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Innovative public–private partnership to target subsidised antimalarials: a study protocol for a cluster randomised controlled trial to evaluate a community intervention in Western Kenya
  1. Jeremiah Laktabai1,
  2. Adriane Lesser2,
  3. Alyssa Platt2,3,
  4. Elisa Maffioli2,4,
  5. Manoj Mohanan2,4,5,
  6. Diana Menya6,
  7. Wendy Prudhomme O'Meara2,6,7,
  8. Elizabeth L Turner2,3
  1. 1Moi School of Medicine, Eldoret, Kenya
  2. 2Duke Global Health Institute, Duke University, Durham, North Carolina, USA
  3. 3Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA
  4. 4Department of Economics, Duke University, Durham, North Carolina, USA
  5. 5Sanford School of Public Policy, Duke University, Durham, North Carolina, USA
  6. 6Moi University School of Public Health, College of Health Sciences, Eldoret, Kenya
  7. 7Division of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA
  1. Correspondence to Dr Elizabeth L Turner; liz.turner{at}duke.edu

Abstract

Introduction There are concerns of inappropriate use of subsidised antimalarials due to the large number of fevers treated in the informal sector with minimal access to diagnostic testing. Targeting antimalarial subsidies to confirmed malaria cases can lead to appropriate, effective therapy. There is evidence that community health volunteers (CHVs) can be trained to safely and correctly use rapid diagnostic tests (RDTs). This study seeks to evaluate the public health impact of targeted antimalarial subsidies delivered through a partnership between CHVs and the private retail sector.

Methods and analysis We are conducting a stratified cluster-randomised controlled trial in Western Kenya where 32 community units were randomly assigned to the intervention or control (usual care) arm. In the intervention arm, CHVs offer free RDT testing to febrile individuals and, conditional on a positive test result, a voucher to purchase a WHO-qualified artemisinin combination therapy (ACT) at a reduced fixed price in the retail sector.

Study outcomes in individuals with a febrile illness in the previous 4 weeks will be ascertained through population-based cross-sectional household surveys at four time points: baseline, 6, 12 and 18 months postbaseline. The primary outcome is the proportion of fevers that receives a malaria test from any source (CHV or health facility). The main secondary outcome is the proportion of ACTs used by people with a malaria-positive test. Other secondary outcomes include: the proportion of ACTs used by people without a test and adherence to test results.

Ethics and dissemination The protocol has been approved by the National Institutes of Health, the Moi University School of Medicine Institutional Research and Ethics Committee and the Duke University Medical Center Institutional Review Board. Findings will be reported on clinicalstrials.gov, in peer-reviewed publications and through stakeholder meetings including those with the Kenyan Ministry of Health.

Trial registration number Pre-results, NCT02461628.

  • community health volunteers
  • malaria
  • antimalarial subsidies
  • rapid diagnostic test

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Footnotes

  • Contributors JL, AL, AP and ELT drafted the manuscript. All authors contributed to the study design. All authors read and approved of the final version of the manuscript.

  • Funding This work is supported by the National Institutes of Health-National Institute of Allergy and Infectious Diseases (NIH-NIAID) grant number R01AI110478. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institute of Allergy and Infectious Diseases or the National Institutes of Health. The study sponsor had no influence on the study design; data collection, analysis or interpretation; content of the manuscript, nor the authors' decision to submit this manuscript. The researchers operated independently from the funder in these matters. All authors had full access to all data and take responsibility for the integrity and accurate analysis of the data.

  • Competing interests All authors have completed the ICMJE uniform disclosure form at http://www.icmje.org/coi_disclosure.pdf and declare: all authors had financial support from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (US) for the submitted work.

  • Ethics approval Moi University School of Medicine Institutional Research and Ethics Committee (approval number 0001403) and the Duke University Medical Center Institutional Review Board (Pro00063384). The study has also been registered on clinicaltrials.gov (NCT02461628).

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

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