title: The impact of retail-sector delivery of artemether-lumefantrine on malaria treatment of children under five in Kenya: a cluster randomized controlled trial.
abstract: BACKGROUND
  It has been proposed that artemisinin-based combination therapy (ACT) be subsidised in the private sector in order to improve affordability and access. This study in western Kenya aimed to evaluate the impact of providing subsidized artemether-lumefantrine (AL) through retail providers on the coverage of prompt, effective antimalarial treatment for febrile children aged 3-59 months.
  
  
  RESULTS
  We used a cluster-randomized, controlled design with nine control and nine intervention sublocations, equally distributed across three districts in western Kenya. Cross-sectional household surveys were conducted before and after the delivery of the intervention. The intervention comprised provision of subsidized packs of paediatric ACT to retail outlets, training of retail outlet staff, and community awareness activities. The primary outcome was defined as the proportion of children aged 3-59 months reporting fever in the past 2 weeks who started treatment with AL on the same day or following day of fever onset. Data were collected using structured questionnaires and analyzed based on cluster-level summaries, comparing control to intervention arms, while adjusting for other covariates. Data were collected on 2,749 children in the target age group at baseline and 2,662 at follow-up. 29% of children experienced fever within 2 weeks before the interview. At follow-up, the percentage of children receiving AL on the day of fever or the following day had risen by 14.6% points in the control arm (from 5.3% [standard deviation (SD): 3.2%] to 19.9% [SD: 10.0%]) and 40.2% points in the intervention arm (from 4.7% [SD: 3.4%] to 44.9% [SD: 11.7%]). The percentage of children receiving AL was significantly greater in the intervention arm at follow-up, with a difference between the arms of 25.0% points (95% confidence interval [CI]: 14.1%, 35.9%; unadjusted p = 0.0002, adjusted p = 0.0001). No significant differences were observed between arms in the proportion of caregivers who sought treatment for their child's fever by source, or in the child's adherence to AL.
  
  
  CONCLUSIONS
  Subsidizing ACT in the retail sector can significantly increase ACT coverage for reported fevers in rural areas. Further research is needed on the impact and cost-effectiveness of such subsidy programmes at a national scale.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN59275137 and Kenya Pharmacy and Poisons Board Ethical Committee for Clinical Trials PPB/ECCT/08/07.
authors.affiliation: Malaria Public Health & Epidemiology Group, Kenya Medical Research Institute-Wellcome Trust Research Programme, Kenya. bkangwana@nairobi.kemri-wellcome.org
authors.forename: Beth P
authors.initials: BP
authors.lastname: Kangwana
authors.forename: Sarah V
authors.initials: SV
authors.lastname: Kedenge
authors.forename: Abdisalan M
authors.initials: AM
authors.lastname: Noor
authors.forename: Victor A
authors.initials: VA
authors.lastname: Alegana
authors.forename: Andrew J
authors.initials: AJ
authors.lastname: Nyandigisi
authors.forename: Jayesh
authors.initials: J
authors.lastname: Pandit
authors.forename: Greg W
authors.initials: GW
authors.lastname: Fegan
authors.forename: James E
authors.initials: JE
authors.lastname: Todd
authors.forename: Simon
authors.initials: S
authors.lastname: Brooker
authors.forename: Robert W
authors.initials: RW
authors.lastname: Snow
authors.forename: Catherine A
authors.initials: CA
authors.lastname: Goodman
mesh_terms: D000962:Antimalarials / Q000191:economics / Q000600:supply & distribution / Q000627:therapeutic use*; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins / Q000191:economics / Q000600:supply & distribution / Q000627:therapeutic use*; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D003430:Cross-Sectional Studies; D004338:Drug Combinations; D004983:Ethanolamines / Q000191:economics / Q000600:supply & distribution / Q000627:therapeutic use*; D005260:Female; D005449:Fluorenes / Q000191:economics / Q000600:supply & distribution / Q000627:therapeutic use*; D006297:Health Services Accessibility; D006801:Humans; D007223:Infant; D007630:Kenya / Q000453:epidemiology; D016778:Malaria, Falciparum / Q000188:drug therapy* / Q000453:epidemiology / Q000469:parasitology; D008297:Male; D010963:Plasmodium falciparum / Q000187:drug effects; D017149:Private Sector; D019035:Rural Health Services; D012424:Rural Population; D016896:Treatment Outcome
chemical_list: D000962:Antimalarials; D000077611:Artemether, Lumefantrine Drug Combination; D037621:Artemisinins; D004338:Drug Combinations; D004983:Ethanolamines; D005449:Fluorenes