Elson, Lynne
Nyawa, Shadrack Mwadai
Matharu, Abneel
Fillinger, Ulrike
Article History
Received: 21 July 2023
Accepted: 6 December 2023
First Online: 12 December 2023
Declarations
:
: The study was approved by the Kenya Medical Research Institute’s Scientific and Ethics Unit (KEMRI-SERU), protocol reference number non-KEMRI 652 prior to the commencing of any activities. All methods were carried out in accordance with relevant guidelines and regulations as set out in the Declaration of Helsinki. Participation was voluntary and the team ensured participants were aware of this. Participants were free to withdraw from the study at any time. During the community entry phase, a presentation was made to the Kilifi County health management team to obtain their approval. In the community a meeting was held with the heads of households and community leaders to introduce the study. Each head of household or their representative had the study explained to them and gave signed informed consent before the study team entered the homestead. It was emphasized that participation was completely voluntary, and subjects had the opportunity to withdraw from the study at any point in the study. A document written in English and Kiswahili (additionally verbally explained in Giriama which is not a written language and most speakers do not read it) was given to the participant to read and understand before being given the informed consent form for signing in agreement to participate. In the case of an illiterate participant, an impartial witness was assigned to attest that the information in the consent forms and any other written information was accurately explained to and apparently understood by the participant and that consent was freely given. The consent form was in such a case also signed by the witness. In the case of minors, consent was sought from parents or legal guardians and prior assent was sought from children for feet examinations.All data collected had personal identifiers to enable the location of the households and individuals at each follow up visit. To protect these, all data were collected on electronic devices protected by passwords and uploaded to electronic databases on servers at the International Centre of Insect Physiology and Ecology (ICIPE) headquarters in Nairobi, also protected by passwords. Only the data managers at ICIPE and the PIs had access to the databases. The tablets, when not in use, were stored safely in a locked desk in a secure room in the field office.All pupils with tungiasis were referred for treatment to the community health workers using a product used and approved in Kilifi and provided by the study. For those with secondary bacterial infection and other illnesses requiring treatment, a referral was made to the nearest health facility.
: Not applicable.
: The authors declare no competing interests.