Strengths
TB, pneumonia, malaria
MALARIA, PNEUMONIA, MALNUTRITION
The cluster-randomized trial design provides population-level evidence of the effectiveness of home-based contact management, which is best delivered at a group level. Availability of estimates of the baseline characteristics from prior work in this setting is a strength of our study design. These were used to provide reasonable sample size estimates and to conduct a covariate-constrained randomization that ensures balance between the study arms [This study utilizes a comprehensive mixed-methods approach to not only determine the effectiveness and cost-effectiveness of community-based contact management, but also to understand how and why the intervention is successful or not.The pragmatic intervention was developed in partnership with the local TB and community health programs, health facilities, providers, and caregivers to ensure this healthcare delivery model could continue after the study is completed. In Ethiopia, this package of care has been integrated into existing community-based services for malaria, malnutrition, pneumonia, and other important cause of under-5 mortality. The expertise, training, and experience of the staff working on this study from within their national health systems is a significant strength of this study.The two high-burden countries have differing health system organization requiring tailored interventions for each setting. The two settings are separately powered to allow us to understand the effectiveness and cost-effectiveness for these two countries and health systems. Ultimately the differences between the two countries may enhance the generalizability of our findings given the differing implementation of home-based services in the two settings.Enrolling child contacts 5 to 14 years of age in Ethiopia will allow us to understand the effectiveness of this intervention for school-aged children to whom the TPT recommendation has only recently been extended. Because this study was funded by IMPAACT4TB, we will also be able to enhance our knowledge of the safety and treatment outcomes for 3HP in children 2 years and older.