The purpose of our study was to understand the reach and effectiveness of an HPV self-sampling intervention as an alternative to a Pap test for cervical screening, among a group of historically under screened (UNS) women in Ontario, Canada. Overall, we successfully utilized a community-based recruitment strategy that was led by community champions to reach over 1,600 women. This strategy helped us to find 202 women who were eligible, of which 69 were interested in trying self-sampling. While some declined to do self-sampling because they were concerned about participating in research, others expressed how their fear and shyness were preventing them from being screened. While our study demonstrates that there is interest and acceptability of self-sampling as an alternative, it also shows us that self-sampling does not address all barriers and concerns to cervical screening like stigma surrounding sexually transmitted infections (STI) and other solutions are needed , as most women still chose not to participate. Similarly, in their study with women experiencing homelessness or housing instability, Ogilvie et al.  found only around 50% of those who were invited to participate, did so. Future programs should address these barriers that prevent women from getting an HPV test or Pap test.
Almost all of the women who elected to try the kit, followed through and mailed it in and successfully received results. During follow-up, all participants who had used the kit said it was user-friendly, suggesting the kit to be acceptable to those who tried it. However, our findings provide guidance for ways to make self-sampling more successful. Some participants had to re-do the kit, which suggests that clearer instruction and/or more support once at home is needed. For most of the participants in Cohort B, their choice not to use the self-sampling device despite being UNS, was more an issue of fear and discomfort over screening and Pap tests, as well as the ‘unknown’ of this new device. Additionally, misconceptions and misinformation about cervical cancer risk led some to decide not to get screened at all, because they felt it was unnecessary. This suggests that for self-sampling to be successful among some UNS women, we must first address the misinformation and misconceptions that lead them to believe screening is unnecessary.
Furthermore, the role of family members in cervical screening also appeared to discourage screening for some women, suggesting that engagement is also needed for the family and friends of UNS women. In particular, engaging male partners or family members seems to be critical to the decision-making process, as some women approached for our study had cited needing their male family members’ permission. This was similarly found in a study of HPV self-sampling acceptability in Kenya, where some women who experienced opposition to screening by male partners, discussed anticipated negative reactions, lack of permission, and abandonment, while those who experienced support did so in the form of transportation, emotional support and encouragement . The involvement of male partners in preventive and sexual health care has been effective in women’s health outcomes and is also found to be generally acceptable to women [52,53,54,55,56]. This is further emphasized by the World Health Organization that recommends the inclusion of family members and particularly male partners when conveying health education messages, is critical to the acceptance of screening services .
Although almost all participants understood the purpose of a Pap test, Pap test initiation, intervals and eligibility was less understood, suggesting that there is ample opportunity for education on current screening guidelines in the province, particularly where there may be confusion with differing guidelines in other provinces and countries. Some participants also expressed being forgetful or needing reminders for when they are due for a Pap test. HPV self-sampling kits can also be useful here, as women who are overdue can be directly mailed a kit. This is a strategy already being used in countries such as Australia, which have switched from Pap tests to HPV tests .
Questions on attitudes towards cervical screening and Pap tests in particular, showed that privacy, comfort and time were a big concern. These barriers were similarly seen when participants were asked why they were overdue for screening. HPV self-sampling begins to address these barriers as women can collect the sample on their own, outside a healthcare space (ie their home), and during a time where it is convenient for them. More people in Cohort A were concerned with privacy during a Pap test, and this could explain why they chose to try self-sampling compared to those in Cohort B who were less concerned. During follow-up, almost all participants confirmed that self-sampling was their preferred method and highlighted the privacy and comfort of the device for cervical screening. This suggests that HPV self-sampling would be acceptable over the Pap test for women concerned with privacy and comfort, and that the HPV self-sampling device was also perceived as less invasive than a Pap test. Concern over confidence to collect the sample, however, still needs to be addressed. Some found the community champion and knowing previous participants as being critical for confidence to try the device. Effective knowledge translation in the form of visuals or peer support to explain the device, will be needed to successfully implement the device as an alternative to a Pap test. Additionally, these devices should have multiple ways to access them, as not everyone has access to a healthcare provider or feels comfortable having this discussion. Being able to access a kit in places in the community will be important to engage more people in screening.
As well, the COVID-19 pandemic shed additional light on the utility of mail-in HPV self-sampling devices. We saw firsthand how participants were able to still complete their screening using these devices, even when Pap tests were put on a pause in the province. Participants were able to receive the kits via mail and return them to the lab to be tested. This also provides an alternative to people who may usually engage in Pap tests but in the context of a pandemic are hesitant to move around in the community or visit a healthcare provider. In the coming months and potentially years, as the province and other jurisdictions work through the backlog of cervical screening for people who missed their Pap test during the pandemic, HPV self-sampling devices may be a useful approach to getting people screened.
It is important to highlight that while self-sampling can improve participation in screening, the study data are insufficient to say that HPV self-sampling can replace clinical cervical cancer screening completely. Screening is only valid for asymptomatic cases and those who are symptomatic would need further clinical examination. There are some potential disadvantages in HPV self-sampling and that can include decreased engagement with healthcare providers that can lead to missed opportunities to address STI screening or health in general. If the HPV self-sample result is abnormal we would want to know that people are willing to see a clinician for follow-up testing, which may see some of the same barriers that have led to underscreening (eg privacy concerns, discomfort, access, etc.).
This study demonstrates the utility of community champions in cervical screening and encouraging uptake, even beyond a research study. For women who elected to try the kit, the confidence they got from their conversation with the community champion and/or peers that had previously participated, were highlighted, suggesting the important role community champions and peers have in the acceptability of the device. Our community champions engaged with the community and built on existing relationships to advertise the study and approach potential participants. The relatedness of community champions to women in the study also helped address some of the discomfort women in this study had, to discuss topics of sexual health, cancer screening and healthcare interactions. For example, emotion-laden responses such as fear, anxiety and shyness around getting a Pap test have been found to prevent many South Asian women from being screened [58,59,60,61,62,63,64,65].
Community champions were particularly effective in engaging women outside of healthcare spaces, including social and entertainment events, neighborhood associations, tea parties and word-of-mouth. This meant we were able to engage women who may not be accessing healthcare, and taking uncomfortable conversations into more casual and familiar environments. The relatedness of the community champions (eg age, gender, ethnicity, immigration experience, language) was effective in creating trust and comfort to try HPV self-sampling, and this was particularly important for building confidence to try the device. Additionally, the approach was effective among some who chose not to try the kit, as it encouraged them to get screened via a Pap test with a healthcare provider. While successful, the community champion approach did face some institutional challenges early on. Traditionally, research ethics approvals do not let people known to interview participants as they are concerned with potential coercion and privacy issues. In the early days of the study, some potential participants declined participating if the community champion they knew was not allowed to interview them. After lengthy discussion, we received ethics approval for our community champions to interview participants they knew, as long as the participant was comfortable with it. All participants had the option to do the interview with another community champion or the study coordinator.
Additionally, the majority of our recruitment occurred in the community and through word-of-mouth, in spaces that are not always used for healthcare. This allowed us to recruit people who may not have been accessing healthcare spaces.
This study has several limitations of note. Due to limited study funds, our study focused recruitment efforts in Peel Region and the demographics and size of our final sample largely reflected that. The majority of our participants were South Asian, particularly identifying as Indian or Pakistani. This is reflective of both the demographics of Peel as well as the community champions themselves. Among our community champions, we were able to provide language assistance in Hindi, Marathi, Gujarati, Punjabi, and Urdu. While this allowed us to recruit many more women than an English-only study, it is not fully representative of all the languages spoken in South or West Asia, the Middle East and North Africa, so our recruitment was limited and our sample size was small . It is also important to highlight the diversity along the lines of religion, ethnicity, social class, and age, to name a few. While our community champions were able to gain access to many different locations and groups, their relatedness and peer status varied with some participants relating more to them than others. Future research and screening programs should employ several community champions that reflect this diversity of South Asian, West Asian, Middle Eastern and North African communities. Our study focused on women and did not include their male partners who play an important role in decision making, Future studies should include male partners in sexual health education and explore the impact it may have on cervical cancer screening uptake.
Furthermore, misconceptions and stigmas surrounding sexually transmitted infections (STIs) including HPV may deter uptake of screening due to entrenched gender norms and stereotypes associated with infections (eg women with STIs may be viewed as immoral, corrupt, or other demeaning labels). Our study did not explore this component as a barrier to screening.
Finally, we were limited by the confines of research as the ‘study’ aspect, including gathering data and signing consent, was a barrier for some women to participate in self-sampling or even trust the research team.