Poultry Management and Child Diarrhea in Uganda
Primary Purpose
Diarrhea
Status
Completed
Phase
Not Applicable
Locations
Uganda
Study Type
Interventional
Intervention
Poultry hygiene intervention
Sponsored by
About this trial
This is an interventional prevention trial for Diarrhea
Eligibility Criteria
Inclusion Criteria:
- At least one person in the household is a member of Self-Help Groups formed by The Water Trust, Uganda
- There is at least one child under the age of 5 years living in the household
- There is an adult (>18 years) primary caregiver of a child <5 years available for participation in study
Exclusion Criteria:
- None
Sites / Locations
- The Water Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Intervention arm
Control arm
Arm Description
This arm received the poultry hygiene intervention.
This arm received no intervention.
Outcomes
Primary Outcome Measures
Prevalence of children <5 years with caregiver-reported diarrhea in past 7 days
Diarrhea defined as 3 or more soft or watery stools in 24-hour period
Secondary Outcome Measures
Proportion of households with E.coli in household environmental samples
Detection of E. coli (general fecal indicator)
Proportion of households with observed poultry feces in compound
Poultry feces occurrences observed in household compounds
Full Information
NCT ID
NCT04580212
First Posted
October 2, 2020
Last Updated
March 8, 2022
Sponsor
North Carolina State University
Collaborators
The Water Trust
1. Study Identification
Unique Protocol Identification Number
NCT04580212
Brief Title
Poultry Management and Child Diarrhea in Uganda
Official Title
Improving Hygienic Management of Poultry in Rural Uganda
Study Type
Interventional
2. Study Status
Record Verification Date
March 2022
Overall Recruitment Status
Completed
Study Start Date
September 1, 2019 (Actual)
Primary Completion Date
August 25, 2021 (Actual)
Study Completion Date
August 25, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
North Carolina State University
Collaborators
The Water Trust
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Fecal contamination from animal sources, specifically chickens, is increasingly recognized as a risk factor for enteric infections in low-income countries where domestic animals are often kept in close proximity to living quarters. Community members typically allow chickens to move freely around their compound and in their homes. Unlike other animals, such as cows or goats, poultry are typically not confined and their feces, which are relatively small, are considered relatively innocuous and therefore largely ignored by adults and children. In this study, the investigators have implemented an intervention to help rural poultry owners with children to hygienically separate chickens from children by focusing on a small set of key factors, including increased risk perception, increased perception of potential livelihood benefits, increased skills, and increased supportive social norms. The investigators hypothesized that the poultry hygiene intervention will lead to improved poultry management practices, which will in turn lead to reduced fecal contamination in the domestic environment and subsequently reduced diarrheal illness in young children. To measure these parameters along the causal chain, the investigators used a combination of household surveys, spot check observations and testing of environmental samples for fecal contamination.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diarrhea
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Masking Description
Investigators and data analysts will be blinded to intervention assignment by using a numerical code for study arm during analysis.
Allocation
Randomized
Enrollment
1307 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Intervention arm
Arm Type
Experimental
Arm Description
This arm received the poultry hygiene intervention.
Arm Title
Control arm
Arm Type
No Intervention
Arm Description
This arm received no intervention.
Intervention Type
Behavioral
Intervention Name(s)
Poultry hygiene intervention
Intervention Description
The intervention will consist of a series of participatory training exercises designed to accomplish three main goals: (1) increase awareness of health risks and lost livelihood benefits of current poultry management practices, (2) build practical skills for poultry management, and (3) build supportive community norms by facilitating savings group discussions on poultry management. The intervention will be delivered through three activities: (1) triggering exercise designed to raise awareness of both the health risks of the current practices and the economic potential of a more active poultry management approach, and ultimately to motivate participants for behavior change, (2) poultry management training activity based on local needs and norms, and (3) periodic follow-on coaching to reinforce messages from the initial training and emphasize action planning, monitoring of plan execution, and troubleshooting.
Primary Outcome Measure Information:
Title
Prevalence of children <5 years with caregiver-reported diarrhea in past 7 days
Description
Diarrhea defined as 3 or more soft or watery stools in 24-hour period
Time Frame
Caregiver reported 7-day prevalence of diarrhea in children <5 years, measured approximately 1 year after initiation of intervention
Secondary Outcome Measure Information:
Title
Proportion of households with E.coli in household environmental samples
Description
Detection of E. coli (general fecal indicator)
Time Frame
Ascertained with analysis of samples from households, collected approximately 1 year after initiation of intervention
Title
Proportion of households with observed poultry feces in compound
Description
Poultry feces occurrences observed in household compounds
Time Frame
Ascertained by spot check observation approximately 1 year after initiation of intervention
Other Pre-specified Outcome Measures:
Title
Prevalence of children <5 years with caregiver-reported respiratory infection in past 7 days
Description
Respiratory infection defined as any of the following symptoms: Constant cough, congestion, runny nose, panting, wheezing, or difficulty breathing
Time Frame
Caregiver reported 7-day prevalence of respiratory infection in children <5 years, measured approximately 1 year after initiation of intervention
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least one person in the household is a member of Self-Help Groups formed by The Water Trust, Uganda
There is at least one child under the age of 5 years living in the household
There is an adult (>18 years) primary caregiver of a child <5 years available for participation in study
Exclusion Criteria:
None
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ayse Ercumen
Organizational Affiliation
North Carolina State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Angela Harris
Organizational Affiliation
North Carolina State University
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Chris Prottas
Organizational Affiliation
The Water Trust
Official's Role
Study Director
Facility Information:
Facility Name
The Water Trust
City
Kampala
Country
Uganda
12. IPD Sharing Statement
Learn more about this trial
Poultry Management and Child Diarrhea in Uganda
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