Evaluating Impact of Improved Floors on Health (SABABU)

London School of Hygiene and Tropical Medicine

Status: Completed

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

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

Study type: Interventional

Funder types: Other

Identifiers

NCT05914363

28307

424/4 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,200 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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2,200 participants in 2 patient groups

Intervention (improved floor)

Experimental group

Description:

* 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

Treatment:

Drug: Routine deworming

Procedure: treatment for tungiasis

Behavioral: Behaviour change intervention

Other: Sealed washable floor plus behaviour change

Control (rudimental floor)

Active Comparator group

Description:

* 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

Treatment:

Drug: Routine deworming

Procedure: treatment for tungiasis