Official Title
COVER-ME: Covid-19 Vaccination Coverage Among Underserved Populations: Developing and Evaluating Community-based Interventions in East London Minority Ethnicity (ME) Populations; Underserved Migrants and Persons With Low Income.
Brief Summary

This is a randomised controlled pilot study evaluating and assessing the feasibility of aco-designed PET. The PET was co-designed in the qualitative work packages with members ofthe community as well as healthcare professionals (Ethical approval: REF QMERC22.266)that precedes this pilot trial.Eligible patients from six GP practises from Tower Hamlets and Newham will be randomisedto the intervention or control during the study.

Detailed Description

It is imperative that local residents' views are heard, particularly in underserved
communities, when trying to address poor vaccine uptake. We are interested to elicit a
wide range of views, and channel these to co-design a feasible and acceptable
intervention with community groups.

This intervention will be evaluated in this randomised pilot study to assess feasibility,
practicality and acceptability. This will be in preparation of a fully powered randomised
controlled trial to evaluate the efficacy afterwards.

Eligible patients at all n=6 practices will be enrolled into the study at two time points
(see below). Patients will be individually randomised 1:1 to receive the PET or routine
care. We will use the Appt-Health workflow tool for both groups, although patients in the
control group will be monitored but will not receive additional interventions than
routine care. The comparison between those randomised to the intervention or control
group is envisaged to be the primary comparison in a subsequent trial to evaluate
efficacy (vaccination uptake). Individual randomisation will be stratified by GP, using a
random block allocation list implemented into the software used for the study.

Participating centres All practices will be selected based on list size (larger practices
with >10,000 patients), technological and practice infrastructure and procedures (to
ensure smooth operability of the PET), demography of the practice population (to ensure
good representation of underserved population groups) and capability and capacity
(decided by the practice and network leads).

Randomisation The practices will be randomised by the study statistician. Individuals
will be randomised, stratified by centre, using randomised block randomisation list
allocations in the practice software. This will be done on the same day or shortly after
the eligible list is determined. The randomised allocation will be visible to staff, but
we will use the feasibility study to explore ways of blinding staff and patients for the
definitive study.

Data collection and Analysis Eligible patients will be identified through the practice IT
system (EMISWeb). We will provide some initial support and training to enable practices
to complete missing ethnicity data. However, patients with unknown ethnicity resident in
areas with index of multiple deprivation greater than the bottom quintile would not be
included. The database associated with the software will record randomisation group, and
record of the intervention to each participant, as well as engagement with different
aspects of the tool (see secondary outcomes).

For analysis, we will extract pseudo-anonymised data and storage in the CASTOR database
and analyse this on a secure research database and environment within the Barts Cancer
Centre network at QMUL. Ethics and information governance approval will be sought for
this.

Withdrawn
COVID-19
Influenza
Vaccination Refusal

Device: Patient Engagement tool

The study intervention (PET) aims to increase uptake of vaccines that are already
recommended through national guidance.The PET will help educate and inform individuals
about the benefits of COVID-19 and Flu vaccinations through culturally adapted
educational support, including content, design, mode and timing of delivery of messages
(text, video or voice messages).

Eligibility Criteria

Inclusion Criteria:

- • Patient registered at study site (included GP surgery)

- Adult (aged 18y+) at time of randomisation

- Eligible for COVID-19 and/or Flu vaccination (ie. Not received either a first,
second or booster vaccination)

AND

From an underserved population group, defined

1. non-white ethnicity OR

2. resident in a postcode in the bottom 20% of index of multiple deprivation OR

3. Those receiving little or no income

We will determine age, ethnicity, post-code and immunisation status from the patients'
EMIS records.

Exclusion Criteria:

- They are unable or unwilling to consent (including those who do not consent to text
messaging; those who opt out from taking part in research studies.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: N/A
Countries
United Kingdom
Locations

Church Road Health
London, United Kingdom

Not Provided

Social Action for Health
NCT Number
Keywords
Vaccination
MeSH Terms
COVID-19