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.
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.



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.



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.



Pre-results, NCT02461628.
Moi School of Medicine, Eldoret, Kenya.
Jeremiah
J
Laktabai
Duke Global Health Institute, Duke University, Durham, North Carolina, USA.
Adriane
A
Lesser
Duke Global Health Institute, Duke University, Durham, North Carolina, USA.|Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.
Alyssa
A
Platt
Duke Global Health Institute, Duke University, Durham, North Carolina, USA.|Department of Economics, Duke University, Durham, North Carolina, USA.
Elisa
E
Maffioli
Duke Global Health Institute, Duke University, Durham, North Carolina, USA.|Department of Economics, Duke University, Durham, North Carolina, USA.|Sanford School of Public Policy, Duke University, Durham, North Carolina, USA.
Manoj
M
Mohanan
Moi University School of Public Health, College of Health Sciences, Eldoret, Kenya.
Diana
D
Menya
Duke Global Health Institute, Duke University, Durham, North Carolina, USA.|Moi University School of Public Health, College of Health Sciences, Eldoret, Kenya.|Division of Infectious Diseases and International Health, Duke University Medical Center, Durham, North Carolina, USA.
Wendy
W
Prudhomme O'Meara
Duke Global Health Institute, Duke University, Durham, North Carolina, USA.|Department of Biostatistics and Bioinformatics, Duke University, Durham, North Carolina, USA.
Elizabeth L
EL
Turner
D000293:Adolescent; D000328:Adult; D000962:Antimalarials / Q000191:economics* / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D016000:Cluster Analysis; D003150:Community Health Workers; D003430:Cross-Sectional Studies; D005260:Female; D006801:Humans; D007223:Infant; D007630:Kenya; D008288:Malaria / Q000517:prevention & control*; D008297:Male; D055818:Public-Private Sector Partnerships; D012107:Research Design; D055815:Young Adult
D000962:Antimalarials
antimalarial subsidies; community health volunteers; malaria; rapid diagnostic test