Evaluating Impact of Improved Floors on Health

NCT05914363 | Completed DMC

• 2 other identifiers: 28307424/4
• Study Type: interventional
• Target: 2,200
• Locations: 1 country
• Sites: 1

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.

Conditions

Diarrhoeal Disease; Hookworm Infection; Ascaris Lumbricoides Infection; Trichuris Infection; Tungiasis

Outcome Measures

Primary Outcomes (3)

• Enteric infections

  Prevalence of enteric infections (detected through PCR) in children under 5 years old will be assessed using cross-sectional stool surveys including all enrolled children under 5 years before installation of floors and 12 months after receiving the floors. Pathogens to be identified from those observed at baseline using a multipathogen panel on a subset of 100 samples.

  12 months

• Tungiasis infections

  Prevalence of tungiasis (detected through clinical examination of hands and feet) in children under 15 years old will be assessed using cross-sectional clinical assessment surveys including all enrolled children under 15 years before installation of floors and 12 months after receiving the floors.

  12 months

• STH infections

  Prevalence of at least one STH infection (hookworm, ascaris and trichuris infections; detected through kato katz) in all household members 12 months and older will be assessed using cross-sectional stool surveys including all enrolled people over 12 months of age before installation of floors and 12 months after receiving the floors.

  12 months

Secondary Outcomes (9)

• Gastrointestinal illness

  12 months

• Intensity and severity of tungiasis

  12 months

• Quality of Life for children aged 8 to 14 years

  12 months

• Quality of Life and subjective wellbeing in primary caregivers

  12 months

• Prevalence of Ascaris lumbricoides infection

  12 months

Study Arms (2)

Intervention (improved floor)

EXPERIMENTAL

* Replacement of rudimentary floors with an improved floor, * Support for behaviour change through 'floor clubs'. * Annual mass treatment for STH infections (400 mg albendazole) * Treatment of tungiasis in those affected by heavy infections (at 0 and 12 months) according to county DoH recommendations

Other: Sealed washable floor plus behaviour change; Behavioral: Behaviour change intervention; Drug: Routine deworming; Procedure: treatment for tungiasis

Control (rudimental floor)

ACTIVE COMPARATOR

* Annual mass treatment for STH infections (400 mg albendazole) * Treatment of tungiasis in those affected by heavy infections (at 0 and 12 months) according to county DoH recommendations

Drug: Routine deworming; Procedure: treatment for tungiasis

Interventions

Sealed washable floor plus behaviour change OTHER

Replacement of rudimentary floors with a cement stabilised floor in all rooms in the dwelling

Intervention (improved floor)

Behaviour change intervention BEHAVIORAL

Support for behaviour change through 'floor clubs' and the provision of printed guides

Intervention (improved floor)

Routine deworming DRUG

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)

Also known as: albendazole

Control (rudimental floor); Intervention (improved floor)

treatment for tungiasis PROCEDURE

Treatment of tungiasis in those affected by heavy infections (at 0 and 12 months) according to county Department of Health recommendations

Control (rudimental floor); Intervention (improved floor)

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Households that are intending to move within the next 12 months, or that have improved flooring in any rooms or are not structurally sound.

Sponsors & Collaborators

• London School of Hygiene and Tropical Medicine: lead
• Kenya Medical Research Institute: collaborator
• Jomo Kenyatta University of Agriculture and Technology: collaborator
• International Centre of Insect Physiology and Ecology (ICIPE): collaborator

Study Sites (1)

Dzombo ward

Kwale, Kwale County, Kenya

Location

Related Publications (1)

• Halliday KE, Kepha S, Legge H, Allen E, Dreibelbis R, Elson L, Kakoi BK, Mcharo C, Muli S, Mwongeli J, Njomo D, Njoroge MM, Ochwal V, Oswald WE, Rono M, Safari TK, Filinger U, Kaluli JW, Mwandawiro CS, Pullan RL. Evaluating impacts of improved flooring on enteric and parasitic infections in rural households in Kenya: study protocol for a cluster-randomised controlled trial. BMJ Open. 2025 Jun 6;15(6):e090464. doi: 10.1136/bmjopen-2024-090464.

  PMID: 40480665 DERIVED

MeSH Terms

Conditions

Hookworm Infections; Trichuriasis; Tungiasis

Interventions

Albendazole; Therapeutics

Condition Hierarchy (Ancestors)

Strongylida Infections; Secernentea Infections; Nematode Infections; Helminthiasis; Parasitic Diseases; Infections; Enoplida Infections; Adenophorea Infections; Flea Infestations; Ectoparasitic Infestations; Skin Diseases, Parasitic

Intervention Hierarchy (Ancestors)

Carbamates; Acids, Acyclic; Carboxylic Acids; Organic Chemicals; Benzimidazoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Rachel Pullan, PhD

  London School of Hygiene and Tropical Medicine

  PRINCIPAL INVESTIGATOR

• Ulrike Fillinger, PhD

  icipe

  PRINCIPAL INVESTIGATOR

• Charles Mwandawiro, PhD

  Kenya Medical Research Institute

  PRINCIPAL INVESTIGATOR

• James Wambua KALULI, PhD

  JKUAT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Single Group Assignment

Study Record Dates

• First Submitted: April 5, 2023
• First Posted: June 22, 2023
• Study Start: April 12, 2023
• Primary Completion: August 31, 2024
• Study Completion: September 30, 2024
• Last Updated: January 30, 2025

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: The quantitative, individual, de-identified, participant data that underlie the results reported in each published article (text, tables, figures, and appendices) will be made available within three months of publication of each article, with no end date.
• Access Criteria: The data will be made available to members of the scientific and medical community for non-commercial use only, upon email request to the corresponding author. Written proposals will be assessed by members of the SABABU Trial Group and a decision made about the appropriateness of the use of data. Data will be stored at LSHTM Data Compass, the London School of Hygiene \& Tropical Medicine digital data repository The data will be available to anyone who wishes to access the data through the LSHTM Data Compass, the London School of Hygiene \& Tropical Medicine digital data repository. URL is https://datacompass.lshtm.ac.uk/

Locations

KE (1)