COVID-19 Vaccine Uptake Amongst Underserved Populations in East London

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

5903 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-11-28

Study Completion Date

2025-04-30

Brief Summary

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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.

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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.

Conditions

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COVID-19 Influenza Vaccination Refusal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Clustered randomised control trial (as participants will be recruited from 6 GP practices)

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Participants

Eligible patients to be randomised 1:1. None of these patients would have received the vaccine prior to entry to the study. These patients who are eligible for the intervention, randomised are to receive one of two workflows on an individual basis (standard of care or the PET).

Study Groups

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Intervention group

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).

Group Type EXPERIMENTAL

Patient Engagement tool

Intervention Type DEVICE

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).

Control Group

The individuals in this group will receive standard care from their GP and nothing additional to this.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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).

Intervention Type DEVICE

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 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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No