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Study Overview

Title:
A randomised controlled feasibility trial of a household play space intervention to reduce infant Campylobacter infection: The CAMPI trial
Study is 3ie funded:
No
Study ID:
RIDIE-STUDY-ID-5de0b6938afb8
Initial Registration Date:
11/29/2019
Last Update Date:
11/18/2019
Study Status:
In Development
Location(s):
Ethiopia
Abstract:

Globally, stunting is the most prevalent form of undernutrition. Poor water, sanitation and hygiene (WASH) facilities are associated with poor infant health (diarrhoea and undernutrition, including wasting and stunting) and so improved household WASH was recently incorporated into the malnutrition framework. Acting as a primary barrier to pathogenic bacteria, it is anticipated that adequate WASH facilities should prevent infection for better infant health outcomes. However large randomised trials have not shown a consistent effect. This might be partly because WASH interventions have focused on containing human excreta and have overlooked the large burden of pathogenic bacteria from animal faecal contamination. Within homes where occupants live closely with animals, infants are exposed to pathogens on contaminated floors, objects and hands from normal crawling and hand-to-mouth behaviours. Further research is needed on potential solutions to block pathogen transmission and reduce infection. This is especially important in subsistence livelihood settings, where significantly changing traditional animal husbandry practices may be unfeasible. Furthermore concerns over antimicrobial resistance surround the use of preventative vaccinations, which also appear less effective due to the changes in gut function seen in undernourished children. The CAMPI trial (Campylobacter Associated Malnutrition Playspace Intervention trial) is a randomised, single site, feasibility control trial. It primarily aims to evaluate the feasibility of a household play space to reduce infant infection. Based on feasibility and infection outcomes it will make recommendations for the feasibility of scaling up into a full trial. Outcomes will provide further evidence for the exposure-infection pathway hypothesis and help fill the knowledge gap for alternative solutions to help reduce infant enteropathogen infection in rural subsistence settings.

Categories:
Health, Nutrition, and Population
Water and Sanitation
Additional Keywords:
WASH, BabyWASH, malnutrition, stunting, growth, Campylobacter, infection, animal husbandry, poultry, enteropathogens
Secondary ID Number(s):

Principal Investigator(s)

Name of First PI:
Dr Paul Hutchings
Affiliation:
Cranfield University
Name of Second PI:
Camila Garbutt
Affiliation:
People in Need

Study Sponsor

Name:
People in Need
Study Sponsor Location:
Czech Republic

Research Partner

Name of Partner Institution:
Hawassa University, College of Medicine & Health Sciences
Type of Organization:
Research institute/University
Location:
Ethiopia
Intervention

Intervention Overview

Intervention:

This trial is a single-centre, non-blinded, controlled randomised feasibility trial. The primary aim is to evaluate the feasibility of a household play space as a complex public health intervention to reduce Campylobacter infection in infants in Ethiopia. The study will recruit households with an infant aged 10-18 months at the trial start who own free-range poultry, cattle, or both, and who live in one of the pre-selected geographical areas of the study. Direct benefits include the high-quality locally made household play space (previously designed and piloted and manufactured by a local artisan: 1.2 x 1.2 metres, made of bamboo, foam and canvas) that will be given to both study groups (to the control group at the trial end). Other direct benefits include any effects from behavioural change messaging and play space use, which may positively impact infant health. Indirect benefits include improving the evidence base for WASH and BabyWASH interventions in rural Ethiopia to reduce infant infection, which may contribute to more informed programmes by PIN and other NGOs, the government, and the private sector.

Theory of Change:

The following activities:

  • Behavioural messaging on infant hygiene and play space safe use and up keep
  • Provision of play spaces to caregivers with infants

Lead to:

  • Caregivers using play spaces as a safe and hygienic space to keep infants during daily activities at household

Which:

  • Reduces infant exposure to faecal and zoonotic pathogens from household and surrounding environment

Resulting in:

  • Lower levels of infant enteric infection and associated improvements in child health including growth
Multiple Treatment Arms Evaluated?
No

Implementing Agency

Name of Organization:
People in Need Hawassa, Ethiopia
Type of Organization:
NGO (International)

Program Funder

Name of Organization:
?eská Republika Pomáhá (Czech Development Agency)
Type of Organization:
Public Sector, e.g. Government Agency or Ministry

Intervention Timing

Intervention or Program Started at time of Registration?
No
Start Date:
01/20/2020
End Date:
03/16/2020
Evaluation Method

Evaluation Method Overview

Primary (or First) Evaluation Method:
Randomized control trial
Other (not Listed) Method:
Additional Evaluation Method (If Any):
Other (not Listed) Method:

Method Details

Details of Evaluation Approach:

As a feasibility trial, the trial does not aim to formally test a hypothesis, or to test effectiveness, as it is underpowered to do so. This trial is designed to assess the feasibility of running a full RCT and to support its development if outcomes suggest to do so.
Key feasibility aims are to:
1.    Evaluate the feasibility of a play space as a public health intervention by measuring intervention fidelity, acceptance, adherence ad attrition 
2.    Evaluate the appropriateness of the study design and research processes, including assessing their delivery against protocols (research fidelity)
3.    Make recommendations for adjusting intervention and research design for future studies and on the feasibility of scaling up into a full trial, or alternative strategies
4.    Contribute further evidence on the infection-exposure hypothesis
Measures of adherence, acceptance and attrition are assessed using specific measures include play space time use, cleanliness and maintenance, and a Barrier Analysis. Measures that assess research fidelity will describe feasibility of the trial in terms of protocols and methods (as suitable to measure efficacy within a full RCT) and will explore the suitability of the research design. Measures of intervention fidelity will describe institutional capacity for delivery. Microbiological analysis of infant faeces for Campylobacter will provide further evidence for the exposure-infection hypothesis. However, it should be re-emphasised that the aim of this trial is not to assess effectiveness (or efficacy) of the play space to reduce Campylobacter infection and it is not powered to do this. Statistical tests to validate the hypothesis will be carried out without adequate power, and will be caveated when writing the study limitations and discussion. Microbiology results are thus a secondary outcome.

Outcomes (Endpoints):

Primary outcome measures

  1. Play space adherence, acceptance and attrition, measured by correct use and maintenance, time use, play space cleanliness and by Barrier Analysis 
  2. Intervention fidelity, measured by the production and distribution of play spaces to agreed standards and delivery of behavioural messaging as per agreed protocols
  3. Research fidelity as measured by research implementation aligning with design criteria including sampling strategy and data collection, processing and analysis (incl. microbiological, anthropometric and social survey data

Secondary outcome measures

  1. Infant health measures, including: anthropometry, nutritional status, breastfeeding, and diarrhoeal prevalenc
  2. Household demographics, SES, WASH facilities and use and animal husbandry practices
  3. Infant faecal Campylobacter prevalence at baseline, midline and endline, measured by culture method
Unit of Analysis:
Household
Hypotheses:

As mentioned, as this is a feasibility trial, the trial does not seek to formally test a hypothesis via a specific objective. However, following the research background as described in the ‘Abstract’ section, the study hypothesises that; blocking specific infant-related transmission pathways (contaminated floors) reduces faecal-oral transmission of Campylobacter, reduces infection and improves growth. 

Unit of Intervention or Assignment:
Households
Number of Clusters in Sample:
2 intervention Kebeles (villages) and 2 control Kebeles in one Woreda (administrative district) within Sidama Zone, SNNPR, Ethiopia
Number of Individuals in Sample:
Approximately 25 households in each Kebele (50 intervention, 50 control, total 100)
Size of Treatment, Control, or Comparison Subsamples:
50 intervention households and 50 control households, total 100 households

Supplementary Files

Analysis Plan:
Other Documents:
Data

Outcomes Data

Description:
Control and intervention groups: survey (SES, demographics, WASH facilities and use, animal husbandry, infant feeding practices, breastfeeding); anthropometry (infant height, weight, MUAC); microbiological sample (infant faeces) Intervention group: survey (play space adherence, acceptance, attrition, time use, cleanliness and maintenance) and barrier analysis
Data Already Collected?
No
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Treatment Assignment Data

Participation or Assignment Information:
Yes
Description:
Data Obtained by the Study Researchers?
Data Previously Used?
Data Access:
Data Obtained by the Study Researchers?
Data Approval Process:
Approval Status:

Data Analysis

Data Analysis Status:

Study Materials

Upload Study Materials:

Registration Category

Registration Category:
Prospective, Category 1: Data for measuring impacts have not been collected
Completion

Completion Overview

Intervention Completion Date:
Data Collection Completion Date:
Unit of Analysis:
Clusters in Final Sample:
Total Observations in Final Sample:
Size of Treatment, Control, or Comparison Subsamples:

Findings

Preliminary Report:
Preliminary Report URL:
Summary of Findings:
Paper:
Paper Summary:
Paper Citation:

Data Availability

Data Availability (Primary Data):
Date of Data Availability:
Data URL or Contact:
Access procedure:

Other Materials

Survey:
Survey Instrument Links or Contact:
Program Files:
Program Files Links or Contact:
External Link:
External Link Description:
Description of Changes:

Study Stopped

Date:
Reason: