Design and execution of a public randomization ceremony to enhance stakeholder engagement within a cluster randomized trial to improve tuberculosis diagnosis in Uganda
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Date
2021
Journal Title
Journal ISSN
Volume Title
Publisher
Contemporary clinical trials communications
Abstract
Public randomization ceremonies have been proposed as a strategy to strengthen stakeholder engagement and
address concerns and misconceptions associated with trial randomization. However, there are few published
examples that describe how to conduct a public randomization ceremony with meaningful stakeholder
engagement or how such ceremonies impact stakeholder perceptions about randomization and the randomization
process. Cluster randomization for the GeneXpert Performance Evaluation for Linkage to Tuberculosis Care
(XPEL-TB) trial was conducted at a public randomization ceremony attended by 70 stakeholders in Kampala,
Uganda. Presentations given by the Acting Assistant Commissioner from the Uganda National Tuberculosis and
Leprosy Programme and trial investigators emphasized how the trial aimed to further national TB goals, as well
as how stakeholders contributed to the intervention design. The purpose and process of randomization were
described using simple text and visuals. Randomization was an interactive activity that required participation of
stakeholders from each trial site. A survey administered to stakeholders at the end of the ceremony suggested
high comprehension of randomization (98%), trust in the randomization process (96%), and satisfaction with
randomization outcomes (96%). Public randomization ceremonies should be considered more routinely to
engage stakeholders in and address potential concerns about the fairness and impartiality of the randomization
process for community-based trials.
Description
Keywords
Public randomization ceremony, Cluster randomized trials, Trial ethics, Stakeholder engagement, Tuberculosis
Citation
Reza, T. F., Nalugwa, T., Nantale, M., Adams, K., Fielding, K., Nakaweesa, A., ... & Cattamanchi, A. (2021). Design and execution of a public randomization ceremony to enhance stakeholder engagement within a cluster randomized trial to improve tuberculosis diagnosis in Uganda. Contemporary clinical trials communications, 22, 100707. https://doi.org/10.1016/j.conctc.2021.100707