Article Text

‘Screen and Treat for Anaemia Reduction (STAR)’ strategy: study protocol of a cluster randomised trial in rural Telangana, India
  1. Bharati Kulkarni1,
  2. Little Flower Augustine1,
  3. Raghu Pullakhandam2,
  4. Anju Sinha Pradhan3,
  5. Teena Dasi1,
  6. Ravindranadh Palika2,
  7. Santosh Kumar Banjara1,
  8. Harshpal Singh Sachdev4
  1. 1Clinical Division, ICMR-National Institute of Nutrition, Hyderabad, Telangana, India
  2. 2Drug Safety Division, ICMR- National Institute of Nutrition, Hyderabad, Telangana, India
  3. 3Reproductive and Child Health, Indian Council of Medical Research, New Delhi, Delhi, India
  4. 4Department of Paediatrics, Sitaram Bhartia Institute of Science and Research, New Delhi, Delhi, India
  1. Correspondence to Dr Bharati Kulkarni; dr.bharatikulkarni{at}


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.

  • anaemia
  • nutrition & dietetics
  • community child health
  • public health

Data availability statement

The data will be shared as per the ICMR Guidelines (currently under development) at the time of completion of the study. Restricted data sets will be shared by the corresponding author in conformity with the regulatory guidelines upon reasonable request.

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Data availability statement

The data will be shared as per the ICMR Guidelines (currently under development) at the time of completion of the study. Restricted data sets will be shared by the corresponding author in conformity with the regulatory guidelines upon reasonable request.

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  • Collaborators None declared.

  • Contributors BK and RPu: conceptualised and developed the study design with input from ASP and HSS. LFA: developed study protocols and wrote the first draft along with BK. TD and RPa: developed the POC screening method and protocol. ASP and SKB contributed to development of study design and methodology. HSS provided critical intellectual input for improving the study design and manuscript. All the authors reviewed and approved the final version of the manuscript and agree to be accountable for all aspects of the work.

  • Funding This work was supported by Indian Council of Medical Research (grant number 5/7/1581/2018-RBMH&CH), V. Ramalingaswami Bhawan, Ansari Nagar, New Delhi, India.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.

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