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NCT07520279
This is a multi-site, observational, cross-sectional clinical study that includes geographically diverse sites within and outside the United States.
NCT07436104
Background: Age specific mortality rate (ASMR) of 16-60 years is very high in Indian tribal areas due to communicable and non-communicable diseases. Objectives: The primary objective is to reduce the ASMR in 16-60 years age group by at-least 30% from 16 tribal villages of Melghat. The secondary objectives are to reduce cause-specific mortality rates (CSMR) in 16-60 years age group because of diarrhoea, malaria, pneumonia, etc. Design: Community-based, single-centered, parallel-arm, cluster randomised controlled trial. Setting: 36 tribal villages/clusters (research phase: 2004-2015) and 44 new villages (replication phase: 2016-2022) were externally randomized by lottery method to intervention arm (IA) or control arm (CA). Participants: All persons in age group of 16-60 years from inaccessible 80 tribal villages. Interventions: Trained VHWs in IA, provided behaviour change communication, treatment and referral. Except principal investigator, other study staff and participants were double blinded.