Community-randomised controlled trial embedded in the Anishinaabek Cervical Cancer Screening Study: human papillomavirus self-sampling versus Papanicolaou cytology.

OBJECTIVES: 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. DESIGN: A community-randomised controlled screening trial. SETTING: First Nations communities in Northwest Ontario, Canada. PARTICIPANTS: Women aged between 25 and 69, living in Robinson Superior Treaty First Nations. The community was the unit of randomisation. INTERVENTIONS: Women were asked to complete a questionnaire and have screening by HPV self-sampling (arm A) or Pap testing (arm B). PRIMARY OUTCOME MEASURES: The number of women who participated in cervical screening. RANDOMISATION: Community clusters were randomised to include approximately equivalent numbers of women in each arm. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION NUMBER: ISRCTN84617261.