Developing low-cost house floors to control sand flea disease (jiggers) in Kenya

ISRCTN	ISRCTN62801024
DOI	https://doi.org/10.1186/ISRCTN62801024
Secondary identifying numbers	KEMRI-SERU-NON-KEMRI 652

Submission date: 29/06/2023
Registration date: 07/07/2023
Last edited: 13/12/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Background and study aims
Tungiasis is a neglected tropical skin disease caused by sand fleas, the adult female of which burrows into the skin of the feet. The parasite rapidly expands its body size by a factor of 2000. The growth causes inflammation with immense itching, pain and debilitation. With no good treatment available people cut out the fleas using plant thorns and dirty blades causing more damage and suffering. The embedded flea lays eggs out of the skin into the soil where they develop into larvae and 3 weeks later adults emerge from pupae ready to infect the same person or another person. Several studies have shown that the main source of infection is inside people’s homes since they have floors of sand or soil. The best way to control tungiasis is to enable people to build houses with sealed, hard floors in which the flea larvae cannot live. In this project we aim to develop and test a hard floor that is affordable for the poorest families, who are the ones most affected by tungiasis.

Who can participate?
The study enrolled households in Kilifi county in Kenya with an earthen floor and at least two tungiasis cases.

What does the study involve?
Houses were randomly allocated to have either a low-cost floor, a concrete floor, or no additional floor.
Floors were installed in houses in December 2019 and children in all houses monitored for infection once a month for 10 months.

What are the possible benefits and risks of participating?
The benefits of participating in the study were receiving a hard sealed floor in the house and all infected children were treated for tungiasis. The main risk was exposure of the infection status of family members to neighbours.

Where is the study run from?
International Centre of Insect Physiology and Ecology (Kenya)

When is the study starting and how long is it expected to run for?
April 2019 to February 2023

Who is funding the study?
The study was funded with a pump-prime grant from UKRI-MRC through the BOVA Network

Who is the main contact?
Dr Ulrike Fillinger of the International Centre for Insect Physiology and Ecology, Nairobi, Kenya; ufillinger@icipe.org

Contact information

Dr Ulrike Fillinger
Principal Investigator

International Centre for Insect Physiology and Ecology (icipe)
Duduville Campus
Thika Road
Nairobi
00100
Kenya

ORCID ID	0000-0002-4037-431X
Phone	+254-791-845259
Email	ufillinger@icipe.org

Dr Lynne Elson
Scientific

P.O. Box 770
Watamu
80202
Kenya

ORCID ID	0000-0003-2264-4459
Phone	+254 729338457
Email	lynne.elson@gmail.com

Study information

Study design	Feasibility study
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Community
Study type	Prevention
Participant information sheet	43866 PIS.pdf
Scientific title	Developing low-cost house floors to control Tungiasis in Kenya
Study objectives	Sealing house floors will prevent development of off-host stages of Tunga penetrans and therefore transmission
Ethics approval(s)	Approved 08/02/2019, KEMRI-SERU (PO Box 54840, Nairobi, 00200, Kenya; +254 722205901; ddrt@kemri.go.ke), ref: NON-KEMRI-652
Health condition(s) or problem(s) studied	Prevention of tungiasis among children under 18 years
Intervention	A low-cost floor retro-fitted into 12 houses of families with at least two cases of tungiasis. A second intervention group of 12 houses received a local standard concrete floor and the control group received no floor until the end of the study. The heads of households were randomized to study arms through a public lottery event. Floors were installed in 24 houses in December 2019 and children in all 36 houses monitored for infection once a month for 10 months.
Intervention type	Other
Primary outcome measure	Proportion of participating children with live fleas embedded in their feet as detected by eye at midline (4 months) and endline (10 months).
Secondary outcome measures	1. Infection intensity of infected children measured by counting the number of all embedded fleas in both feet of participants at midline (4 months) and endline (10 months). 2. Acute symptom scores of infected children measured by counting the number of zones (9 in each foot) exhibiting each symptom (thermographic hotspot, desquamtation, fissures, ulcers, abscess) at midline (4 months) and endline (10 months).
Overall study start date	11/04/2019
Completion date	12/02/2023

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	6 Months
Upper age limit	18 Years
Sex	Both
Target number of participants	36 households
Total final enrolment	36
Key inclusion criteria	1. Households with at least two children infected with tungiasis and having at least 5 embedded fleas each 2. House with an unsealed floor 3. Houses with a maximum floor area of 36m² 4. Head of household willing and able to move out of the house while the floor is installed and provide informed consent
Key exclusion criteria	1. Households with a concrete sealed floor 2. Houses larger than 36m² 3. Household not willing or able to move out of the house while the floor is installed
Date of first enrolment	09/10/2019
Date of final enrolment	22/11/2019

Locations

Countries of recruitment

Kenya

Study participating centre

Dabaso Tujengane

P.O. Box 770
Watamu
80202
Kenya

Sponsor information

International Centre of Insect Physiology and Ecology
Research organisation

Duduville Campus
Thika Road
Kasarani
Nairobi
00100
Kenya

Phone	+254-20-8632000
Email	icipe@icipe.org
Website	icipe.org
"ROR"	https://ror.org/03qegss47

Funders

Funder type

Research council

Medical Research Council
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date	01/12/2023
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Stored in publicly available repository, Published as a supplement to the results publication
Publication and dissemination plan	Results will be published in a high impact peer-reviewed open-access journal and shared at national conferences and at the BOVA Network meetings.
IPD sharing plan	The datasets generated during the current study will be stored in a publicly available repository associated with the publication.

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Participant information sheet			04/07/2023	No	Yes
Results article		12/12/2023	13/12/2023	Yes	No

Additional files

43866 PIS.pdf

Editorial Notes

13/12/2023: Publication reference added.
04/07/2023: Trial's existence confirmed by Kenya Medical Research Institute.