NCT04895683

Brief 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. 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120,000

participants targeted

Target at P75+ for not_applicable covid19

Timeline
Completed

Started May 2021

Typical duration for not_applicable covid19

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2021

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

May 17, 2021

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 20, 2021

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 11, 2022

Completed
Last Updated

May 24, 2021

Status Verified

May 1, 2021

Enrollment Period

8 months

First QC Date

May 17, 2021

Last Update Submit

May 20, 2021

Conditions

Keywords

text messagevaccinationCOVID-19

Outcome Measures

Primary Outcomes (1)

  • COVID-19 vaccination uptake at 3 weeks

    COVID-19 vaccination uptake at 3 weeks

    3 weeks from invitation text message

Secondary Outcomes (2)

  • COVID-19 vaccination uptake at 8 weeks

    8 weeks from invitation text message

  • COVID-19 vaccination uptake by demographics

    3 and 8 weeks

Study Arms (3)

Arm 1 - Control SMS

ACTIVE COMPARATOR

Control (current practice) text message invitation

Behavioral: Text message content

Arm 2 - Behavioural Science informed SMS content

EXPERIMENTAL

Experimental text message invitation

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.

Behavioral: Text message content

Interventions

Behavioural science-informed text messages aimed at improving COVID-19 vaccination uptake.

Arm 1 - Control SMSArm 2 - Behavioural Science informed SMS contentArm 3 - Pre-alert and behavioural science informed SMS content

Eligibility Criteria

Age18 Years - 49 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 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.

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Officials

  • Sarah Huf, MBBS PhD

    Imperial College Health Care Trust

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sarah Huf, MBBS PhD

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The researcher conducting the data analysis will do so using a trial arm code. They will not have the key to unlock which trial arm is which.
Purpose
PREVENTION
Intervention Model
PARALLEL
Model Details: 3-armed parallel randomised controlled trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 17, 2021

First Posted

May 20, 2021

Study Start

May 11, 2021

Primary Completion

December 31, 2021

Study Completion

May 11, 2022

Last Updated

May 24, 2021

Record last verified: 2021-05

Data Sharing

IPD Sharing
Will not share

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.