COVID-19COVER-MENCT05866237
COVID-19 Vaccine Uptake Amongst Underserved Populations in East London
A study testing Patient Engagement tool in people with COVID-19 and Influenza, run by Queen Mary University of London at 5 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19, Influenza, Vaccination Refusal
- What is being tested?
- Patient Engagement tool
- Type of treatment
- Vaccines, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5,903 participants
- Where
- 5 sitesUnited Kingdom
- Study dates
- 28 Nov 2023to 30 Apr 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- • 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
Show all 9Show fewer
- 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.
Who cannot join
- 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.
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United Kingdom5 sites
Church Road Health
London, E12 6AQ
Glen Road Surgery
London
St Andrews Health Centre/ St Pauls Way Health Centre
London
St Stephen's Health Centre
London
Stratford Village Health Centre
London
About this study
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.
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.
Read the 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.
- Conditions
- COVID-19, Influenza, Vaccination Refusal
- Being tested
- Patient Engagement tool
- Keywords
- Vaccination
- Medical subject headings
- COVID-19, Influenza, Human, Vaccination Refusal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Engagement toolDevice
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).
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: Through study completion, until 6 months follow-up (>180 days since randomisation).
Secondary outcomes (3)
Acceptability of the intervention
- 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
Measured: at 6 months
Feasibility of the intervention and randomisation
- Number and proportion of eligible patients randomised
- Clinical capacity: number of slots available for vaccination bookings for each GP surgery and each day, by appointment time
Measured: 6 months
Feasibility of the study design for a subsequent trial
- Number and proportion of patients with all inclusion / exclusion data available on the electronic health records
- Number and proportion of patients eligible for the intervention
- Number and proportion of patients randomised who are sent material from the intervention (letter / sms)
- Number and proportion of patients eligible by vaccination status (none, first, second, with booster or without booster)
- Number and proportion of patients who opt out for their data to be used or withdraw from the study
- Number and proportion of patients who consent for further questionnaires
- Number and proportion of patients who are booked for a vaccination appointment
- Number and proportion of patients who are categorised a "failed encounter" (not booked, no more action taken)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2023
- Study start28 Nov 2023
- Primary completion8 Jun 2024
- Study completion30 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- More trials run by Queen Mary University of LondonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Clustered randomised control trial (as participants will be recruited from 6 GP practices)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 5,903 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Collaborators
- Social Action for Health
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05866237
- Sponsor's protocol ID
- 151164
- Acronym
- COVER-ME
- Status last verified
- Sep 2025
- First submitted
- 5 May 2023
- Last updated
- 18 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data collected will anonymised and only available to people who are from the internal research team, and external collaborators mentioned. Anonymised data may be shared later on during dissemination through publications and conferences.
Publications
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.
PubMed 40107676
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT05866237
- Acronym / sponsor ID
- COVER-ME / 151164
- Conditions
- COVID-19, Influenza, Vaccination Refusal
- Keywords
- Vaccination
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5,903 participants (actual)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Collaborators
- Social Action for Health
- Study start
- 28 Nov 2023 (actual)
- Primary completion
- 8 Jun 2024 (actual)
- Study completion
- 30 Apr 2025 (actual)
- First posted
- 19 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Clustered randomised control trial (as participants will be recruited from 6 GP practices)
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Device: Patient Engagement toolIndividuals 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). |
| Control Group | No intervention | –The individuals in this group will receive standard care from their GP and nothing additional to this. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- • Patient registered at study site (included GP surgery)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Engagement toolThe 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). | Device | Intervention group |
Primary outcome
The primary outcome is vaccination uptake in patients individually randomised.
Time frame: 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).
3 secondary outcomes
Acceptability of the intervention
Time frame: at 6 months
Feasibility of the intervention and randomisation
Time frame: 6 months
Feasibility of the study design for a subsequent trial
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2025.
- Derived from this study: PubMed 40107676Chaudhry 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.
- Individual participant dataSharing planned: No. Data collected will anonymised and only available to people who are from the internal research team, and external collaborators mentioned. Anonymised data may be shared later on during dissemination through publications and conferences.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Patient Engagement tool in people with COVID-19 and Influenza, run by Queen Mary University of London at 5 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The primary outcome is vaccination uptake in patients individually randomised. (time frame: Through study completion, until 6 months follow-up (>180 days since randomisation).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05866237, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Sep 2025.