title: Community-randomised controlled trial embedded in the Anishinaabek Cervical Cancer Screening Study: human papillomavirus self-sampling versus Papanicolaou cytology.
abstract: The incidence of cervical cancer is up to 20-fold higher among First Nations women in Canada than the general population, probably due to lower participation in screening. Offering human papillomavirus (HPV) self-sampling in place of Papanicolaou (Pap) testing may eventually increase screening participation and reduce cervical cancer rates in this population.
  
  
  
  A community-randomised controlled screening trial.
  
  
  
  First Nations communities in Northwest Ontario, Canada.
  
  
  
  Women aged between 25 and 69, living in Robinson Superior Treaty First Nations. The community was the unit of randomisation.
  
  
  
  Women were asked to complete a questionnaire and have screening by HPV self-sampling (arm A) or Pap testing (arm B).
  
  
  
  The number of women who participated in cervical screening.
  
  
  
  Community clusters were randomised to include approximately equivalent numbers of women in each arm.
  
  
  
  6 communities were randomised to arm A and 5 to arm B. One community withdrew, leaving 5 communities in each group (834 eligible women). Participation was <25%. Using clustered intention-to-treat (ITT) analysis, initial and cumulative averaged uptakes in arm A were 1.4-fold (20% vs 14.3%, p=0.628) and 1.3-fold (20.6% vs 16%, p=0.694) higher compared to arm B, respectively. Corresponding per protocol (PP) analysis indicates 2.2-fold (22.9% vs 10.6%, p=0.305) and 1.6-fold (22.9% vs 14.1%, p=0.448) higher uptakes in arm A compared to arm B. Screening uptake varied between communities (range 0-62.1%). Among women who completed a questionnaire (18.3% in arm A, 21.7% in arm B), the screening uptake was 1.8-fold (ITT; p=0.1132) or 3-fold (PP; p<0.01) higher in arm A versus arm B.
  
  
  
  Pap and HPV self-sampling were compared in a marginalised, Canadian population. Results indicated a preference for self-sampling. More research on how to reach underscreened Indigenous women is necessary.
  
  
  
  ISRCTN84617261.
authors.affiliation: Probe Development and Biomarker Exploration, Thunder Bay Regional Research Institute (TBRRI), Thunder Bay, Ontario, Canada.|Department of Biology, Lakehead University, Thunder Bay, Ontario, Canada.|Northern Ontario School of Medicine, Clinical Sciences, Thunder Bay, Ontario, Canada.
authors.forename: Ingeborg
authors.initials: I
authors.lastname: Zehbe
authors.affiliation: Probe Development and Biomarker Exploration, Thunder Bay Regional Research Institute (TBRRI), Thunder Bay, Ontario, Canada.|Biotechnology Program, Lakehead University, Thunder Bay, Ontario, Canada.
authors.forename: Robert
authors.initials: R
authors.lastname: Jackson
authors.affiliation: School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Brianne
authors.initials: B
authors.lastname: Wood
authors.affiliation: Northern Ontario School of Medicine, Clinical Sciences, Thunder Bay, Ontario, Canada.
authors.forename: Bruce
authors.initials: B
authors.lastname: Weaver
authors.affiliation: Northern Ontario School of Medicine, Clinical Sciences, Thunder Bay, Ontario, Canada.|Department of Pathology and Laboratory Medicine, Thunder Bay Regional Health Sciences Centre, Thunder Bay, Ontario, Canada.
authors.forename: Nicholas
authors.initials: N
authors.lastname: Escott
authors.affiliation: Viral Exanthemata and STD Section, National Microbiology Laboratory, Public Health Agency of Canada, Winnipeg, Manitoba, Canada.
authors.forename: Alberto
authors.initials: A
authors.lastname: Severini
authors.affiliation: BC Centre for Disease Control, Vancouver, British Columbia, Canada.
authors.forename: Mel
authors.initials: M
authors.lastname: Krajden
authors.affiliation: Department of Biology, Lakehead University, Thunder Bay, Ontario, Canada.
authors.forename: Lisa
authors.initials: L
authors.lastname: Bishop
authors.affiliation: Department of Biology, Lakehead University, Thunder Bay, Ontario, Canada.
authors.forename: Kyla
authors.initials: K
authors.lastname: Morrisseau
authors.affiliation: BC Centre for Disease Control, Vancouver, British Columbia, Canada.|School of Population and Public Health, Faculty of Medicine, University of British Columbia, Vancouver, British Columbia, Canada.
authors.forename: Gina
authors.initials: G
authors.lastname: Ogilvie
authors.affiliation: Ontario HIV Treatment Network, Toronto, Ontario, Canada.|Dalla Lana School of Public Health, University of Toronto, Toronto, Ontario, Canada.
authors.forename: Ann N
authors.initials: AN
authors.lastname: Burchell
authors.affiliation: School of Epidemiology, Public Health and Preventive Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Julian
authors.initials: J
authors.lastname: Little
mesh_terms: D000328:Adult; D017677:Age Distribution; D000368:Aged; D055088:Early Detection of Cancer / Q000379:methods*; D005260:Female; D006266:Health Education; D006801:Humans; D007198:Indians, North American; D008137:Longitudinal Studies; D008403:Mass Screening; D008875:Middle Aged; D009864:Ontario / Q000453:epidemiology; D027383:Papillomaviridae / Q000302:isolation & purification*; D030361:Papillomavirus Infections / Q000150:complications / Q000175:diagnosis* / Q000453:epidemiology; D010342:Patient Acceptance of Health Care / Q000706:statistics & numerical data; D012648:Self Care; D013048:Specimen Handling; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000453:epidemiology / Q000517:prevention & control; D014626:Vaginal Smears; D016387:Women's Health; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000453:epidemiology / Q000517:prevention & control
keywords: HPV self-sampling; Indigenous health; Pap testing; cervical screening; cluster randomized controlled trial