Background

The Ethiopia Trachoma programme is implementing a 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.

Methods

We developed a three-arm Adaptive Staggered Parallel Effectiveness -Implementation Hybrid Cluster Randomised Controlled Trial (ASPECT) to monitor the efficacy and implementation of child azithromycin MDA compared to the standard annual MDA. Technical experts contributed to the development of the trial protocol, statistical analysis plan, communication strategy, policy profile, and clinical trial simulation code. The protocol draft was submitted to the Bill & Melinda Gates Foundation DAC team in March 2023.

Key Design Components

The adaptive stepped-wedge design allows simultaneous evaluation of efficacy and implementation outcomes.
Repeated MDA for children aged 1–9 years, one month after annual MDA, is the central intervention.
Engagement of technical experts ensured a robust, high-impact trial design.
The proposal and protocol draft were finalized and submitted for review by the Gates Foundation.
The project lays the groundwork for evidence-based improvements in trachoma control strategies.