title: Longlasting insecticidal nets for prevention of Leishmania donovani infection in India and Nepal: paired cluster randomised trial.
abstract: OBJECTIVE
  To test the effectiveness of large scale distribution of longlasting nets treated with insecticide in reducing the incidence of visceral leishmaniasis in India and Nepal.
  
  
  METHODS
  Paired cluster randomised controlled trial designed to detect a 50% reduction in incidence of Leishmania donovani infection.
  
  
  METHODS
  Villages in Muzaffarpur district in India and Saptari, Sunsari, and Morang districts in Nepal.
  
  
  METHODS
  13 intervention and 13 control clusters. 12 691 people were included in the analysis of the main outcome (infection), and 19 810 were enrolled for the secondary (disease) end point.
  
  
  METHODS
  Longlasting insecticidal nets (treated with deltamethrin) were distributed in the intervention clusters in December 2006.
  
  
  METHODS
  Infection was determined by direct agglutination test at 12 and 24 months after the intervention in those who had negative results (titre <1:1600) at baseline. The effect estimate was computed as the geometric mean of the risk ratios for seroconversion for each cluster pair (net/no net), with its 95% confidence interval. Formal tests of effect of no intervention were obtained with a paired t test.
  
  
  RESULTS
  There was no significant difference in the risk of seroconversion over 24 months in intervention (5.4%; 347/6372) compared with control (5.5%; 345/6319 people) clusters (risk ratio 0.90, 95% confidence interval 0.49 to 1.65) nor in the risk of clinical visceral leishmaniasis (0.99, 0.46 to 1.40). Adjustment for covariates did not alter these conclusions.
  
  
  CONCLUSIONS
  There is no evidence that large scale distribution of longlasting insecticidal nets provides additional protection against visceral leishmaniasis compared with existing control practice in the Indian subcontinent. The observed effect was small and not significant, though the confidence intervals did not exclude a 50% change in either direction.
  
  
  BACKGROUND
  Clinical Trials NCT 2005-015374.
authors.affiliation: London School of Hygiene and Tropical Medicine, London WC1E 7HT, UK.
authors.forename: Albert
authors.initials: A
authors.lastname: Picado
authors.forename: Shri Prakash
authors.initials: SP
authors.lastname: Singh
authors.forename: Suman
authors.initials: S
authors.lastname: Rijal
authors.forename: Shyam
authors.initials: S
authors.lastname: Sundar
authors.forename: Bart
authors.initials: B
authors.lastname: Ostyn
authors.forename: François
authors.initials: F
authors.lastname: Chappuis
authors.forename: Surendra
authors.initials: S
authors.lastname: Uranw
authors.forename: Kamlesh
authors.initials: K
authors.lastname: Gidwani
authors.forename: Basudha
authors.initials: B
authors.lastname: Khanal
authors.forename: Madhukar
authors.initials: M
authors.lastname: Rai
authors.forename: Ishwari Sharma
authors.initials: IS
authors.lastname: Paudel
authors.forename: Murari Lal
authors.initials: ML
authors.lastname: Das
authors.forename: Rajiv
authors.initials: R
authors.lastname: Kumar
authors.forename: Pankaj
authors.initials: P
authors.lastname: Srivastava
authors.forename: Jean Claude
authors.initials: JC
authors.lastname: Dujardin
authors.forename: Veerle
authors.initials: V
authors.lastname: Vanlerberghe
authors.forename: Elisabeth Wreford
authors.initials: EW
authors.lastname: Andersen
authors.forename: Clive Richard
authors.initials: CR
authors.lastname: Davies
authors.forename: Marleen
authors.initials: M
authors.lastname: Boelaert
mesh_terms: D000818:Animals; D016000:Cluster Analysis; D005260:Female; D006801:Humans; D007194:India / Q000453:epidemiology; D007300:Insect Control / Q000379:methods; D007303:Insect Vectors; D057148:Insecticide-Treated Bednets; D007306:Insecticides; D007893:Leishmania donovani; D007898:Leishmaniasis, Visceral / Q000453:epidemiology / Q000517:prevention & control*; D008297:Male; D009390:Nepal / Q000453:epidemiology; D009570:Nitriles; D010691:Phlebotomus; D011379:Prognosis; D011722:Pyrethrins; D055815:Young Adult
chemical_list: D007306:Insecticides; D009570:Nitriles; D011722:Pyrethrins; C017180:decamethrin