COVID-19 Vaccine Uptake Amongst Underserved Populations in East London

Study Overview
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Brief Summary
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This is a randomised controlled feasibility study to evaluate a patient engagement tool (PET) that has been designed for the target population. The PET will be evaluated from previous qualitative data collected from community this feasibility 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
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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.

Official Title
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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.

Conditions
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COVID-19, Influenza, Vaccination Refusal

Intervention / Treatment
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* Device: Patient Engagement tool


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: • Patient registered at study site (included GP surgery) Adult (aged 18y+) at time of randomisation Eligible for COVID-19 vaccination (ie. Not received either a first, second or booster vaccination) AND From an underserved population group, defined non-white ethnicity OR resident in a postcode in the bottom 20% of index of multiple deprivation OR 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Clustered randomised control trial (as participants will be recruited from 6 GP practices)
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Individuals allocated to this group will be receiving care from their GP as well as the patient engagement tool (intervention). This will include messages being sent to patients in regards to vaccine information and uptake at different time points (three times). | Device: Patient Engagement tool<br>* 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 vaccination through culturally adapted educational support, including content, design, mode and timing of delivery of messages (text, video or voice messages).<br>|
| No Intervention: Control Group<br>The individuals in this group will receive standard care from their GP and nothing additional to this. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Engagement with tool (PET) | To determine the feasibility, acceptability, and implementation of a patient-engagement tool (PET) for increasing uptake of COVID-19 vaccination. | Through study completion, an average of 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vaccine uptake whilst using PET | To determine: vaccination uptake, its variation by population group, and other parameters (surveys will be used not yet decided which ones to use) the feasibility and practicality of implementing the PET. level of support needed for health care providers at site-level to ensure successful implementation of the PET and to identify supporting activities needed to implement interventions for COVID-19 vaccinations. | Through study completion, an average of 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccination