EMPOWHPVR: exploring the factors that impact HPV self-sampling uptake amongst Black women and people with a cervix in Peel region, Ontario – a qualitative study protocol

Abstract

Introduction

Every 2 minutes, a woman dies from cervical cancer, resulting in over 300 000 preventable deaths globally. Nearly all cervical cancers are caused by human papillomavirus (HPV) and are preventable with HPV vaccination and screening through Papanicolaou (Pap) and HPV tests. In Canada, cervical cancer mortality rates have declined in recent decades with more accessible cervical cancer screening programmes. However, screening rates remain low, particularly among Black women and people with a cervix (WPC).

Cervical cancer screening studies of Black WPC in Ontario—Canada’s most populous province—are limited. These studies indicate Black WPCs are at elevated risk for under-screening, with many overdue for screening.

An innovative approach to begin addressing delays is HPV self-sampling (HPVSS). Self-sampling is a cost-effective and more accurate test for detecting high-risk HPV infections associated with precancerous changes versus the Pap test. Self-sampling supports Canada’s action plan—a response to WHO’s global strategy—to eliminate cervical cancer by 2040.

Despite Canada’s plan, research on the state of Black WPCs’ HPV knowledge and self-sampling interventions tailored to them is scant. These scarcities are concerning as Ontario plans to implement HPV primary screening and offer HPVSS soon.

The study objective is to codevelop an HPVSS intervention tailored for and made by Black WPC in Peel region, Ontario. This protocol focuses on phase one of a two-phased study.

Methods and analysis

In phase one, a qualitative, community-informed approach, co-led by community research assistants, will be used to purposively recruit 10 service providers (eg, clinicians, social workers, community care workers) and 40 Black WPC who will undergo one-on-one semistructured interviews and sociodemographic surveys to explore the state of: (1) Black WPC’s level of HPV, cervical cancer and cervical cancer screening knowledge; (2) Black WPC’s motivators, beliefs, attitudes and misconceptions towards HPVSS; (3) Black WPC’s perceived barriers and facilitators to HPVSS and (4) service providers’ perspectives on Black WPC’s barriers and facilitators to HPVSS. Charmaz’s grounded theory approach and intersectionality will guide data collection and analysis.

Ethics and dissemination

Ethical approval has been obtained from the Trillium Health Partners Research Ethics Board (ID#1207). Study findings will be disseminated through community healthcare events, conference presentations, peer-reviewed publications and virtual and physical pamphlets. Additionally, summaries of the findings will be shared and tailored to collaborators, healthcare leadership and researchers and community health centres. Wide dissemination will help enhance understanding of the state of cervical cancer screening, HPV and HPVSS among Black WPC. Given Canada’s commitment to eliminating cervical cancer, study findings will be used to begin developing an HPVSS intervention for Black communities.

STRENGTHS AND LIMITATIONS OF THIS STUDY.

• Uses the intersectionality and the learning health system frameworks to help capture the various social, institutional and societal factors that impact Black women and people living with a cervix’s perspectives of human papillomavirus (HPV), cervical cancer and HPV self-sampling (HPVSS).

• Uses a community-informed approach throughout the study to increase Black WPC participation and community buy-in for future HPVSS work.

• Community research assistants’ support and development of this study will strengthen trust among and provide social access to underserved participants, particularly those who may be less inclined to partake in a study about HPVSS, yielding more diverse insight into factors that impact HPVSS.

• One-on-one semistructured interviews encourage more natural dialogue, empower participants to steer the conversation and yield richer, more nuanced data.

• Some prospective participants may be hesitant to participate due to taboos surrounding sexual health discussions in many Black communities and time required for the sociodemographic survey and interview.

Introduction

Every 2 minutes, a woman dies from cervical cancer, resulting in over 300 000 preventable deaths globally.¹ Nearly all cervical cancers are preventable with human papillomavirus (HPV) vaccination and screening using Papanicolaou (Pap) and/or HPV tests. The tests look for precancerous cells and the virus’s presence, respectively.² The highly preventable nature of this cancer caused the WHO to devise a global health strategy to eliminate cervical cancer as a public health problem. They proposed targets such as 70% of women and people with a cervix (WPC) are screened at 35 years and 45 years of age by 2030 for countries to move towards eliminating this cancer.³ Despite the presence of a universal healthcare system and various prevention strategies, cervical cancer is presently the fastest rising cancer among WPC in Canada, with an incidence rate of 3.7% per year since 2015.⁴ In Ontario—Canada’s most populous province—cervical cancer is the third most commonly diagnosed cancer for WPC.⁵ This cancer is a significant public health issue, impacting individuals’ life expectancy, quality of life, productivity and can cause economic burden.

Many WPCs get this often symptomless sexually transmitted infection between the ages of 15–25 years.⁶ Precancerous cervical lesions can develop one to five years post HPV infection. If left untreated, invasive cancer may take 15–20 years to develop. This time frame provides ample opportunity to screen for and identify precancerous lesions. Despite this time frame, US cancer data indicate that non-Hispanic Black women are 75% more likely to die from cervical cancer than their white counterparts.⁷

Cervical cancer screening studies focused on Black WPC in Ontario are limited. These studies indicate Black WPC are at elevated risk for underscreening.8,11 In particular, a scoping review that explored the state of cancer research on Black Canadians found they were underscreened for cervical cancer.⁸ An Ontario study reviewing screening rates of immigrant women from Muslim-majority countries found over half their Sub-Saharan African participants were overdue for screening.¹⁰ Further, immigrants are less likely to have received and/or completed HPV vaccination than the general population, increasing their risk of cervical cancer.¹² These findings are alarming as these screening and vaccination gaps may lead to worse health outcomes. As Canadian cancer data are often not disaggregated by race,¹³ researchers and policymakers are prevented from gaining a clear picture of screening rates among Black populations. Conversely, the USA disaggregates its data and studies have found that Black individuals have lower screening rates.⁷ Another study found Black women had lower HPV knowledge than white women in the USA.¹⁴ While these findings cannot be directly applied to the Canadian context due to differences in cultural, ethnic, societal and political factors,¹⁵ they underscore the need for additional studies about HPV knowledge and cervical cancer screening research focused on Black Canadian WPC. Additionally, some barriers to screening among Black Canadian and WPC from other equity-deserving groups (eg, South Asian) include limited access to family physicians, cultural barriers (eg, modesty) and sexual stigma.^{11 16 17} Screening delays prompted by the pandemic have likely exacerbated pre-existing barriers, leading to a potentially dangerous backlog that could take years to address.¹⁶

HPV self-sampling

An innovative approach to begin addressing delays to cervical cancer screening is HPV self-sampling (HPVSS). Self-sampling is a cost-effective,¹⁸ sensitive and accurate test for detecting high-risk HPV infections associated with precancerous cell changes.¹⁹ Individuals are provided with a kit that they then use to collect their own HPV sample. They then send the sample to a laboratory where the self-collected specimen is tested and test results are shared with individuals.¹⁹ This test allows WPC to self-sample, with the potential of testing at a time and place of their choosing. Self-sampling could help address cervical cancer underscreening and significantly improve equity in screening participation by overcoming some of the known barriers to screening.^{20 21} A study in British Columbia, Canada found self-sampling was a viable way to reach women who lacked safe, stable and affordable housing, particularly those who did not undergo regular cervical screening.²² Another Canadian study found self-sampling increased participation among many underscreened or never-screened women and addressed concerns around logistics, privacy and fear as women could sample wherever they felt comfortable.⁹ An international scoping review that explored barriers to cervical screening in transgender men found most preferred self-sampling as it reduced their emotional distress and increased their sense of agency and control.²³ Several countries, including the Netherlands, Australia, the UK and Denmark, have already implemented HPVSS²⁴ to increase screening rates. Overall, the literature indicates HPVSS has comparable validity to clinician collected samples and supports women’s acceptance and positive views of self-sampling.^{21 24} Self-sampling also supports the Canadian Partnership Against Cancer’s action plan—a response to WHO’s global strategy—to eliminate cervical cancer by 2040. The plan includes goals like 90% of WPC undergoing HPV testing and anticipates implementing HPVSS across the country by 2030.²⁴

Despite Canada’s plan and commitment to implement HPVSS, research on the state of Black WPCs’ HPV knowledge and self-sampling interventions tailored to them is scant. Further, the literature on Black WPC’s sexual health literacy in Canada is lacking. These scarcities are concerning as Ontario plans to implement HPV primary screening and will offer HPVSS in the near future.²⁵ To ensure that the current pattern of cervical cancer underscreening and screening barriers does not persist once HPVSS is available for Black WPCs, research must be conducted.

Methods and analysis

Study objective

In phase one of this study, we will conduct one-on-one semistructured interviews (online supplemental material 1) with service providers (eg, clinicians, social workers, community care workers) and lack WPC to explore the state of:

1. Black WPC’s level of HPV, cervical cancer and cervical cancer screening knowledge.

2. Black WPCs’ motivators, beliefs, attitudes and misconceptions towards HPVSS.

3. Black WPCs’ perceived barriers and facilitators to HPVSS.

4. Service providers’ perspectives on Black WPCs’ HPVSS barriers and facilitators.

As with community-informed research, the aforesaid objectives may be revised and refined based on feedback from the community research assistants (CRAs), research team and community leaders. Study findings will inform phase two, which entails the co-development of an HPVSS intervention tailored for and made by Black WPC in Peel region, Ontario. The study is anticipated to start in November 2025 and end in December 2026, respectively.

Study design

This qualitative, community-informed study will be guided by the intersectionality and shaped by the Learning Health System (LHS) frameworks to help develop the basis for an intervention that reflects Black WPC’s needs. Intersectionality is a theoretical framework that emerged from the work and lived experiences of African-American women. It is used to understand how individuals’ numerous social identities (eg, race, gender identity, biological sex) interconnect to reflect overlapping systems of oppression and privilege within societies.²⁶ Intersectionality will be used in the study to help guide participant recruitment and data analysis to explore and reflect on connections between participants’ social identities and societal factors that impact their perspectives of HPV, cervical cancer and HPVSS within healthcare systems.

The LHS framework will help determine how the proposed intervention may interact with and need support from the healthcare system to function. The framework operates on partnerships with CRAs, community leaders, researchers, healthcare delivery organisations (eg, community healthcare centres) to fuel ongoing, healthcare system change. Using rigorous research methods, learning cycles are comprised of gathering and understanding data, codesigning solutions and then deploying rapid-cycle evaluation and adaption. The LHS encourages a continuous, bidirectional cycle of research informing practice and policy and, in turn, enhancing patients’ and communities’ health.²⁷ The framework will help shape data collection and analysis through, for instance, the active inclusion and incorporation of CRAs, community leaders and researchers’ feedback.

Ethics approval was granted from Trillium Health Partners Research Ethics Board (ID#1207). All study participants will be consented prior to participating.

Study setting

The study will occur in Peel Region, Ontario, Canada. Peel is comprised of three local municipalities—the cities of Brampton, Mississauga and the Town of Caledon—and has the second largest population after Toronto, Ontario. According to Statistics Canada, Peel is home to over 1.45 million people.²⁸ Nearly 70% of its population identifies as racialised, with most of these individuals living in Brampton and Mississauga, respectively.²⁹ Black-identifying individuals are the second largest visible minority population in the region at 9.5%.²⁸ This is higher than the total overall percentage of Black populations in Ontario (5.5%).³⁰ This study will be housed at the Institute for Better Health (IBH), the research and innovation department at Trillium Health Partners hospital system in Mississauga, Ontario.

Data collection instruments: participant recruitment, survey and one-on-one semistructured interviews

A minimum of 10 service providers and 40 Black WPC will be recruited. Individuals and the CRAs will be required to: (1) self-identify as Black WPC; (2) be aged 25–69 years who have ever been sexually active and (3) live or provide healthcare services (eg, clinicians, social workers, community health workers) in Peel region. The first two inclusion criteria align with the study population of interest. The age range mirrors provincial guidelines recommended for cervical cancer screening at the time of writing.³¹ Those not matching the inclusion criteria will be excluded from participating. Some providers are included to gain a healthcare systems view of factors that, for instance, impact HPV testing and cervical cancer screening programmes. The sample size accounts for attrition and reflects a suggestion within grounded theory that 20–30 participants be recruited to achieve theoretical saturation—collecting additional information reveals no new study insights.³²

Identifying potential participants will be done via snowball and purposive sampling. Both sampling approaches are commonly used together in qualitative research. Purposive sampling is used to identify relevant cases and choose individuals with knowledge about the study’s foci.^{33 34} Snowball sampling involves asking eligible study participants to recommend other individuals who match the study’s inclusion criteria who are then invited to become participants in the study. Both sampling strategies are evidence-based and effective means of recruiting individuals from underserved populations. These sampling approaches were selected as discussions about HPV and cervical cancer can be taboo subjects in many Black communities and some Black WPC are underserved and face barriers (eg, cultural, transportation) to healthcare. Additionally, others may not participate in the study without recommendation from a trusted peer due to past, negative and racist study experiences.

Electronic, plain language flyers will be posted on social media and physical flyers placed in high traffic areas at community health centres and organisations that deliver social and/or healthcare services to Black WPC in Peel region. The poster will be translated to reflect the most commonly spoken languages (eg, English, French, Somali) by Black communities in Ontario.³⁵

Community research assistants

We will recruit two CRAs—Black WPC peers from Black communities in Peel region—with help from the study team and community health centres. Studies indicate CRAs’ relatedness (eg, same gender identity, age) and similar lived experiences foster trust among and provide social access to participants.^{9 36} The CRAs will match the study inclusion criteria and support various components of this study (eg, participant recruitment, one-on-one semistructured interviews, data analysis, report writing). The CRAs may encourage individuals that may have experienced discrimination within healthcare and research to participate in the study. Their inclusion may also counter some participants’ cultural taboos about in-depth discussions of sexual and reproductive health. The CRAs will receive training (eg, interviewing skills), as needed from the primary author and other members of the research team.

The survey and one-on-one semistructured interviews

On signing the informed consent forms, individuals will complete an anonymous sociodemographic survey (paper or online versions). In keeping with qualitative methodology, the survey will help researchers ensure that a broad range of views has been explored within the study’s social milieu of focus and, accordingly, a mixture of participants of varying ages, perspectives about cervical cancer and HPV status, genders, sexual orientations, level of education and socioeconomic statuses will be sought. The survey will ask participants about their: age, municipality they live or work in (eg, Mississauga, Brampton, Caledon), gender identity (eg, cisgender woman, transgender man), sexual orientation, race, citizenship status, level of education, employment status, household income, past testing for HPV and past screenings for cervical cancer. Survey results will determine if participant recruitment should be modified to increase participant heterogeneity and HPVSS perspectives. The resulting data will be aggregated when collected, identifying information removed and stored to ensure participants’ anonymity.

The survey will be followed by in-depth, one-on-one semistructured interviews led by the CRAs. Together, the survey and interview will take approximately 60 min to complete. This semi-structured interview format aligns with LHS as it fosters participant engagement and empowers them to direct the conversation. This allows researchers to collect information from healthcare users that will shape the healthcare system. The intersectionality framework will help develop questions that encourage participants to reflect on the ways their lived experiences and the sociostructural factors they face may impact, for example, their HPV and HPVSS knowledge. The survey and interview questions will be pilot tested by the CRAs, study team and community partners to ensure that the language and questions are clear and user friendly. Based on participants’ preference, interviews will occur at a mutually agreed on location in person or virtually.

The objectives of the interview component include exploring participants’ knowledge of cervical cancer, HPV, HPVSS and screening knowledge. These objectives may undergo some modifications and refinements based on CRA’s and community partners’ feedback. At present, key areas include:

• Gaining an understanding of cervical and cervical cancer screening and HPV and HPVSS knowledge among Black WPC.

• Identifying any knowledge gaps and any key sources of cervical cancer, HPV and HPVSS information.

• Understanding the factors that would help or prevent Black participants/WPC clients undergoing HPVSS.

• Understanding the information needed to determine if HPVSS is right for them or their clients.

Patient and public involvement

Community members, community partners and service providers will help guide and shape this study. The CRAs will play an important role in the development and execution of this study. As noted, they will conduct data collection and support the analysis and dissemination of study findings. Interviews will help explore patients’ and service providers’ cervical cancer, HPV, HPVSS and screening knowledge as well as factors that may encourage or deter HPVSS. Participant recruitment will occur with support from the CRAs, community healthcare centres and organisations that deliver social and/or healthcare services to Black WPC. Participants will be provided with clear information and support during the consent process and told they may withdraw from the study at any time, without repercussion. Participants’ and CRAs’ compensation will align with the IBH’s guidance.

Data analysis approach

Best practices in qualitative methodology will be used to record, transcribe and analyse data. Participants’ survey data will be anonymised and then analysed via descriptive statistics to describe the sociodemographic characteristics of individuals partaking in the study. Data will be stored on a secure, password-protected server that can only be accessed by the team. Once transcripts of the audio recordings of interviews have been reviewed and anonymised, the original recordings will be destroyed.

Charmaz’s grounded theory approach will be used as a practical tool for data collection and analysis. This systematic approach to conducting qualitative research encourages researchers to frequently move between data collection and analysis, allowing for real-time changes to the research design. Researchers are prompted to reflect on how their privileges and preconceived notions may inform data collection and analysis.³² This approach, combined with an intersectional lens, allows for greater reflexivity of researcher positionalities (eg, community member-scholar)³⁷ and centring participants’ lived experiences and expertise in this study.

As per Charmaz’s³² approach, data analysis and collection will occur simultaneously. Qualitative data analysis software (NVivo V.12 plus) will support analysis of anonymised interview transcripts and data management. The CRAs will be mentored by the primary author who will also teach them how to use this software and analyse transcripts. The team will first analyse approximately three of the same transcripts, meet to review, compare analyses, discuss and agree on the analysis strategy. The selected strategy will be used to analyse subsequent interviews. The research team will engage in reflexive practice via a methodological journal. Interviews will undergo initial coding (assigning categories and meaning to data), focused coding (identifying commonly occurring categories) and theoretical coding (identifying and highlighting relationships between categories).³² Further reflexivity of the findings will occur by sharing findings with and gaining insight from the study team, CRAs and community health centre colleagues.

The Standards for Reporting Qualitative Research (SRQR) writing guide was used when drafting this article’s introduction and methods sections. The completed SRQR checklist (online supplemental material A) has been attached to demonstrate adherence to the reporting guideline.³⁸

Ethics and dissemination

Ethical approval for this study has been obtained from the Trillium Health Partners Research Ethics Board (ID#1207). Study findings will be disseminated through community healthcare events, conference presentations, peer-reviewed publications and virtual and physical pamphlets. Additionally, summaries of the findings will be shared with and tailored to collaborators, healthcare leadership and researchers and community health centres. Wide dissemination will help enhance understanding of Black WPC’s cervical cancer screening, HPV and HPVSS perspectives and inform ways to empower this population to engage in HPVSS.

Discussion

This appears to be the first study to focus on HPVSS among Black WPC in Peel region, Ontario. The study results will be used in two ways. First, findings will help researchers begin understanding the state of cervical cancer screening, HPV and HPVSS knowledge among Black WPC. Second, findings will inform the second part of this study—the development of a community informed, CRA led, HPVSS intervention tailored for and made by Black WPC. The CRAs will undergo training to enhance their ability to support the intervention’s development.

The results will be disseminated in academic publications, community reports and may be used to strengthen ongoing calls for additional government investment and resources into cervical cancer, HPV screening among equity-deserving groups and inform population-based strategies for improving cervical cancer and HPV testing rates among Black WPC. This study could increase equitable access to HPV testing and cervical cancer screening. It could better prepare healthcare systems to support Black WPC’s HPVSS needs once HPVSS is implemented. Finally, the study may help reduce cervical cancer morbidity and mortality and provide a template to inform HPVSS interventions for WPC from other equity-deserving groups.