Ethiopia Trachoma Adaptive Trial DAC Trial Planning Grant

Date of Start
November 2022

Date of Completion
February 2028

Funder
Bill and Melinda Gates Foundation

Aim
Enhance the informativeness and impact of the Ethiopia trachoma adaptive trial by funding technical experts to partner in the production of trial protocol, statistical analysis plan, communication plan, target policy profile and clinical trial simulation code.

Background
The Ethiopia Trachoma programme is planning a phased implementation of more frequent than annual (MFTA) azithromycin MDA to accelerate elimination in districts with persistent and recrudescent trachoma. This entails repeating MDA for children in the age group of 1 – 9 years (referred as “child MDA”) one month after community-wide annual MDA. The rationale for this is that children form the core group for Chlamydia trachomatis infection transmission. However, there is no concrete evidence that child MDA will result in more rapid trachoma elimination than the standard annual community-wide treatment. We will conduct an adaptive stepped-wedge-effectiveness-implementation hybrid cluster randomised trial to evaluate both the efficacy of child MDA and its implementation process as compared to standard annual MDA. Gates Foundation has funded the trial protocol preparation of this trial to hire the necessary technical experts to contribute to the production of the trial protocol, statistical analysis plan, clinical trial simulation code and associated results and recommendations, target policy profile, and communication plan to enhance the informativeness and impact of the trial.

Progress
The first draft of the five deliverables of the project: trial protocol, statistical analysis plan, clinical trial simulation code and associated results and recommendations, target policy profile, and communication plan have been completed and submitted to the DAC team at Gates Foundation for review