Cervical cancer is the fourth most common cancer in women and presents a significant risk to all people with a cervix [1-3]. In 2018, an estimated 570,000 women were newly diagnosed with cervical cancer worldwide, with 311,000 deaths from the disease [4]. In Canada, >1300 women are diagnosed with and >400 women die from cervical cancer each year [5]. Cytology testing using the Papanicolaou smear, commonly referred to as the Pap test, allows for the detection and subsequent treatment of precancerous lesions that may lead to cervical cancer. Canadian women have been widely screened for cervical cancer using the Pap test for >50 years [6]. There are guidelines in each province and territory that currently recommend screening every 1 to 3 years, starting at the age of 21 or 25 years [7], and most Canadian jurisdictions have organized screening programs [8].

Cervical cancer is caused by persistent infection with high-risk human papillomavirus (HPV) types [9]. The HPV test, which detects high-risk HPV DNA in cervical cells, has emerged as a significant improvement over cytology for cervical cancer screening. Compared with cytology-based screening, HPV-based screening has been shown to offer 60% to 70% higher protection against the development of cervical cancer [10,11]. The HPV test shows improved sensitivity, and negative test results have high negative predictive value, thus providing greater reassurance against cervical lesion development [12]. Furthermore, this allows for increased intervals between cervical screenings and reduced testing costs [12]. HPV testing also introduces the possibility for vaginal self-sampling by the patient. This is not possible with cytology, which requires cervical cell collection by a health care provider, a process that can be uncomfortable or invasive [13,14]. Meta-analyses have shown that self-sampling has similar test accuracy when compared with health care provider–administered sampling [15] and could increase uptake among those who are underscreened when provided as a screening option [15,16].

Therefore, currently, HPV testing is considered the preferred method of screening by the World Health Organization [17] and is recommended by multiple specialty organizations worldwide (eg, United States Preventive Services Task Force [18], European Society of Gynaecologic Oncology, and European Federation of Colposcopy [19]). Several countries have implemented HPV-based organized screening programs (eg, Australia, the United Kingdom, and the Netherlands), including the use of self-sampling as a collection option [20,21]. However, program implementations have encountered challenges. For example, in Australia, before the introduction of HPV testing, a web-based petition against the proposed changes gained widespread support. In an analysis of comments on the petition, Australian women felt that the policy devalued or threatened women’s health and represented a government cost-cutting measure and that increased screening intervals and later age of screening initiation would prevent early detection of cervical abnormalities [22]. Similarly, in Wales, increase in screening intervals associated with the shift to HPV-based screening has been met with public backlash, with >1.2 million signatures on a web-based petition against the change at the time of writing [23]. Although these guidelines are grounded in evidence, a disconnect has been observed between women’s and public health authorities’ views on cervical cancer screening changes. These health authorities failed to effectively and proactively communicate why changes were warranted, why screening intervals may change, and what HPV test results indicate [22-26].

In Canada, provinces and territories are in different planning phases for HPV-based cervical cancer screening programs [7,27], and the nationwide introduction of HPV-based primary screening is a key priority of the recent Canadian Partnership Against Cancer (CPAC) Action Plan for the Elimination of Cervical Cancer [5]. Although cytology-based screening is well established in Canada, screening coverage has failed to reach the CPAC target of including ≥80% of women [28]. This suggests that innovative approaches are needed to reach those women who are underscreened (ie, longer than 3 years since their previous Pap test or never screened). Approximately 40% of women in Canada diagnosed with cervical cancer report either never having had a Pap test or not having had one in >3 years [29]. Underscreened women are often members of ethnic, linguistic, gender, and sexual minorities or have lower socioeconomic status [30-33]. In Canada, only 65% of recent female immigrants reported having a Pap test in the previous 3 years, and 26% of non-English or French speakers reported never having a Pap test [29]. In a study of cancer screening registries in Ontario, transgender patients were significantly less likely than cisgender patients to be screened for cervical cancer (56% vs 72%) [32], reflective of barriers faced by transgender and other gender-diverse people in seeking cervical cancer screening [2]. A study by Decker et al [34] comparing screening rates and outcomes between First Nations women and all other women in Manitoba suggested lower screening rates among First Nations women aged ≥40 years and significantly higher rates of cervical lesions and cancers in First Nations women overall. Targeted solutions must consider these factors. For underscreened women, the introduction of HPV self-sampling could be important for ensuring that cervical cancer screening is more accessible and acceptable [13-15,35,36]. A meta-analysis of 37 studies by Nelson et al [37] found that women who used and indicated acceptability of self-sampling for future screening did so because of its convenience, privacy, and ease of use. However, identified barriers include women’s lack of confidence in their ability to correctly collect the specimen, lack of confidence in the test result, and discomfort with the procedure [37,38].

The concerns of adequately screened women (ie, <3 years since their previous Pap test) must also be addressed. Clear and open dialogue with these women is needed to prevent confusion and provide reassurance that the switch to HPV-based screening is evidence-based and represents an improvement over cytology-based screening. Currently, there is a dearth of research examining Canadian women’s perceptions and understanding of HPV-based screening and potential changes to screening guidelines. To avoid problems that may arise in Canada as program implementations advance, efforts should be made to understand and address the concerns of women.

From both theoretical and practical perspectives, knowledge is a determinant of engagement in protective health behaviors [24,39,40]. In a systematic review of psychosocial factors associated with intentions and acceptability of HPV testing, knowledge was associated with greater acceptability of screening using the HPV test [24]. In Canada, poor cervical cancer screening knowledge has been identified as a key barrier to screening in populations such as immigrant women and ethnic minority communities [41-43]. In a recent systematic review, specific attitudes and beliefs about HPV testing have been identified as both barriers to and facilitators of HPV test acceptability [24]. For example, high perceived benefits of the HPV test were associated with greater HPV test acceptability, whereas negative emotions (eg, shame associated with testing for a sexually transmitted infection) related to HPV testing were associated with lower HPV test acceptability. Importantly, these findings and many additional attitudes and beliefs (eg, high perceived susceptibility to cervical cancer, negative perceived emotional reaction to HPV test results, and high perceived severity of HPV infection) have not been studied and confirmed in Canada-wide samples.

Several measures exist for cervical cancer knowledge [44-47], a subscale has been developed for measuring knowledge of HPV testing [48], and 2 measures of HPV testing and self-sampling attitudes and beliefs have been developed [49,50]. However, existing measures have shown insufficient psychometric testing or suboptimal psychometric properties. In addition, in a fast-moving field, many measures are not up-to-date with evidence from the literature on cervical cancer and HPV testing or do not include other important factors associated with HPV test acceptability (eg, negative emotions related to HPV testing [24]). As women’s perceptions of cervical cancer and HPV testing are multifaceted, comprehensive and valid measurement tools are crucial for identifying attitudes, beliefs, and knowledge gaps that could be barriers to the acceptance and uptake of HPV-based screening.

Preferences refer to a distinct form of attitude that provides information about the relative value and ranking an individual assigns to certain options over others. Measuring preferences is important in the context of cervical cancer screening, as multiple approaches (eg, varying screening intervals and use of self-sampling) are being considered for implementation [5]. Understanding Canadian women’s preferences can provide insight into the acceptability of different screening options and illuminate any potential disconnect between women and public health regarding the implementation of HPV-based screening programs. In particular, by examining women’s preferences for screening intervals and age of screening initiation, 2 major points of contention observed in other program implementations [22,51,52], public health can optimize communications to address concerns and ensure acceptability of HPV-based screening guidelines [24]. Furthermore, examining the preferences of underscreened women and adequately screened women separately can help to inform targeted communications for these groups.

The proposed study will use a multistep approach to examine women’s knowledge, attitudes, beliefs, and preferences toward HPV testing and self-sampling. A preparatory study (study 1) was focused on the development and psychometric validation of scales measuring cervical cancer screening–related knowledge, attitudes, and beliefs. In addition, given the challenges of investigating women’s views toward a screening approach that has not yet been implemented, this study examined the feasibility and structure of a survey that examines these factors in Canadian women. Results of study 1 will yield validated scales to administer to a large sample of Canadian women (study 2) to estimate the associations between psychosocial factors and women’s intentions to participate in HPV-based screening programs. Furthermore, study 2 will survey and compare differences in psychosocial factors and HPV test intentions among adequately screened women and underscreened women, providing timely data to address emerging challenges in both groups.

The main objectives of study 1 (scale and questionnaire development) are as follows:

The main objectives of study 2 (expanded population-based survey of Canadian women) are as follows:

As of May 2022, data collection has not begun for study 2. Data collection is expected to begin in June 2022 or July 2022, and results are expected to be published in late 2022 and early 2023.

This study will use 2 complementary cross-sectional web-based surveys of Canadian women to develop psychometrically tested scales measuring cervical cancer knowledge, HPV testing knowledge, HPV testing attitudes and beliefs, and HPV self-sampling attitudes and beliefs and, then, include these scales in a broad survey to investigate the psychosocial correlates of women’s intentions to engage in HPV-based cervical cancer screening.

Scales developed in study 1 will be informed by measures in the extant literature and further enhanced by the generation of new items based on systematic evaluation of themes in the psychosocial literature on HPV testing. Using the TPB and HBM to guide item selection will further ensure that the scales provide meaningful insights into the factors affecting screening behaviors. Application of advanced psychometric methods, including item response theory, which facilitates the development of parsimonious measures [94], will help to ensure that the scales are comprehensive, while being brief and easy to administer. We expect the cervical cancer knowledge scale to expand on the psychometric methods applied for similar measures such as the Cervical Cancer Awareness Measure developed by Simon et al [44] and the HPV testing knowledge scale to show increased reliability compared with the existing subscale developed by Waller et al [48]. The HPV testing and self-sampling attitudes and beliefs scales will expand on existing measures by using advanced psychometrics in an up-to-date and representative sample. Accordingly, we expect our scales to represent a new measurement standard for investigating the attitudes, beliefs, and knowledge associated with HPV-based screening. In addition, the use of BWS to estimate preferences for cervical cancer screening will enable evaluation of women’s perceptions of trade-offs between different testing methods, and importantly, screening intervals and ages of initial screening. These changes have been barriers in other countries where HPV-based screening has been implemented [22,52].

Our expanded population-based survey (study 2) will provide comprehensive data to inform and support the development of Canadian HPV-based cervical cancer screening programs. Through objective 1, the specific evaluation of differences in knowledge, attitudes, and beliefs about HPV testing among women who are underscreened and those who are adequately screened will enable the development of targeted interventions to improve knowledge, address negative attitudes and beliefs, and reassure women about upcoming changes. In objective 2, analyzing the sociodemographic and psychosocial factors associated with screening intention stages will provide insight into developing interventions that consider the multiplicity of barriers to screening. Our investigation will offer a valuable response to calls to action to examine inequalities in cervical cancer screening in the interest of cervical cancer elimination [8]. Furthermore, by comparing women’s knowledge, attitudes, beliefs, and preferences toward HPV-based screening with the proposed guidelines, our findings will help to inform screening recommendations and ensure successful transition from cytology to HPV-based screening in Canada.

To reach both research and health professional audiences, the study findings will be published in open-access, peer-reviewed scientific journals. Presentations will be made at national and international scientific meetings (eg, Canadian Association of Psychosocial Oncology, International Papillomavirus Society conference, and International Psycho-Oncology Society) and in webinars (eg, Consortium for Infectious Disease Control and International Papillomavirus Society). To reach policy makers, we will share a final research report with the Public Health Agency of Canada, CPAC, Canadian Task Force on Preventive Health Care, and provincial and territorial cancer screening program advisory boards. We will also share our results with nonprofit organizations such as the Canadian Cancer Society, the Society of Obstetricians and Gynaecologists of Canada, the College of Family Physicians of Canada, and HPV Global Action who have expressed strong interest in disseminating our results. We will produce content (eg, infographics) and engage with Canadian women on social media (Twitter, Facebook, etc). Research summaries will be drafted for dissemination to national media outlets to inform women about this public policy change and encourage discussions about HPV-based cervical cancer screening.

A major strength of this study is the rigorous and comprehensive process to develop psychometrically validated scales informed by theoretical frameworks. In addition, examination of the feasibility of the developed questionnaire through study 1 will ensure that the survey used in study 2 will be easy to understand and relevant to Canadian women. BWS presents an innovative approach to assess preferences that controls for biases observed in typical multiple-choice or ranking assessments of preferences. The use of PAPM to examine intentions toward HPV testing and self-sampling will provide a theoretically informed and nuanced understanding of women’s decision-making compared with other studies using continuous or binary measures. Using a market research polling firm will enable time-efficient and cost-efficient recruitment and data collection. Furthermore, the web-based survey methodology will prevent the issue of missing data. Quota-based sampling will allow us to recruit a nationally representative sample based on recent census data. Attention check items and data cleaning techniques will allow us to identify and exclude unmotivated or careless responders, ensuring that high-quality data will be collected and analyzed.

The study design has some limitations. Relying on respondents’ self-report for their screening history of having had a Pap test in the past 3 years or not is subject to recall bias. Our anonymous web-based survey design prevents us from verifying it against health records data. To minimize this limitation, women will be provided with a reminder informative statement explaining what a Pap test is and how it is performed before asking them about their screening history. Given that the COVID-19 pandemic has prevented and continues to prevent women from engaging in cervical cancer screening, this may affect women’s report of their screening history and change the composition of women in our underscreened and adequately screened categories. It is not clear how this will affect our data, as the effect of the COVID-19 pandemic on screening access in Canada is not well understood in most provinces and territories [95]. To address this issue, we will include an item asking those participants who report being underscreened whether the COVID-19 pandemic had prevented them from receiving screening, and sensitivity analyses will be performed to examine the pandemic’s impact on screening. In addition, the lack of investigation at 2 different time points precludes any investigation of how intentions for HPV testing and self-sampling may relate to uptake and acceptability as these testing methods are introduced. Longitudinal examinations of acceptability and intentions toward HPV-based screening will be needed as implementation occurs in Canada. Unfortunately, our study design and recruitment strategy may preclude specific analyses in gender and sexual minority groups, considering the low case counts observed in population-wide web surveys (eg, 0.4% gender-diverse individuals in study 1). Recognizing the unique barriers faced by these groups in screening for cervical cancer, future research should specifically investigate the perceptions of gender and sexual minority Canadians toward HPV testing and self-sampling implementation [3,14,96]. Similarly, comprehensive understanding of cervical cancer screening and HPV in the First Nations, Inuit, and Métis populations is critical [5,34]. Our study could highlight certain issues in these populations (considering 2.9% representation in study 1), but unique participatory action initiatives involving relevant nongovernmental organizations and community advocacy groups are needed to fully understand their views and address their concerns.

Understanding the psychosocial factors that might affect women’s perceptions of and intentions to engage in HPV-based screening will be critical as Canada plans to implement changes to cervical screening programs and guidelines. Through this multistep study, we will develop several validated scales to facilitate population-based investigations of these factors by other researchers. The use of these scales to investigate a representative sample of Canadian women’s perceptions of HPV-based screening will provide directly applicable knowledge to public health and health care professionals.