EQUITy in Black Adult health (EQUITA) - a randomised feasibility trial of a co-produced and faith-placed intervention to increase uptake of breast, cervical, bowel, and AAA screening in the North East of England, Leeds and Scotland: study protocol

EQUITy in Black Adult health (EQUITA) - a randomised feasibility trial of a co-produced and faith-placed intervention to increase uptake of breast, cervical, bowel, and AAA screening in the North East of England, Leeds and Scotland: study protocol | Research Square Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Help Center Sign In Submit a Preprint Cite Share Download PDF Study protocol EQUITy in Black Adult health (EQUITA) - a randomised feasibility trial of a co-produced and faith-placed intervention to increase uptake of breast, cervical, bowel, and AAA screening in the North East of England, Leeds and Scotland: study protocol Judith Eberhardt, Kathryn A. Robb, Farhin Ahmed, Alex McConnachie, and 10 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-8316847/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 7 You are reading this latest preprint version Abstract Background: Breast, bowel, cervical, and abdominal aortic aneurysm (AAA) screening save lives, yet significant inequities in uptake persist among ethnic minority groups, particularly within Black communities. Lower screening rates increase the risk of late diagnosis and mortality. Culturally tailored, community-centred, and participatory approaches show promise in addressing these inequities. This 24-month study aims to assess the feasibility and acceptability of a co-produced, faith-placed intervention to increase uptake of these four screening programmes among Black communities. Methods: Building on earlier work co-producing a faith-based intervention with Muslim women and adapting it for prostate cancer awareness among Black men, this study will co-design and tailor a peer-led, church-based workshop in partnership with Black communities. The intervention will incorporate education from a Black GP, video testimonials, survivor and community perspectives, discussions on navigating healthcare, religious leader input, and a social component with food and music. Guided by the Integrated Screening Action Model, a mixed-methods, multicentre, two-arm randomised feasibility trial will be conducted. Three hundred Black participants (women aged 25–74; men aged 50–74), not fully up to date with eligible NHS screening programmes, will be recruited from churches in Scotland, North East of England, and Leeds. Churches will be randomised to intervention or control arms. A process evaluation will explore feasibility and acceptability through six focus groups with up to 8 participants, one online focus group with Public Involvement Community Engagement (PICE) members and peer facilitators (n=12) and interviews with key stakeholders (n=10). A preliminary health economic evaluation will also be conducted. Trial parameters will be assessed using pre-specified progression criteria and a traffic-light system (STOP-AMEND-GO) to inform a future definitive trial. Preliminary indications of effectiveness will be captured through changes in knowledge, screening intentions (baseline and three-month follow-up), and NHS screening attendance (six-month follow-up). Discussion: This study addresses critical health inequities through the development and feasibility testing of a peer-led, culturally appropriate intervention tailored to Black communities in the UK. A rigorous process evaluation and strong community engagement will inform future scalability and effectiveness testing. A knowledge-mobilisation plan will support dissemination, and further funding will be sought if progression criteria are met. Trial registration: ClinicalTrials.gov Identifier: NCT06981182. https://clinicaltrials.gov/study/NCT06981182?term=NCT06981182&rank=1 health screening black communities health inequalities co-production faith-based intervention feasibility trial cancer screening abdominal aortic aneurysm Figures Figure 1 Background Population screening in the UK can reduce morbidity and mortality from cancer and Abdominal Aortic Aneurysm (AAA) (1). The UK offers four population screening programmes for asymptomatic adults (breast, cervical, and bowel cancer; AAA), and screening targeting specific groups (diabetic eye screening, pregnancy and newborn, lung health checks). The success of screening programmes largely depends on uptake among the invited populations. However, stark inequities in the uptake exist for people from ethnic minority groups and across the life-course (2–11). There are more than 2.4 million Black, Black British, Black Caribbean or African people in the UK (12,13). The term ‘Black’ is used throughout for simplicity, while acknowledging the diversity within this population. Black people are the most likely of all ethnic groups to live in the most deprived neighbourhoods, with 20.2% of Black African, 18.2% of Black Caribbean, and 21.6% of people identified as ‘Black Other’ living in the most income-deprived decile of neighbourhoods compared to 8.7% White British and 17.4% Asian people, according to the 2019 English indices of deprivation (14). Screening uptake is significantly lower in more deprived areas (15,16). This trend is particularly alarming within Black communities, whereby lower screening rates contribute to delayed diagnosis and poorer survival outcomes across several cancer types (10,17). Advanced-stage diagnosis may reflect multiple factors, including tumour biology, the existence of co-morbidities, as well as screening uptake and timely medical help-seeking (17). In a large population-based study of 243,825 patients, fewer Black patients (5.1%) were diagnosed with cancer via screening compared to White (8.3%), Asian (10.9%), and Mixed (9.5%) patients, particularly for breast and bowel cancer (17). Screening programmes save lives, improve health, and offer informed choice (1). Early disease detection through population-screening programmes can reduce treatment costs and improve health-related quality of life. Economic evaluations suggest that screening for colorectal, cervical, breast and AAA diseases is cost-effective, yielding gains in quality-adjusted life-years (QALYs) despite some variation across conditions and settings (18–21). Breast, bowel, and cervical cancer screening programmes Breast, bowel, and cervical screening programmes in the UK all show a consistent pattern of inequity. Across these programmes, Black populations have lower incidence but are diagnosed at later stages and experience poorer outcomes than White populations. Breast cancer, which accounts for around 15% of all UK cancer cases, has seen mortality fall by more than a third since the 1970s, in part due to organised screening and awareness campaigns (22) (23). Yet Black women are typically younger at diagnosis, more likely to present with advanced disease, and have worse survival despite lower incidence (10). Breast screening attendance is lowest among Black African and Caribbean women: one study found that only 49% of Black African women attended their first breast screening invitation, compared with 67% of White British women (11). Bowel cancer, the fourth most common cancer in the UK (24), shows a similar pattern. Although the overall incidence among Black populations is lower, Black African and Caribbean women and Caribbean men are more likely to be diagnosed at later stages (25). Since the introduction of the national bowel screening programme, uptake has remained consistently lower among ethnic minority groups, particularly among Black adults (5,7,26). Cervical cancer incidence and mortality have declined markedly since the introduction of screening, yet participation remains inequitable. Attendance is lower among ethnic minority women, and Black women are less likely to be aware of or engaged with cervical screening (4,8,27). This is compounded by lower HPV vaccination rates among Black populations, despite HPV being the main risk factor for cervical cancer (28). Taken together, these findings indicate that Black communities are less likely to benefit from advances in early diagnosis and prevention, despite universal eligibility. Lower participation, delayed diagnosis, and worse outcomes point to enduring structural and cultural barriers within cancer screening systems that disproportionately disadvantage Black people in the UK. Abdominal aortic aneurysm (AAA) screening AAA screening follows a similar pattern to the major national cancer screening programmes. White men are at higher risk of AAA, than Black/Black British and Asian/Asian British men (3). Deprivation is negatively associated with the uptake of AAA screening. An English study reported an uptake of 62.1% in the most deprived Index of Multiple Deprivation (IMD) decile vs. 84.1% in the least deprived decile (15). Ethnicity data are often missing from AAA screening uptake data (15),  but Black people are the most likely of all ethnic groups to live in the most deprived neighbourhoods, suggesting lower uptake of AAA screening among Black men in the UK. A US study (n=6,682) found that Black patients had 27% lower odds of receiving AAA screening within a year of eligibility compared to White patients (29). Despite lower prevalence, Black men in both the US and UK experience worse outcomes after AAA repair, including higher rates of complications, renal failure, and reoperation (30,31). Opportunities to increase screening uptake Barriers and facilitators to screening uptake show a complex interplay of individual, social, environmental, and economic factors and can vary depending on specific programmes; however, there are common themes and substantial overlap. For example, racial bias and discrimination have been reported as barriers to accessing healthcare (32,33), with a survey of 2051 Black people finding that 65% experienced discrimination from healthcare professionals (34). The NHS Race and Health Observatory (NHSRHO, 2023) emphasised the urgent need to address unjust racial disparities, particularly experienced in health and healthcare by Black communities. NHSRHO highlights institutional racism and cultural insensitivity as factors discouraging attendance by Black people (35,36). A history of unethical medical experiments, mistreatment, and poor experiences has led to a deep-seated mistrust of society, governments, and healthcare institutions among Black communities (37,38). In a survey with 100 Black women with breast cancer, 96% stated that they do not see women of colour represented enough in the media talking about breast cancer, despite their higher mortality (39). The NHS is said to represent Black people insufficiently in health promotion and health education materials discussing cancer, despite known health inequities (10). Cultural factors, including social stigma, language, health literacy factors (40), and communication with healthcare providers (41), also act as core barriers. Deprivation, a key determinant of health, disproportionately affects ethnic minority groups (39), making screening particularly vital to this group. Additionally, living with long-term illnesses and disabilities can heighten common barriers to screening (e.g., prior negative experiences of health care) and add additional barriers (e.g., treatment burden). Multimorbidity is more prevalent, and occurs at a younger age, among people living in the most disadvantaged communities and from minority ethnic groups, including Black people (42). The health inequities experienced by Black communities are unjust, preventable, and contravene the UK Equality Act 2010. Yet, no specific interventions or policies to tackle these inequities for Black people have been reported in the UK. Review of existing evidence and rationale We conducted a systematic search across five major databases: PubMed, Medline, PsycINFO, Scopus, and Web of Science. Searches were divided among team members by screening type and later collated. The search strategy focused on health screening among Black populations, combining specific and broad terms (see supplementary material). Peer-reviewed, English-language articles published in the past ten years were included. After initial title and abstract screening, relevant data were extracted from full texts. Evidence suggests that interventions tailored to specific communities are significantly more effective than general population-level approaches to increasing screening uptake, particularly when culturally tailored messages are consistent with individuals’ belief systems (43). They also align with international evidence indicating that community engagement interventions, involving ethnic minority groups in the design, development, and delivery of health initiatives, can improve health behaviours (44). However, evidence is limited on the effectiveness and cost-effectiveness of such approaches in the UK (45), despite guidance from the Medical Research Council emphasising the importance of community-supported intervention development (46). The findings highlight the importance of co-producing interventions with Black people, who are underrepresented in targeted public health strategies (41,47). Community-centred health initiatives that empower individuals through participatory methods appear to be essential in improving screening uptake and addressing health inequities (2). Structural disadvantage and discrimination can contribute to feelings of powerlessness, while empowerment processes can support resilience and healthier communities (48,49). Researchers and public health practitioners have consistently highlighted community knowledge as vital for developing effective health solutions (48,49). Involvement in collective activities can strengthen social cohesion, increase individual self-efficacy (50), and improve health literacy (51). However, few UK studies have directly engaged Black communities in faith-based or multi-screening contexts, highlighting a continuing gap in applied research. The underpinning work This study builds on the research team’s extensive experience in developing and evaluating community-centred and participatory approaches to improve screening uptake among underrepresented groups. The EQUITA intervention is directly informed by two studies—IMCAN (Improving Muslim Women’s CANcer Screening Uptake) (52–54) and PROCAN-B (Early diagnosis of PROstate CANcer for Black men (33,55–58), which provide the foundation for adapting this approach to multiple screening programmes targeting Black communities in the UK. The IMCAN and PROCAN-B studies both tested community-centred, faith-based interventions designed through participatory co-production. IMCAN was a non-randomised feasibility trial with Muslim women that developed a peer-led, two-hour workshop including group discussions on screening barriers, GP-delivered health education, survivor video testimonials, and a faith-based perspective delivered by an Alimah (female religious scholar) (52–54). PROCAN-B adapted this model in partnership with Christian Black men to promote prostate cancer awareness and early diagnosis (33,55–58). The peer-led workshop featured similar components (community discussions, education by a Black general practitioner, video testimonials from Black survivors, and faith-based messages from religious leaders) alongside an additional element co-designed with Black women to highlight men’s health-seeking behaviours as part of family wellbeing. Delivered in Glasgow and the North East of England, both interventions were highly acceptable to participants, who reported increased awareness, stronger intentions to engage in health checks, and greater confidence in navigating healthcare services (54,58). The IMCAN and PROCAN-B studies adopted a genuinely participatory approach, embedding community involvement throughout the research process. Part-time Community Recruitment Leads (CRLs), appointed in each region, played a key role in facilitating community engagement and participant recruitment. As active members of the research team, CRLs attended all team meetings, ensuring consistent community representation. Both studies also established dedicated Public Involvement and Community Engagement (PICE) groups who contributed to the co-production of the interventions. In addition, community members were trained as peer facilitators to support culturally appropriate intervention delivery. The EQUITA study uses the same community-centred and participatory approach to apply a whole-community, multi-screening strategy to encourage uptake of breast, bowel, cervical, and AAA screening among Black communities. The intervention will retain the core elements of the participatory approach, including the CRLs on the research team, PICE group for co-production, trained peer facilitators, and faith-based engagement while expanding its scope to multiple screening programmes and a broader population. The structured workshop format, which has demonstrated feasibility and acceptability in previous studies (33,52,59),  will be tailored with Black communities to ensure cultural relevance. Aims and research questions EQUITA’s primary objective is to assess the feasibility and acceptability of a co-produced, faith-placed intervention to increase uptake of breast, cervical, bowel and AAA screening among Black communities in the North East of England, Leeds and Scotland. A further objective is to assess the feasibility of evaluating this intervention in a cluster randomised controlled trial (cRCT) in these settings. Research questions : Can the existing intervention be adapted in partnership with a PICE group to improve engagement with breast, cervical, bowel, and AAA screening programmes in Black communities? Can a two-arm cluster-randomised feasibility trial of the peer-led intervention be delivered in three sites: Leeds, North East and Scotland? What are the perspectives of participants, peer facilitators, and key stakeholders on intervention and trial methodology, acceptability, and intervention implementation? What is the feasibility trial’s performance on key parameters and predefined progression criteria? Is it feasible to conduct an economic evaluation to assess the cost-effectiveness of the intervention, including whether data collection processes meet predefined feasibility and progression criteria? What are effective data dissemination strategies, and how can findings from this feasibility study inform the development of a study protocol and logic model for a future definitive trial? The six research questions correspond to the objectives outlined in Work Packages 1–6, with each work package addressing one primary research question and its related sub-activities. Methods Theoretical framework This research is underpinned by the Integrated Screening Action Model (I-SAM) (60). The I-SAM integrates: 1) the stages of behaviour change of the Precaution Adoption Process Model (61), 2) targets for behaviour change of the Capability, Opportunity, Motivation, and Behaviour (COM-B) model (62), and 3) the interrelationship between individual, social, and environmental factors reflected in the socio-ecological model (60). The I-SAM identifies seven stages of screening behaviour which enable interventions to be tailored to individuals' position in the screening decision-making process: (1) unaware of screening, (2) unengaged, (3) undecided about participation, (4) decided to act, (5) taking up screening, (6) repeat participation, and (7) decided not to act. The I-SAM also highlights the interaction between individual and environmental factors that influence behaviour, such as how screening is offered and people's capability, opportunity, and motivation, as conceptualised by the COM-B model. For behaviour to change, at least one of these components must be addressed. This study recognises that participants will be at different stages of the screening process. Some may be unaware that AAA, breast, cervical, or bowel screening is available through the NHS, while others may be aware but are not currently engaged due to personal or contextual barriers. The intervention will begin by introducing cancer and AAA screening and explaining their benefits, while also addressing factors that may discourage uptake among Black communities. Participants’ stage in the screening process will be assessed at baseline using the I-SAM and again at three-month follow-up to monitor change. Setting The EQUITA study will be conducted in three socioeconomically deprived and under-researched areas: Leeds, the North East of England, and Scotland. In the North East, recruitment will span Newcastle, Durham, Sunderland, North and South Tyneside, and the Middlesbrough area. Including Black populations in regions with lower ethnic diversity is essential to capturing diverse experiences and improving representation in research. The inclusion of both England and Scotland also enables consideration of two distinct healthcare systems, supporting future scalability and implementation. Our previous studies in the North East of England and Scotland provide a foundation for recruitment and intervention delivery. As part of this feasibility assessment, Leeds will be introduced as a third site to evaluate the intervention in a new setting. Findings from this multi-site approach will inform the design and feasibility of a future full-scale trial. Christian church settings will be used, as Black majority churches have been growing in the UK (63). In Black communities, churches serve as a community hub and often hold a position of trust and credibility. This trust can be leveraged to disseminate health information and promote health behaviours (64). The substantial presence of Black Christians within the target regions supports the research approach and recruitment strategy. According to 2021 census data, approximately 41,000 individuals in the North East of England identify as Black, including those of mixed White and Black African/Caribbean heritage (12). Leeds has a similar demographic profile, with around 60,000 individuals identifying in these categories (12). In Glasgow, 2011 census data report approximately 9,000 Christians born in Africa, the Caribbean, or the Americas (65). The decision to specifically engage with Christian groups is informed by the proportionally higher number of individuals who identify as such within Black communities compared to their White counterparts. Data from the 2011 census indicate that out of 1.9 million people identifying as Black/African/Caribbean/Black British across England and Wales, 1.3 million reported being Christian (compared to around 30 million Christians among 48 million people identifying as White) (66). This observation suggests that churches are not only prevalent and influential in these communities but also serve as crucial access points for engagement and communication. The substantial presence of Black Christians in the targeted regions means that churches in these areas offer viable and practical venues for participant recruitment. Design This study is a mixed-methods, two-arm, cluster-randomised feasibility trial using the Integrated Screening Action Model (I-SAM) (60). The study’s primary aim is to examine the feasibility and acceptability of both the intervention and the trial procedures, including the ability to randomise churches and recruit and collect data from participants across intervention and control arms. The study will run for 24 months from March 2025, until February 2027. Feasibility studies are an important step in developing complex interventions (67). A qualitative process evaluation will be included, using focus groups and interviews. A mixed-methods approach will help identify and anticipate problems that might undermine intervention delivery, implementation, or evaluation in a subsequent definitive trial (68). The study will follow the reporting standards of the SPIRIT (Standardised Protocol Items: Recommendations for Intervention Trials) statement (69) and the CONSORT (Consolidated Standards of Reporting Trials statement) extension for feasibility studies (70). The research includes six work packages. Figure 1 displays the SPIRIT (69) schedule with planned time points for participant eligibility screening, informed consent, baseline data collection, allocation, intervention delivery, and follow-up assessments at post-intervention, 3 months, and 6 months. Additional activities include process evaluation and economic evaluation at follow-up. The populated SPIRIT checklist is provided in the supplementary material. Work Package 1 (WP1)—Adaptation of intervention Objective 1 : To adapt the existing intervention in partnership with a PICE group to improve engagement with breast, cervical, bowel, and AAA screening programmes. Through the CRLs, a PICE group of at least twelve men and women from Black communities will be recruited, aiming for at least four individuals from each region. To obtain wide-ranging perspectives, we will use purposive sampling to target participants (aged 25+) and aim for balance and diversity regarding characteristics such as a) age, b) gender, c) ethnic background within Black communities, and d) location. Barriers and facilitators to breast, cervical, bowel, and AAA screening among Black communities will be explored through three online focus groups with PICE members based in the North East of England, Leeds, and Scotland. The online format is appropriate given the geographic spread and has proven effective in previous studies, including IMCAN and PROCAN-B (52,59), for both engagement and data collection. The CRLs will provide technical support where needed to ensure accessibility. Topic guides from earlier research will be adapted to structure discussions. To support inclusive participation, focus groups will be held as mixed-gender sessions, unless feedback from the PICE group suggests modifications are needed for cultural sensitivity and participant comfort. Findings from the initial focus groups will inform an iterative intervention adaptation process through three co-design workshops. These online workshops with the PICE group will use the World Café method (53,71), a participatory approach that fosters collaborative dialogue in a relaxed, inclusive setting. This method supports the exchange of diverse perspectives, encourages creative problem-solving, and has been used effectively in previous studies including the EQUITA pilot, IMCAN, and PROCAN-B. It is particularly valuable for engaging marginalised communities and generating rich, actionable insights (72). Participants will be placed in small online groups to facilitate open, interactive discussion. Each session will begin with a topic or question, followed by brief individual reflection. Participants will then discuss their ideas in small groups, using the existing intervention and its components as a starting point. Groups will be reshuffled for subsequent rounds to encourage new perspectives and deeper exploration of key themes. The session will conclude with a whole-group discussion to share insights. This approach draws on peer learning principles, with a focus on social network influences and empowerment (73). Focus groups and workshops will be audio-recorded and professionally transcribed. Thematic analysis (74) will be used to analyse and map data to the I-SAM, with findings from each session feeding into subsequent focus groups or workshops. A draft intervention strategy will be developed using the Behaviour Change Wheel, drawing on its core components: sources of behaviour (capability, opportunity, and motivation), intervention functions, and policy categories. The content and delivery mode of the intervention will be informed by relevant Behaviour Change Techniques (BCTs) (62) guided by the BCT Ontology to ensure alignment between behavioural domains and techniques (75). The intervention will take the form of a peer-led, multidimensional community workshop. It will incorporate components from the existing IMCAN and PROCAN-B interventions, such as health education on breast, cervical, bowel, and AAA screening delivered by healthcare providers, opportunities for questions, survivor testimonials, community discussions, and input from peer supporters and religious leaders, if endorsed by the PICE group. All components will be delivered in culturally appropriate ways. The initial intervention prototype will be shaped through ongoing discussions with the PICE group. Intervention decisions will be guided by the APEASE criteria (Affordability, Practicability, Effectiveness and cost-effectiveness, Acceptability, Side-effects/safety, and Equity) (62). As part of WP1, peer facilitators will be trained as trusted sources to deliver the intervention. They will be central to both sustainable implementation and building community research capacity (49). Work Package 2—Delivery of the feasibility trial Objective 2: To deliver a two-arm cluster-randomised feasibility trial of the peer-led intervention in three sites: Leeds, the North East of England, and Scotland. Control/comparator group The EQUITA study will invite six churches to participate, with two in each location. Depending on the size of the congregations, this number may be adapted to support participant recruitment. CRLs, who are community members with strong local networks, will support the identification and recruitment of these churches. Cluster randomisation, with the church as the unit of randomisation, will be undertaken. Churches will be randomised in pairs as soon as two eligible churches are confirmed. For each pair, one church will be allocated to the intervention group and one to the control group. Pairing will be based on Index of Multiple Deprivation (IMD) profile where possible, to ensure broadly similar conditions. Randomisation will be performed centrally by the Robertson Centre for Biostatistics, using pre-prepared randomisation codes, with allocation communicated back to the study team. The intervention will be delivered twice in each location. Control churches will continue with regular activities but will receive the intervention after data collection is complete. Study population Participants are eligible if they are members of participating churches, self-identify as Black, and fall within the age range of 25–74 years for women and 50–74 years for men. In addition, participants must not be up to date with all NHS screening tests for which they are eligible. For example, a woman who is up to date with breast screening but not with cervical or bowel screening would still be eligible to participate. Since this study assesses outcomes across four specific screening programmes (breast, cervical, bowel, and AAA screening), the targeted age groups and sexes align with the eligibility criteria for these programmes. Currently, eligibility for bowel screening differs between England (60+) and Scotland (50+); however, as England is in the process of aligning its age criteria with Scotland’s (76), participants aged 56 and above will be included. To ensure recruitment focuses on individuals who would benefit most from the intervention and who may not already have positive attitudes toward screening, the strategy will prioritise those who are not up to date with the screening for which they are eligible, following the approach used in the IMCAN study. Sample and recruitment To obtain wide-ranging perspectives and ensure a diverse sample, purposive sampling will be used to target diverse churches and participants of various age groups as well as different backgrounds. Snowball sampling, through participants and the CRLs’ networks, will also be applied to ensure sample sizes are achieved. This approach has been successfully implemented in both the PROCAN-B and IMCAN studies. Earlier guidance suggested pragmatic sample sizes, typically in the range of 24–50 participants, and audits of UK feasibility trials reported a median of 36 participants per arm (range 10–300) (77). More recent work has highlighted that sample sizes can also be justified in relation to pre-specified progression criteria, offering a more structured approach that may be particularly valuable in informing a future definitive trial (78). Against this background, the study aims to recruit 150 participants per arm, with a target of 100 participants per site (total N = 300; see Table 1). This sample size is designed to generate robust estimates of recruitment and retention rates, as well as the distribution of key outcomes, thereby informing future sample size calculations for a definitive trial (79). The proposed sample is consistent with recruitment targets commonly employed in feasibility studies registered with the United Kingdom Clinical Research Network. Table 1. Sample sizes for the feasibility trial North East of England Leeds Scotland Intervention (n=50) Control (n=50) Intervention (n=50) Control (n=50) Intervention (n=50) Control (n=50) Work Package 3—Qualitative Process Evaluation Objective 3: To explore perspectives of participants, peer facilitators, and key stakeholders on intervention and trial methodology, acceptability, and intervention implementation. Data collection According to MRC guidance, process evaluation is essential in designing and testing complex interventions (46). The qualitative process evaluation will involve focus groups with participants (six groups of approximately eight individuals), conducted face-to-face where possible. Online focus groups will be held with PICE members and peer facilitators (n=12). In addition, semi-structured interviews will be conducted with stakeholders (n=10), either face-to-face or online, depending on participant preference. Stakeholders will include professionals such as public health practitioners, representatives from local councils who play key roles in implementing health policies and programmes at the community level, as well as community leaders from local organisations (80). Focus groups with intervention participants will assess the acceptability of the intervention’s content and delivery, identify barriers and facilitators to implementation, and consider potential adaptations to enhance participant experience and support behaviour change. Participants’ views on factors influencing screening behaviours not directly addressed by the intervention (e.g., barriers related to pre-existing conditions or disabilities) will also be explored. In addition, PICE members, peer facilitators, and stakeholders such as healthcare professionals and religious or community leaders involved in the intervention will be invited to share their perspectives on the implementation process, including elements perceived as effective and areas for improvement. Questions will draw on the Theoretical Framework of Acceptability (TFA) and will explore the perceived appropriateness of the intervention components and delivery processes in real-world settings. This will include reflections on participant recruitment, implementation, and the practical aspects of delivering the intervention (81). Data analysis Interviews and focus groups will be audio-recorded and transcribed. Thematic analysis will examine themes and patterns in people’s perspectives (82). This work package will provide a detailed qualitative analysis of participants’, stakeholders’, and peer facilitators' perspectives regarding what worked and suggestions for modification of the feasibility trial and the intervention. Work Package 4- Examine feasibility of a definitive trial Objective 4 : To examine the feasibility of a definitive trial by assessing the feasibility trial’s performance on key parameters and predefined progression criteria. Primary Research Question: How did the trial perform on key parameters: Participant eligibility/recruitment/retention to follow-up Peer-facilitator recruitment/retention/training Randomisation Completion of secondary outcome measures Data collection tools/processes Potential effect size for full trial Intervention content and delivery (fidelity, modality) Protocol adherence Feasibility and acceptability of the intervention Secondary Research Questions: Did knowledge of and attitudes toward screening programmes change? What proportion of people self-report uptake of screening they are eligible for within 3 months of baseline? What proportion of participants undertake NHS screening within 6 months of baseline? Methods for data collection The primary outcomes will consist of process data, including time, costs, recruitment, training, delivery, and any challenges encountered, which will be logged for implementation insights. STOP-AMEND-GO progression criteria and a traffic light system, following CONSORT recommendations (83), will indicate whether or how to proceed to a definitive trial. Preliminary progression criteria are presented in Table S1 in the supplementary material. Progression to a definitive trial will be determined against a set of pre-specified feasibility criteria spanning recruitment, retention, acceptability, and implementation. At the organisational level, we will assess whether churches can be recruited within the planned timeframe, whether they are willing to accept randomisation, and whether the number and size of churches are sufficient to meet participant targets. At the participant level, feasibility will be judged by the ability to achieve adequate recruitment across all age groups and screening programmes, and by retaining at least 60% of participants at 3-month follow-up. Acceptability of trial procedures will be assessed in relation to consent processes, data collection tools, and the willingness of participants to provide access to NHS screening data. Feasibility of obtaining NHS data across all four screening programmes will also be examined. Finally, the acceptability and feasibility of the intervention itself will be evaluated, including the recruitment, training, and retention of peer facilitators. Findings will be reviewed within context, including qualitative process evaluation data, to make continuation decisions. The presence of amber or red indicators in some categories does not necessarily preclude feasibility. Rather, such outcomes require careful analysis to understand underlying causes and identify strategies to address challenges (84). Final decisions regarding trial progression will be informed by these considerations and reviewed in consultation with the independent Steering Committee. Secondary outcomes The secondary outcomes will consist of measures of screening-related knowledge, attitudinal change, intention, preparedness, likelihood of screening uptake, self-reported screening uptake, and actual NHS screening attendance will capture secondary outcomes. Cancer Awareness Measures (CAM) EQUITA will use adapted scales from Cancer Research UK’s Cervical, Breast, and Bowel Cancer Awareness Measure (CAM) (95). The CAM is a widely used questionnaire developed by Cancer Research UK to assess public awareness of cancer symptoms, risk factors, and barriers to help-seeking. While only the 2008 version was formally validated, the tool has been regularly updated; the 2023 version will be used in this study. The CAM covers knowledge of breast, cervical, and bowel cancer symptoms and risk factors, awareness of NHS screening programmes, and perceived barriers to screening across emotional and practical domains. It also captures attitudinal change, self-reported screening uptake, intention, preparedness, and sociodemographic information. Socioeconomic status will be assessed via education, housing tenure, and postcode, and will be analysed as a predictor of participation, retention, follow-up, and key outcome measures. The CAM includes separate sections for each cancer type, making the full survey lengthy when assessing breast, bowel, and cervical cancer awareness. To improve feasibility and reduce participant burden in the IMCAN study, the survey was streamlined by removing some knowledge-based items that required detailed understanding. Given the overlap in barriers across different screening types, a pragmatic approach was adopted by combining certain items. For example, rather than asking separate questions for each type, participants respond to a general item such as ‘I am too busy for cancer screening’ using a 4-point Likert scale. Where cancer-specific concerns are relevant, such as perceptions of cervical screening as painful or bowel screening as messy, distinct items were retained to reflect these nuances. AAA screening knowledge and awareness For AAA screening, questions assessing knowledge and awareness will be adapted from existing literature (96). These survey items, previously trialled in the UK and informed by other studies, include multiple-choice questions with single-choice responses on AAA definition, risk factors, detection methods, and the screening process. Theoretical framework and behavioural constructs The EQUITA survey was developed using a theory-driven and participatory approach. It is underpinned by I-SAM (60) and, in addition to CAM items, includes constructs from the Precaution Adoption Process Model [PAPM] (97), with separate stage-of-change items for each screening type. Items assess knowledge, intention, behaviour, and psychosocial barriers mapped to I-SAM stages and COM-B constructs. Psychosocial constructs The survey includes additional psychosocial constructs identified as particularly relevant to the study population. One such construct is modesty, included to reflect cultural and faith-based concerns around privacy, gendered interactions, and bodily exposure in healthcare settings. The modesty measure is adapted from previously validated scales, including the Modesty Measure for Muslim Women (98) and Andrews’ (2011) Modesty Scale (99). Items are selected based on face validity for use with Christian Black communities in the UK and focus on themes such as discomfort with physical exposure, preference for same-gender healthcare providers, and conservative dress norms. Responses are rated on a 5-point Likert scale, with higher scores reflecting stronger modesty-related values. Religious health fatalism has been shown to influence engagement with cancer screening among African American Christian populations (100,101) and may also be relevant among Black communities in the UK (102). The study uses an adapted version of the Religious Health Fatalism Questionnaire (RHFQ) (101), which includes three subscales: Divine Provision (e.g., belief that health is in God’s hands), Destined Plan (e.g., illness is part of God's will), and Helpless Inevitability (e.g., belief that one has limited control over health outcomes). The full 17-item scale is retained, with responses rated on a 5-point scale. Including this measure enables exploration of how spiritual beliefs may interact with screening attitudes and behaviours. Sociodemographic and health characteristics The survey collects a range of demographic variables to describe the sample and explore potential associations with screening attitudes and behaviours. Participants are asked about their ethnicity (with detailed response options for Black African, Black Caribbean, mixed backgrounds, and open-text alternatives). Socioeconomic status (SES) is assessed using a self-coded method aligned with the five-class version of the National Statistics Socio-economic Classification (NS-SEC). This includes questions on current or most recent employment status (employee or self-employed), supervisory responsibilities, size of organisation, and type of work. Participants classify their occupation using examples derived from the eight occupational groups outlined in the ONS guidance, which have been adapted for accessibility and cultural relevance. This approach enables categorisation into NS-SEC groups while maintaining participant comprehension and feasibility of administration. Additional items capture main language spoken at home, sex assigned at birth, age, full postcode, and church location (North East, Leeds, or Scotland). These data will enable characterisation of the sample and assessment of potential sociodemographic influences on screening engagement. Living with long-term illnesses or disabilities can heighten and add barriers to screening (42). Alongside other participant characteristics (e.g., sex, age, socioeconomic status), self-reported long-term conditions and disabilities will be captured and examined as potential moderators of intervention reach and effectiveness. To avoid widening inequities, it is important to consider if interventions are equally accessible and effective for people living with long-term conditions and disabilities – if not, this is crucial to reflect on and address in future iterations and ahead of a trial. Therefore, long-term conditions will be assessed using an open-ended self-report item. Participants are asked whether they have ever been diagnosed with any long-term health conditions and are invited to list them in a free-text box. The question prompts participants to report any illnesses or conditions diagnosed by a doctor or healthcare professional, with examples including diabetes, high blood pressure, asthma, cancer, arthritis, or depression. This approach allows for the identification of multimorbidity without constraining responses to predefined categories and supports later coding by condition type and count for quantitative analysis. The approach will also allow for information on the type and number of conditions while adequately capturing both mental and physical health conditions (80). An open-ended question will be included at the end of the survey to allow participants to provide any additional insights, ensuring that their perspectives are fully captured. The feasibility of using these measures will be assessed through data monitoring, identifying determinants of missing data to inform the full trial design. Administration and feasibility of measures Participants will complete secondary measures at baseline, post-workshop, and 3-month follow-up. The survey will be administered via the Qualtrics platform. Participants who prefer a paper-based format will be accommodated. To minimise bias, self-completion will be encouraged; however, based on previous experience, some individuals may require assistance from peer facilitators or CRLs. Providing options for in-person and telephone survey completion is expected to enhance participation rates and reduce missing data. Peer facilitators will receive training to support participants in survey completion where needed. To further promote inclusivity, survey instruments will be translated into participants’ preferred languages to facilitate administration. Peer facilitators and CRLs will assess whether and which translations are required. Translations will be outsourced to professional translators. Screening uptake Self-reported screening uptake will be collected at follow-up to assess participant retention and the feasibility of measuring screening outcomes. In addition, with participants’ consent and the collection of NHS numbers, actual NHS screening attendance, uptake, and any requests for appointments or screening kits will be obtained at the six-month follow-up. These data will provide preliminary estimates to inform the design of a definitive trial, in which actual screening uptake will serve as the primary outcome. To ensure the privacy of participants’ NHS screening data, approvals will be obtained from the relevant NHS screening programmes or hubs before data linkage. The research team will share participants’ NHS numbers, study IDs, dates of birth, names, and addresses with the NHS screening programmes to enable linkage. All data linkage will be conducted exclusively by the NHS, and screening attendance data linked to participant study IDs will be transferred directly from the screening programmes to the Robertson Centre for Biostatistics at the University of Glasgow. Identifiable information will not be accessed or handled by the research team at any stage of the process. Data and statistical analysis Qualitative and quantitative analysis methods will be used as appropriate. Recruitment and retention rates will be reported with 90% confidence intervals, summarised according to baseline characteristics. Differences in retention rates will be assessed using logistic regression methods, sample sizes permitting. Participants’ scores on outcome scales, and changes from baseline to post-intervention and at 3-month follow-up, will be reported using descriptive methods. Paired t-tests, or nonparametric alternatives, will estimate changes over time, with 90% confidence intervals. Correlations between baseline and follow-up measures will be reported with 90% confidence intervals. Feasibility studies with wide confidence intervals can lead to unreliable decisions about larger trials and a 95% confidence level might be too stringent and misrepresent effect sizes. Using a lower confidence level offers a more balanced approach by providing narrower intervals while maintaining sufficient precision (103). Data will be presented descriptively, and changes within groups from baseline to post-intervention and follow-up will be analysed. Mixed-effects regression models will be employed to examine outcome distributions and temporal patterns, adjusting for baseline values and random cluster effects, and to generate preliminary intervention effect estimates with confidence intervals. These estimates will be used to inform sample size considerations for a future definitive trial; however, greater emphasis will be placed on clinically important effect sizes to support robust planning, given that initial estimates may be imprecise. We will estimate intraclass correlation coefficients (ICCs) at different levels for all measures, in line with CONSORT guidelines for cluster-randomised trials. However, we are aware that there may be considerable uncertainty in these estimates. Non-response to follow-up will also be assessed, and its likely impact on all estimated parameters considered. The qualitative analysis has been described in WP3. Work-package 5—Health economic evaluation Objective 5: To evaluate the feasibility of a future health economic evaluation of the intervention, generating evidence to inform a full trial. The feasibility of using resource use logs to identify and capture the cost of delivering the intervention will be tested by refining and adapting the data collection instruments developed in the IMCAN study to the EQUITA population and intervention. We will capture the full range of resources involved in the delivery of the intervention (e.g., cost of venue, time and opportunity cost of peer educators, transport costs, and opportunity cost of travel for participants and staff). Suitable reference costs will also be identified (104). A rapid, non- systematic scoping review will identify suitable frameworks to project the effect of increased screening uptake on lifetime costs and outcomes (105). A pre-trial economic model (i.e., a probabilistic decision analytic model) will be developed to evaluate the potential cost-effectiveness of the EQUITA intervention compared to the control, thus informing the economic evaluation of a future, full-scale trial. Either separate disease-specific models or a single integrated model will be developed for breast, bowel, cervical, and AAA screening to capture the impact of increased screening uptake generated by the intervention on cost savings and improvements in survival rates and QALYs over the long term. The models will be populated using the evidence generated in the EQUITA feasibility study (i.e., rates of screening uptake) and secondary literature parameters. The NHS personal social service perspective will be used in the base-case analysis; in line with NICE updated guidance, the use of a broader societal perspective will also be explored (106). An expected value of perfect information (EVPI) analysis will also be carried out to explore the value of removing all decision uncertainty in the cost-effectiveness results, thus informing whether conducting a full-scale trial of the intervention versus control is worthwhile (107). If UK–based estimates are not available, we will use estimates from systematic reviews or meta-analyses (108,109). If estimates of cancer or AAA incidence are not available for the EQUITA target population, average population statistics will be used, and sensitivity analyses will test the sensitivity of results to changes in the incidence parameter. The model assumptions, including the identification of plausible scenarios for sensitivity analyses, will be discussed with the clinical team. Work package 6- Data dissemination and development of the next phase Objective 6: To develop effective knowledge mobilisation and dissemination strategies and prepare the next phase by designing a study protocol for a definitive trial and logic model for implementation, if this feasibility trial finds this is warranted. Dissemination, outputs, and anticipated impact The EQUITA project aims to tackle inequities in breast, cervical, bowel, and AAA screening outcomes by working in partnership with the community to co-design and deliver a culturally tailored intervention. In the short term, we aim to increase knowledge and awareness of breast, cervical, bowel, and AAA screening among members of Black communities taking part in this study, offering them informed choice, encouraging uptake of screening, and improving help-seeking behaviours. Leveraging this approach may also lead to indirect benefits when our participants raise awareness among other members in their social environment by telling them about the intervention. In the long term, we plan to conduct a randomised controlled trial (RCT) to assess the effectiveness and cost-effectiveness of the intervention if EQUITA findings indicate this is feasible. Establishing feasibility is a vital first step to informing a definitive trial. Testing the intervention in a subsequent trial has scope for national and international implementation, which will ensure that as many Black people as possible, in the UK and beyond, benefit from the intervention and ultimately increase early diagnosis and breast, cervical, bowel cancer and AAA survival rates. Dissemination during the study To maximise study impact, for objective 6, engagement with the PICE group, peer facilitators, participants, and stakeholders provides an essential route to dissemination and support for ongoing mobilisation, and implementation of the research findings with Black communities, service providers, policymakers, and the general public. Continuous engagement with these stakeholders throughout the research process will ensure that emerging findings and research outputs will be fed back to study participants in a timely manner and accessible format. Community involvement has been integral to the development of this study. During the planning phase, members of the community contributed through PPI meetings, with a PPI co-applicant actively participating in protocol development discussions. Throughout the study, community members will be engaged at each study site and involved across all work packages to ensure meaningful participation and alignment with community needs. The research team, including CRLs and with input from the Steering Committee and PICE group, will develop a knowledge mobilisation (KM) plan throughout the project using the KM toolkit (2023) (110). Strategies include disseminating findings through peer facilitators, community organisations and events, partner organisations (councils and NHS entities), a project website, media, academic journals and conferences. The peer facilitators will also play a key role in mobilising emerging findings with their organisations/sites by acting as local champions. Additionally, they will be central to developing accessible outputs as part of the guidance documents and dissemination activity. Dissemination events will be held in each study location to share findings with participants, PICE members, local community groups, local authorities, service providers, academics, and policymakers. Informed by insights from the PROCAN-B study, which highlighted the importance of community events in effectively engaging Black communities, dissemination will be embedded within existing community gatherings where possible. These events will include concise and accessible presentations, supported by visual materials such as banners and the aforementioned infographic, to ensure clarity and inclusivity. This community-centred dissemination strategy aims to build trust, support informed decision-making, and promote screening uptake. A project website has been established to support recruitment and dissemination throughout the study and for one year following its completion (www.beacon4health.com/EQUITA). Website engagement metrics will be monitored to assess reach and impact. Dissemination and implementation after study completion A report summarising the study findings will be produced, including plain English summaries for participants, developed in collaboration with the PICE group. Building on our approach in the IMCAN and PROCAN-B studies, we will also develop manuals detailing the intervention delivery and peer facilitator training for the EQUITA study. These manuals will serve as toolkits and will be disseminated to researchers, service providers, and community organisations, as well as made available on the project website. To maximise public and stakeholder engagement, we will coordinate regular press releases and collaborate with institutional communication teams to engage with local media. This will ensure that the study and its progress are communicated effectively to the public, service providers, and policymakers. The study findings will also be disseminated through publications in international peer-reviewed journals and presentations at relevant national and international conferences. Establishing links with policymakers within the Department of Health and Social Care and the Home Office will be essential to ensuring that the study findings are disseminated at the highest governmental levels. Engagement with Select Committees will help establish connections and lay the groundwork for integrating findings from the feasibility study and future trial into policy discussions. Our well-connected co-investigators and collaborators will play a key role in facilitating the dissemination of EQUITA's findings to policymakers and national commissioning bodies. Additionally, NIHR evidence-sharing mechanisms, including press releases and targeted publicity, will enhance dissemination efforts and promote the adoption of findings into practice. Project management This section outlines the study’s overall governance, management structure, and oversight arrangements. Day-to-day management of EQUITA will be jointly led by FC and JE. Weekly meetings will be held with research staff, while monthly online meetings will convene the wider research team to review progress and address challenges. The full project team, including Steering Committee Collaborators (SCC), will meet biannually, with one meeting held online and one in person, to ensure the SSC’s expertise informs all project stages. The PICE group will meet six times annually. All meetings will be minuted, and project management tools will be employed to track progress and ensure the timely delivery of project milestones. Any protocol amendments will be reviewed and approved by the sponsor and Research Ethics Committee before implementation, with updates communicated to the SSC, funder, and trial registry, and to participants if changes may affect their involvement. Research governance and ethics approval Ethical approval was obtained from the Research Ethics Committee of the University of Sunderland in July 2025 (# 032100). In August 2025, we received confirmation that NHS Research Ethics Committee approval is not required in England, and we have applied for approval in Scotland. Permission to access NHS screening data at 6-month follow-up will be sought in England from the NHS England Research and Innovation Development Advisory Committee (RIDAC) and in Scotland from the Glasgow & Greater Clyde and Lothian Health Boards’ Caldicott Guardian. We will comply with the UK Research Integrity Office Code of practice for research throughout the project. Non-coercive recruitment methods will be used, including advertisement through community organisations’ platforms. Gatekeepers may explain the EQUITA study but will not actively recruit. Written informed consent will be obtained, emphasising voluntary participation and data sharing. Participants will receive gift vouchers in recognition of their time. To ensure fairness, the control group will be offered the intervention after completion of the 3-month follow-up. Data management Data will be stored electronically using secure institutional networks, servers, and storage systems. Contact details and signed informed consent forms will be encrypted and stored separately and destroyed when the project is completed. Audio recordings will be removed from the digital recording device, stored on the institutional secure local network, and destroyed when the project is completed. Access to the full dataset will be restricted to the research team. However, to promote open research, we will deposit anonymised data from interviews, focus groups, workshops, feasibility assessments, and health economic analyses from all work packages in the University of Sunderland’s data repository SURE. We will place an 18-month embargo after study completion to complete primary analyses and reporting. Thereafter, de-identified data will be available on reasonable request to the chief investigator, subject to a prespecified protocol, evidence of research ethics approval, and a data-sharing agreement. Topic guides and survey instruments, alongside the anonymised datasets, will also be made available via SURE for at least ten years after publication of the main findings. All data will be treated and stored in accordance with the 2018 Data Protection Act (109). Personal identifying information (name, address, date of birth, and NHS number) will be collected only where required for participant contact and NHS data linkage. This identifiable information will be stored securely and separately from the main study dataset, accessible only to authorised members of the research team responsible for follow-up and data linkage. Study data will be pseudonymised through the use of unique study IDs before being shared with the Robertson Centre for Biostatistics (RCB) for analysis. RCB will not have access to any personal identifiers. Demographic data (age, sex, employment, marital status, ethnicity, and cancer screening status) will be collected for study purposes. Although ethnicity data are classified as sensitive personal data, all outputs and analyses will use pseudonymised or aggregated data to ensure that individuals cannot be identified. Identifiable information used for linkage and contact will be deleted once data linkage has been completed and verified. Only pseudonymised datasets will be retained for analysis and archiving in accordance with sponsor and funder requirements. Discussion This feasibility trial presents several operational and practical considerations. First, recruiting Black communities from churches across three geographically and administratively distinct regions (Scotland, the North East of England, and Leeds) may pose logistical challenges, including variability in engagement levels, church leadership structures, and local healthcare service delivery. To address this, the study includes CRLs in each site and maintains regular communication with local stakeholders to support consistent delivery and engagement. Second, the use of cluster randomisation at the church level introduces complexity in trial design and necessitates careful planning to minimise contamination between sites. While the intervention will be delivered within church settings, outcome data will be collected exclusively from individuals who meet eligibility criteria. This approach aims to maintain methodological rigour while leveraging the social support and engagement potential of community-based delivery. Its feasibility and acceptability will be explored through the process evaluation to inform future implementation. Third, maintaining participant engagement over a 3-month follow-up period may be challenging, particularly in underserved populations with complex life demands. The use of culturally tailored content and peer facilitators from within the community is designed to foster trust and sustain interest. Finally, external factors such as budgetary constraints or shifts in government policy may influence the implementation of recommendations following the study. Changes in national screening guidelines during the project period could also impact participant eligibility or screening pathways. To mitigate these risks, the research team will maintain ongoing engagement with policy stakeholders, ensuring findings remain relevant and responsive to the evolving healthcare context. Conclusion This study will assess the feasibility and acceptability of a church-based, co-produced intervention to increase screening uptake in Black communities. The findings will inform the design and delivery of a future definitive trial, including considerations around recruitment, data collection, intervention fidelity, and policy alignment. Ongoing engagement with stakeholders will be critical to ensure that the intervention remains responsive to changes in the policy landscape and community needs. Declarations Ethics approval and consent to participate Ethical approval was obtained from the University of Sunderland Research Ethics Committee in July 2025 (reference number 032100). In August 2025, we received confirmation that NHS Research Ethics Committee approval is not required in England, and an application is under review in Scotland. Permission to access NHS screening data at 6-month follow-up has been sought from NHS England’s Research and Innovation Development Advisory Committee (RIDAC) and the relevant Caldicott Guardians in Scotland. Written informed consent will be obtained from all participants prior to enrolment. Consent for publication Not applicable. No data are reported in this manuscript. Availability of data and materials Not applicable at this stage. Data generated during the feasibility trial will be deposited in the University of Sunderland’s SURE Research Data Repository once the study is complete, in accordance with funder and institutional data-sharing policies. Pseudonymised datasets will be made available for reuse under an appropriate data-sharing agreement. Competing interests The authors declare that they have no competing interests. Funding This study is funded by the National Institute for Health and Care Research (NIHR) Public Health Research Programme (NIHR164073). The views expressed are those of the authors and not necessarily those of the NIHR or the Department of Health and Social Care. Authors’ contributions FCdJ is the Chief Investigator and developed the original conceptual idea for the study. FCdJ secured the funding together with the Joint Lead (JE) and the Co-Investigators (KR, MM, AMcC, AM, EM, IK, KW, LN, MA, PvdG, LA, MD). FA is the Post-doctoral Research Associate, and DH, MN, and IK are employed by the project as Community Recruitment Leads. JE drafted the protocol manuscript and coordinated revisions based on feedback from the project team. All authors contributed to the manuscript and approved the final version. 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