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Background  The AWED (Applying  Wolbachia  to Eliminate Dengue) trial is a parallel, two-arm, non-blinded cluster randomised controlled trial that is under way in Yogyakarta, Indonesia, with the aim of measuring the efficacy of  Wolbachia -infected  Aedes aegypti  deployments in reducing dengue incidence in an endemic setting. Enrolment began in January 2018 and is ongoing. The original study protocol was published in April 2018. Here, we describe amendments that have been made to the study protocol since commencement of the trial.    Methods  The key protocol amendments are (1) a revised study duration with planned end of participant enrolment in August 2020, (2) the addition of new secondary objectives (i) to estimate serotype-specific efficacy of the  Wolbachia  intervention and (ii) to compare  Ae. aegypti  abundance in intervention versus untreated clusters, (3) an additional exposure classification for the per-protocol analysis where the  Wolbachia  exposure index is calculated using only the cluster-level  Wolbachia  prevalence in the participant’s cluster of residence, (4) power re-estimation using a multinomial sampling method that better accounts for randomness in sampling, and (5) the addition of two trial stopping rules to address the potential for persistently low rates of virologically confirmed dengue case enrolment and  Wolbachia  contamination into untreated clusters. Additional minor changes to the protocol are also described.    Discussion  The findings from this study will provide the first experimental evidence for the efficacy of  Wolbachia  in reducing dengue incidence. Enrolment in the trial will conclude this year (2020) and results will be reported shortly thereafter.    Trial registration   ClinicalTrials.gov , identifier:  NCT03055585 . Registered on 14 February 2017. Last updated 22 March 2020.

Update to the AWED (Applying Wolbachia to Eliminate Dengue) trial study protocol: a cluster randomised controlled trial in Yogyakarta, Indonesia