NCT04580212

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,307

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2019

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

October 2, 2020

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 8, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 25, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 25, 2021

Completed
Last Updated

March 23, 2022

Status Verified

March 1, 2022

Enrollment Period

2 years

First QC Date

October 2, 2020

Last Update Submit

March 8, 2022

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (2)

  • Proportion of households with E.coli in household environmental samples

    Ascertained with analysis of samples from households, collected approximately 1 year after initiation of intervention

  • Proportion of households with observed poultry feces in compound

    Ascertained by spot check observation approximately 1 year after initiation of intervention

Other Outcomes (1)

  • Prevalence of children <5 years with caregiver-reported respiratory infection in past 7 days

    Caregiver reported 7-day prevalence of respiratory infection in children <5 years, measured approximately 1 year after initiation of intervention

Study Arms (2)

Intervention arm

EXPERIMENTAL

This arm received the poultry hygiene intervention.

Behavioral: Poultry hygiene intervention

Control arm

NO INTERVENTION

This arm received no intervention.

Interventions

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.

Intervention arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Water Trust

Kampala, Uganda

Location

MeSH Terms

Conditions

Diarrhea

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ayse Ercumen

    North Carolina State University

    PRINCIPAL INVESTIGATOR
  • Angela Harris

    North Carolina State University

    PRINCIPAL INVESTIGATOR
  • Chris Prottas

    The Water Trust

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Masking Details
Investigators and data analysts will be blinded to intervention assignment by using a numerical code for study arm during analysis.
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

October 2, 2020

First Posted

October 8, 2020

Study Start

September 1, 2019

Primary Completion

August 25, 2021

Study Completion

August 25, 2021

Last Updated

March 23, 2022

Record last verified: 2022-03

Locations