Document is current

Article History

Received: 26 July 2024

Revised: 28 May 2025

Accepted: 29 May 2025

First Online: 11 August 2025

Declarations

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: Dr. Trent discloses the following declarations: SpeeDx, LLC has provided research supplies to Johns Hopkins University through MTA for an RCT, and Visby Inc. has provided an honorarium for a lecture. Neither contributed to this study. The remaining authors declare no competing interests.

: The study protocol was approved by the University of Minnesota Institutional Review Board (protocol number STUDY00006904), the Institutional Review Board of MUHAS (study number DA.282/298/01.C) and the [Tanzanian] National Institute for Medical Research (protocol number NIMR/HQ/R.8a/Vol.IX/3020). All enrollees received a consent form outlining the voluntary nature of the study, study tasks, benefits (i.e., education) and risks (e.g., COVID prevention measures), assurances of confidentiality and had the opportunity to ask questions and have them answered prior to enrolling in the study. To enroll, all participants needed to sign the form indicating their consent. Given the study occurred in 2021 during the COVID pandemic, all participant procedures were conducted with a COVID prevention protocol approved by the University of Minnesota Office of Vice President for Research. The study protocol is available upon request. This study was considered a “not beyond everyday risk” study by our IRBs, so a data monitoring committee was deemed not necessary. The trial was registered at ClinicalTrials.gov, study number: NCT03923582. The study data and protocols are available at the Data Repository of the University of Minnesota (DRUM) repository.

: Informed consent was obtained from all individual participants included in the study.