Plain English Summary
Background and study aims
The Human Papillomavirus (HPV) is a common sexually transmitted virus responsible for most cases of cervical cancer. Immunisation against HPV requires completion of three vaccinations. Since 2008, a routine HPV vaccination programme aimed at 12-13 year-old girls has been rolled out in England and Wales, generating good uptake rates. Uptake of a catch-up HPV vaccination programme aimed at girls aged 17-18 years, however, has been significantly below the 80% target set by the NHS. One way of improving this is to offer girls money for getting vaccinated. The offer of money however, could potentially have a negative effect on the quality of girls' decisions to get vaccinated. Specifically, it is possible that the offer of money might tempt girls with negative attitudes towards the HPV vaccination and/or insufficient knowledge of the vaccination to get vaccinated. The study's aim is to find out whether offering teenage girls money for getting vaccinated against HPV could improve vaccination uptake rates. It also aims to find out whether the offer of money has a negative effect on the quality of girls' decisions to get vaccinated, as assessed by their attitudes towards the HPV vaccination and their knowledge of the HPV vaccination.
Who can participate?
One thousand girls aged 16 to 18 were invited to participate in the HPV vaccination programme: Five-hundred had received a previous invitation to get vaccinated but had failed to attend their first vaccination appointment (previous non-attenders) and 500 had never previously received a vaccination invitation (first-time invitees). Girls were randomly selected from eligible participants who i) who were registered with a GP within areas covered by the administration of the Birmingham East and North (BEN) and Heart of Birmingham Primary Care Trusts, ii) had not been previously vaccinated against HPV and iii) were eligible to receive the vaccinations through clinics. Girls were excluded from the study if they were feeling unwell at the time of presenting for the vaccinations.
What does the study involve?
The two groups of girls were randomly allocated to receive either a standard letter inviting them to attend the first HPV vaccination session or a modified invitation letter including the offer of vouchers worth £45 for receiving the three vaccinations: £20 for receiving the first vaccination; £5 for receiving the second vaccination; and £20 for receiving the third vaccination. Girls who were sent the modified invitation letters were also sent text messages reminding them of their second and third vaccination appointments. When attending their first vaccination session, all girls were also requested to complete a questionnaire to assess the quality of their decisions to undertake the HPV vaccinations.
What are the possible benefits and risks of participating?
By participating in the study girls became immunised against HPV, thus lowering their chances of developing cervical cancer. There are no risks associated with participating in the study
Where is the study run from?
The study is run by the Birmingham East and North Primary Care Trust (BEN PCT) in association with the Young Foundation as part of the Healthy Incentives partnership between these two organisations.
When is the study starting and how long is it expected to run for?
Recruitment for the study began in February 2010 and was completed in September 2010. Evaluation of the trial began in April 2011.
Who is funding the study?
The trial is funded by the Birmingham East and North Primary Care Trust. The evaluation is funded by the Wellcome Trust, as part of a Strategic Award in Biomedical Ethics; programme title: 'The Centre for the Study of Incentives in Health'; grant number: 086031/Z/08/Z.
Who is the main contact?
Professor Theresa Marteau
theresa.marteau@kcl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Prof Theresa Marteau
ORCID ID
Contact details
Psychology Department (at Guy's)
Health Psychology Section
King's College London
5th Floor Bermondsey Wing
Guy's Campus
London
SE1 9RT
United Kingdom
+44 (0)20 7188 0192
theresa.marteau@kcl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
086031; Version 1
Study information
Scientific title
Financial incentives to increase uptake of human papillomavirus (HPV) vaccination: a randomised controlled trial
Acronym
Study hypothesis
There are two questions being addressed by this project:
1. Does the offer of financial incentives increase the uptake of human papillomavirus (HPV) vaccination in girls aged 16 - 18 years?
2. Does the offer of financial incentives to undergo HPV vaccination reduce the quality of decision-making?
Ethics approval
Birmingham East, North and Solihull Research Ethics Committee, pending approval as of 18/02/2010
Study design
Randomised controlled single-centre trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Other
Trial type
Prevention
Patient information sheet
Not available in web format, please contact Narinder Kular at narinder.kular@benpct.nhs.uk to request a patient information sheet
Condition
Human papillomavirus (HPV) vaccination / cervical cancer
Intervention
Those allocated to the control group are invited to attend a local community centre on three occasions to undergo HPV vaccination. Those allocated to the intervention group receive the same invitation. In addition, the intervention group is being offered shopping vouchers for attending for each of three vaccinations (sum of £45; £20 for the first vaccination; £5 for the second; and £20 for the third).
Intervention type
Biological/Vaccine
Phase
Drug names
Primary outcome measures
Proportion of participants who have the HPV vaccine when a financial incentive is offered, measured when participants attend one of the three community clinics in the trial
Secondary outcome measures
Quality of decision, assessed using a short form of the Multidimensional Measure of Informed Choice, measured when participants attend one of the three community clinics in the trial
Overall trial start date
01/02/2010
Overall trial end date
01/06/2010
Reason abandoned
Eligibility
Participant inclusion criteria
1. Female, aged between 16 and 18 years
2. Living in Birmingham
Participant type
Patient
Age group
Child
Gender
Female
Target number of participants
In total 1000 participants will be recruited for the trial
Participant exclusion criteria
Feeling unwell at the time of presenting for vaccination
Recruitment start date
01/02/2010
Recruitment end date
01/06/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
King's College London
London
SE1 9RT
United Kingdom
Sponsor information
Organisation
NHS Birmingham East and North Primary Care Trust (UK)
Sponsor details
c/o Andrea Docherty
Richard House
Aston
Birmingham
B7 4AA
United Kingdom
-
andrea.docherty@benpct.nhs.uk
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Charity
Funder name
Healthy Incentives (UK) - covered the costs of research activities at NHS Birmingham East and North Primary Care Trust
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
The Wellcome Trust (UK) (grant ref: 086031) - covered the cost of the evaluation at Kings College London
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary
2012 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/22947332
2015 results in: http://www.ncbi.nlm.nih.gov/pubmed/25133822
Publication citations
-
Protocol
Mantzari E, Vogt F, Marteau TM, Using financial incentives to increase initial uptake and completion of HPV vaccinations: protocol for a randomised controlled trial., BMC Health Serv Res, 2012, 12, 301, doi: 10.1186/1472-6963-12-301.
-
Results
Mantzari E, Vogt F, Marteau TM, Financial incentives for increasing uptake of HPV vaccinations: a randomized controlled trial, Health Psychol, 2015 , 34, 2, 160-171, doi: 10.1037/hea0000088.