title: Diarrhea and dengue control in rural primary schools in Colombia: study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Diarrheal diseases and dengue fever are major global health problems. Where provision of clean water is inadequate, water storage is crucial. Fecal contamination of stored water is a common source of diarrheal illness, but stored water also provides breeding sites for dengue vector mosquitoes. Poor household water management and sanitation are therefore potential determinants of both diseases. Little is known of the role of stored water for the combined risk of diarrhea and dengue, yet a joint role would be important for developing integrated control and management efforts. Even less is known of the effect of integrating control of these diseases in school settings. The objective of this trial was to investigate whether interventions against diarrhea and dengue will significantly reduce diarrheal disease and dengue entomological risk factors in rural primary schools.
  
  
  METHODS
  This is a 2×2 factorial cluster randomized controlled trial. Eligible schools were rural primary schools in La Mesa and Anapoima municipalities, Cundinamarca, Colombia. Eligible pupils were school children in grades 0 to 5. Schools were randomized to one of four study arms: diarrhea interventions (DIA); dengue interventions (DEN); combined diarrhea and dengue interventions (DIADEN); and control (C). Schools were allocated publicly in each municipality (strata) at the start of the trial, obviating the need for allocation concealment. The primary outcome for diarrhea is incidence rate of diarrhea in school children and for dengue it is density of adult female Aedes aegypti per school. Approximately 800 pupils from 34 schools were enrolled in the trial with eight schools in the DIA arm, nine in the DEN, eight in the DIADEN, and nine in the control arms. The trial status as of June 2012 was: completed baseline data collections; enrollment, randomization, and allocation of schools. The trial was funded by the Research Council of Norway and the Lazos de Calandaima Foundation.
  
  
  CONCLUSIONS
  This is the first trial investigating the effect of a set of integrated interventions to control both dengue and diarrhea. This is also the first trial to study the combination of diarrhea-dengue disease control in school settings.
  
  
  BACKGROUND
  Current Controlled Trials ISRCTN40195031.
authors.affiliation: Department of Mathematical Sciences and Technology, Norwegian University of Life Sciences, Ås, Norway. hans.overgaard@umb.no
authors.forename: Hans J
authors.initials: HJ
authors.lastname: Overgaard
authors.forename: Neal
authors.initials: N
authors.lastname: Alexander
authors.forename: Maria Ines
authors.initials: MI
authors.lastname: Mátiz
authors.forename: Juan Felipe
authors.initials: JF
authors.lastname: Jaramillo
authors.forename: Victor Alberto
authors.initials: VA
authors.lastname: Olano
authors.forename: Sandra
authors.initials: S
authors.lastname: Vargas
authors.forename: Diana
authors.initials: D
authors.lastname: Sarmiento
authors.forename: Audrey
authors.initials: A
authors.lastname: Lenhart
authors.forename: Razak
authors.initials: R
authors.lastname: Seidu
authors.forename: Thor Axel
authors.initials: TA
authors.lastname: Stenström
mesh_terms: D002985:Clinical Protocols; D003105:Colombia; D003625:Data Collection; D003715:Dengue / Q000517:prevention & control*; D003967:Diarrhea / Q000517:prevention & control*; D006801:Humans; D012423:Rural Health; D018401:Sample Size; D012574:Schools