- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04580212
Poultry Management and Child Diarrhea in Uganda
March 8, 2022 updated by: Ayse Ercumen, North Carolina State University
Improving Hygienic Management of Poultry in Rural Uganda
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
1307
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Kampala, Uganda
- The Water Trust
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: SINGLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Intervention arm
This arm received the poultry hygiene intervention.
|
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.
|
NO_INTERVENTION: Control arm
This arm received no intervention.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of children <5 years with caregiver-reported diarrhea in past 7 days
Time Frame: Caregiver reported 7-day prevalence of diarrhea in children <5 years, measured approximately 1 year after initiation of intervention
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Diarrhea defined as 3 or more soft or watery stools in 24-hour period
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Caregiver reported 7-day prevalence of diarrhea in children <5 years, measured approximately 1 year after initiation of intervention
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Proportion of households with E.coli in household environmental samples
Time Frame: Ascertained with analysis of samples from households, collected approximately 1 year after initiation of intervention
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Detection of E. coli (general fecal indicator)
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Ascertained with analysis of samples from households, collected approximately 1 year after initiation of intervention
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Proportion of households with observed poultry feces in compound
Time Frame: Ascertained by spot check observation approximately 1 year after initiation of intervention
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Poultry feces occurrences observed in household compounds
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Ascertained by spot check observation approximately 1 year after initiation of intervention
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prevalence of children <5 years with caregiver-reported respiratory infection in past 7 days
Time Frame: Caregiver reported 7-day prevalence of respiratory infection in children <5 years, measured approximately 1 year after initiation of intervention
|
Respiratory infection defined as any of the following symptoms: Constant cough, congestion, runny nose, panting, wheezing, or difficulty breathing
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Caregiver reported 7-day prevalence of respiratory infection in children <5 years, measured approximately 1 year after initiation of intervention
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Investigators
- Principal Investigator: Ayse Ercumen, North Carolina State University
- Principal Investigator: Angela Harris, North Carolina State University
- Study Director: Chris Prottas, The Water Trust
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
September 1, 2019
Primary Completion (ACTUAL)
August 25, 2021
Study Completion (ACTUAL)
August 25, 2021
Study Registration Dates
First Submitted
October 2, 2020
First Submitted That Met QC Criteria
October 2, 2020
First Posted (ACTUAL)
October 8, 2020
Study Record Updates
Last Update Posted (ACTUAL)
March 23, 2022
Last Update Submitted That Met QC Criteria
March 8, 2022
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 698
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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