Funding for this research was provided by:
Norges Forskningsråd (FRIPRO project no. 250443)
Received: 16 September 2017
Accepted: 19 January 2018
First Online: 20 February 2018
Change Date: 24 December 2018
Change Type: Correction
Change Details: In the original publication , the first of two objectives was to “Assess the effect of periodically treating water storage containers with a pyriproxyfen/spinosad combination on entomological and epidemiological outcomes”.
Ethics approval and consent to participate
: This trial was approved by the Khon Kaen University Ethics Committee (KKUEC) (Record No. 4.4.01: 29/2017, Reference No. HE601221, 1 September 2017) and the London School of Hygiene and Tropical Medicine Ethical Committee, UK (LSHTM Ethics Ref: 14275, 16 August 2017). Ethical review of the Regional Committee for Medical and Health Research Ethics, Section B, South East Norway (REK) is ongoing. Any follow-on protocol amendments will be reviewed and approved by these committees. The ISRCTN trial registry will also be informed in a timely manner of such amendments.All subjects will be engaged in a process of documented informed consent, and assent where appropriate, before participating in any study activities (Additional fileInternalRef removed). These processes will be conducted by staff of the Office of Disease Prevention and Control in Khon Kaen supervised by Khon Kaen University. There will be three consent processes in this trial:1.Request for household participation in a research project. Before starting the baseline data collections, households will be informed about the trial, and the household head will sign a consent form requesting his/her household to participate in the trial. Household agreement to participate means that its members may be subjected to individual request for participation, as stated in the following two points.2.Request for individual participation in a research project. Individual consent, and assent if appropriate, to participate will be sought from each household member at the time when they have been identified as having a fever during the study observation period. Fever cases will be identified by the VHVs.3.Request for blood spot collections. Consent (assent) will be sought from the two persons per household identified and selected for regular monthly blood spot collections each time blood spots are requested. These two individuals will be provided a small monetary compensation (50 baht = USD 1.50) for each blood sample.Each of the three consent processes will take place at the households. Informed consent will be documented by means of a written signed and dated consent form after (1) a full description of the study on the information sheet is given to the participant, and (2) the procedures, advantages, disadvantages, and responsibilities and participant’s rights to withdraw at any time have been discussed, clarified, and fully understood by the participant. All forms and questionnaires are translated from English into the Thai language and tested for accuracy and interpretation before use.Children will be given a chance to decide for themselves whether they want to participate or not without pressure or coercion from parents or project staff. The assent forms, adapted to the children’s ability to read and write, provide a simple and general overview of what participation in the project entails. The children will also be informed about the project verbally in easy-to-understand language. Children will sign the forms before their parents or legal guardians sign. The assent form is for children 7–13 years old. Children 14–17 years old will use the same consent form as that for adults, which has space for both children and parents/guardians to sign. Although the age of majority in Thailand is 20 years, 18 is commonly used as an age of consent for treatment purposes [CitationRef removed]. All consent and assent forms explain the risks and benefits of the study. For participants who cannot read, the entire informed consent form will be read and explained by the project staff in the presence of a community witness. After consenting, these people will mark an inked thumb impression on the form, and the witness will be asked to sign it. Consent and assent forms approved and stamped by the KKUEC are used in accordance with the Ethics Committee’s guidelines.
: All authors have consented to publication of this article.
: The authors declare that they have no competing interests.
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