Clinical trial NCT06981182: EQUITA - A Feasibility Trial of a Faith-placed Intervention to Increase Screening Uptake in Black Adults
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
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Breast Cancer
Bowel Cancer
Cervical Cancer
Abdominal Aortic Aneurysm
Keywords: Cancer screening
Breast Cancer
Bowel Cancer
Cervical Cancer
Abdominal Aortic Aneurysm
Faith-placed intervention
Black adults
Randomised Controlled Trial
Feasibility study
Faith-based
Lead sponsor: University of Sunderland
Sponsor class: OTHER
Collaborators: name: University of Glasgow
First posted: 2025-05-20
Enrollment: 300
Sex: ALL
Minimum age (years): 25
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Waitlist control
Primary purpose: OTHER

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.

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 outcomes:
measure: Narrative description of feasibility
timeFrame: Month 1 - 24
measure: (1) Number of churches recruited into the study
timeFrame: Month 3 - 7
measure: (2) Number of churches that consent to randomisation will be documented
timeFrame: Month 3 - 7
measure: (3) Number of participants recruited
timeFrame: Month 3 - 7
measure: (4) Distribution of recruited participants across age groups and screening programmes
timeFrame: Month 7 - 13
measure: (5) Proportion of participants retained at 3-month follow up
timeFrame: Month 10 - 15
measure: (6) Acceptability of the informed consent procedures to participants
timeFrame: Month 10 - 18
measure: (7) Suitability of data collection tools
timeFrame: Month 10 - 21
measure: (8) Proportion of participants providing consent to provide access to NHS screening data
timeFrame: Month 13 - 19
measure: (9) Feasibility of accessibility of NHS screening data
timeFrame: Month 13 - 19
measure: (10) Number of participants who become peer facilitators and time taken to train them
timeFrame: Month 4 - 13
measure: (11) Acceptability of the intervention to participants
timeFrame: Month 10 - 18
Secondary outcomes:
measure: Attitude
timeFrame: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention
measure: Religious Health Fatalism Questionnaire (RHFQ)
timeFrame: Baseline (prior to intervention)
measure: Modesty
timeFrame: Baseline (prior to intervention)
measure: Socio-demographic Descriptions
timeFrame: Baseline (prior to intervention)
measure: Cancer knowledge questions adapted from Cancer Awareness Measures (CAM) by Cancer Research UK
timeFrame: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention
measure: AAA Knowledge Screening
timeFrame: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention
measure: Self-reported screening uptake
timeFrame: Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention
measure: Actual screening uptake
timeFrame: 6 months post- intervention
measure: Quality of life measure
timeFrame: Baseline (prior to intervention)
measure: Multimorbidity measure
timeFrame: Baseline (prior to intervention)
Other outcomes:
Locations:
city: Glasgow
country: United Kingdom
facility: University of Glasgow
state: Scotland
city: Leeds
country: United Kingdom
facility: Leeds Beckett University
city: Sunderland
country: United Kingdom
facility: University of Sunderland
Study officials:
References: