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ClinicalTrials.gov ID

NCT06981182

Lead Sponsor

University of SunderlandOTHER

Overall Status

Not yet recruiting

Study Type

Interventional

Phase

Not Applicable

Enrollment

300Estimated

Last Update Posted

May 20, 2025Actual

Start Date

Sep 1, 2025Estimated

Primary Completion Date

Feb 28, 2027Estimated

Completion Date

Feb 28, 2027Estimated

Official Title

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

Brief Summary

The goal of this randomised feasibility trial is to examine feasibility and acceptability of a co-produced and faith-placed intervention to increase uptake of breast, cervical, bowel, and abdominal aortic aneurysm (AAA) screening among Black communities in the North East of England, Leeds and Scotland, United Kingdom (UK).

Participants will be invited to attend a two-hour workshop at each of the three study sites and will be randomly assigned to either the intervention group or the control group.

This 24-month feasibility study will inform the development of a full-scale randomised-controlled trial co-produced for Black people that uses culturally appropriate messages that support screening for early diagnosis in this underserved group.

Detailed Description

Over 2.4 million Black, Black British, Black Caribbean or African people live in the UK Black community, where lower screening rates place them at a higher risk of death due to lack of early diagnosis and provision of effective early treatment. Population health screening is largely under-researched in Black communities in the UK. Few studies have been conducted focusing on Black people and national screening programmes.

The EQUITA study builds on the IMCAN (Improving Muslim Women's CANcer Screening Uptake), and PROCAN-B ((Early diagnosis of PROstate CANcer for Black men) studies by using 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 Community Recruitment Leads on the research team, Public Involvement and Community Engagement (PICE) group for co-production, trained peer-facilitators, and faith-based engagement. The structured workshop format, which has demonstrated feasibility and acceptability in previous studies, will be tailored in collaboration with Black communities to ensure cultural relevance.

The study consists of six objectives with aligned work packages:

1. Can the existing intervention be adapted in partnership with a PICE group to improve engagement with breast, cervical, bowel, and AAA screening programmes in the Black community?
2. Can a two-arm cluster-randomised feasibility trial of the peer-led intervention be delivered in three sites: Leeds, North East of England and Scotland?
3. What are the perspectives of participants, peer facilitators, and key stakeholders on intervention and trial methodology, acceptability, and intervention implementation?
4. What is the feasibility trial's performance on key parameters and predefined progression criteria?
5. Is it feasible to conduct an economic evaluation to assess the cost-effectiveness of the intervention?
6. What are effective data dissemination strategies, and can the next phase be prepared by designing a study protocol for a definitive trial and logic model for implementation?

This feasibility trial will involve delivering a 2-hour workshop to 300 Black people (females aged 25-74 and males 50-74) in churches in Scotland, North East of England, and Leeds, who are either not or partially up to date with the screening they are eligible for. Participants will be randomly allocated to either the intervention or control group at each site. A process evaluation, including focus groups and stakeholder interviews, will guide modifications to the trial and intervention.

• Breast Cancer
• Bowel Cancer
• Cervical Cancer
• Abdominal Aortic Aneurysm

• Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities.

Ages Eligible for Study

Adult (18-64)Older Adult (65+)

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Yes

Eligibility Criteria

Inclusion Criteria:

• Members of participating churches (North East of England, Leeds, Scotland)
• Self-identify as Black,
• Female aged 25-74,
• Male aged 50-74,
• Not up to date with all screening tests for which they are eligible, e.g., women who are up to date with one form of screening (e.g., breast) will be eligible for recruitment if they are not up to date with others (e.g., cervical or bowel).

Exclusion Criteria:

• Not a member of participating churches (North East of England, Leeds, Scotland).
• Individuals who do not self-identify as Black
• Do not self-identity as Black
• Females aged outside the range of 25-74
• Males aged outside the range of 50-74.
• Individuals who are up to date with all screening tests for which they are eligible.

Primary Purpose

Other

Allocation

Randomized

Interventional Model

Parallel Assignment

Masking

None (Open Label)

Lead Sponsor

University of SunderlandOTHER

Collaborators

University of GlasgowOTHER

Farhin.Ahmed@sunderland.ac.uk0191 515 300

Farhin.Ahmed@sunderland.ac.uk0191 515 300