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Article History

Received: 22 December 2022

Accepted: 12 January 2023

First Online: 22 March 2023

Declarations

:

: The WHO-PEN@Scale study was approved by the Institutional Review Boards at the University of Heidelberg, the University of Eswatini, and the EHHRRB. Furthermore, the EHHRRB reviews the project on a yearly basis and has approved all submitted requests as well as an ethics amendment request, which was required due to a change in the design of the study arms.In the household survey, members of the selected households will be approached by a survey team (data collector and sample collector) trained in research methods and good clinical practice. The data collector will explain the risks and benefits of the survey using a standardized information sheet and consent form in SiSwati or English (see Additional file ). Participants will be informed that participation is fully voluntary, and refusal to participate or discontinuation in the survey will not have any influence on any aspect of their lives. The potential participant will be given the opportunity to ask questions. Special attention will be given to the elderly or other vulnerable individuals interviewed to ensure that they have the mental capacity to provide informed consent. Informed consent from the legally authorized representative will be sought if needed. If potential participants are non- or minimally literate, the survey team will read out the consent form and consent will be provided with a thumbprint with a literate witness present.Data protectionAll participants will be given a study-specific identifier. No identifying information will be reported on study forms apart from the consent form. The link between identifiers and participant’s names will be held by a designated person at the CHAI who will not be involved directly in data analysis. Field staff will never have access to data after collection. Data collection procedures will be conducted at participants’ homes on encrypted mobile tablet computers using the KOBO Toolbox platform. Questionnaires will be locked once validated and finalized by the research managers in the field, so that they cannot be re-opened in the field. At this point, data forms are encrypted using asymmetric public key encryption. Once collected, data will be transferred to a secure server located at CHAI. This server is located in a locked room. In order to export data from the server, an asymmetric private key is used.

: Not applicable.

: The authors declare that they have no competing interests.