COVID-19 Vaccine Uptake Amongst Underserved Populations in East London

NCT05866237 | Completed

• 1 other identifier: 151164
• Study Type: interventional
• Target: 5,903
• Locations: 1 country
• Sites: 5

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.

Conditions

COVID-19; Influenza; Vaccination Refusal

Keywords

Vaccination

Outcome Measures

Primary Outcomes (1)

• The primary outcome is vaccination uptake in patients individually randomised.

  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).

  Through study completion, until 6 months follow-up (>180 days since randomisation).

Secondary Outcomes (3)

• Acceptability of the intervention

  at 6 months

• Feasibility of the intervention and randomisation

  6 months

• Feasibility of the study design for a subsequent trial

  6 months

Other Outcomes (2)

• Vaccination uptake in patients after 3- and 9-months follow-up (>90 and >270 days). This will be measured as the number (percent) of relevant SNOMED codes in eligible patients identified during the period.

  Through study completion, after 3- and 9-months follow-up (>90 and >270 days)

• Mean vaccination rate after 3-, 6- and 9-months follow-up.

  After 3-, 6- and 9-months follow-up

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control Group

NO INTERVENTION

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

Interventions

Patient Engagement tool 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).

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Queen Mary University of London: lead
• Social Action for Health: collaborator

Study Sites (5)

Church Road Health

London, E12 6AQ, United Kingdom

Location

Glen Road Surgery

London, United Kingdom

Location

St Andrews Health Centre/ St Pauls Way Health Centre

London, United Kingdom

Location

St Stephen's Health Centre

London, United Kingdom

Location

Stratford Village Health Centre

London, United Kingdom

Location

Related Publications (1)

• Chaudhry T, Tum P, Tam HZ, Brentnall A, Smethurst H, Kielmann K, Kunst H, Hargreaves S, Campbell CNJ, Griffiths C, Zenner D. COVER-ME: developing and evaluating community-based interventions to promote vaccine uptake for COVID-19 and influenza in East London minority ethnicity (ME) and underserved individuals - protocol for a pilot randomised controlled trial. BMJ Open. 2025 Mar 18;15(3):e092568. doi: 10.1136/bmjopen-2024-092568.

  PMID: 40107676 DERIVED

MeSH Terms

Conditions

COVID-19; Influenza, Human; Vaccination Refusal

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Orthomyxoviridae Infections; Treatment Refusal; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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).
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: May 5, 2023
• First Posted: May 19, 2023
• Study Start: November 28, 2023
• Primary Completion: June 8, 2024
• Study Completion: April 30, 2025
• Last Updated: September 18, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (5)