COVID-19 Vaccine Uptake Amongst Underserved Populations in East London

Not Applicable

Completed

• Conditions: Vaccination Refusal; Influenza; COVID-19

• Registration Number: NCT05866237
• Lead Sponsor: Queen Mary University of London

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2023-05-05
• Study First Submitted QC: 2023-05-17
• Study First Posted: 2023-05-19
• Study Start: 2023-11-28
• Primary Completion: 2024-06-08
• Study Completion: 2025-04-30
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-11
• Last Update Posted: 2025-09-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5903

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The primary outcome is vaccination uptake in patients individually randomised.	Through study completion, until 6 months follow-up (>180 days since randomisation).	This will be measured as the number (percent) of relevant SNOMED codes in eligible patients. Uptake will be measured from the time that the eligible group in each practice is identified (and randomised) until 6 months follow-up (\>180 days since randomisation).

Secondary Outcome Measures

Name	Time	Method
Acceptability of the intervention	at 6 months	a. To patients: Proportion of patients randomised to the intervention who engage with the PET and / or linked patient resources, as determined by user statistics logged on the software for i. The SMS messaging tool (number of SMS sent) ii. Number (percent) of patients who view the linked patient awareness resources iii. Usage of the patient work list tool b. To staff: Number and proportion of eligible patients randomised to the intervention processed using the patient work list tool
Feasibility of the intervention and randomisation	6 months	1. Number and proportion of eligible patients randomised; 2. Clinical capacity: number of slots available for vaccination bookings for each GP surgery and each day, by appointment time
Feasibility of the study design for a subsequent trial	6 months	1. Number and proportion of patients with all inclusion / exclusion data available on the electronic health records; 2. Number and proportion of patients eligible for the intervention; 3. Number and proportion of patients randomised who are sent material from the intervention (letter / sms); 4. Number and proportion of patients eligible by vaccination status (none, first, second, with booster or without booster); 5. Number and proportion of patients who opt out for their data to be used or withdraw from the study; 6. Number and proportion of patients who consent for further questionnaires; 7. Number and proportion of patients who are booked for a vaccination appointment; 8. Number and proportion of patients who are categorised a "failed encounter" (not booked, no more action taken)

Trial Locations

Locations (5)

Glen Road Surgery; 🇬🇧 London, United Kingdom

St Andrews Health Centre/ St Pauls Way Health Centre; 🇬🇧 London, United Kingdom

St Stephen's Health Centre; 🇬🇧 London, United Kingdom

Stratford Village Health Centre; 🇬🇧 London, United Kingdom

Church Road Health; 🇬🇧 London, United Kingdom