Clinical trial

Evaluating the Impact of an Improved Household Flooring Intervention on Enteric and Parasitic Infections in Rural Settings in the Counties of Bungoma and Kwale, Kenya

Name
28307
Description
The goal of this intervention study is to learn about the impact of household flooring on health in rural Kenya, and test whether providing an improved (cement stabilised, washable) floor improves the health of children and their care providers. The main questions the study aims to answer are: * What is the effect of providing a sealed, washable floor on the prevalence of infections that cause diarrhoea, intestinal worms and sand flea infections? * To what extent does the intervention reduce contamination of floors with pathogens within the home? * What is its effect of the intervention on the wellbeing of caregivers and children? * Over the course of a year, do the new floors remain undamaged, with no cracks? * Do participants living with the new floors, and the masons that helped to install the floors, like them and feel they are practical and affordable? The study will involve a trial, where half of the recruited households will be randomly chosen to receive the new floor in addition to some support on how to care for the floor and keep it clean. The other half of households will not receive anything at first, but at the end of the research project will also receive a new floor. Before the new floors are installed, the investigators will make several assessments in all study households. These will include a survey to measure household characteristics; a stool survey, to measure how many people are infected with diarrhoea-causing microorganisms and parasitic worms; a jigger flea examination among children; wellbeing assessments among children and caregivers; and soil sampling to identify microorganisms on the floor of the household. When households receive the new floor, participants will have to move out of their house for up to 7 days during installation. Participants will also be asked to attend some group meetings to discuss ways of taking care of the floor and keeping it clean. Assessments will be repeated 12 months after the floor has been delivered, and additional interviews will be held with a small number of randomly selected participants. Throughout the 12 months following delivery of the intervention, investigators will make unannounced visits to households to check the condition of the floor. Participants will also be offered treatment for parasitic worm infections after assessments have been completed at the start and end of the project.
Trial arms
Trial start
2023-04-12
Estimated PCD
2024-08-01
Trial end
2024-12-01
Status
Recruiting
Treatment
Sealed washable floor plus behaviour change
Replacement of rudimentary floors with a cement stabilised floor in all rooms in the dwelling
Arms:
Intervention (improved floor)
Behaviour change intervention
Support for behaviour change through 'floor clubs' and the provision of printed guides
Arms:
Intervention (improved floor)
Routine deworming
Treatment of all household members for STH infections (400 mg albendazole in those aged 24 months and above; 200 mg albendazole in those aged 12-23 months)
Arms:
Control (rudimental floor), Intervention (improved floor)
Other names:
albendazole
treatment for tungiasis
Treatment of tungiasis in those affected by heavy infections (at 0 and 12 months) according to county Department of Health recommendations
Arms:
Control (rudimental floor), Intervention (improved floor)
Size
2200
Primary endpoint
Enteric infections
12 months
Tungiasis infections
12 months
STH infections
12 months
Eligibility criteria
Inclusion Criteria: * Household with a child under 5 years of age that meets structural criteria (unimproved earthen flooring throughout, structurally sound), with members willing to temporarily relocate. Exclusion Criteria: * Households that are intending to move within the next 12 months, or that have improved flooring in any rooms or are not structurally sound.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Single Group Assignment', 'primaryPurpose': 'PREVENTION', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 2200, 'type': 'ESTIMATED'}}
Updated at
2024-06-11

1 organization