title: A Cluster Randomised Trial Introducing Rapid Diagnostic Tests into Registered Drug Shops in Uganda: Impact on Appropriate Treatment of Malaria.
abstract: BACKGROUND
  Inappropriate treatment of malaria is widely reported particularly in areas where there is poor access to health facilities and self-treatment of fevers with anti-malarial drugs bought in shops is the most common form of care-seeking. The main objective of the study was to examine the impact of introducing rapid diagnostic tests for malaria (mRDTs) in registered drug shops in Uganda, with the aim to increase appropriate treatment of malaria with artemisinin-based combination therapy (ACT) in patients seeking treatment for fever in drug shops.
  
  
  METHODS
  A cluster-randomized trial of introducing mRDTs in registered drug shops was implemented in 20 geographical clusters of drug shops in Mukono district, central Uganda. Ten clusters were randomly allocated to the intervention (diagnostic confirmation of malaria by mRDT followed by ACT) and ten clusters to the control arm (presumptive treatment of fevers with ACT). Treatment decisions by providers were validated by microscopy on a reference blood slide collected at the time of consultation. The primary outcome was the proportion of febrile patients receiving appropriate treatment with ACT defined as: malaria patients with microscopically-confirmed presence of parasites in a peripheral blood smear receiving ACT or rectal artesunate, and patients with no malaria parasites not given ACT.
  
  
  RESULTS
  A total of 15,517 eligible patients (8672 intervention and 6845 control) received treatment for fever between January-December 2011. The proportion of febrile patients who received appropriate ACT treatment was 72·9% versus 33·7% in the control arm; a difference of 36·1% (95% CI: 21·3 - 50·9), p<0·001. The majority of patients with fever in the intervention arm accepted to purchase an mRDT (97·8%), of whom 58·5% tested mRDT-positive. Drug shop vendors adhered to the mRDT results, reducing over-treatment of malaria by 72·6% (95% CI: 46·7- 98·4), p<0·001) compared to drug shop vendors using presumptive diagnosis (control arm).
  
  
  CONCLUSIONS
  Diagnostic testing with mRDTs compared to presumptive treatment of fevers implemented in registered drug shops substantially improved appropriate treatment of malaria with ACT.
  
  
  BACKGROUND
  ClinicalTrials.gov NCT01194557.
authors.affiliation: Ministry of Health, Box 7272, Kampala, Uganda; School of Public Health, College of Health Sciences, Makerere University, Kampala, Uganda.
authors.forename: Anthony K
authors.initials: AK
authors.lastname: Mbonye
authors.affiliation: Centre for Medical Parasitology, Faculty of Health and Medical Sciences, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Pascal
authors.initials: P
authors.lastname: Magnussen
authors.affiliation: Department of Disease Control, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Sham
authors.initials: S
authors.lastname: Lal
authors.affiliation: Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Kristian S
authors.initials: KS
authors.lastname: Hansen
authors.affiliation: Department of Infectious Disease Epidemiology, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Bonnie
authors.initials: B
authors.lastname: Cundill
authors.affiliation: Department of Global Health and Development, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Clare
authors.initials: C
authors.lastname: Chandler
authors.affiliation: Department of Disease Control, London School of Hygiene and Tropical Medicine, London, United Kingdom.
authors.forename: Siân E
authors.initials: SE
authors.lastname: Clarke
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000962:Antimalarials / Q000191:economics / Q000627:therapeutic use*; D002648:Child; D002675:Child, Preschool; D016000:Cluster Analysis; D003955:Diagnostic Tests, Routine / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D008288:Malaria / Q000175:diagnosis* / Q000188:drug therapy*; D008297:Male; D008875:Middle Aged; D016896:Treatment Outcome; D014454:Uganda; D055815:Young Adult
chemical_list: D000962:Antimalarials