‘Screen and Treat for Anaemia Reduction (STAR)’ strategy: study protocol of a cluster randomised trial in rural Telangana, India

INTRODUCTION: Current anaemia control programme focusing on prophylactic iron supplementation and facility-based screening with haemoglobin estimation is inadequate to reduce the high prevalence of anaemia in India. This study aims to examine the impact of community level ‘screen and treat’ strategy for increasing population mean haemoglobin and reducing anaemia prevalence in the rural population. METHODS AND ANALYSIS: An open-labelled cluster randomised controlled trial will be conducted in rural areas of Medchal district, Telangana, India. All individuals served by one Accredited Social Health Activist (ASHA) constitute one cluster and will be randomised in the ratio of 1:1 by covariate constrained randomisation. Eligible members aged between 6 months and 50 years (men, women, children and adolescents) will be included in the study. Intervention group will be screened for anaemia using a point of care haemoglobin estimation followed by treatment with iron–folic acid for 3 months. The intervention delivered by the ASHAs will be supported by an electronic decision support system and simplified medication regimen. Educational videos and interactive voice response system will be used to enhance compliance. The control group will continue to receive benefits of ongoing anaemia control programmes but there will be no active intervention by the study team. At 6 months, haemoglobin will be measured in participants from both arms. The primary outcome will be the difference in population mean haemoglobin in two arms and the secondary outcome will be the difference in the anaemia prevalence in two arms among 6–59 months old children. Multilevel models will be used for analysis accounting for data clustering. ETHICS AND DISSEMINATION: The study is approved by the institutional ethics committee of National Institute of Nutrition, Hyderabad. The results will be published in peer-reviewed journals and disseminated to policymakers. Findings will also be shared with study participants and community leaders. TRIAL REGISTRATION NUMBER: CTRI/2019/01/016918.