practices and lack of caregiver knowledge of diarrhea prevention as important risk factors for diarrheal disease in pediatric populations Water sanitation and hygiene WASH interventions promoting household chlorination of drinking water and hand washing with soap have the potential to reduce diarrheal disease incidence in children less than five years of age an estimated 30 to 40 However there has been limited success in encouraging households to sustain these behaviors over time Furthermore community-based WASH interventions are expensive and often difficult to implement in an urban context in low resource settings
Previous studies have found that at the time of a severe illness such as cholera outbreaks households have higher perceived severity and benefits of water treatment In Madagascar an intervention which promoted the use of chlorine and 20 liter jerry cans reached peak sales during the high season for cholera Consistent findings were observed in Zambia where sales of a water treatment product called Clorin significantly increased during a cholera epidemic Furthermore in Dhaka Bangladesh the use of a community level point of use chlorine dispenser peaked after cholera deaths in a slum area of the city Therefore admission at a health care facility for the treatment of severe diarrhea could potentially serve as an ideal opportunity to promote WASH interventions on improved water treatment and hygiene practices
The research team developed a Hospital Based WASH intervention which is entitled CHoBI7 Cholera Hospital-Based Intervention for 7 days Chobi means picture in Bangla for the pictorial WASH module delivered as part of the program The CHoBI7 intervention was initially designed to reduce cholera infection among family members of hospitalized cholera cases during the one week high risk period after the case presents at the hospital This Hospital Based WASH intervention is disseminated by health facility based promoters to hospitalized diarrhea patients and the family members and includes 1 A pictorial module on diarrhea transmission and prevention and 2 A diarrhea prevention package which contains chlorine tablets for water treatment a soapy water bottle and a hand washing station and a sealed water vessel to ensure safe water storage The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days CHoBI7 demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections and had significant sustained impacts on hand washing with soap behaviors and improved water quality 12 months post intervention
In an effort to build evidence to take the CHoBI7 intervention to scale in Bangladesh the investigators partnered with the Bangladesh Ministry of Health and Family Welfare MoHFW to develop and evaluate scalable approaches for CHoBI7 intervention delivery The CHoBI7 intervention was broaden during this time to include diarrhea patients of all etiology not just cholera In addition the investigators developed the CHoBI7 WASH mobile health mHealth program to serve as a low cost scalable approach to reinforce the CHoBI7 WASH pictorial module delivered in the health facility without the need for home visits After health facility delivery of the CHoBI7 pictorial module by a health worker diarrhea patient households receive weekly voice and text messages from the CHoBI7 mHealth program over a 12 month period The CHoBI7 WASH mHealth program significantly decreased diarrhea and stunting among young children and lead to sustained handwashing with soap practices and improved stored drinking water quality during the 12 month surveillance period in an urban setting in Dhaka Bangladesh during the investigators recent randomized controlled trial
The investigators goal for this study is to develop a scalable version of the CHoBI7 program that can be delivered in district hospitals and sub-district health complexes in rural and urban Bangladesh This scalable version of the CHoBI7 program will provide only a soapy water bottle and chlorine tablets and encourage households to construct a handwashing station themselves using items in the homes
Previous studies have found that at the time of a severe illness such as cholera outbreaks households have higher perceived severity and benefits of water treatment In Madagascar an intervention which promoted the use of chlorine and 20 liter jerry cans reached peak sales during the high season for cholera Consistent findings were observed in Zambia where sales of a water treatment product called Clorin significantly increased during a cholera epidemic Furthermore in Dhaka Bangladesh the use of a community level point of use chlorine dispenser peaked after cholera deaths in a slum area of the city Therefore admission at a health care facility for the treatment of severe diarrhea could potentially serve as an ideal opportunity to promote WASH interventions on improved water treatment and hygiene practices
The research team developed a Hospital Based WASH intervention which is entitled CHoBI7 Cholera Hospital-Based Intervention for 7 days Chobi means picture in Bangla for the pictorial WASH module delivered as part of the program The CHoBI7 intervention was initially designed to reduce cholera infection among family members of hospitalized cholera cases during the one week high risk period after the case presents at the hospital This Hospital Based WASH intervention is disseminated by health facility based promoters to hospitalized diarrhea patients and the family members and includes 1 A pictorial module on diarrhea transmission and prevention and 2 A diarrhea prevention package which contains chlorine tablets for water treatment a soapy water bottle and a hand washing station and a sealed water vessel to ensure safe water storage The findings from previous recent randomized controlled trials of The Cholera Hospital Based Intervention for 7 Days CHoBI7 demonstrated that this intervention was effective in significantly reducing symptomatic cholera infections and had significant sustained impacts on hand washing with soap behaviors and improved water quality 12 months post intervention
In an effort to build evidence to take the CHoBI7 intervention to scale in Bangladesh the investigators partnered with the Bangladesh Ministry of Health and Family Welfare MoHFW to develop and evaluate scalable approaches for CHoBI7 intervention delivery The CHoBI7 intervention was broaden during this time to include diarrhea patients of all etiology not just cholera In addition the investigators developed the CHoBI7 WASH mobile health mHealth program to serve as a low cost scalable approach to reinforce the CHoBI7 WASH pictorial module delivered in the health facility without the need for home visits After health facility delivery of the CHoBI7 pictorial module by a health worker diarrhea patient households receive weekly voice and text messages from the CHoBI7 mHealth program over a 12 month period The CHoBI7 WASH mHealth program significantly decreased diarrhea and stunting among young children and lead to sustained handwashing with soap practices and improved stored drinking water quality during the 12 month surveillance period in an urban setting in Dhaka Bangladesh during the investigators recent randomized controlled trial
The investigators goal for this study is to develop a scalable version of the CHoBI7 program that can be delivered in district hospitals and sub-district health complexes in rural and urban Bangladesh This scalable version of the CHoBI7 program will provide only a soapy water bottle and chlorine tablets and encourage households to construct a handwashing station themselves using items in the homes
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?:
None
Is an FDA AA801 Violation?:
None