1 Introduction

Cervical cancer is the second most diagnosed cancer in individuals eligible for cervical screening under 45 years of age in the UK [1]. Clinician screening using high risk human papillomavirus (HPV) testing is routinely offered to women and other individuals with a cervix between the ages of 25 and 64 years via the NHS cancer screening programmes in the UK [2-5]. Cervical screening coverage has steadily declined in the UK over the last decade and currently stands at 69.6% in Wales [6], 68.7% in Scotland [7], 68.8% in England [8] and 66.7% in Northern Ireland [9]. Uptake remains below the target level of 80% which is needed to reduce incidence of cervical cancer and to ensure screening cost-effectiveness [10].

The HPV vaccination programme was introduced in the UK for under 18s in 2008, with potential to prevent over 80% of the most common types of cervical cancer [11]. However, it could be decades until the UK population comprises mainly of vaccinated individuals and screening remains the main strategy for cervical cancer prevention. Individuals from low socioeconomic groups [12], ethnic minority backgrounds [13], younger/older age groups [13-15], those who have disabilities [16], transgender men and nonbinary people [17] and those who are lesbian and bisexual [18] are less likely to participate in cervical screening. During the COVID-19 pandemic, cervical screening was paused temporarily [19]. When screening re-started in the UK, one in five eligible individuals reported being less likely to take part [20]. Common barriers [21, 22] to cervical screening such as embarrassment, body image concerns, lack of available appointments, cultural sensitivity or time to attend [21, 22], could be reduced by providing the option of HPV self-sampling, where a sample for HPV testing is taken by the person themselves at home or other preferred location. Taking sampling out of the clinic setting could also reduce workload pressures on primary care staff.

The European Cancer Organisation recommends HPV self-sampling as a central component of organised cervical screening programmes [23]. HPV self-sampling could have a positive impact on uptake in under-screened populations [24, 25]. HPV self-sampling has already been implemented in several countries such as Australia and Denmark and the WHO has recommended that HPV self-sampling is an additional approach to sampling in cervical screening [26]. In 2019, HPV self-sampling was welcomed as a potential option for cervical screening in a UK joint position statement [27]. The HPValidate study in England identified that while some self-sampling methods were effective [25], participants welcomed the choice in cervical screening mode but needed support selecting HPV self-sampling or clinician sampling [28]. The UK National Screening Committee has called for research into the acceptability and clinical feasibility of HPV self-sampling screening and patients' preferred involvement in decisions about cervical screening mode [29].

HPV self-sampling can address some of the barriers to traditional clinician sample collection. It also presents unique barriers, including low confidence in personal ability to collect a sample and lack of trust in the result [30, 31]. UK healthcare policy advocates preference-based decision-making through the concept of shared decision-making when choices exist [32]. Informed decision-making is a process that enables individuals to make health-care decisions after they have considered information about the options available and how options fit with their preferences [33]. If HPV self-sampling becomes an additional option for cervical screening in the UK, it will be important to incorporate decision support into cervical screening programmes to enable informed decision-making at population level, and to ensure that the offer of choice does not have a negative impact on engagement in under-screened populations [33]. The way in which changes to the cervical screening programmes are communicated to the public is important to avoid negative public perceptions and lack of trust [34, 35]. Theoretical models such as the integrated screening action model (I-SAM) [36] and Implement-SDM [37] can be used to understand behaviour and guide targets for interventions [38], such as communication strategies to promote informed decision-making [33] about choice in cervical screening (self-sampling vs clinician sampling). As depicted in Figure 1, the I-SAM expands the Precaution Adoption Process Model (PAPM) [39] by conceptualising screening participation behaviour as a pathway from individuals being unaware of and unengaged with screening options, to deciding whether or not to take part in screening and adhering to repeat screening rounds. The individual's perceived capability, opportunity and motivation also influence their movement across the screening pathway. In cervical screening, the I-SAM can incorporate a dynamic screening communication and decision pathway for individuals who are at various stages of the decision-making process. The I-SAM is particularly complemented by the Implement-SDM model which outlines the stages needed to facilitate informed decision-making through a process of shared decision-making.

Implement-SDM (Figure 2) interjects at the ‘undecided’ stage of the I-SAM screening behaviour process, with potential to support deliberation and preference-based decision-making for informed cervical screening participation (including repeat participation). Furthermore, Implement-SDM is able to account for the distributed nature of the decision-making process over initial and repeat cervical screening rounds.

In the SUCCEED study, we aimed to develop evidence-based recommendations for a communication strategy to support informed decision-making for choice between HPV self-sampling or clinician HPV sampling, should HPV self-screening become available in the UK. The study was underpinned by the I-SAM [36] and Implement-SDM [37] models.

2 Methods

3 Results

Throughout the interactive recruitment process, recruitment stopped once no new significant themes were identified during the interviews which was 30 interviews. Throughout the process thirty-five individuals eligible for cervical screening expressed an interest in taking part in an interview; thirty individuals were interviewed (86%) (Table 1), Five out of the thirty-five individuals did not participate for the following reasons: change in personal circumstances (n = 2), withdrew consent (n = 1), lost contact (n = 1), ineligible (n = 1). Participants had a wide range of demographic characteristics. This included age (mean 37.9 years, range 25–63, standard deviation 10.52), screening history (never screened n = 10, late or irregular responder n = 7, regular responder n = 13) and ethnicity (White/White British n = 16, other ethnic groups n = 14). Most participants identified as female (n = 28) and most were educated below degree level (n = 15). Interviews lasted an average of 37 min (range 20–53 min).

Twenty-three stakeholders were recruited, from a range of backgrounds; n = 12 clinical and public health, n = 9 third sector organisations, n = 2 mixed clinical and third sector organisations (Table 2). Stakeholder interviews lasted an average of 36 min (range 16–53 min).

Four main themes across both participant groups were identified: misunderstanding of clinician screening, attitudes towards choice, communication preferences and decision-support needs. Each theme included multiple sub-themes, which will be described below with exemplar quotes, with participants referred to as SH = stakeholder and where their role is based (e.g. SH23, public health) and P = individuals eligible for cervical screening, their cervical screening attendance and gender identity (e.g. P13, nonresponder, male).

3.5 Logic Model Development

Qualitative data themes were triangulated and mapped to the I-SAM and Implement-SDM theories. During the theme mapping, it became evident that the communication strategy would need to have two distinct points. The first was the lead up to the introduction of choice in cervical screening mode which would address the unaware/unengaged stages of the I-SAM and the unaware/choice introduction stages of the Implement-SDM model. The second was supporting the consideration of options during the ‘undecided’ stage of the I-SAM by incorporating the stages of ‘option presentation’, ‘increasingly tailored information’ and ‘decision-support tools’ aspects from Implement-SDM. This would support movement to ‘act’ phases of I-SAM to facilitate informed decision-making about mode of cervical screening (or decision not to screen).

The communication strategy is presented in two logic models, presenting theoretically informed (by the I-SAM and Implement-SDM) ‘active components’ needed to develop a communication strategy for offering choice in cervical screening. Model 1, the communication launch strategy model (Figure 3) targets the ‘uninformed/unaware’ aspects of choice in as per I-SAM and the ‘preparation/choice introduction’ aspects of Implement-SDM. The decision-support intervention logic model, Model 2 (Figure 4) targets the ‘undecided’ aspect of I-SAM and the ‘review/revisit’ aspects of Implement-SDM. Both models aim to support informed decision-making.

4 Discussion

There is increasing global interest in the possibility of offering HPV self-sampling for cervical screening at population level as well as to non-attenders, and 17 countries have already introduced self-sampling for non-attenders (e.g. Australia, Denmark) or as a population-based screening option (e.g. Albania) [45]. The World Health Organization endorses primary HPV testing as well as self-sampling to broaden access to healthcare services [46]. The global use of self-sampling is likely to increase in the coming years [45] and to ensure that the introduction does not exacerbate current inequalities in access to healthcare there is a need for timely communication about programme changes. SUCCEED is the first study to combine behaviour change and decision-support theory to inform a communication strategy to facilitate informed decision-making for mode of cervical screening. The study explored communication needs amongst individuals who are part of an organised cervical screening programme and findings could be relevant to other countries with similar programmes in preparation for communication plans introducing HPV self-sampling as an option. In SUCCEED, we explored knowledge, values and preferences among cervical screening responders and those who have traditionally not taken up the screening invitation (including sub-groups by age, socioeconomic group, ethnicity, gender identity and sexual orientation), as well as professional stakeholders about communication needs should HPV self-sampling be incorporated into cervical screening programmes in the UK. We present two novel theory-informed, evidence-based logic models for a communication strategy with public health intervention targets for (1) communicating new cervical screening programme changes to the eligible population to raise awareness and promote equitable engagement and (2) supporting person-centred informed decisions about self-sampling and clinician-sampling for HPV screening

In line with other recent UK and international studies [25, 47], participants were positive overall about the possibility of HPV self-sampling. However some were sceptical about the reasoning behind the offer of a choice and cervical screening programme changes. This seems to be due to a perceived lack of transparency of the benefits of self-sampling to both NHS staff and members of the public. Previous consumer-based research has identified that scepticism can arise from a lack of transparency about reasons for introducing change [48]. Transparency about all outcomes, including those that are self-serving, such as cost savings for national health institutions, have been shown in previous literature to reduce mistrust [48].

We found a lack of understanding about the overall aim of offering screening options, which is consistent with previous studies [31, 49]. Some participants felt they could opt into self-sampling between other testing episodes undertaken by clinicians or if they developed relevant gynaecological symptoms. In addition to a general lack of understanding of screening as has been reported in other studies [50-52], we identified a low level of knowledge about HPV and cervical screening. There was misunderstanding of the current screening programme, which has for some nations shifted from cytology to primary HPV testing, meaning that the offer of HPV self-sampling was incongruent with perceived current routine screening modes. This resulted in self-sampling being seen as completely different, new and potentially inferior to clinician sampling. A novel finding from this study is the high perceived knowledge about cervical screening from the screening-eligible population, despite this knowledge being factually inaccurate for many participants. Such misconceptions can influence the level of engagement that screening-eligible people have with educational material. There is a need for a transparent whole-population multi-modal and multi-agency (e.g. schools, public health, primary care, secondary care) campaign to promote understanding about why HPV self-sampling is being introduced.

When discussing the offer of choice in cervical screening, decision-support needs were high for participants. In line with other studies [30], concern over the accuracy of results and the potential cervical screening journey where there might be a need for clinician sampling in the case of HPV-positive self-sampling were raised. A clear need for multiplatform and multiformat tailored decision aids was identified. Core content focusing on choice introduction, clear justification for the need to offer self-sampling, option presentation (comparison between clinician sampling and self-sampling), and access to further support, like helplines or healthcare professional appointments, is required. Tailored content is needed for communities and individuals, such as those who have been through sexual violence, immigrants and certain religious and LGBTQ groups. A recent study has identified that individuals born outside the UK, adult immigrants and non-English speakers sought stronger recommendations for cervical screening [53]. This highlights the need for culturally tailored interventions which explicitly present the reasons behind offering choice in cervical screening mode [54].

5 Conclusion

Self-sampling in cervical screening could be an acceptable option to screening-eligible individuals and stakeholders, so it could plausibly broaden screening participation. However, public misunderstanding of the motives for its introduction could lead to uninformed non-participation. The introduction of HPV self-sampling as a choice in countries with national cervical screening programmes needs to be carefully planned. Introduction needs to be supported by a robust lead-in phase for a communication strategy to increase public awareness and engagement, accompanied by the development of multi-modal decision support to facilitate informed decision-making about cervical screening. The logic models presented in this study can inform the content of an overarching communication strategy to support informed, equitable participation.

6 Further Research

This study sets out the pathway for the creation of a communication campaign for supporting preference-based cervical screening decisions. There is a need to develop and test the feasibility of the communication strategy informed by the logic models with coproduction from key community members who have been represented in this work and others who have not, such as non-English speakers, individuals from other UK nations such as Northern Ireland as well as internationally and stakeholders from other sectors responsible for guiding health-seeking behaviours in the population.

Author Contributions

Denitza Williams: conceptualisation, investigation, funding acquisition, writing – original draft, methodology, validation, writing – review and editing, formal analysis, data curation, supervision, visualisation. Eleanor Clarke: investigation, writing – original draft, methodology, writing – review and editing, formal analysis, project administration, validation, data curation, software, visualisation. Kate J. Lifford: conceptualisation, funding acquisition, writing – review and editing, methodology. Lindsay Haywood: conceptualisation, funding acquisition, writing – review and editing, formal analysis, validation. Fiona Wood: conceptualisation, funding acquisition, writing – review and editing, methodology, supervision. Jo Waller: conceptualisation, funding acquisition, writing – review and editing, supervision, methodology. Adrian Edwards: conceptualisation, funding acquisition, writing – review and editing, methodology, supervision. Natalie Joseph-Williams: funding acquisition, methodology, writing – review and editing, supervision. Caroline Evans: funding acquisition, conceptualisation, validation, formal analysis, writing – review and editing. Gareth Powell: funding acquisition, conceptualisation, supervision, writing – review and editing. Rhiannon Phillips: conceptualisation, funding acquisition, writing – review and editing, supervision. Andrew Carson-Stevens: conceptualisation, funding acquisition, writing – review and editing, supervision. Katie Walbeoff: conceptualisation, funding acquisition, validation, writing – review and editing. Ardiana Gjini: conceptualisation, funding acquisition. Kate Brain: conceptualisation, funding acquisition, writing – review and editing, writing – original draft, methodology, validation, supervision.

Ethics Statement

This study received approval from the School of Medicine Research Ethics Committee at Cardiff University Ref SMREC 22/88.

Consent

All participants provided fully informed consent before taking part in the study. They were provided with a study information sheet and consent form and were given at least seven days between information provision and interview.

Conflicts of Interest

The authors declare no conflicts of interest.