title: The RooPfs study to assess whether improved housing provides additional protection against clinical malaria over current best practice in The Gambia: study protocol for a randomized controlled study and ancillary studies.
abstract: In malaria-endemic areas, residents of modern houses have less malaria than those living in traditional houses. This study will determine if modern housing provides incremental protection against clinical malaria over the current best practice of long-lasting insecticidal nets (LLINs) and prompt treatment in The Gambia, determine the incremental cost-effectiveness of the interventions, and analyze the housing market in The Gambia.
  
  
  
  A two-armed, household, cluster-randomized, controlled study will be conducted to assess whether improved housing and LLINs combine to provide better protection against clinical malaria in children than LLINs alone in The Gambia. The unit of randomization will be the household, defined as a house and its occupants. A total of 800 households will be enrolled and will receive LLINs, and 400 will receive improved housing before clinical follow-up. One child aged 6 months to 13 years will be enrolled from each household and followed for clinical malaria using active case detection to estimate malaria incidence for two malaria transmission seasons. Episodes of clinical malaria will be the primary endpoint. Study children will be surveyed at the end of each transmission season to estimate the prevalence of Plasmodium falciparum infection, parasite density, and the prevalence of anemia. Exposure to malaria parasites will be assessed using light traps, followed by detection of Anopheles gambiae species and sporozoite infection. Ancillary economic and social science studies will undertake a cost-effectiveness analysis and use qualitative and participatory methods to explore the acceptability of the housing modifications and to design strategies for scaling-up housing interventions.
  
  
  
  The study is the first of its kind to measure the efficacy of housing on reducing clinical malaria, assess the incremental cost-effectiveness of improved housing, and identify mechanisms for scaling up housing interventions. Trial findings will help inform policy makers on improved housing for malaria control in sub-Saharan Africa.
  
  
  
  ISRCTN Registry, ISRCTN02622179 . Registered on 23 September 2014.
authors.affiliation: School of Biological and Biomedical Sciences, Durham University, Durham, UK.|Medical Research Council's (MRC) Unit The Gambia, Banjul, The Gambia.
authors.forename: Margaret
authors.initials: M
authors.lastname: Pinder
authors.affiliation: Health Economics Group, Department of Infectious Disease Epidemiology, School of Public Health, Imperial College, London, UK.
authors.forename: Lesong
authors.initials: L
authors.lastname: Conteh
authors.affiliation: Medical Research Council's (MRC) Unit The Gambia, Banjul, The Gambia.
authors.forename: David
authors.initials: D
authors.lastname: Jeffries
authors.affiliation: Centre for Tropical Medicine and Global Health, University of Oxford/Kemri-Wellcome Trust Research Programme, Kilifi, Kenya.
authors.forename: Caroline
authors.initials: C
authors.lastname: Jones
authors.affiliation: Schools of Architecture, Design and Conservation (KADK), Copenhagen, Denmark.
authors.forename: Jakob
authors.initials: J
authors.lastname: Knudsen
authors.affiliation: National Malaria Control Programme, Banjul, The Gambia.
authors.forename: Balla
authors.initials: B
authors.lastname: Kandeh
authors.affiliation: Medical Research Council's (MRC) Unit The Gambia, Banjul, The Gambia.
authors.forename: Musa
authors.initials: M
authors.lastname: Jawara
authors.affiliation: Health Economics Group, Department of Infectious Disease Epidemiology, School of Public Health, Imperial College, London, UK.
authors.forename: Elisa
authors.initials: E
authors.lastname: Sicuri
authors.affiliation: Medical Research Council's (MRC) Unit The Gambia, Banjul, The Gambia.
authors.forename: Umberto
authors.initials: U
authors.lastname: D'Alessandro
authors.affiliation: School of Biological and Biomedical Sciences, Durham University, Durham, UK. S.W.Lindsay@durham.ac.uk.
authors.forename: Steve W
authors.initials: SW
authors.lastname: Lindsay
mesh_terms: D000293:Adolescent; D000367:Age Factors; D000740:Anemia / Q000469:parasitology / Q000517:prevention & control; D002648:Child; D002675:Child, Preschool; D003362:Cost-Benefit Analysis; D005260:Female; D005714:Gambia / Q000453:epidemiology; D017048:Health Care Costs; D006798:Housing / Q000191:economics; D006801:Humans; D015994:Incidence; D007223:Infant; D057148:Insecticide-Treated Bednets / Q000191:economics; D016778:Malaria, Falciparum / Q000191:economics / Q000469:parasitology / Q000517:prevention & control* / Q000635:transmission; D008297:Male; D009032:Mosquito Control / Q000191:economics / Q000379:methods*; D015995:Prevalence; D012107:Research Design; D012307:Risk Factors; D012621:Seasons; D013997:Time Factors
keywords: Clinical malaria; Cost-effectiveness; House screening; Household randomized controlled trial; Housing; Insecticide-treated bed net; Long-lasting insecticidal nets; Malaria control