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

Abstract

ObjectivesThe 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.DesignA community-randomised controlled screening trial.SettingFirst Nations communities in Northwest Ontario, Canada.ParticipantsWomen aged between 25 and 69, living in Robinson Superior Treaty First Nations. The community was the unit of randomisation.InterventionsWomen were asked to complete a questionnaire and have screening by HPV self-sampling (arm A) or Pap testing (arm B).Primary outcome measuresThe number of women who participated in cervical screening.RandomisationCommunity clusters were randomised to include approximately equivalent numbers of women in each arm.Results6 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.ConclusionsPap 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 numberISRCTN84617261.

Self-sampling for human papillomavirus (HPV) testing: a systematic review and meta-analysis

“…After two independent reviewers screened in duplicate and gained consensus, 149 articles were pulled for full-text review. Of these, 33 studies (reported in 34 articles) were included in the review 21–54…”

Self-Sampling as a Plausible Alternative to Screen Cervical Cancer Precursor Lesions in a Population with Low Adherence to Screening: A Systematic Review

“…With respect to the second objective of this study, we found that Allende et al [19] reported a 4.7-fold increase in adherence to self-sampling compared to physiciansampled material. In the study by Zehbe et al [20], there was an increase in adherence of 20% in arm A (self-sampling) and an increase of 14.3% in arm B (samples obtained by physicians). Winer et al [4] reported a 93.3% increase in adherence with the introduction of self-sampling.…”

“…Acta Cytologica 2020;64:332-343 DOI: 10.1159/000505121 Zehbe [20] 2016 The difference in uptake between both arms was 45% Women from arm A found self-sampling quite comfortable, while women from arm B were neutral or did not mind cervical sampling Population characteristics in arm A and B, namely level of education, employment, and former Pap smear, were not statistically significant except for the number of women living in the reserve, which was higher in arm B…”

Awareness of Young Japanese Women on HPV Self-Sampling Trial using Opt-in Method

“…However, there is a lack of studies that discussed awareness, preference, recognition/perception, and anxiety of women to self-sampling [17][18][19][20][21]. In a previous study of a community-based Canadian women, there was not a significant difference of preference between a Pap smear test performed by clinician or selfsampling, although they indicated a preference of self-sampling, due to comfort and personal feelings [22].There is no other study on the reasons of young women wanting or not wanting to perform selfsampling. In a trial performed in a rural city in Hokkaido, Japan, 90.1% of subjects did not want to do self-sampling [23], but the reason for it was not clarified.…”

“…The incidence of CC excepted of carcinoma insitu (CIS) in 25-29 year old Japanese women was 3.0 (per 100,000 people) in 2016 [3],and the mortality of the women was 0.3 (per 100,000 people) in 2017 [4]. However, the rate of people attending CC screenings, a preventive measure, was 42.4% in 25-69 year old and 26.5% in [20][21][22][23][24][25][26][27][28][29] year old Japanese women in 2016, being markedly lower than those in Western countries, and similar to middle income country rates [5].…”