title: A cluster-randomised controlled trial integrating a community-based water, sanitation and hygiene programme, with mass distribution of albendazole to reduce intestinal parasites in Timor-Leste: the WASH for WORMS research protocol.
abstract: BACKGROUND
  There is limited evidence demonstrating the benefits of community-based water, sanitation and hygiene (WASH) programmes on infections with soil-transmitted helminths (STH) and intestinal protozoa. Our study aims to contribute to that evidence base by investigating the effectiveness of combining two complementary approaches for control of STH: periodic mass administration of albendazole, and delivery of a community-based WASH programme.
  
  
  METHODS
  WASH for WORMS is a cluster-randomised controlled trial to test the hypothesis that a community-based WASH intervention integrated with periodic mass distribution of albendazole will be more effective in reducing infections with STH and protozoa than mass deworming alone. All 18 participating rural communities in Timor-Leste receive mass chemotherapy every 6 months. Half the communities also receive the community-based WASH programme. Primary outcomes are the cumulative incidence of infection with STH. Secondary outcomes include the prevalence of protozoa; intensity of infection with STH; as well as morbidity indicators (anaemia, stunting and wasting). Each of the trial outcomes will be compared between control and intervention communities. End points will be measured 2 years after the first albendazole distribution; and midpoints are measured at 6 months intervals (12 months for haemoglobin and anthropometric indexes). Mixed-methods research will also be conducted in order to identify barriers and enablers associated with the acceptability and uptake of the WASH programme.
  
  
  BACKGROUND
  Ethics approval was obtained from the human ethics committees at the University of Queensland, Australian National University, Timorese Ministry of Health, and University of Melbourne. The results of the trial will be published in peer-reviewed journals presented at national and international conferences, and disseminated to relevant stakeholders in health and WASH programmes. This study is funded by a Partnership for Better Health--Project grant from the National Health and Research Council (NHMRC), Australia.
  
  
  BACKGROUND
  ACTRN12614000680662; Pre-results.
authors.affiliation: Research School of Population Health, Australian National University, Canberra, Australian Capital Territory, Australia.
authors.forename: Susana Vaz
authors.initials: SV
authors.lastname: Nery
authors.affiliation: Clinical Tropical Medicine Laboratory, QIMR Berghofer Medical Research Institute, Brisbane, Queensland, Australia.
authors.forename: James S
authors.initials: JS
authors.lastname: McCarthy
authors.affiliation: Faculty of Veterinary and Agricultural Sciences, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Rebecca
authors.initials: R
authors.lastname: Traub
authors.affiliation: Menzies School of Health Research, Charles Darwin University, Northern Territory, Australia.
authors.forename: Ross M
authors.initials: RM
authors.lastname: Andrews
authors.affiliation: Nossal Institute for Global Health, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Jim
authors.initials: J
authors.lastname: Black
authors.affiliation: Research School of Population Health, Australian National University, Canberra, Australian Capital Territory, Australia.
authors.forename: Darren
authors.initials: D
authors.lastname: Gray
authors.affiliation: WaterAid Australia, Timor-Leste.
authors.forename: Edmund
authors.initials: E
authors.lastname: Weking
authors.affiliation: Sax Institute, Sydney, New South Wales, Australia.
authors.forename: Jo-An
authors.initials: JA
authors.lastname: Atkinson
authors.affiliation: Research School of Population Health, Australian National University, Canberra, Australian Capital Territory, Australia.
authors.forename: Suzy
authors.initials: S
authors.lastname: Campbell
authors.affiliation: Nossal Institute for Global Health, Melbourne School of Population and Global Health, The University of Melbourne, Melbourne, Victoria, Australia.
authors.forename: Naomi
authors.initials: N
authors.lastname: Francis
authors.affiliation: Kirby Institute for Infection and Immunity in Society, University of New South Wales, Kensington, New South Wales, Australia.
authors.forename: Andrew
authors.initials: A
authors.lastname: Vallely
authors.affiliation: School of Public Health, The University of Queensland, Brisbane, Queensland, Australia.
authors.forename: Gail
authors.initials: G
authors.lastname: Williams
authors.affiliation: Research School of Population Health, Australian National University, Canberra, Australian Capital Territory, Australia.
authors.forename: Archie
authors.initials: A
authors.lastname: Clements
mesh_terms: D000293:Adolescent; D000328:Adult; D015766:Albendazole / Q000627:therapeutic use*; D000818:Animals; D000871:Anthelmintics / Q000627:therapeutic use; D000981:Antiprotozoal Agents / Q000627:therapeutic use; D002648:Child; D002675:Child, Preschool; D006376:Helminths; D006801:Humans; D006920:Hygiene; D007223:Infant; D007422:Intestines / Q000469:parasitology*; D010271:Parasites; D010272:Parasitic Diseases / Q000469:parasitology / Q000517:prevention & control*; D012107:Research Design; D012111:Residence Characteristics; D012424:Rural Population; D012499:Sanitation; D049648:Timor-Leste; D014867:Water / Q000469:parasitology*
chemical_list: D000871:Anthelmintics; D000981:Antiprotozoal Agents; D014867:Water; D015766:Albendazole
keywords: EPIDEMIOLOGY; INFECTIOUS DISEASES; PARASITOLOGY