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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04580212
Other study ID # 698
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date September 1, 2019
Est. completion date August 25, 2021

Study information

Verified date March 2022
Source North Carolina State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 1307
Est. completion date August 25, 2021
Est. primary completion date August 25, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Behavioral:
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.

Locations

Country Name City State
Uganda The Water Trust Kampala

Sponsors (2)

Lead Sponsor Collaborator
North Carolina State University The Water Trust

Country where clinical trial is conducted

Uganda, 

Outcome

Type Measure Description Time frame Safety issue
Other Prevalence of children <5 years with caregiver-reported respiratory infection in past 7 days Respiratory infection defined as any of the following symptoms: Constant cough, congestion, runny nose, panting, wheezing, or difficulty breathing Caregiver reported 7-day prevalence of respiratory infection in children <5 years, measured approximately 1 year after initiation of intervention
Primary 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 Caregiver reported 7-day prevalence of diarrhea in children <5 years, measured approximately 1 year after initiation of intervention
Secondary Proportion of households with E.coli in household environmental samples Detection of E. coli (general fecal indicator) Ascertained with analysis of samples from households, collected approximately 1 year after initiation of intervention
Secondary Proportion of households with observed poultry feces in compound Poultry feces occurrences observed in household compounds Ascertained by spot check observation approximately 1 year after initiation of intervention
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