Clinical trial NCT05866237: COVID-19 Vaccine Uptake Amongst Underserved Populations in East London
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.
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: COVID-19
Influenza
Vaccination Refusal
Keywords: Vaccination
Lead sponsor: Queen Mary University of London
Sponsor class: OTHER
Collaborators: name: Social Action for Health
First posted: 2023-05-19
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Clustered randomised control trial (as participants will be recruited from 6 GP practices)
Primary purpose: PREVENTION

Brief summary: This is a randomised controlled pilot study evaluating and assessing the feasibility of a co-designed PET. The PET was co-designed in the qualitative work packages with members of the 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 randomised to 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.

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.

Primary outcomes:
measure: Vaccine uptake through engagement with tool (PET)
timeFrame: Through study completion, an average of 1 year
Secondary outcomes:
measure: Vaccine uptake and feasibility of using PET
timeFrame: Through study completion, an average of 1 year
Other outcomes:
Locations:
city: London
country: United Kingdom
facility: Church Road Health
Study officials:
References: