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Randomized Controlled Trial
, 7 (3), e013972

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

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Randomized Controlled Trial

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

Jeremiah Laktabai et al. BMJ Open.

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.

Keywords: antimalarial subsidies; community health volunteers; malaria; rapid diagnostic test.

Conflict of interest statement

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.

Figures

Figure 1
Figure 1
Study area and health facility access in selected community units.
Figure 2
Figure 2
Diagram of intervention strategy. CHWs, community health workers.
Figure 3
Figure 3
Expected behaviour and test results of febrile study participants in the intervention and control arms. ACT, artemisinin combination therapy.

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