Kengo Nagashima

Ripple effect of temporary self-sampling HPV test on screening uptake in the next round: A secondary analysis of the ACCESS randomized controlled trial

The self-sampling human papillomavirus (HPV) test improves participation in cervical cancer screening. However, the ripple effect of this test on participation in the next screening round has not yet been examined. This study, a secondary analysis of the Accelerating Cervical Cancer Elimination by Self-Sampling test (ACCESS) trial, aims to clarify this effect. Women who had not participated in the cervical cancer screening program of Ichihara City for 3 years or more were included. The participants were randomly assigned to intervention ( n  = 7337) and control groups ( n  = 7770). In the initial round, the intervention group could perform a self-sampling HPV test or undergo cytology as the primary screening method, while the control group could undergo cytology only. In the next round, both groups could undergo cytology. In intention-to-screen analysis, screening uptake in the next round was 10.0% (95% confidence interval [CI]: 9.3%, 10.7%) in the intervention group and 10.2% (95% CI: 9.5%, 10.8%) in the control group, with no significant difference between groups ( p  = 0.717). In conclusion, offering a one-time self-sampling HPV test had no effect on screening uptake in the next round, suggesting that the test needs to be offered on an ongoing basis to continuously improve screening uptake.

Effectiveness of self‐sampling human papillomavirus test on precancer detection and screening uptake in Japan: The ACCESS randomized controlled trial

AbstractJapan is lagging in cervical cancer prevention. The effectiveness of a self‐sampling human papillomavirus (HPV) test, a possible measure to overcome this situation, has not yet been evaluated. A randomized controlled trial was performed to evaluate the effectiveness of a self‐sampling HPV test on detection of cervical intraepithelial neoplasia grade 2 or worse (CIN2+) and screening uptake. Women between 30 and 58 years old who did not participate in the cervical cancer screening program for ≥3 years were eligible and assigned to the intervention group (cytology or self‐sampling HPV test) or control group (cytology). Participants assigned to the intervention group were sent a self‐sampling kit according to their ordering (opt‐in strategy). A total of 7337 and 7772 women were assigned to the intervention and control groups, respectively. Screening uptake in the intervention group was significantly higher than that in the control group (20.0% vs. 6.4%; risk ratio: 3.10; 95% confidence interval [CI]: 2.82, 3.42). The compliance rate with cytology triage for HPV‐positive women was 46.8% (95% CI: 35.5%, 58.4%). CIN2+ was detected in five and four participants in the intervention and control groups, respectively; there was no difference for intention‐to‐screen analysis (risk ratio: 1.32; 95% CI: 0.36, 4.93). Self‐sampling of HPV test increased screening uptake; however, no difference was observed in the detection of CIN2+, probably due to the low compliance rate for cytology triage in HPV‐positive women. Efforts to increase cytology triage are essential to maximize precancer detections.

Study protocol of the ACCESS trial: a randomised trial to evaluate the effectiveness of human papillomavirus testing by self-sampling in cervical cancer screening uptake and precancer detection

IntroductionRecently, the incidence of cervical cancer has increased in Japan, probably because of an interruption in human papillomavirus (HPV) vaccination and a low cervical cancer screening rate. There is a lack of evidence for self-sampling HPV testing as a cervical cancer screening tool in Japan. The Accelerating Cervical Cancer Elimination by Self-Sampling test trial aims to compare the effectiveness of screening using the self-sampling HPV test with that of routine screening concerning screening uptake and precancer detection.Methods and analysisThis trial has a single-municipality, open-label, parallel, superiority and randomised design. Approximately 20 000 women who have not undergone cervical cancer screening for at least 3 years will be assigned randomly to the self-sampling arm and the control arm using a 1:1 ratio. Participants assigned to the control arm will undergo routine cervical cancer screening (cytology test) provided by Ichihara City, while those assigned to the self-sampling arm will choose the routine screening or self-sampling HPV test. HPV tests will be performed using the cobas 8800 system (Roche Diagnostics, Rotkreuz, Switzerland). Participants who will undergo the self-sampling HPV testing will be recommended to undergo routine screening. The results of the cytology test and further tests, such as colposcopy and biopsy, will be collected and used for this trial. The risk ratio and risk difference in the proportion of participants with cervical intraepithelial neoplasia two or worse between the two arms will be calculated. The test for the null hypothesis (the detection rates are equal between the two arms) will be performed using Pearson’s χ2 test.Ethics and disseminationThis trial was approved by the Research Ethics Committees of the Chiba Foundation for Health Promotion and Disease Prevention and the collaborating research institutes. The results will be disseminated through peer-reviewed journals and conference presentations.Trial registration numberjRCT1030200276. Pre-results.

Acceptability of self-sampling human papillomavirus test for cervical cancer screening in Japan: A questionnaire survey in the ACCESS trial

PurposeIn terms of medical policy for cervical cancer prevention, Japan lags far behind other industrialized countries. We initiated a randomized controlled trial to evaluate the self-sampling human papillomavirus (HPV) test as a tool to raise screening uptake and detection of pre-cancer. This study was conducted to explore the acceptability and preference of self-sampling using a subset of the data from this trial.MethodsA pre-invitation letter was sent to eligible women, aged 30−59 years who had not undergone cervical cancer screening for three or more years. After excluding those who declined to participate in this trial, the remaining women were assigned to the self-sampling and control groups. A second invitation letter was sent to the former group, and those wanting to undergo the self-sampling test ordered the kit. A self-sampling HPV kit, consent form, and a self-administered questionnaire were sent to participants who ordered the test.ResultsOf the 7,340 participants in the self-sampling group, 1,196 (16.3%) administered the test, and 1,192 (99.7%) answered the questionnaire. Acceptability of the test was favorable; 75.3−81.3% of participants agreed with positive impressions (easy, convenient, and clarity of instruction), and 65.1−77.8% disagreed with negative impressions (painful, uncomfortable, and embarrassing). However, only 21.2% were confident in their sampling procedure. Willingness to undergo screening with a self-collected sample was significantly higher than that with a doctor-collected sample (89.3% vs. 49.1%; p<0.001). Willingness to undergo screening with a doctor-collected sample was inversely associated with age and duration without screening (both p<0.001), but that with a self-collected sample was not associated.ConclusionsAmong women who used the self-sampling HPV test, high acceptability was confirmed, while concerns about self-sampling procedures remained. Screening with a self-collected sample was preferred over a doctor-collected sample and the former might alleviate disparities in screening rates.