The research

A) CBIG-SCREEN will engage with key stakeholders on multiple levels (WP2 – WP7).

We will generate an action framework and policy recommendations to address the CC divide between and within European countries with active involvement of key stakeholders. At the micro-level, we will use and develop strategies for eliciting preferences for and beliefs about CCS from women who have not yet participated in organised screening, and collect information on cognitive and behavioural factors that may influence adherence to follow up. Though health services directly influence patient-level outcomes for illnesses, population health is determined by a broader range of meso- and macro-level factors. Stakeholders’ perspectives, their experiences and expectations are key to frame any targeted policy. Policies must close the health gap within and between countries and increase equity and social justice by prioritising underprivileged and vulnerable groups.

B) We will elicit stakeholders’ preferences (WP2 and WP4)

and use this knowledge to inform our design of context specific interventions that encourage tailored CCS in high-risk women. CBIG-SCREEN will use quantitative methods drawn from behavioural economics to identify the main barriers to CCS and study the preferences of vulnerable women for potential interventions to increase screening.  CBIG-SCREEN will build on the qualitative evidence generated across its WPs to maximise perceived benefits while mitigating risks and fears (e.g., stigma, coercion) of users that could result from implementing commonly used interventions to increase uptake of cancer screening. CBIG-SCREEN will explore the potential effectiveness of interventions designed to enhance screening uptake in participating countries. We will generate evidence on the relative likely effects of interventions that rely on structural adaptation of existing screening programmes, e.g., financial and non-financial incentives to change behaviours, and on their optimal design.

 CBIG-SCREEN will quantify the extent to which tailored CCS can be generalised, and assess specific barriers (WP2,WP3, WP4 and WP6).

We will analyse population-based interventions designed to increase demand for cancer screening (e.g., sending reminders, financial incentives, mass media and small media, group education and one-on-one education), interventions designed to reduce barriers to screening (e.g., lowering structural barriers, reducing out-of-pocket costs, home-based screening tests, or less invasive tests), and provider-directed interventions aimed at clinicians (e.g., provider assessment and feedback, provider incentives, clinical guidelines, use of triaging biomarkers, or integrated services).

To address the socioeconomic and contextual factors of relevance to the targeted region and community, we will combine information across settings only if it is reasonable to compare intervention effects across context, to determine if effects are comparable. We will formally quantify the extent of generalizability of the aggregate results by comparing uncertainty within trials to uncertainty across trials to reveal the role contextual variables play in predicting efficacy at the country and intervention level. The certainty of the evidence will be evaluated according to GRADE criteria and presented in evidence-to-decision tables.

CBIG-SCREEN will develop models specific to different settings (WP3 and WP5).

To evaluate the cost-effectiveness of interventions found to increase screening participation among vulnerable women, we will build on P03-LSHTM’s expertise in developing mathematical models in specific high-risk groups like women sex workers, women living with HIV, and socially disadvantaged women.

There are many reasons we cannot directly observe benefits (e.g., mortality reduction) and harms of CCS. For example, it is unethical to set up unscreened control groups where screening is offered. Also, even though we can observe intermediate outcomes like changes in participation in screening and follow-up, the effects of HPV and pre-cancer detection on mortality and cancer overdiagnosis will only become evident over the long-term. We can quantify benefits and harms over a lifetime if we use a model that integrates the natural history of disease and risk factors (e.g., HIV status, HPV vaccination, and CCS history) on cancer-related outcomes. These factors determine the likelihood a woman will have an HPV infection or Cervical Intraepithelial Neoplasia, and the rates at which they would progress.

We will model alternative future scenarios for screening uptake based on our findings about uptake rates and costs for each intervention, across different settings. The final output from the modelling exercise will consist of predictions for alternative settings, risk groups, and intervention strategies in terms of cases of CC averted, life-years saved, and cost-effectiveness (cost per quality-adjusted life-years).

Using qualitative and quantitative methods, CBIG-SCREEN (WP4, WP5 and WP6) will validate the feasibility,  acceptability, and efficacy of setting-specific interventions to increase the proportion of women who complete each step in the CCS sequence.

We will test the proposed model for tailored CCS by implementing it in three exemplar countries, ideally suited for testing the steps of tailored CCS and evaluating its success: Estonia, Portugal, and Romania. These countries were strategically selected since they are located in three regions of Europe (northeast, east and southwest) and have markedly different contexts, e.g., health care systems, HPV vaccination policies and coverage, cancer characteristics, screening organization and management, capacity, resources, socioeconomic and cultural background, and cancer registries.

We will be able to reflect the heterogeneity within Europe between and to some extent within the countries.

Our partners in these exemplar countries were chosen for their expertise in monitoring and evaluating CCS, and their extensive national and regional networks. They will draw on these networks to smooth implementation of tailored field interventions and data collection integrated to existing systems of CCS, and the consortium will exploit their knowledge of the region to identify and manage potential difficulties while we conduct our research. Moreover, the experience we gain in these exemplar countries will help us identify difficulties likely to arise in other countries and develop solutions before the project is introduced in other EU states. As there is a strong expectation to include the pathway to referral for positive cases, we will both implement interventions that motivate women to return for the HPV self-sampling kits and, when HPV test results are positive, interventions that encourage women to return for a cytology test followed by colposcopy if cytology is abnormal (colposcopy directly after a positive HPV test is also an acceptable option).

We will use results from WP2 and WP3 to propose the most promising models of combined intervention and validate key elements for successful implementation using a quasi-experimental design trial in the three exemplar countries. The intervention is likely to be multicomponent because there are barriers to several steps in the screening cascade that must each be overcome to increase adherence.

Definition of essential results, both quantitative and qualitative, on which we will base our suggestions to adapt EU guidelines on cancer screening (WP2 – WP7).

At each of the steps described above, we will extract these essential results to adapt guidelines for tailored CCS. This will be done in close collaboration with members of the Collaborative User Boards to ensure co-creation and make room for multi-level stakeholder insights. Key results include data on effectiveness, affordability, acceptability to the population, cost-effectiveness, and suitability for implementation.

With the support of our partners, based on the results of the different WPs, we will design a toolkit of interventions to promote health equity in CC prevention programmes. These programmes can be adapted to European countries based on requirements of the demand side (characteristics of the target population) and the supply side (health care resources, staff competences, and involvement).

We will disseminate our results to all stakeholders inside and outside the consortium, s, and especially to high-risk women who are affected by the screening interventions. The CBIG-SCREEN consortium will develop a communications strategy to:

1. ensure the best avenues for communication (like patient associations, e-advertising through modern communication tools), 

2. define the target audience (general population, at-risk patients, politicians, policymakers),

3. suggest ways to measure how effectively the adapted CCS guidelines are being disseminated within the target audience.