Condition category
Infections and Infestations
Date applied
30/07/2013
Date assigned
01/08/2013
Last edited
11/10/2016
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Although we lack accurate figures, there are an estimated 360,000 Travellers in the UK who live in different communities. We are using the term 'Traveller' in its broadest sense to include Gypsy, Traveller and Roma communities; who may be settled or nomadic, and may live on authorised or unauthorised sites, or in houses. However, we are aware these are distinct groups both ethnically and culturally. What is very clear from research with Travellers is that they experience significantly poorer heath and have shorter life expectancy than the general population. Travellers also are less likely to use health services and this includes taking up immunisations. There have been a few small studies, often with just one Traveller community, which have identified some reasons for low uptake of immunisations. However, whilst Traveller communities share similar features that distinguish them from the general population, they can have very different beliefs, traditions and languages. This means that in order to develop programmes to improve immunisation uptake that meet the specific needs of the different Traveller communities, we need to understand what helps and hinders individuals in taking up immunisations in those particular communities. It is also important to consider that some of the issues may be the same across communities as for the general population; there may also be differences in views within communities. At the moment we just do not know. Our research will address this. This study aims to explore the reasons for taking up and not taking up immunisations amongst Traveller communities and to identify ideas for programmes to increase uptake of immunisations. Our main focus will be immunisations that are offered within the UK childhood immunisation programme. However, to understand issues relating to adult immunisation, we will also explore views on flu vaccination and on the whooping cough vaccine that is offered to pregnant women.

Who can participate?
Ideally we will attract a mix of Traveller men and women, across ages (including teenage girls) with different experiences of taking up/not taking up immunisations; and a mix of frontline workers and those with a more strategic role.

What does the study involve?
In Phase 1 we will do interviews (24 to 32 Travellers in each community) with men and women across generations of families including adults eligible for the flu vaccine (pregnant, over 65, with specified long long-term medical conditions e.g. asthma, bronchitis). We will also run discussions with girls aged 13 to 15 years and with mothers of pre-school children/women planning families. In Phase 2 we will interview health and community workers with responsibility for local policy making and/or providing services for the Traveller communities interviewed in Phase 1 (6-8 in each city). In Phase 3 a sub sub-sample of participants from Phase 1 and 2 will be re-approached to take part in a feedback workshop, specifically between 10 and 12 Traveller participants per community and 3 to 4 Health and Community Workers per city. We will analyse the data collected in Phases 1 and 2 and the findings will be used to develop ideas for immunisation programmes.

What are the possible benefits and risks of participating?
Traveller participants may immediately benefit from taking part in an interview or workshop by having the opportunity to share their views on, and experiences of, childhood (including teenager) and adult immunisations. We cannot promise that taking part in this study will remove the barriers to immunisation that participants identify or lead to the implementation of their ideas for interventions to increase uptake of immunisations. Health and community worker participants may also immediately benefit from taking part in an interview or workshop by having the opportunity to reflect on and discuss the views of the Travellers (with whom they work) about immunisations; and to consider their own views and approach in light of this. This has the potential to eventually improve the quality of the support for immunisation that these professionals can provide, tailored to the needs of the Traveller community/communities with whom they work. We don't anticipate any risks of participating.

Where is the study run from?
The study has three linked phases. Each phase will be carried out in four UK cities: York (English Roma), Bristol (English Gypsies, Eastern European Roma), East London (Irish Travellers) and Glasgow (Eastern European Roma, Occupational Travellers).

When is the study starting and how long is it expected to run for?
September 2013 to October 2014

Who is funding the study?
National Institute for Health Research (NIHR) (UK)

Who is the main contact?
Dr Cath Jackson
cath.jackson@york.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Cath Jackson

ORCID ID

http://orcid.org/0000-0003-3181-7091

Contact details

York Trials Unit
Department of Health Sciences
University of York
Heslington
York
YO10 5DD
United Kingdom
-
cath@validresearch.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

HTA 12/17/05

Study information

Scientific title

Understanding the barriers and facilitators to immunisation uptake in Traveller communities to inform interventions to promote uptake: An ecological approach

Acronym

UNITING

Study hypothesis

1. Investigate the barriers and facilitators to acceptability and uptake of immunisations amongst six Traveller communities (comprising five distinct ethnic/cultural groups) across four UK cities.
2. Identify possible interventions to increase uptake of immunisations in diverse Traveller communities, to test in a subsequent feasibility study.

More details can be found at http://www.nets.nihr.ac.uk/projects/hta/121705
Protocol can be found at http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0010/82738/PRO-12-17-05.pdf

Ethics approval

NRES Committee Yorkshire and The Humber – Leeds East, 23/04/2013, ref. 13/YH/02

Study design

Three-phase qualitative study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Community

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Public health - immunisation

Intervention

In Phase 1 we will do interviews (24 to 32 Travellers in each community) with men and women across generations of families including adults eligible for the flu vaccine (pregnant, over 65, with specified long long-term medical conditions e.g. asthma, bronchitis). We will also run discussions with girls aged 13 to 15 years and with mothers of pre-school children/women planning families. In Phase 2 we will interview health and community workers with responsibility for local policy making and/or providing services for the Traveller communities interviewed in Phase 1 (6-8 in each city). In Phase 3 a sub sub-sample of participants from Phase 1 and 2 will be re-approached to take part in a feedback workshop, specifically between 10 and 12 Traveller participants per community and 3 to 4 Health and Community Workers per city. We will analyse the data collected in Phases 1 and 2 and the findings will be used to develop ideas for immunisation programmes.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

We will analyse the interview data to identify barriers and facilitators and ideas for interventions to increase uptake of immunisations.

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/09/2013

Overall trial end date

31/10/2015

Reason abandoned

Eligibility

Participant inclusion criteria

PHASES 1 and 3
1. Member of a participating Traveller community
2. Willing and able to provide informed consent to participate
3. We will include both men and women living in extended families across generations
4. We will include young women planning families, parents and grandparents to capture a life span/cross generational perspective as well as teenage girls eligible for their 3-in-1 teenage booster (diphtheria, tetanus, poliomyelitis, given at 13 to 18 years) and HPV vaccine (given at 12 to 13 years in school)
5. Adults eligible for the flu vaccine (pregnant - also eligible for pertussis vaccine, over 65 years and with specified long term conditions)

PHASES 2 and 3:
1. Health and Community worker able to influence local policy making, drive health improvement, and/or providing or commissioning services for participating Traveller communities
2. Willing and able to provide informed consent to participate
3. We will purposively sample these 'Health and Community Workers' in each of the 4 cities to ensure we interview a mix of 'frontline workers' (e.g. heath visitors, practice nurses, community midwives, school nurses, GPs, social workers, range of community workers including third sector) and those working in more strategic/commissioning role (e.g. local decision makers in health protection/public health/Health and Wellbeing Boards/Clinical Commissioning Groups)

Participant type

Mixed

Age group

Adult

Gender

Both

Target number of participants

224

Participant exclusion criteria

1. Not willing or able to provide informed consent
2. Not able to take part in an interview/feedback workshop

Recruitment start date

01/09/2013

Recruitment end date

01/10/2014

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of York
York
YO10 5DD
United Kingdom

Sponsor information

Organisation

University of York (UK)

Sponsor details

c/o Sue Final
Research Grants and Contracts
Heslington Hall
Heslington
York
YO10 5DD
United Kingdom

Sponsor type

Not defined

Website

Funders

Funder type

Government

Funder name

Health Technology Assessment Programme

Alternative name(s)

NIHR Health Technology Assessment Programme, HTA

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

IPD sharing plan
The trialists have decided not to share the data because of concerns about deductive disclosure.

Intention to publish date

01/11/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/26056124
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/27686875

Publication citations

Additional files

Editorial Notes

10/10/2016: Publication reference added. 19/05/2016: Publication reference added.