Condition category
Cancer
Date applied
18/02/2010
Date assigned
09/03/2010
Last edited
21/07/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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

http://benpct.nhs.uk/

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

  1. 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.

  2. 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.

Additional files

Editorial Notes