Clinical trial NCT05914363: Evaluating Impact of Improved Floors on Health
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diarrhoeal Disease
Hookworm Infection
Ascaris Lumbricoides Infection
Trichuris Infection
Tungiasis
Lead sponsor: London School of Hygiene and Tropical Medicine
Sponsor class: OTHER
Collaborators: name: Kenya Medical Research Institute
name: Jomo Kenyatta University of Agriculture and Technology
name: International Centre of Insect Physiology and Ecology (ICIPE)
First posted: 2023-06-22
Enrollment: 2200
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Single Group Assignment
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: Earthen floors are often damp or dusty and difficult to clean, providing an ideal environment for faecal pathogens and parasites. Cross-sectional studies have revealed associations between household flooring and health outcomes, but robust experimental evidence is scant. This study will evaluate the impact of an improved household flooring intervention on enteric infections, soil-transmitted helminth (STH) infections, and tungiasis through implementation of a cluster-randomised trial in two rural settings in Kwale and Bungoma Counties, Kenya.

The primary aim of this study is to evaluate the effectiveness of an improved flooring intervention in reducing the burden of enteric infections, STH and tungiasis in participating households through implementation of a randomised controlled trial (RCT) in two distinct settings in rural Kenya. The primary objectives are to quantify impact on the prevalence of enteric infections, STH infections, and tungiasis. Secondary objectives include assessing impact on the wellbeing of caregivers and children, self-report gastrointestinal illness in children, and the extent to which entero-pathogen and parasitic contamination of floors is reduced within the home. We will also examine the differential effects across community and household contexts (including water, sanitation, and hygiene (WASH) infrastructure, animal husbandry, user adherence and study site). Lastly, we deliver a process evaluation to determine the practicality, acceptability, costs, and durability of the improved flooring intervention and how environmental, installation, and use factors affect these.

In total, 440 clusters (households) across both sites are allocated to either control or intervention group, in which a low-cost, sealed, washable cement-based floor is installed in all eligible buildings of the dwelling, alongside a floor care guide provided during an induction meeting. Prevalence of enteric infections in children under 5 years will be assessed via stool surveys and PCR; prevalence of tungiasis infection in children 1-14 years based on clinical exam; and prevalence of STH infection in all household members over 1 year assessed via Kato-Katz. Following the 12-month implementation period and final assessments, control households will be offered improved floors.

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.

Primary outcomes:
measure: Enteric infections
timeFrame: 12 months
measure: Tungiasis infections
timeFrame: 12 months
measure: STH infections
timeFrame: 12 months
Secondary outcomes:
measure: Gastrointestinal illness
timeFrame: 12 months
measure: Intensity and severity of tungiasis
timeFrame: 12 months
measure: Quality of Life for children aged 8 to 14 years
timeFrame: 12 months
measure: Quality of Life and subjective wellbeing in primary caregivers
timeFrame: 12 months
measure: Prevalence of Ascaris lumbricoides infection
timeFrame: 12 months
measure: Prevalence of hookworm infection
timeFrame: 12 months
measure: Prevalence of Trichuris trichiura infection
timeFrame: 12 months
measure: Environmental contamination - enteric pathogens
timeFrame: 12 months
measure: Environmental contamination - tungiasis
timeFrame: 6 months
Other outcomes:
Locations:
city: Kwale
country: Kenya
facility: Dzombo ward
Study officials:
affiliation: London School of Hygiene and Tropical Medicine
name: Rachel Pullan, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: icipe
name: Ulrike Fillinger, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Kenya Medical Research Institute
name: Charles Mwandawiro, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: JKUAT
name: James Wambua KALULI, PhD
role: PRINCIPAL_INVESTIGATOR
References: