Diarrhoeal DiseaseSABABUNCT05914363
Evaluating Impact of Improved Floors on Health
A study testing Sealed washable floor plus behaviour change, Behaviour change intervention and Routine deworming in people with Diarrhoeal Disease and Hookworm Infection, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
Trial 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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Diarrhoeal Disease, Hookworm Infection, Ascaris Lumbricoides Infection
- What is being tested?
- Sealed washable floor plus behaviour change, Behaviour change intervention and Routine deworming
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,200 participants
- Where
- 1 siteKenya
- Study dates
- 12 Apr 2023to 30 Sep 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
About this study
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
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:
Read more
- 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.
Read the 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.
- Conditions
- Diarrhoeal Disease, Hookworm Infection, Ascaris Lumbricoides Infection, Trichuris Infection, Tungiasis
- Being tested
- Sealed washable floor plus behaviour change, Behaviour change intervention, Routine deworming, treatment for tungiasis
- Medical subject headings
- Hookworm Infections, Trichuriasis, Tungiasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sealed washable floor plus behaviour changeOther
Replacement of rudimentary floors with a cement stabilised floor in all rooms in the dwelling
Behaviour change interventionBehavioural
Support for behaviour change through 'floor clubs' and the provision of printed guides
Routine dewormingDrug
Also called albendazole
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)
treatment for tungiasisProcedure or surgery
Treatment of tungiasis in those affected by heavy infections (at 0 and 12 months) according to county Department of Health recommendations
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Drug: Routine deworming; Procedure: treatment for tungiasis |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 12 months
Secondary outcomes (9)
Gastrointestinal illness
Prevalence of gastrointestinal illness in children under 5 years - assessed in both study arms based on caregiver reported symptoms
Measured: 12 months
Intensity and severity of tungiasis
Intensity of tungiasis and severity of acute and chronic tungiasis-associated pathology in children <15 years - assessed using clinical severity scores (range: 0-110, high scores indicating increased severity/worse outcome)
Measured: 12 months
Quality of Life for children aged 8 to 14 years
Quality of Life assessed in children ages 8 to 14 years in both arms using the standardised EQ5D-Y (EuroQol 5-dimension health-related quality of life tool for children; values are anchored at 1 (full health) and 0 (a state as bad as being dead))
Measured: 12 months
Quality of Life and subjective wellbeing in primary caregivers
Quality of Life assessed in primary caregivers in both arms using the standardised EQ5D tool (EuroQol 5-dimension health-related quality of life tool for adults; values are anchored at 1 (full health) and 0 (a state as bad as being dead))
Measured: 12 months
Prevalence of Ascaris lumbricoides infection
Ascaris lumbricoides (roundworm) infection prevalence in all household members >1 year assessed using Kato Katz
Measured: 12 months
Prevalence of hookworm infection
Hookworm infection prevalence in all household members >1 year assessed using Kato Katz
Measured: 12 months
Prevalence of Trichuris trichiura infection
- trichiura (whipworm) infection prevalence in all household members >1 year assessed using Kato Katz
Measured: 12 months
Environmental contamination - enteric pathogens
Environmental contamination for human-specific and animal faecal markers - assessed from dust/soil samples from household cooking areas and living rooms using PCR.
Measured: 12 months
Environmental contamination - tungiasis
Contamination of floors with eggs, larvae, pupae and adults of T. penetrans - assessed through entomology soil surveys
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start12 Apr 2023
- Primary completion31 Aug 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diarrhoeal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Single Group Assignment
- Masking
- None (open label)
- Enrolment
- 2,200 participants (actual)
Sponsor and investigators
- Lead sponsor
- London School of Hygiene and Tropical Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Kenya Medical Research Institute, Jomo Kenyatta University of Agriculture and Technology, International Centre of Insect Physiology and Ecology (ICIPE)
- Responsible party
- Sponsor
- Investigators
- Rachel Pullan, PhD, Principal investigator, London School of Hygiene and Tropical MedicineUlrike Fillinger, PhD, Principal investigator, icipeCharles Mwandawiro, PhD, Principal investigator, Kenya Medical Research InstituteJames Wambua KALULI, PhD, Principal investigator, JKUAT
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05914363
- Sponsor's protocol ID
- 28307
- Other IDs
- 424/4
- Acronym
- SABABU
- Status last verified
- Jun 2024
- First submitted
- 5 Apr 2023
- Last updated
- 30 Jan 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data collected from this study and underlying each article (text, tables, figures, and appendices), including quantitative, de-identified, individual participant data and a data dictionary, will be made available following publication of the article(s).
Publications
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.
PubMed 40480665
Study at a glance
From the registry record, last updated by the sponsor on 30 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05914363
- Acronym / sponsor ID
- SABABU / 28307
- Conditions
- Diarrhoeal Disease, Hookworm Infection, Ascaris Lumbricoides Infection, Trichuris Infection, Tungiasis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,200 participants (actual)
- Lead sponsor
- London School of Hygiene and Tropical MedicineUniversity, hospital or other
- Collaborators
- Kenya Medical Research Institute, Jomo Kenyatta University of Agriculture and Technology, International Centre of Insect Physiology and Ecology (ICIPE)
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 31 Aug 2024 (actual)
- Study completion
- 30 Sep 2024 (actual)
- First posted
- 22 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Single Group Assignment
| Arm | Type | Receives |
|---|---|---|
| Intervention (improved floor) | Experimental | Other: Sealed washable floor plus behaviour change, Behavioral: Behaviour change intervention, Drug: Routine deworming, Procedure: treatment for tungiasis* 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 |
| Control (rudimental floor) | Active comparator | Drug: Routine deworming, Procedure: treatment for tungiasis* 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 |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Households that are intending to move within the next 12 months, or that have improved flooring in any rooms or are not structurally sound.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Sealed washable floor plus behaviour changeReplacement of rudimentary floors with a cement stabilised floor in all rooms in the dwelling | Other | Intervention (improved floor) |
| Behaviour change interventionSupport for behaviour change through 'floor clubs' and the provision of printed guides | Behavioural | Intervention (improved floor) |
| Routine dewormingAlso: albendazoleTreatment 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) | Drug | Control (rudimental floor), Intervention (improved floor) |
| treatment for tungiasisTreatment of tungiasis in those affected by heavy infections (at 0 and 12 months) according to county Department of Health recommendations | Procedure or surgery | Control (rudimental floor), Intervention (improved floor) |
Primary outcome
Enteric infections
Time frame: 12 months
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.
Tungiasis infections
Time frame: 12 months
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.
STH infections
Time frame: 12 months
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.
9 secondary outcomes
Gastrointestinal illness
Time frame: 12 months
Intensity and severity of tungiasis
Time frame: 12 months
Quality of Life for children aged 8 to 14 years
Time frame: 12 months
Quality of Life and subjective wellbeing in primary caregivers
Time frame: 12 months
Prevalence of Ascaris lumbricoides infection
Time frame: 12 months
Prevalence of hookworm infection
Time frame: 12 months
Prevalence of Trichuris trichiura infection
Time frame: 12 months
Environmental contamination - enteric pathogens
Time frame: 12 months
Environmental contamination - tungiasis
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jan 2025.
- Derived from this study: PubMed 40480665Halliday 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.
- Individual participant dataSharing planned: Yes. Data collected from this study and underlying each article (text, tables, figures, and appendices), including quantitative, de-identified, individual participant data and a data dictionary, will be made available following publication of the article(s).
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Pullan, PhD principal investigator
London School of Hygiene and Tropical Medicine
Ulrike Fillinger, PhD principal investigator
icipe
Charles Mwandawiro, PhD principal investigator
Kenya Medical Research Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Sealed washable floor plus behaviour change, Behaviour change intervention and Routine deworming in people with Diarrhoeal Disease and Hookworm Infection, run by London School of Hygiene and Tropical Medicine at 1 site in Kenya.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Kenya. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enteric infections (time frame: 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05914363, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jan 2025.