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

Misuzu Fujita; Kengo Nagashima; Minobu Shimazu; Misae Suzuki; Ichiro Tauchi; Miwa Sakuma; Setsuko Yamamoto; Hideki Hanaoka; Makio Shozu; Nobuhide Tsuruoka; Tokuzo Kasai; Akira Hata

doi:10.1371/journal.pone.0286909

. 2023 Jun 8;18(6):e0286909. doi: 10.1371/journal.pone.0286909

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

Misuzu Fujita ^1,^2,^*, Kengo Nagashima ^3,⁴, Minobu Shimazu ⁵, Misae Suzuki ⁶, Ichiro Tauchi ⁶, Miwa Sakuma ⁶, Setsuko Yamamoto ⁶, Hideki Hanaoka ⁵, Makio Shozu ⁷, Nobuhide Tsuruoka ⁸, Tokuzo Kasai ¹, Akira Hata ^1,⁹

Editor: Ruofei Du¹⁰

¹Department of Health Research, Chiba Foundation for Health Promotion and Disease Prevention, Chiba, Japan

²Department of Public Health, Chiba University Graduate School of Medicine, Chiba, Japan

³Biostatistics Unit, Clinical and Translational Research Center, Keio University Hospital, Shinjuku-ku, Tokyo, Japan

⁴Research Center for Medical and Health Data Science, The Institute of Statistical Mathematics, Tachikawa, Tokyo, Japan

⁵Clinical Research Center, Chiba University Hospital, Chiba, Japan

⁶Municipal Health Center, Department of Health and Welfare, Ichihara City, Ichihara, Chiba, Japan

⁷Departments of Reproductive Medicine, Chiba University Graduate School of Medicine, Chiba, Japan

⁸Yushudai Clinic, Ichihara, Chiba, Japan

⁹Center for Preventive Medical Sciences, Chiba University, Chiba, Japan

¹⁰University of Arkansas for Medical Sciences, UNITED STATES

Competing Interests: The authors have declared that no competing interests exist.

^✉

* E-mail: mi-hujita@kenko-chiba.or.jp

Roles

Misuzu Fujita: Conceptualization, Data curation, Formal analysis, Investigation, Methodology, Validation, Visualization, Writing – original draft, Writing – review & editing

Kengo Nagashima: Conceptualization, Methodology, Writing – review & editing

Minobu Shimazu: Conceptualization, Methodology, Supervision, Writing – review & editing

Misae Suzuki: Conceptualization, Investigation, Methodology, Writing – review & editing

Ichiro Tauchi: Conceptualization, Investigation, Methodology, Writing – review & editing

Miwa Sakuma: Conceptualization, Investigation, Methodology, Writing – review & editing

Setsuko Yamamoto: Conceptualization, Investigation, Methodology, Writing – review & editing

Hideki Hanaoka: Conceptualization, Methodology, Supervision, Writing – review & editing

Makio Shozu: Conceptualization, Supervision, Writing – review & editing

Nobuhide Tsuruoka: Conceptualization, Supervision, Writing – review & editing

Tokuzo Kasai: Conceptualization, Methodology, Supervision, Writing – review & editing

Akira Hata: Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Writing – review & editing

Ruofei Du: Editor

PMCID: PMC10249862 PMID: 37289798

Abstract

Purpose

In 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.

Methods

A 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.

Results

Of 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.

Conclusions

Among 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.

Introduction

Cervical cancer is caused by a persistent high-risk human papillomavirus (HPV) infection and can be prevented by the adequate implementation of both HPV vaccination and organized screening programs [1, 2]. However, in Japan, the Ministry of Health, Labour and Welfare suspended active HPV vaccine recommendations in 2013 and the vaccination rate dropped to almost 0% in 2015 [3, 4]. The recommendations were reinstated in April 2022; however, the negative effects of the suspended recommendations remain. Additionally, compared to other developed countries, the screening rate in Japan is extremely low [5]. Likely due to these factors, cervical cancer morbidity and mortality have recently increased [6]. As the strategy to prevent cervical cancer depends greatly on the screening program, improving the screening rate is an urgent concern in Japan.

Cervical cytology has been widely implemented worldwide as a cervical cancer screening modality, which cannot be performed on a self-collected sample because of possible failure in securing a sufficient number of cervical cells. Therefore, this conventional screening needs to be performed at a medical institution to enable the collection of the sample by a doctor, and thus, involves physical and psychological barriers, such as a lack of time, embarrassment, discomfort, and fear [7–11]. In 2020, the guidelines for cervical cancer screening published by the National Cancer Center Japan were revised, and they recommended HPV testing as a primary screening method for the first time. Unlike cytology, HPV testing can be performed on a self-sampled specimen because of the strong concordance of HPV detection between physician-collected and self-collected samples [12–14]; additionally, there is similar accuracy in the detection of cervical intraepithelial neoplasia (CIN) grade 2 or worse and grade 3 or worse [15–17]. HPV testing using a self-sampled specimen can overcome the barriers in conventional screening using cytology. Meta-analyses indicated that self-sampling HPV testing increased screening uptake [17, 18] and resulted in increased detection of CIN 2 or worse [17]. Therefore, the self-sampling HPV test has been implemented as an alternative option for conventional screening non-responders in several countries [19, 20]. However, the guidelines in Japan do not recommend the use of self-collected samples for HPV testing because of insufficient evidence of the effectiveness and feasibility in the country. Therefore, robust evidence of the test’s effectiveness is strongly sought.

In line with this, we initiated a randomized controlled trial in 2020, the Accelerating Cervical Cancer Elimination by Self-Sampling test (ACCESS) trial, to evaluate the effectiveness of the self-sampling HPV test in cervical cancer screening uptake and pre-cancer detection. We conducted a pre-planned questionnaire survey as a part of this trial to examine the main reasons for not undergoing cervical cancer screening, knowledge about HPV, acceptability of the self-sampling HPV test, and screening preference among Japanese women. The opinions based on the experience of self-sampling in the target population for cervical cancer screening will provide meaningful information to implement the test as a practice.

Materials and methods

Participants

This study is a questionnaire survey linked with the ACCESS trial, an ongoing randomized controlled trial. The trial is registered at the Japan Registry of Clinical Trials (jRCT, 1030200276), and the study protocol including the statistical analysis plan has been published [21]. The sample size was determined based on the primary endpoint in the ACCESS trial. A flowchart of this study is presented in Fig 1.

Fig 1 — Participants of this study are indicated in the gray cell.

A total of 20,555 women who met the inclusion criteria were extracted from the database of Ichihara City Hall on December 22, 2020, and a pre-invitation letter was sent to them on February 1, 2021. Inclusion criteria were 1) women living in Ichihara City as of December 22, 2020; 2) women aged 30−59 years as of April 1, 2021; 3) the target population for cervical cancer screening provided by Ichihara City in 2021—that is, women whose age was an even number (the city set this eligibility requirement to offer cervical cancer screening once every two years to all women); and 4) women who had not received routine cervical cancer screening provided by Ichihara City for three or more years. The fourth inclusion criterion was established because we assumed that if implemented in Japan, the self-sampling HPV test would be used by routine screening non-responders as in other countries where the test has been implemented [19, 20]. The pre-invitation letter indicated that the women can refuse to participate in the trial (opt out) and the procedures. Of the 20,555 women who met the inclusion criteria, 12 women whose pre-invitation letter was returned owing to an incorrect address and 4,283 women who opted out prior to February 22, 2021, were excluded, and the remaining 16,260 women were assigned randomly to the self-sampling (N = 8,145) and control groups (N = 8,115) at a 1:1 ratio according to computer-generated numbers. Participants assigned to the self-sampling group could receive a cytology test or screening with a self-sampling HPV test of their own free will, while those in the control group could receive a cytology test. For participants assigned to the self-sampling group, a second invitation letter was sent on March 10, 2021. The letter indicated that they could use a self-sampling HPV test and provided instructions to order the test. For participants who ordered the test by June 30, 2021, a self-sampling kit (Evalyn® Brush, Rovers® Medical Devices, Netherland), an instruction manual explaining how to take a sample, a booklet explaining how to send a sample, an informed consent form, a questionnaire, and a return addressed envelope with cash on delivery were sent. The participants of this questionnaire survey were those in the self-sampling group who submitted three items by September 3, 2021: the completed consent form, self-collected sample, and completed questionnaire. Some of the authors had access to information that could identify individual participants during and after data collection to administrate the data for this trial.

Questionnaire

The questionnaire was developed with reference to previous studies [7, 8, 22–27] and is available elsewhere [21]. As reasons for not undergoing cervical cancer screening provided by Ichihara City, 15 items were presented to the participants, and they could select all applicable options. Experience of self-sampling was examined with eight items: five for acceptability that were related to pain, discomfort, embarrassment, ease, and convenience; two for clarity of instruction; and one for confidence in self-sampling. Responses were given on a five-point Likert scale: “Fully disagree,” “Somewhat disagree,” “Neither agree nor disagree,” “Somewhat agree,” and “Fully agree.” To examine the women’s knowledge about HPV before and after participating in this trial, the following questions were asked: “Did you know that HPV is the cause of cervical cancer before participating in this trial?” and “Do you know that HPV is the cause of cervical cancer now?” Participants could select one of two options: “I did not know (I don’t know)” or “I knew (I know).” To examine cervical cancer screening preference, we asked the following questions: “Will you receive cervical cancer screening in the future via sampling conducted by a doctor?” and “Will you receive cervical cancer screening in the future via sampling conducted by yourself?” Participants could select one of the following three options for each condition: “I will receive,” “I will not receive,” or “Unknown.”

Other data

Participants’ age as of April 1, 2021, and the latest year to have undergone cervical cancer screening provided by Ichihara City were extracted from the database of the Ichihara City Hall and provided for this trial. Using the latter, the duration without screening was calculated. Age was categorized as 30−39, 40−49, and 50−59 years. The duration without screening was categorized as 3−5 years, 6 years or more, and no screening records.

Statistical analysis

Statistical analyses were performed using STATA software version 16.0 (STATA LP, College Station, TX). The database was locked to this questionnaire survey on October 6, 2021. A comparison between the questionnaire participants and questionnaire non-responders was performed using the student’s t-test and chi-squared test. Answers to the questions related to screening preference were converted to a binary: “I will receive” and “others” (including “I will not receive” and “Unknown”). For binary data, frequency, percentage, and 95% confidence intervals were calculated. To compare knowledge about HPV before and after participating in this trial, McNemer’s test was conducted. McNemer’s test was also performed to compare the willingness to undergo two hypothetical screenings—screening with a doctor-collected sample and that with a self-collected sample. As a sensitivity analysis, the willingness was compared excluding participants who selected “I had an opportunity to undergo cytology testing other than the screening provided by the city” as the reason for not undergoing screening. As post-determined analyses, experience of self-sampling, knowledge about HPV, and willingness to undergo screening were compared with age and duration without screening using the chi-squared test and logistic regression analysis. After calculating the estimates using logistic regression analysis, a linear trend test was performed using the “contrast p.” command of STATA. For this analysis, items of self-sampling experience were converted into a binary: “Agree” (including “Fully agree” and “Somewhat agree”) and “Others” (including “Neither agree nor disagree,” “Somewhat disagree,” and “Fully disagree”). Missing values were included in the aggregate but excluded from the statistical test. A two-tailed p-value of <0.05 was considered significant.

Ethics statement

The questionnaire survey is a secondary analysis of the ACCESS trial. Written consent was obtained from the participants who underwent HPV testing and completed the questionnaire survey. The details have already been published [21]. The trial was approved by the Research Ethics Committees of the Chiba Foundation for Health Promotion and Disease Prevention (approval numbers R2-2 and R2-7), Graduate School of Medicine, Chiba University (approval number 3979), and the Institute of Statistical Mathematics (approval number ISM20-001) and conducted in accordance with the Declaration of Helsinki and the Ethical Guidelines for Medical and Health Research Involving Human Subjects.

Results

Of the 7,340 participants in the self-sampling group, 1,372 (18.7%) ordered the self-sampling HPV test, and 1,196 (16.3%) returned both the completed consent form and a self-collected sample. Of those, 1,192 (99.7%) also returned the completed questionnaire as shown in Fig 1. Characteristics of the questionnaire survey participants and questionnaire non-responders are shown in Table 1. Age and duration without screening were significantly different between the two.

Table 1. Characteristics of the questionnaire survey participants and non-responders.

	Participants	Non-responders	p-value
Number	1,192	6,148
Age (years)
Mean (Standard deviation)	44.1 (8.2)	44.7 (8.4)	0.013 ^b
Age category ^a
30−39 years	384 (32.2)	1,788 (29.1)	0.001 ^c
40−49 years	451 (37.8)	2,186 (35.6)
50−59 years	357 (30.0)	2,174 (35.4)
Duration without screening ^a
3−5 years	203 (17.0)	570 (9.3)	<0.001 ^c
6 years or more	279 (23.4)	1,188 (19.3)
No screening records	710 (59.6)	4,390 (71.4)

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Participants were those who returned the completed consent form, self-collected sample, and completed questionnaire.

^a Number (%)

^b Student’s t-test

^c Chi-square test

The most common reasons for not undergoing screening were a lack of time to undergo screening (45.4%), followed by being too bothered to make an appointment (44.7%), embarrassment (24.7%), having an opportunity to undergo cytology other than the screening provided by the city (23.6%), and pain or discomfort (17.8%) as shown in Fig 2. Zero participants selected hysterectomy as the reason, likely because we instructed participants who had received a hysterectomy to not order the self-sampling HPV test in the second invitation letter.

Fig 2 — The number of subjects was 1,192. Participants could select all applicable reasons.

Impressions of the self-sampling HPV test based on experience are detailed in Fig 3. More than 60% of the participants answered “Fully disagree” or “Somewhat disagree” for the items related to negative impressions of the sampling, such as painful, uncomfortable, and embarrassing. More than 70% answered “Fully agree” or “Somewhat agree” for the items related to positive impressions, such as easy and convenient. Additionally, most participants felt that the user instructions were clear and the device worked as the instructions explained. However, most participants did not have confidence in their sample collection; only 21.2% answered “Fully agree” or “Somewhat agree” to the item “I believe I was successful in collecting the sample.”

The association of sampling experience with age and duration without screening are shown in S1–S8 Tables in S1 File. Older women more frequently felt that the sampling was painful (p for trend = 0.002) and less frequently that the sampling was easy (p for trend = 0.030) compared with younger women.

Knowledge about HPV significantly increased after participating in this trial (46.9% vs. 86.7%; p<0.001) as shown in Table 2. There were no associations between age and knowledge before and after participation. In contrast, longer duration without screening was significantly associated with less knowledge about HPV before participation (p for trend = 0.027), but not after (p for trend = 0.291).

Table 2. Knowledge about HPV before and after participation in this trial.

	All	N ^d	Percent (95% CI)	OR (95% CI)	p-value
Before participation in this trial
All	1,156^a	542	46.9 (44.0−49.8)	―	<0.001^e
Age
30−39 years	381^b	171	44.9 (39.8−50.0)	1.00	0.046^f
40−49 years	446^b	231	51.8 (47.0−56.5)	1.32 (1.00−1.74)	0.784^g
50−59 years	351^b	154	43.9 (38.6−49.2)	0.96 (0.72−1.29)
Duration without screening
3−5 years	201^b	108	53.7 (46.6−60.8)	1.00	0.077^f
6 years or more	275^b	133	48.4 (42.3−54.4)	0.81 (0.56−1.16)	0.027^g
No screening records	702^b	315	44.9 (41.1−48.6)	0.70 (0.51−0.96)
After participation in this trial
All	1,156^a	1,002	86.7 (84.6−88.6)	―	―
Age
30−39 years	376^c	316	84.0 (79.9−87.6)	1.00	0.112^f
40−49 years	438^c	390	89.0 (85.7−91.8)	1.54 (1.03−2.32)	0.345^g
50−59 years	342^c	296	86.5 (82.5−90.0)	1.22 (0.81−1.85)
Duration without screening
3−5 years	197^c	174	88.3 (83.0−92.5)	1.00	0.273^f
6 years or more	269^c	239	88.8 (84.5−92.3)	1.05 (0.59−1.88)	0.291^g
No screening records	690^c	589	85.4 (82.5−87.9)	0.77 (0.48−1.25)

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CI: confidence interval; OR: odds ratio

^a Number of participants who answered both questions related to knowledge about HPV before and after participation in this trial. Missing values were 36.

^b Number of participants who answered a question related to knowledge about HPV before participation in this trial. Missing values were 14.

^c Number of participants who answered a question related to knowledge about HPV after participation in this trial. Missing values were 36.

^d Number of participants who answered “I knew” or “I know.”

^e Comparison of knowledge before and after participation in this trial in all participants using McNemer’s test.

^f Association of knowledge with age or duration without screening using chi-squared test.

^g Association of knowledge with age or duration without screening using linear trend test.

Willingness to undergo screening with self-collected samples was significantly higher than that with doctor-collected samples (89.3% vs. 49.1%; p<0.001) as shown in Table 3. Additionally, older age and longer duration without screening were associated with lower willingness to undergo screening with doctor-collected samples (p for trend <0.001 for both), but there were no such associations with self-collected samples (p for trend = 0.182 and 0.702, respectively). After excluding those who answered “I had an opportunity to undergo cytology testing other than the screening provided by the city” as the reason for not undergoing screening, similar results were observed, as shown in S9 Table in S1 File.

Table 3. Willingness to undergo screening per type of sample collection.

	All	N ^d	Percent (95% CI)	OR (95% CI)	p-value
Screening with doctor-collected samples
All	1,126 ^a	553	49.1 (46.2−52.1)	―	<0.001 ^e
Age
30−39 years	371 ^b	216	58.2 (53.0−63.3)	1.00	<0.001 ^f
40−49 years	429 ^b	220	51.3 (46.4−56.1)	0.76 (0.57−1.00)	<0.001 ^g
50−59 years	337 ^b	124	36.8 (31.6−42.2)	0.42 (0.31−0.57)
Duration without screening
3−5 years	199 ^b	123	61.8 (54.7−68.6)	1.00	<0.001 ^f
6 years or more	261 ^b	136	52.1 (45.9−58.3)	0.67 (0.46−0.98)	<0.001 ^g
No screening records	677 ^b	301	44.5 (40.7−48.3)	0.49 (0.36−0.68)
Screening with self-collected samples
All	1,126 ^a	1,005	89.3 (87.3−91.0)	―
Age
30−39 years	377 ^c	343	91.0 (87.6−93.7)	1.00	0.356 ^f
40−49 years	441 ^c	390	88.4 (85.1−91.3)	0.76 (0.48−1.20)	0.182 ^g
50−59 years	348 ^c	306	87.9 (84.0−91.2)	0.72 (0.45−1.16)
Duration without screening
3−5 years	201 ^c	180	89.6 (84.5−93.4)	1.00	0.771 ^f
6 years or more	273 ^c	246	90.1 (85.9−93.4)	1.06 (0.58−1.94)	0.702 ^g
No screening records	692 ^c	613	88.6 (86.0−90.9)	0.91 (0.54−1.51)

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CI: confidence interval; OR: odds ratio

^a Number of participants who answered both questions related to willingness to undergo screening with doctor-collected samples and self-collected samples. Missing values were 66.

^b Number of participants who answered a question related to willingness to undergo screening with doctor-collected samples. Missing values were 55.

^c Number of participants who answered a question related to willingness to undergo screening with self-collected samples. Missing values were 26.

^d Number of participants who answered, “I will receive.”

^e Comparison of willingness between two screenings using McNemer’s test.

^f Comparison of willingness with age or duration without screening using chi-squared test.

^g Comparison of willingness with age or duration without screening using linear trend test.

Discussion

In this study, which was a secondary analysis of the ACCESS trial, we revealed the main reasons for not undergoing cervical cancer screening, the degree of knowledge about HPV before and after participating in this trial, the acceptability of self-sampling, and future screening preference.

Previous studies reported that the main reasons for not having a cytology test were practical barriers, such as a lack of time to undergo the test and forgetting to schedule an appointment, and emotional barriers, such as embarrassment, discomfort, and pain [7–11]. This study confirmed similar reasons in a relatively large sample of Japanese women for the first time. The reasons for not undergoing screening are common across countries and most barriers might be resolved through implementation of the self-sampling test. Meanwhile, a reason specific to Japan was also observed: “having an opportunity to undergo cytology testing other than the screening provided by the city,” which was the fourth most frequent reason. In Japan, cervical cancer screening is performed as organized screening, which is generally provided by municipalities and companies, or opportunistic screening. Unlike other countries, such as the Netherlands, Japan does not have a registry system for cervical cancer screening. Therefore, we could not truly determine screening non-responders and under-responders. Although we extracted women who did not undergo cervical cancer screening for three or more years from Ichihara City Hall’s database, which is the most reliable method of extraction, some participants had an opportunity to undergo a cytology test provided by other sites.

Acceptability of the self-sampling HPV test was favorable. This result is consistent with many previous studies across various countries [7, 22–28]. In contrast to the overall favorable acceptability of the test, concerns about the self-sampling procedures were recognized. Although a simple comparison cannot be made because of methodological differences, the proportion of participants who had confidence in their sampling seemed to be lower than that reported by previous studies in Australia [7], the Netherlands [22, 24], Hong Kong [29], and Finland [25, 26]. One reason might be that the test was not familiar to Japanese women, because the self-sampling HPV test has not been recommended by official guidelines and has been rarely implemented in Japan. We recently reported that the self-sampling HPV test rarely yielded invalid results among Japanese women [30], which is consistent with previous studies [10, 31–35]. Additionally, the results of HPV testing using a self-collected sample have strong concordance with a doctor-collected sample [12–14], and similar accuracy in the detection of CIN grade 2 or worse and grade 3 or worse between self-collected and doctor-collected samples was also confirmed [15–17]. To eliminate women’s concerns related to the accuracy of the self-sampling HPV test, informing them of these facts in advance would be useful, especially when they undergo the test for the first time.

Knowledge about HPV increased after participating in this trial, suggesting that experience of the self-sampling HPV test improved knowledge. We also found a significant association between longer duration without screening and less knowledge before participating in this trial; however, the association disappeared after participation. Previous studies reported evidence of disparity with regard to women’s knowledge about HPV; the knowledge was less among women whose cervical cancer mortality was disproportionately high, including racial and ethnic minorities and those with low socioeconomic status [36, 37], who had lower cervical cancer screening rate in general [38, 39]. This study’s results suggest that experience of the test can not only improve knowledge but also reduce disparities related to knowledge.

As for future screening preference, screening with self-collected samples was preferred over that with doctor-collected samples, which is consistent with previous studies [7, 22, 23]. Unexpectedly, 49.1% of participants were willing to undergo future screening even if samples would be collected by a doctor. Given that the participants were limited to those who had not undergone screening for three years or more, this value is higher than expected. However, this might be overestimated, because we could not extract true cervical screening non-responders and under-responders owing to a lack of a registry system of cervical cancer screening. Thus, as a sensitivity analysis, participants who selected “I had an opportunity to undergo cytology testing other than the screening provided by the city” as the reason for not undergoing the screening were excluded. As a result, 43.5% of women remained willing. Experience with the self-sampling HPV test may strengthen the willingness to undergo a cytology test, which requires a doctor-collected sample, over practical and emotional barriers.

Additionally, older age and longer duration without screening were associated with a lower willingness to undergo screening with doctor-collected samples, but these associations were not observed in the screening with self-collected samples. In all subgroups, approximately 90% of participants were willing to undergo screening with self-collected samples. A comparison between age and impressions of the self-sampling test revealed that older women more frequently experienced pain and were less likely to feel that self-sampling was easy compared with younger women. Nonetheless, most older women seemed to prefer the self-sampling method. These results suggest that the self-sampling HPV test is an acceptable method regardless of age and the duration without screening and may result in reducing disparities in screening rates.

A major limitation of this study is the low proportion of participants who underwent the self-sampling HPV test, that is 16.3% of the eligible women. This affects the interpretation of the results. First, even if the acceptability of the test is favorable, under the assumed situation that the screening uptake in the self-sampling group is lower than that in the control group, the self-sampling HPV test is useless. This trial is ongoing. Therefore, conclusions about the effectiveness of the self-sampling HPV test must await the results of the primary endpoint. However, given that the subjects of this trial were women who had not received cervical cancer screening for three or more years, this participation rate is thought to be meaningful. Additionally, the previous studies observed similar participation rates [40–45] and reported that the self-sampling HPV test contributed to improving the screening uptake [40–42, 44, 45]. Second, selection bias might be induced. As the subjects of this questionnaire survey were women who underwent the self-sampling HPV test at their own will and the participation rate was 16.3%, the subjects may be biased toward those who had a positive impression of the test. As a result, favorable acceptability and a strong preference for self-sampling might be overestimated compared to the general population. Indeed, significant differences were observed in the characteristics of the questionnaire participants and questionnaire non-responders. However, relatively low participation rates for a self-sampling test were observed in previous studies, which revealed the acceptability of the test [8, 25, 27, 28]. This is inevitable to establish the subject’s autonomous participation. The current study revealed high acceptance and preference for the self-sampling HPV test among women who experienced the test, not in the general population. It is a strength of the study that almost all the participants who underwent self-sampling answered the questionnaire (99.7%), which was similar to or higher than the previous studies [8, 23, 25, 27, 28]. In Japan, women are not familiar with a self-sampling HPV test. Therefore, most participants experienced the test for the first time. The following descriptions were found frequently in the questionnaire’s free text box; “I thought it was difficult to take a sample by myself at first, when I tried, it was easy.” This suggests that the initial impressions changed with experience. Although there would be women with negative impressions of the self-sampling HPV test in the general population, such women might also change their minds through experience. Providing opportunities for women to perform the self-sampling test, even on a trial basis, would be useful in Japan.

In conclusion, this study reveals high acceptability and preference for the self-sampling HPV test among women who used the test and adds further evidence to strengthen a hypothesis that the test is acceptable to women across cultures and countries. Additionally, this study suggests that the self-sampling HPV test reduces disparities in knowledge about HPV and screening rates. Thus, this study provides useful evidence to decision-makers to implement the self-sampling HPV test as a practice in Japan, where cervical cancer prevention measures are seriously lacking.

Supporting information

S1 File

(DOCX)

Click here for additional data file.^{(51.4KB, docx)}

S1 Data

(XLS)

Click here for additional data file.^{(282.5KB, xls)}

S1 Checklist. STROBE statement—checklist of items that should be included in reports of observational studies.

(DOCX)

Click here for additional data file.^{(33.9KB, docx)}

Acknowledgments

We sincerely appreciate the invaluable help and support of the mayor of Ichihara City Hall, Joji Koide. We also sincerely appreciate the support of the president of the Chiba Foundation for Health Promotion and Disease Prevention, Takehiko Fujisawa, and the staff members, Chiori Suzuki, Fumika Kumahara, Fumiya Chiwaki, Hideaki Nagai, Ikumu Matsushita, Kenji Ishii, Makoto Koumi, Michiko Fusaeda, and Saeri Omori. We would like to thank Editage (www.editage.com) for English language editing.

Data Availability

All relevant data are within the Supporting Information File (S1 Data).

Funding Statement

This work was supported by Japan Society for the Promotion of Science (JSPS) KAKENHI Grant (AH, Number 20H03906, http://www.jsps.go.jp/j-grantsinaid). The funder had no role in the study design, writing the report, or the decision to submit the report for publication.

References

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PLoS One. doi: 10.1371/journal.pone.0286909.r001

Decision Letter 0

Ruofei Du

28 Dec 2022

PONE-D-22-28147Acceptability of self-sampling human papillomavirus test for cervical cancer screening in Japan: Questionnaire survey in the ACCESS trialPLOS ONE

Dear Dr. Fujita,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

You might want to focus on below listed revisions in addition to the reviewers’ comments:

1. English writing needs to be improved. Awkward or ambiguous English expressions and incorrect grammar are seen in current version, e.g. the 3^rd sentence in Methods of Abstract, the last sentence in Results of Abstract, ... The authors are advised please to check thoroughly the entire manuscript for language improvement, and/or ask help for English editing if available at your own end.

2. The current manuscript is unnecessarily lengthy. Please check the reviewers’ comments as well. Please write concisely in the revision with removing irrelevant sentences/paragraphs and duplicated/redundant materials.

3. Although the parenting study is an ongoing control randomized trial, however the current manuscript analyzed a subset of the data from one arm only. Please make this crystal clear, specially in abstract and here there when it needs to be clarified.

4. Please look at Reviewer 2’s comment about the sampling bias concern. Please define your study population explicitly and give the limitation where your findings can be generalized to.

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Reviewers' comments:

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Comments to the Author

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Reviewer #1: Yes

Reviewer #2: No

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: No

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Reviewer #1: Yes

Reviewer #2: Yes

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4. Is the manuscript presented in an intelligible fashion and written in standard English?

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Reviewer #1: Yes

Reviewer #2: Yes

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5. Review Comments to the Author

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Reviewer #1: The authors conducted a pre-planned questionnaire survey as a part of this trial to examine the main reasons for not undergoing cervical cancer screening, knowledge about HPV, acceptability of the self-sampling HPV test, and screening preference in the future in Japanese women.

They show that the acceptability of the self-sampling HPV test was confirmed, while concerns about self-sampling procedures remained.

They also suggested Screening with a self-collected sample might alleviate disparities in screening rates. This study is well conducted, and the methods used are appropriate. The data is presented clearly. These findings will be of interest to obstetrical practitioners, as well as researchers in the field.

I would like to express my homage to the authors for completing a valuable study and for the extensive analysis. I am convinced that this manuscript has an important message to obstetrical clinicians. This manuscript can be considered positively for publication, but I suggest the authors revise the following points to improve this manuscript for publication.

1. I have a question about patient selection criteria. Please explain briefly why you excluded patients who received regular cervical cancer screening and included only those who had not been screened for three years or more. We believe that asking patients who are regularly screened for their opinion on self-sampling is also helpful and has the advantage of reducing selection bias.

2. It is important to note that more than 60% of patients had negative feelings about self-sampling in the results of this study. The authors simply state that "This may reflect the Japanese personality (Page 18, line 302)" as one of the reasons. This sentence alone does not have enough grounds for the reason. It would be desirable to include suggestions on improving this result, which I believe will give readers more valuable tips.

3. The statement by the authors, "There would be women with negative impressions of the self-sampling HPV test in the general population, such women might also change their minds of experience.'' (Page 21, lines 359-361) I think this is an essential suggestion for the spread of self-sampling in Japan in the future. I think it would be more interesting for the readers if you mentioned it as a Finding instead of a Limitation and put forward proactive proposals for raising awareness of patients in Japan in the Discussion.

4. Overall, the text is large and redundant, so please try to keep it concise by omitting content that is not directly related to this research as much as possible. For example, it is not common for research papers targeting populations to develop an argument based on individual responses to the questionnaire (Page13, line219-223Pape21, line357-359). We also agree that the description about COVID-19 (page 21, line 367-372) is essential, but it is not directly related to the results of this study, so I recommend that you delete it.

Reviewer #2: This manuscript is a descriptive study(not RCT) to evaluate the acceptability and preference of self-sampling human papillomavirus(HPV) test.

The authors state that majority of the participants agreed with positive impressions about the self-sampling HPV test and they conclude this tool would help to raise screening uptake and detection of pre-cancer.

The HPV vaccine issue is a major public health challenge in Japan, and the author's awareness of the problem of evaluating self-sampling HPV tests to improve the effectiveness of screening is very important.

However, the response rate of the participants in this manuscript was very low. It therefore has an extremely large sampling bias. This bias could affect the conclusions of this manuscript and is fatal to the study.

Also, the purpose of this manuscript was to evaluate the acceptance and preference of self-sampling HPV test, which is difficult to evaluate because there was no comparison between the intervention group and the control group.

This study is a descriptive study, but the description of the study format is ambiguous.

Based on the above, we judge that this study is not of sufficient quality to be published in this journal.

The following are some of the issues to be addressed in detail.

1. The proportion of those who chose the self-sampling HPV test was very low (16.3%), which may cause sampling bias. Since the main purpose of this manuscript is to evaluate the positive impression of the self-sampling HPV test, this bias is a major problem that directly affects the conclusion of the manuscript, and is also insufficiently addressed in the limitation.

The table 1 describes only the background of the intervention group. It is possible that the intervention and non-intervention groups have different backgrounds.

2. Ⅼ225-227 states that older people tend to experience more difficulty regarding the pain of self-sampling HPV tests, while Ⅼ334-339 emphasizes that there is no association with age in the collection of HPV tests. The logic is inconsistent.

3.Table 2 and other tables have many items but are redundant and need to be made more compact. It would be desirable to consider changing to bar graphs, etc., which are visually easy to understand.

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Reviewer #1: Yes: Eijiro Hayata

Reviewer #2: No

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PLoS One. 2023 Jun 8;18(6):e0286909. doi: 10.1371/journal.pone.0286909.r002

Author response to Decision Letter 0

2 Apr 2023

Responses to the Editor and Reviewers’ Comments

Submission ID: PONE-D-22-28147

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

We appreciate the Editor’s and Reviewers’ comments toward improving our paper. We have revised the manuscript to address all the comments, and our point-by-point responses are provided below. We have included the page and line numbers of the revisions made in the main text. Revisions in response to the Editor’s and Reviewers’ comments are highlighted in yellow in the revised manuscript with track changes.

Point-by-point responses

Academic editor

Comment 1

English writing needs to be improved. Awkward or ambiguous English expressions and incorrect grammar are seen in current version, e.g. the 3rd sentence in Methods of Abstract, the last sentence in Results of Abstract, ... The authors are advised please to check thoroughly the entire manuscript for language improvement, and/or ask help for English editing if available at your own end.

Response 1

Thank you for your comment. Although we had asked an English editing company to edit our English, some incorrect expressions remained. We checked the entire manuscript and asked the company to re-edit our manuscript.

Comment 2

The current manuscript is unnecessarily lengthy. Please check the reviewers’ comments as well. Please write concisely in the revision with removing irrelevant sentences/paragraphs and duplicated/redundant materials.

Response 2

In line with comments from reviewers, we changed Table 2 to a graph (from page 12, lines 214–215) and deleted the descriptions based on individual responses in the Results section and those related to COVID-19 in the Discussion section. Additionally, some sentences in the Discussion section were deleted.

Comment 3

Although the parenting study is an ongoing control randomized trial, however the current manuscript analyzed a subset of the data from one arm only. Please make this crystal clear, specially in abstract and here there when it needs to be clarified.

Response 3

We added an explanation in the Abstract (page 3, lines 31–32) and revised the description in the Materials and Methods section (page 7, lines 126–129).

Comment 4

Please look at Reviewer 2’s comment about the sampling bias concern. Please define your study population explicitly and give the limitation where your findings can be generalized to.

Response 4

Thank you for your comment. In line with a comment from Reviewer 2, we revised Table 1 (from page 10, line 199, to page 11, line 204) and added explanations in the Discussion section (from page 19, line 352, to page 20, line 362). A major revision was to specify that the population of this study was women who had undergone the self-sampling HPV test, rather than the general population. Additionally, the Abstract (page 4, lines 49–50), the Statistical analysis section (page 9, lines 160–162), the Results section (from page 10, lines 195–197), and the Conclusion section (page 20, line 374) were also revised.

Reviewer 1

Comment 1

I have a question about patient selection criteria. Please explain briefly why you excluded patients who received regular cervical cancer screening and included only those who had not been screened for three years or more. We believe that asking patients who are regularly screened for their opinion on self-sampling is also helpful and has the advantage of reducing selection bias.

Response 1

Thank you for your comment. Self-sampling HPV testing has already been implemented in other countries, such as the Netherlands and Denmark, and the test has only been recommended for regular screening non-responders. Therefore, we assumed that a self-sampling HPV test, if implemented in Japan, would be performed by regular screening non-responders. We added this explanation from page 6, lines 110–112.

Comment 2

It is important to note that more than 60% of patients had negative feelings about self-sampling in the results of this study. The authors simply state that “This may reflect the Japanese personality (Page 18, line 302)” as one of the reasons. This sentence alone does not have enough grounds for the reason. It would be desirable to include suggestions on improving this result, which I believe will give readers more valuable tips.

Response 2

We agree with you and have deleted this sentence due to the lack of grounds for the reason. As already described in the text, to eliminate women’s concerns related to the accuracy of the self-sampling HPV test, it is necessary to provide information related to the self-sampling test in advance, such as the probability of invalid test results and the accuracy of the tests. We recently reported that the probability of invalid test results was rare among Japanese women; accordingly, we cited this article in the text (page 17, lines 303–305).

Comment 3

The statement by the authors, "There would be women with negative impressions of the self-sampling HPV test in the general population, such women might also change their minds of experience.'' (Page 21, lines 359-361) I think this is an essential suggestion for the spread of self-sampling in Japan in the future. I think it would be more interesting for the readers if you mentioned it as a Finding instead of a Limitation and put forward proactive proposals for raising awareness of patients in Japan in the Discussion.

Response 3

Thank you for your comment. We are glad that you recognize the importance of this study. In line with your comment, the descriptions were indicated in the Discussion section as a finding after the explanation of this study’s strengths. Additionally, a suggestion to promote the self-sampling test in Japan was added (from page 20, lines 364–372).

Comment 4

Overall, the text is large and redundant, so please try to keep it concise by omitting content that is not directly related to this research as much as possible. For example, it is not common for research papers targeting populations to develop an argument based on individual responses to the questionnaire (Page13, line219-223Pape21, line357-359). We also agree that the description about COVID-19 (page 21, line 367-372) is essential, but it is not directly related to the results of this study, so I recommend that you delete it.

Response 4

Thank you for your comment. We deleted the descriptions based on individual responses in the Results section and those related to COVID-19 in the Discussion section. Additionally, some sentences in the Discussion section were deleted.

Reviewer 2

Comment 1

The proportion of those who chose the self-sampling HPV test was very low (16.3%), which may cause sampling bias. Since the main purpose of this manuscript is to evaluate the positive impression of the self-sampling HPV test, this bias is a major problem that directly affects the conclusion of the manuscript, and is also insufficiently addressed in the limitation.

The table 1 describes only the background of the intervention group. It is possible that the intervention and non-intervention groups have different backgrounds.

Response 1

Thank you for your comment. We also recognize the selection bias in this study. In line with your comment, we revised Table 1 (from page 10, line 199, to page 11, line 204) and added explanations in the Discussion section (from page 19, line 352, to page 20, line 362). A major revision was to specify that the population of this study was women who had undergone the self-sampling HPV test, rather than the general population. Additionally, the Abstract (page 4, lines 49–50), the Statistical analysis section (page 9, lines 160–162), the Results section (from page 10, lines 195–197), and the Conclusion section (page 20, line 374) were also revised.

Comment 2

Ⅼ225-227 states that older people tend to experience more difficulty regarding the pain of self-sampling HPV tests, while Ⅼ334-339 emphasizes that there is no association with age in the collection of HPV tests. The logic is inconsistent.

Response 2

Thank you for your comment. We agree with you.

We would like to advocate that self-sampling HPV testing is an acceptable method regardless of age and duration without screening. Therefore, we deleted statements explaining that self-sampling HPV testing is more acceptable to the younger generation and revised the explanation in the Discussion section (page 19, lines 335–341).

Comment 3

Table 2 and other tables have many items but are redundant and need to be made more compact. It would be desirable to consider changing to bar graphs, etc., which are visually easy to understand.

Response 3

According to your comment, we changed Table 2 to a graph (from page 12, lines214–215). The other tables remain unchanged because graphs would not allow for the presentation of some meaningful information.

Attachment

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PLoS One. doi: 10.1371/journal.pone.0286909.r003

Decision Letter 1

Ruofei Du

2 May 2023

PONE-D-22-28147R1Acceptability of self-sampling human papillomavirus test for cervical cancer screening in Japan: A questionnaire survey in the ACCESS trialPLOS ONE

Dear Dr. Fujita,

Please submit your revised manuscript by Jun 16 2023 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

We look forward to receiving your revised manuscript.

Kind regards,

Ruofei Du, PhD

Academic Editor

PLOS ONE

Journal Requirements:

Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

Additional Editor Comments:

The manuscript needs additional clarifications before it can be accepted for publication.

Page 6, Line 107: It is unclear to define an inclusion criterion by stating “women considered the target population for cervical cancer screening by Ichihara City in 2021’. Please provide details on what this criterion really entails.

Page 8, Line 156: The numbers of participants falling into the category of ‘without registration’ are substantial as shown in different tables (Tables 1&2&3). The unknown composition of this category has the potential to bias the results. Could the authors provide information on the possible reasons that led to women not being registered and discuss how the study results would be affected under different scenarios?

Page 9, Statistical Analysis: Please add a description of how the trend test analysis was applied in the study.

Page 10, Line 195-197: There appears to be a lack of sufficient description and interpretation about the data presented in Table 1. For instance, although there is a statistically significant difference in the mean ages between the groups in Table 1, a difference of 44.1 vs. 44.7 may not be clinically meaningful. What are the implications of the differences in the distributions of age and duration without screening?

Page 12, Line 232-233: There are no 49.1% vs. 89.3% shown in Table 2. Should that be 46.9% vs. 86.7%?

Page 18, Line 315: Please rewrite this sentence ‘the knowledge was less in vulnerable women with lower screening rates’. Do you mean that women who had lower screening rates and are considered more vulnerable had less knowledge about HPV?

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

Reviewer #1: Yes

Reviewer #2: No

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Reviewer #1: I would like to express my homage to the authors for sincerely responding to the reviewers' comments. I am convinced that this manuscript has been well revised and has an important message to clinicians. This paper is a significant contribution, and I recommend that it be accepted for publication.

Reviewer #2: The authors have addressed the issue of sampling bias as pointed out by the reviewers, and have also restructured the manuscript to make it more compact. In addition, the authors have revised the tables comparing participants who responded to the questionnaire with those who did not respond to. Based on the above, I concluded that this manuscript is acceptable.

**********

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Reviewer #1: No

Reviewer #2: No

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PLoS One. 2023 Jun 8;18(6):e0286909. doi: 10.1371/journal.pone.0286909.r004

Author response to Decision Letter 1

22 May 2023

Responses to the Editor’s Comments

Submission ID: PONE-D-22-28147

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

We appreciate the Editor’s comments toward improving our paper. We have revised the manuscript to address all the comments, and our point-by-point responses are provided below. We have included the page and line numbers of the revisions made in the main text. Revisions in response to the Editor’s comments are highlighted in yellow in the revised manuscript with tracked changes.

Point-by-point responses

Academic editor

Comment 1

Response 1

Thank you for your comment. The target population for cervical cancer screening provided by Ichihara City in 2021 was women whose age was an even number. The city set this eligibility requirement to offer cervical cancer screening once every two years to all women. We have added the relevant explanation in the manuscript (page 6, lines 111–114).

Comment 2

Response 2

Thank you for your comment. As our descriptions were misleading, we have revised them and the changed the category’s name (page 8 lines 161–162). The category “no screening records” comprised women who had no records regarding cervical cancer screening provided by Ichihara City, such as the date of the screening. As described in the Discussion section (page 17, lines 294–300), Japan does not have a registry system for cervical cancer screening. Therefore, we could not truly determine screening non-responders and under-responders. Therefore, there is a possibility that all the categories pertaining to the duration without screening included women who had undergone the screening provided by other site, not the city. Explanations of the sensitivity analyses regarding this point are presented in the Statistical analysis (page 9, lines 174–177), Results (page 14, lines 263–265), and Discussion (from page 18, line 328–page 19, line 336) sections. 　

Comment 3

Page 9, Statistical Analysis: Please add a description of how the trend test analysis was applied in the study.

Response 3

We have added the explanation in the Statistical analysis section (page 9, lines 179–181).

Comment 4

Response 4

We have described these differences in the Discussion section (page 20, lines 363–365). As you have mentioned, these differences may be trivial. However, because of the significant differences, we accepted the possibility that the sample included this study did not represent general population. This has been explained in the manuscript (page 20, lines 359–369).

Comment 5

Page 12, Line 232-233: There are no 49.1% vs. 89.3% shown in Table 2. Should that be 46.9% vs. 86.7%?

Response 5

Thank you for bringing this to our attention. Per your comment, we have corrected these numbers (page 12, line 238–page 13, line 239).

Comment 6

Response 6

Thank you for your comment. We have revised the description as presented in page 18, lines 321–324. Additionally, we have cited more articles (reference numbers 38 and 39) in the revised manuscript.

Attachment

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PLoS One. doi: 10.1371/journal.pone.0286909.r005

Decision Letter 2

Ruofei Du

26 May 2023

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

PONE-D-22-28147R2

Dear Dr. Fujita,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Ruofei Du, PhD

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments:

PLoS One. doi: 10.1371/journal.pone.0286909.r006

Acceptance letter

Ruofei Du

30 May 2023

PONE-D-22-28147R2

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

Dear Dr. Fujita:

I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now with our production department.

If your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information please contact onepress@plos.org.

If we can help with anything else, please email us at plosone@plos.org.

Thank you for submitting your work to PLOS ONE and supporting open access.

Kind regards,

PLOS ONE Editorial Office Staff

on behalf of

Dr. Ruofei Du

Academic Editor

PLOS ONE

Associated Data

This section collects any data citations, data availability statements, or supplementary materials included in this article.

Supplementary Materials

S1 File

(DOCX)

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S1 Data

(XLS)

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S1 Checklist. STROBE statement—checklist of items that should be included in reports of observational studies.

(DOCX)

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Data Availability Statement

All relevant data are within the Supporting Information File (S1 Data).

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PERMALINK

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

Misuzu Fujita

Kengo Nagashima

Minobu Shimazu

Misae Suzuki

Ichiro Tauchi

Miwa Sakuma

Setsuko Yamamoto

Hideki Hanaoka

Makio Shozu

Nobuhide Tsuruoka

Tokuzo Kasai

Akira Hata

Roles

Abstract

Purpose

Methods

Results

Conclusions

Introduction

Materials and methods

Participants

Fig 1. Study flowchart.

Questionnaire

Other data

Statistical analysis

Ethics statement

Results

Table 1. Characteristics of the questionnaire survey participants and non-responders.

Fig 2. Reasons for not undergoing cervical cancer screening provided by the city.

Fig 3. Impressions of the self-sampling HPV test based on experience.

Table 2. Knowledge about HPV before and after participation in this trial.

Table 3. Willingness to undergo screening per type of sample collection.

Discussion

Supporting information

Acknowledgments

Data Availability

Funding Statement

References

Decision Letter 0

Ruofei Du

Roles

Author response to Decision Letter 0

Decision Letter 1

Ruofei Du

Roles

Author response to Decision Letter 1

Decision Letter 2

Ruofei Du

Roles

Acceptance letter

Ruofei Du

Roles

Associated Data

Supplementary Materials

Data Availability Statement

ACTIONS

PERMALINK

RESOURCES

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