EQUITA - A Feasibility Trial of a Faith-placed Intervention to Increase Screening Uptake in Black Adults
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age25-74
SponsorUniversity of Sunderland
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Members of participating churches (North East of England, Leeds, Scotland)
Self-identify as Black,
Female aged 25-74,
Male aged 50-74,
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Faith-placed intervention to promote breast, cervical, bowel, and AAA screening uptake in Black communities.
Other interventionThe intervention includes a two-hour workshop, delivered in person to the entire congregation, that aims to promote the uptake of breast, cervical, bowel, and AAA screening among Black communities in the North East of England, Leeds and Scotland. However, we will only include effectiveness data (i.e., surveys and screening uptake) from those who meet the study eligibility criteria. The intervention will be a peer-led, multidimensional community workshop. It will incorporate multiple components that tackle barriers to screening and that are present in the existing IMCAN and PROCAN-B interventions, if the PICE group believe these are helpful, such as health education about breast, cervical, bowel and AAA screening delivered by a healthcare provider with an opportunity to ask questions, personal testimonials through survivors' stories, as well as members of the community discussing experiences of screening, and utilising community and peer support and religious leaders.
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: In-person WorkshopExperimental treatment 1 intervention
Group B: No workshopNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Narrative description of feasibility
Using a mixed-methods approach and summarised as a narrative synthesis according to the progression criteria described below (Measures 1 - 11). Key feasibility domains include: time required for study setup and delivery; recruitment and retention of churches and participants; training and retention of peer facilitators; intervention delivery and adherence; data completeness and quality; and acceptability of procedures. Data sources will include recruitment and training logs, screening and consent forms, follow-up tracking sheets, and participant feedback surveys. Challenges and facilitators encountered will be documented in field notes by the study team. Quantitative data will be summarised descriptively (counts, percentages), and qualitative data will be thematically analysed. Findings will be assessed against pre-specified progression criteria to inform the viability of a future definitive trial.
Time frame
Month 1 - 242
(1) Number of churches recruited into the study
The number of churches recruited will be recorded using a site recruitment log maintained by the study team. This log will record church name, date of agreement to participate, and contact details of church representatives. Descriptive statistics (e.g., counts and percentages) will be used to summarise the data.
Time frame
Month 3 - 73
(2) Number of churches that consent to randomisation will be documented
A log will document the number of churches that agree to be randomised, including consent status and allocation group.
Time frame
Month 3 - 74
(3) Number of participants recruited
Participant screening and enrolment at baseline will be tracked in a participant recruitment log that includes date of screening, eligibility status, consent obtained (yes/no), and enrolment status. Numbers will be summarised using counts and percentages to assess recruitment feasibility.
Time frame
Month 3 - 7Secondary outcomes
1
Attitude
Change in attitude of barriers perceived towards screening programmes. This outcome is self-reported by participant
Time frame
Baseline (prior to intervention), Within 2 week post-intervention, 3 months post-intervention, 6 months post-intervention2
Religious Health Fatalism Questionnaire (RHFQ)
A questionnaire will be given to participants to test how religious beliefs influence health beliefs and willingness to obtain screening and medical treatments. RHFQ includes 8 statements that are answered on 5-point Likert scale: 1=strongly disagree, 2=disagree, 3=undecided, 4=agree, 5=strongly agree Total scores range from 8 to 40. Higher scores indicate higher levels of religious fatalism, thus a lower willingness to attend screening due to religious beliefs.
Time frame
Baseline (prior to intervention)3
Modesty
The modesty measure for EQUITA is designed to assess the influence of cultural and religious values related to bodily privacy on cancer screening behaviours. Using two previously validated scales, the Modesty Measure for Muslim Women (MMM-W) by Padela et al. (2019) and Andrews' (2011) Modesty Scale. The measure comprises six items, rated on a 5-point Likert scale from Strongly Disagree (1) to Strongly Agree (5). Higher scores indicate stronger modesty beliefs related to bodily privacy. Scores will be analysed to examine the relationship between modesty and screening intentions or behaviours.
Time frame
Baseline (prior to intervention)4
Socio-demographic Descriptions
Participant characteristics, such as age, location, education level, ethnicity, professional occupation and marital status, will be recorded and used for descriptive statistics ad subgroup analysis.
Time frame
Baseline (prior to intervention)Sponsors and contacts
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University of Sunderland
Lead sponsor
University of Glasgow
Collaborator
Source ClinicalTrials.gov
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