Abstract
Azithromycin mass drug administration (MDA) for 1- to 59-month-olds reduces child mortality. However, guidelines restrict eligibility to 1- to 11-month-olds because of concerns about antimicrobial resistance. This cluster-randomized implementation trial was conducted in parallel with a larger efficacy trial and compared implementation outcomes between these approaches. Rural communities in Niger were randomly assigned to receive biannual azithromycin MDA for either 1- to 59-month-olds or 1- to 11-month-olds over 1 year. The primary outcome was the community-level cost per dose delivered. Secondary outcomes included reach (coverage), as well as acceptability, appropriateness, and feasibility according to participants and providers. In November 2020, 40 eligible communities were randomly assigned to each arm, with 37 communities in the 1- to 59-month arm and 39 communities in the 1- to 11-month arm contributing to analyses. The mean cost per dose delivered was $6.50 lower (95% CI -$10.40 to -$3.70; P-value <0.001) in the 1- to 59-month arm ($1.60; 95% CI $1.00 to $2.30) compared with the 1- to 11-month arm ($8.20; 95% CI $7.60 to $8.80). Treatment coverage was similar by arm and exceeded 90% in both distributions. More caregivers in the 1- to 59-month arm found the intervention acceptable (mean difference 4.2%; 95% CI 0 to 8.4%; P-value 0.04) and appropriate (3.4%; 95% CI 0.1 to 6.8%; P-value 0.04) compared with the 1- to 11-month arm. When combining arms, all groups indicated that including 1- to 59-month-olds was more acceptable, appropriate, and feasible than restricting to 1- to 11-month-olds. No serious adverse events were reported. Overall, including 1- to 59-month-olds resulted in a lower cost per dose delivered than restricting to 1- to 11-month-olds. Community groups perceived both interventions to be acceptable, appropriate, and feasible, but they strongly preferred the 1- to 59-month treatment.