Plain English Summary
Background and study aims:
Human papilloma virus (HPV) is the name given to a group of viruses that affect the skin and moist membranes lining the body; these include the cervix. In some cases, it can cause abnormal tissue growth and changes to cells in the cervix; this, in turn, can lead to the development of cervical cancer. A vaccination against HPV is available as part of the UK childhood immunisation programme. It is recommended for all girls aged 12-13 years old (in Year 8 at school) and most of the time it is given at school. Most girls get the vaccine, but there are some girls who do not. For a girl to be able to have the vaccine she needs written permission from a parent. Consent forms or permission forms have to be returned whether permission for vaccination is or is not being given. Some consent forms are not returned. Research has suggested that if the parents of girls who do not return their consent forms are prompted, the consent forms are likely to be returned and to say ‘yes’ to vaccination. It is thought that offering girls a reward to return their consent forms might help improve consent form return and the number of girls getting the vaccine. Researchers need to find out if offering a reward improves the number of consent forms that are returned and the number of girls getting the vaccine. This can be done via a study where girls are randomly selected to either be offered the reward or not be offered the reward. This is called a randomised controlled trial or RCT. Before this RCT can be run, it is important to check that such a study is possible. The aim of this study is to find out whether is it possible to carry out a RCT of offering girls a reward to return their consent forms.
Who can participate?
All secondary schools in Lambeth, Southwark and Enfield. Parents of girls in Year 8 who attend the schools that take part are be asked if their daughter can participate.
What does the study involve?
Half of the schools taking part are randomly chosen to be in the reward group and half are randomly chosen to be in the standard invitation group. Girls attending schools in the standard invitation group are given an invitation to receive the HPV vaccine as they would normally do as part of the childhood immunisation programme. Girls attending schools in the reward group are given the normal invitation and are also be told that they will be entered into a prize draw to win a £50 ‘Love2Shop’ voucher if they return their consent form signed by their parent (it does not matter if consent to vaccination is given or is not given).
What are the possible benefits and risks of participating?
There are no expected risks or benefits to taking part in this study.
Where is the study run from?
The study is run from University College London and will be carried out in at least six secondary schools in Lambeth, Southwark and Enfield.
When is the study starting and how long is it expected to run for?
July 2016 and will finish in March 2017
Who is funding the study?
Cancer Research UK.
Who is the main contact?
Dr Alice Forster
Ms Lauren Rockliffe
Health Behaviour Research Centre
Dr Alice Forster
Health Behaviour Research Centre
A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination among girls
reWARD off HPV
The aim is to establish the feasibility of conducting a cluster RCT of an adolescent incentive intervention to increase uptake of HPV vaccination among girls.
UCL Research Ethics Committee, 09/06/2016, ref: 6615/002
Two-arm single blind cluster randomised feasibility trial
Primary study design
Secondary study design
Cluster randomised trial
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Human papillomavirus (HPV)
Standard invitation arm:
The standard invitation arm comprises adolescents being provided with an information leaflet about the HPV vaccine and a consent form by their school, which they are asked to give to their parents (delivered by hand) and return to the school before a prescribed date. Immunisation nurses may engage in additional promotional activities with schools to improve uptake of the vaccine and this information about these activities will be collected informally.
Incentive intervention arm:
Participants in the incentive intervention arm will receive the standard invitation. They will also be advised by their school form tutor and in a letter that they will be entered into a prize draw to win a £50 'Love2Shop' voucher if they return their consent form, with a 1 in 10 chance of winning. It will be made clear that adolescents are eligible for prize draw entry regardless of whether consent is given, so long as the consent form is returned. The voucher can be exchanged at a large number of retailers.
Blocked randomisation will be performed by the statistical advisor using computer generated random numbers.
Primary outcome measures
There is no primary outcome as this is a feasibility study. The first outcome that will be assessed is schools’ and parents’ willingness to participate in the study and schools’ willingness to be randomised. Measured by recording number of schools contacted, number who express initial interest and number who participate. Measured at baseline.
Secondary outcome measures
1. Response rates to questionnaires by parents and girls (assessed by recording number of completed questionnaires returned)
2. Data completeness regarding the proportion of missing data: whether consent form was returned, whether consent was given (reported by schools and reported by parents in brief questionnaire), socio-demographic characteristics (ascertained through brief questionnaire completed and index of multiple deprivation (IMD) score, ascertained through girls’ postcode provided by schools) and all other questionnaire items.
3. Girls’ attitudes towards the incentive offered (assessed through brief questionnaire).
4. Parents’/guardians’ attitudes towards the incentive offered (assessed through brief questionnaire).
5. School staff experiences of participating (ascertained through brief interviews)
6. School staff fidelity to the intervention (ascertained through brief interviews)
7. Detailed description of immunisation processes performed in each school (i.e. what additions to the standard invitation were performed) by the immunisation teams and school staff (ascertained through brief interviews with school staff and informal information provided by immunisation teams)
8. Unintended consequences of the intervention:
8.1. Girls’ perceptions of why incentive was offered (assessed through brief questionnaire)
8.2. Parents’/guardians’ informed decision making (assessed through brief questionnaire, using measure described by Mantzari et al. 2015)
8.3. Girls’ attitudes towards returning future consent forms (assessed through brief questionnaire)
9. Mechanisms of action (assessed through brief girls’ questionnaire)
10. Cost per returned consent form and cost per consent form that is agreeing to vaccination.
All information will be collected after vaccination day
Researchers will also estimate intervention effect on:
11. Initiation of the vaccination series (whether consent was given to vaccination reported by schools and self-reported by parents in a brief questionnaire after vaccination day)
12. Consent form return rates (reported by schools)
Overall trial start date
Overall trial end date
Participant inclusion criteria
Inclusion criteria at the cluster-level:
1. Secondary schools based in the London boroughs of Enfield, Lambeth and Southwark and who participate in the HPV immunisation programme
Inclusion criteria at the individual-level:
2. Adolescent girls attending participating schools
3. Adolescent girls who enter Year 8 in the autumn academic term
4. School staff employed at participating schools
5. Parent/guardians of adolescent girls participating in the trial
Target number of participants
At least 6 clusters (schools), with approximately 100 adolescent girls per cluster. We will collect questionnaire data from parents/guardians of participating adolescent girls. We will conduct interviews with 18 members of school staff.
Participant exclusion criteria
Exclusion criteria at the cluster-level:
1. Secondary schools based outside of the London boroughs of Enfield, Lambeth and Southwark
2. Secondary schools not participating in the HPV immunisation programme
Exclusion criteria at the individual-level:
3. Adolescent girls not attending participating schools
4. Adolescent girls not in year 8 in the autumn academic term
5. School staff employed at schools not participating in the trial
6. Parents/guardians of adolescent girls not participating in the trial
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
University College London
Health Behaviour Research Centre Gower Street
Cancer Research UK
Funding Body Type
private sector organisation
Funding Body Subtype
Results and Publications
Publication and dissemination plan
1. Study protocol (September 2016)
2. Full results paper (March 2017)
3. Dissemination to stakeholders: Findings will be disseminated to all participating schools by means of a copy of the final report in March 2017
4. Social media and online: Findings will be written about in online blogs and referred to on social media, such as Twitter (March 2017)
Intention to publish date
Participant level data
Available on request
Results - basic reporting