Vacc on Track: Facilitating the delivery of catch-up vaccination in adolescent and adult migrants and Black, Asian and Minority Ethnic (BAME) communities through UK general practice
| ISRCTN | ISRCTN39246519 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN39246519 |
| ClinicalTrials.gov (NCT) | Nil known |
| Clinical Trials Information System (CTIS) | Nil known |
| Integrated Research Application System (IRAS) | 286347 |
| Protocol serial number | IRAS 286347 |
| Sponsor | St George's, University of London |
| Funder | National Institute for Health Research |
- Submission date
- 28/05/2021
- Registration date
- 17/06/2021
- Last edited
- 31/07/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Other
Plain English summary of protocol
Background and study aims
Evidence suggests that in the UK, migrants who were born overseas may be less likely to have had all of their recommended vaccinations. This may also be the case for people of non-White ethnicities, but evidence is currently limited. Improving vaccine coverage for routine vaccines in under-immunised groups in the UK is a key priority, and the core focus of this project, alongside understanding risk-factors for under immunisation in migrants and wider BAME communities.
We are conducting this study to test whether, by prompting the primary care team to check a patient’s vaccination status, we can help identify individuals who have not received all of their recommended vaccinations and refer them to routine care appointments to catch-up on the missing vaccinations to bring them in line with the UK vaccine schedule. Patients don’t have to participate or receive vaccinations if they don’t want to. This project is co-designed with migrants on our Project Advisory Board, who help us design, deliver and disseminate the research, and is being done in collaboration with Public Health England.
Who can participate?
Adolescent and adult (16+ years) migrants (defined as being born outside of the UK, but not including Western Europe, North America, Australia, or New Zealand) and BAME individuals (defined as non-White-British ethnicities) currently residing in the UK.
What does the study involve?
Participants are asked a small number of standardised questions about their ethnicity, country of origin, vaccination history, and any history of vaccine-preventable diseases they may have had. Depending on their answers, they may be offered catch-up vaccination(s) to align them with the UK schedule. Participants choose whether to accept the catch-up vaccination(s). We will collect follow-up data relating to whether participants went on to receive the vaccine(s), and how many doses, for up to 18 months after participants joined the study.
What are the possible benefits and risks of participating?
We do not anticipate any major disadvantages or risks of taking part. Discussing personal history or experiences might be uncomfortable for some participants, but all participants are told that the interview can stop at any point to take a break, or that they can leave if they feel they can’t continue. There are possible benefits. Participants may be referred for routine vaccination on the NHS which is free and will help to bring them in line with the UK immunisation schedule and reduce their risk of contracting vaccine-preventable diseases. They may find it fulfilling to take part in research aimed at improving access to vaccination on the NHS for migrant and BAME populations in the UK. Participants will be able to take an active part in improving your own and your community’s health.
Where is the study run from?
St George's, University of London (UK)
When is the study starting and how long is it expected to run for?
January 2020 to October 2022
Who is funding the study?
National Institute for Health Research (NIHR) (UK).
Who is the main contact?
Dr Sally Hargreaves, s.hargreaves@sgul.ac.uk
Contact information
Scientific
St George's, University of London
Cranmer Terrace
Tooting
London
SW17 0RE
United Kingdom
 ORCID ID |
0000-0003-2974-4348 |
|---|---|
| s.hargreaves@sgul.ac.uk |
Study information
| Primary study design | Observational |
|---|---|
| Study design | Observational prospective cohort pilot study with a quantitative database analysis |
| Secondary study design | Cohort study |
| Study type | Participant information sheet |
| Scientific title | Facilitating the delivery of catch-up vaccination in adolescent and adult migrants and Black, Asian and Minority Ethnic (BAME) communities through UK general practice: a pilot study |
| Study acronym | Vacc on Track |
| Study objectives | This research seeks to understand whether innovative engagement strategies in UK general practice can facilitate catch-up vaccination in adolescent and adult migrants and Black, Asian and Minority Ethnic (BAME) groups. This is important because these population groups have been shown to be underimmunised, and there are currently no systems in place in many GP practices to offer catch-up vaccination to adult migrants and BAME to align them with the UK vaccine schedule. The reasons why and which groups in particular are affected are currently poorly understood. In general practice, the new patient health check (NPHC) and other existing approaches offer untapped opportunities to gather vaccination history of new migrant/BAME patients and refer them for catch-up vaccination through existing care pathways in primary care. This study seeks to develop and test pathways to ensure these groups are offered catch-up vaccination to align them to the UK vaccine schedule with the aim of improving vaccine coverage in these groups. |
| Ethics approval(s) | Approved 18/12/2020, Yorkshire and the Humber - South Yorkshire Research Ethics Committee (NHSBT Newcastle Blood Donor Centre, Holland Drive, Newcastle upon Tyne, NE2 4NQ, UK; +44 (0)207 104 8079; southyorks.rec@hra.nhs.uk), ref: 20/YH/0342 |
| Health condition(s) or problem(s) studied | Underimmunisation in adolescent and adult migrants and Black, Asian and Minority Ethnic (BAME) groups |
| Intervention | Migrant and BAME participants aged 16+ years will be offered catch-up vaccinations to fully align them with the UK vaccination schedule. Participants are asked standardised questions about their ethnicity, country of origin, vaccination history, and history of vaccine-preventable diseases. Catch-up vaccination(s) will be offered where required according to UK guidelines. Participants may accept or refuse any combination of these vaccinations. Follow-up data will be collected for up to 18 months and will include whether which vaccine(s), and how many doses were received. |
| Intervention type | Biological/Vaccine |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | MMR vaccine |
| Primary outcome measure(s) |
Rates of underimmunisation and uptake/delivery of MMR vaccine measured through a review of the notes of consenting patients at the end of the study |
| Key secondary outcome measure(s) |
Delivery of other required vaccinations, previous vaccine-preventable disease, predictors of under-immunisation measured through a review of the notes of consenting patients at the end of the study |
| Completion date | 01/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Mixed |
| Lower age limit | 16 Years |
| Sex | All |
| Target sample size at registration | 1000 |
| Total final enrolment | 59 |
| Key inclusion criteria | 1. Phase 1: Adolescent and adult (16+ years) migrants (defined as being born outside of the UK, but not including Western Europe, North America, Australia or New Zealand) 2. Phase 2: BAME individuals (defined as non-White-British ethnicities) 3. Currently residing in the UK |
| Key exclusion criteria | Age under 16 years |
| Date of first enrolment | 18/05/2021 |
| Date of final enrolment | 01/10/2022 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
c/o Barnet Federated GPs Ltd
311 Ballards Lane
North Finchley
London
N12 8LY
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not expected to be made available |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to the non-disclosure policies of the GP practices providing the data. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | 03/05/2024 | 31/07/2024 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
Editorial Notes
31/07/2024: Contact details updated. Publication reference added.
17/02/2023: The following changes were made to the trial record:
1. The recruitment end date was changed from 01/06/2022 to 01/10/2022.
2. The total final enrolment was added.
3. The intention to publish date was changed from 01/02/2023 to 01/12/2023.
03/06/2021: Trial's existence confirmed by Yorkshire & The Humber - South Yorkshire Research Ethics Committee
