Covid19NCT04895683
Using Text Messages to Improve COVID-19 Vaccination Uptake
A study testing Text message content in people with Covid19, run by Imperial College Healthcare NHS Trust.
Trial summary
COVID-19 vaccinations significantly reduce the risk of getting seriously ill or dying from COVID-19. Since December 2020, the UK has rolled out vaccinations according to the Joint Committee for Vaccinations and Immunity (JCVI) priority groups. Read more about this study
- Who is it for?
- Ages 18 to 49 yearsHealthy volunteers can take part
- Conditions the study is for
- Covid19
- What is being tested?
- Text message content
- Type of treatment
- Vaccines, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120,000 participants
- Where
- No sites listed yet
- Study dates
- 11 May 2021to 11 May 2022
- 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 to 49 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Residents registered with a GP practice in the Central London (Westminster) Clinical Commissioning Group (CCG)
- Age 18-49
- Not previously invited for COVID-19 vaccination
Who cannot join
- Patients who have notified their GP that they wish to decline the COVID-19 vaccination.
- Patients' whose medical records report a severe allergy to medicines (as per the JCVI guidance)
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Can Behavioural-science Informed Text Messages Improve COVID-19 Vaccination Uptake in North West London? A RCT
COVID-19 vaccinations significantly reduce the risk of getting seriously ill or dying from COVID-19. Since December 2020, the UK has rolled out vaccinations according to the Joint Committee for Vaccinations and Immunity (JCVI) priority groups. However, despite data indicating that more than 90% of the UK population intends to get vaccinated, there are geographical and ethnic variations in vaccination acceptance. As younger cohorts with lower risk from COVID-19 become eligible for vaccination, it is expected that uptake rates may also be lower than they have been in previous cohorts.
It was recently announced that a national NHS text message service will be introduced to invite individuals eligible for the COVID-19 vaccine to book a vaccination appointment. Many GP practices and CCGs have already implemented text messages to invite eligible residents and patients for the vaccine.
Read more
However, recent research has shown that the message content of text messages inviting members of the public to other preventative health opportunities (e.g. personalised messages and GP-endorsements in cancer screening) can impact uptake.
This 3-arm randomised controlled trial will be conducted across the Central London (CL) Clinical Commissioning Group (CCG) which to-date has seen the lowest rates of COVID-19 vaccination uptake in the country. The study aims to investigate the most effective text message strategy to inform local, regional and national practice.
The intervention text message content to be tested is informed by behavioural science theory is personalised to include the recipient's name and GP practice name. All patients in the Central London CCG who are unvaccinated, aged 18-49, who have not declined the vaccine will be included as their cohort becomes eligible for vaccination according to the JCVI guidelines. The trial will compare the uptake of the COVID-19 vaccination by trial arm at 3 and 8 weeks after the intervention is deployed.
Read the detailed description
The COVID-19 vaccine is an effective way to reduce morbidity and mortality from COVID-19. Increasing uptake of the COVID-19 vaccine is a major public health priority. People's willingness to receive the COVID- 19 vaccine in the UK has been at record highs - 9 in 10 people said they would receive it when the NHS notifies them that it is their turn. However, evidence suggests that willingness to get vaccinated is lower amongst younger age groups and BAME populations. Additionally, high willingness to be vaccinated may not translate into high uptake, particularly as the vaccine rollout extends to younger, less vulnerable cohorts.
Uptake of the COVID-19 vaccine may be influenced by many factors, including personal beliefs such as perceived low personal risk from COVID-19, perceived social and cultural norms or a concerns around vaccine safety or efficacy. Additionally, process barriers, such as the effort required to attend an appointment may reduce vaccine uptake. With more than 95% of UK households having a mobile phone, text messages can be an effective way to improve uptake of healthcare services and medicine adherence. In particular, recent research has shown that reminder text messages about flu vaccination appointments can improve uptake by up to 10%, and that some messages may be more effective for specific groups. However, more research is needed to maximise the effectiveness of messages to increase uptake of the COVID-19 vaccine specifically and to explore how the effectiveness of messaging differs across different age and ethnicity groups.
The proposed research will determine which message strategy increases COVID-19 vaccine vaccination rates in the cohort aged between 18 and 49 years old as they become eligible for the vaccine according to JCVI categories.
During the trial, each cohort that newly becomes eligible to be vaccinated will be randomised to one of the five trial text message strategies.
The trial arms will include the current practice text message invitation which will act as the control and four intervention trial arms. The intervention text message strategies and message content have been based on behavioural science theory.
The usual care team will deploy the text messages according to the trial arm allocation. The vaccination status will be recorded in the patients electronic health record (EHR) as per usual practice. Researchers will have access to the pseudonymised datasets through a secure data platform which only holds pseudonomised data (see data Study Procedure section).
Analysis will measure and compare the vaccination uptake across trial arms.
- Conditions
- Covid19
- Being tested
- Text message content
- Keywords
- text message, vaccination, COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Text message contentBehavioural
Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 - Control SMS | Active comparator | Control (current practice) text message invitation Receives: Behavioral: Text message content |
| Arm 2 - Behavioural Science informed SMS content | Experimental | Experimental text message invitation Receives: Behavioral: Text message content |
| Arm 3 - Pre-alert and behavioural science informed SMS content | Experimental | Two text messages, including a pre-alert SMS and the text message intervention in trial arm 2. Receives: Behavioral: Text message content |
What is being measured
The primary outcome is the main question the study is designed to answer.
COVID-19 vaccination uptake at 3 weeks
COVID-19 vaccination uptake at 3 weeks
Measured: 3 weeks from invitation text message
Secondary outcomes (2)
COVID-19 vaccination uptake at 8 weeks
COVID-19 vaccination uptake at 8 weeks
Measured: 8 weeks from invitation text message
COVID-19 vaccination uptake by demographics
Exploratory analysis of COVID-19 vaccination uptake by demographics (age, gender, IMD decile, ethnicity, previous flu vaccination)
Measured: 3 and 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2021
- Study start11 May 2021 (estimated)
- Primary completion31 Dec 2021 (estimated)
- Study completion11 May 2022 (estimated)
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 Covid19Studies of the same condition, open and under way.
- 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
- 3-armed parallel randomised controlled trial
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 120,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College Healthcare NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Central London CCG, Imperial College Health Partners (ICHP), Institute for Global Health Innovations, The Behavioural Insights Team
- Responsible party
- Sponsor
- Investigators
- Sarah Huf, MBBS PhD, Principal investigator, Imperial College Health Care Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04895683
- Sponsor's protocol ID
- 21SM6815
- Status last verified
- May 2021
- First submitted
- 17 May 2021
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The data is only available through the WSIC dataset through a de-identified dataset platform. The get access to this platform, researchers would need to get approval through the usual process to be able to access the data. The de-identified dataset cannot be exported from this trusted research environment.
Publications
Huf SW, Grailey K, Crespo RF, Woldmann L, Chisambi M, Skirrow H, Black K, Hassanpourfard B, Nguyen J, Klaber B, Darzi A. Testing the impact of differing behavioural science informed text message content in COVID-19 vaccination invitations on vaccine uptake: A randomised clinical trial. Vaccine. 2024 Apr 19;42(11):2919-2926. doi: 10.1016/j.vaccine.2024.03.059. Epub 2024 Mar 28.
PubMed 38553291
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Can Behavioural-science Informed Text Messages Improve COVID-19 Vaccination Uptake in North West London? A RCT
- ClinicalTrials.gov ID
- NCT04895683
- Acronym / sponsor ID
- 21SM6815
- Conditions
- Covid19
- Keywords
- text message, vaccination, COVID-19
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120,000 participants (estimated)
- Lead sponsor
- Imperial College Healthcare NHS TrustUniversity, hospital or other
- Collaborators
- Central London CCG, Imperial College Health Partners (ICHP), Institute for Global Health Innovations, The Behavioural Insights Team
- Study start
- 11 May 2021 (estimated)
- Primary completion
- 31 Dec 2021 (estimated)
- Study completion
- 11 May 2022 (estimated)
- First posted
- 20 May 2021 (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.
COVID-19 vaccinations significantly reduce the risk of getting seriously ill or dying from COVID-19. Since December 2020, the UK has rolled out vaccinations according to the Joint Committee for Vaccinations and Immunity (JCVI) priority groups. However, despite data indicating that more than 90% of the UK population intends to get vaccinated, there are geographical and ethnic variations in vaccination acceptance. As younger cohorts with lower risk from COVID-19 become eligible for vaccination, it is expected that uptake rates may also be lower than they have been in previous cohorts.
It was recently announced that a national NHS text message service will be introduced to invite individuals eligible for the COVID-19 vaccine to book a vaccination appointment. Many GP practices and CCGs have already implemented text messages to invite eligible residents and patients for the vaccine.
However, recent research has shown that the message content of text messages inviting members of the public to other preventative health opportunities (e.g. personalised messages and GP-endorsements in cancer screening) can impact uptake.
This 3-arm randomised controlled trial will be conducted across the Central London (CL) Clinical Commissioning Group (CCG) which to-date has seen the lowest rates of COVID-19 vaccination uptake in the country. The study aims to investigate the most effective text message strategy to inform local, regional and national practice.
The intervention text message content to be tested is informed by behavioural science theory is personalised to include the recipient's name and GP practice name. All patients in the Central London CCG who are unvaccinated, aged 18-49, who have not declined the vaccine will be included as their cohort becomes eligible for vaccination according to the JCVI guidelines. The trial will compare the uptake of the COVID-19 vaccination by trial arm at 3 and 8 weeks after the intervention is deployed.
Detailed description
The COVID-19 vaccine is an effective way to reduce morbidity and mortality from COVID-19. Increasing uptake of the COVID-19 vaccine is a major public health priority. People's willingness to receive the COVID- 19 vaccine in the UK has been at record highs - 9 in 10 people said they would receive it when the NHS notifies them that it is their turn. However, evidence suggests that willingness to get vaccinated is lower amongst younger age groups and BAME populations. Additionally, high willingness to be vaccinated may not translate into high uptake, particularly as the vaccine rollout extends to younger, less vulnerable cohorts.
Uptake of the COVID-19 vaccine may be influenced by many factors, including personal beliefs such as perceived low personal risk from COVID-19, perceived social and cultural norms or a concerns around vaccine safety or efficacy. Additionally, process barriers, such as the effort required to attend an appointment may reduce vaccine uptake. With more than 95% of UK households having a mobile phone, text messages can be an effective way to improve uptake of healthcare services and medicine adherence. In particular, recent research has shown that reminder text messages about flu vaccination appointments can improve uptake by up to 10%, and that some messages may be more effective for specific groups. However, more research is needed to maximise the effectiveness of messages to increase uptake of the COVID-19 vaccine specifically and to explore how the effectiveness of messaging differs across different age and ethnicity groups.
The proposed research will determine which message strategy increases COVID-19 vaccine vaccination rates in the cohort aged between 18 and 49 years old as they become eligible for the vaccine according to JCVI categories.
During the trial, each cohort that newly becomes eligible to be vaccinated will be randomised to one of the five trial text message strategies.
The trial arms will include the current practice text message invitation which will act as the control and four intervention trial arms. The intervention text message strategies and message content have been based on behavioural science theory.
The usual care team will deploy the text messages according to the trial arm allocation. The vaccination status will be recorded in the patients electronic health record (EHR) as per usual practice. Researchers will have access to the pseudonymised datasets through a secure data platform which only holds pseudonomised data (see data Study Procedure section).
Analysis will measure and compare the vaccination uptake across trial arms.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- 3-armed parallel randomised controlled trial
| Arm | Type | Receives |
|---|---|---|
| Arm 1 - Control SMS | Active comparator | Behavioral: Text message contentControl (current practice) text message invitation |
| Arm 2 - Behavioural Science informed SMS content | Experimental | Behavioral: Text message contentExperimental text message invitation |
| Arm 3 - Pre-alert and behavioural science informed SMS content | Experimental | Behavioral: Text message contentTwo text messages, including a pre-alert SMS and the text message intervention in trial arm 2. |
Who may qualify
- Ages
- 18 to 49 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Residents registered with a GP practice in the Central London (Westminster) Clinical Commissioning Group (CCG)
- Age 18-49
- Not previously invited for COVID-19 vaccination
Key exclusion criteria (2 listed)
- Patients who have notified their GP that they wish to decline the COVID-19 vaccination.
- Patients' whose medical records report a severe allergy to medicines (as per the JCVI guidance)
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 |
|---|---|---|
| Text message contentBehavioural science-informed text messages aimed at improving COVID-19 vaccination uptake. | Behavioural | Arm 1 - Control SMS, Arm 2 - Behavioural Science informed SMS content, Arm 3 - Pre-alert and behavioural science informed SMS content |
Primary outcome
COVID-19 vaccination uptake at 3 weeks
Time frame: 3 weeks from invitation text message
COVID-19 vaccination uptake at 3 weeks
2 secondary outcomes
COVID-19 vaccination uptake at 8 weeks
Time frame: 8 weeks from invitation text message
COVID-19 vaccination uptake by demographics
Time frame: 3 and 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Derived from this study: PubMed 38553291Huf SW, Grailey K, Crespo RF, Woldmann L, Chisambi M, Skirrow H, Black K, Hassanpourfard B, Nguyen J, Klaber B, Darzi A. Testing the impact of differing behavioural science informed text message content in COVID-19 vaccination invitations on vaccine uptake: A randomised clinical trial. Vaccine. 2024 Apr 19;42(11):2919-2926. doi: 10.1016/j.vaccine.2024.03.059. Epub 2024 Mar 28.
- Individual participant dataSharing planned: No. The data is only available through the WSIC dataset through a de-identified dataset platform. The get access to this platform, researchers would need to get approval through the usual process to be able to access the data. The de-identified dataset cannot be exported from this trusted research environment.
Related trials for Covid19
Not yet recruitingPhase 1
A Safety, Reactogenicity and Immunogenicity Trial of RVX-sCPD9 Booster Intranasal COVID-19 Vaccine
COVID -19
Not yet recruitingPhase 3
Dapagliflozin for Long COVID Syndrome
COVID - 19, Long COVID Syndrome
RecruitingPhase 1
A Safety and Immunogenicity Trial of OCU500, ChAd36 Vector Encoding SARS-CoV-2 Spike Vaccine Via Intranasal and Inhalational Routes in Previously Vaccinated Adults
COVID-19
Active, not recruitingObservational study
Analysis of Coronavirus Disease 19 (COVID-19) Convalescent Plasma
Asymptomatic COVID-19 Infection Laboratory-Confirmed, Symptomatic COVID-19 Infection Laboratory-Confirmed
Not yet recruitingPhase 1
Phase I Open-Label Safety Trial of Pembrolizumab for Neurological Post- Acute Sequelae of SARS-CoV-2 (PD1-PASC I)
Post-Acute COVID-19 Syndrome
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.
Sarah Huf, MBBS PhD principal investigator
Imperial College Health Care Trust
Questions about this trial
What is this clinical trial studying?
A study testing Text message content in people with Covid19, run by Imperial College Healthcare NHS Trust.
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 3 inclusion and 2 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: status not confirmed, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sarah Huf, MBBS PhD (07496632732, s.huf@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
COVID-19 vaccination uptake at 3 weeks (time frame: 3 weeks from invitation text message). 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 NCT04895683, 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 24 May 2021.