Does offering girls a reward increase the number of vaccination consent forms that are returned? A study to look at whether a future larger study of rewards is feasible

ISRCTN	ISRCTN72136061
DOI	https://doi.org/10.1186/ISRCTN72136061

Submission date: 16/08/2016
Registration date: 26/09/2016
Last edited: 10/10/2023

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Infections and Infestations

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-how-to-increase-the-number-of-young-women-having-the-hpv-vaccine

Contact information

Ms Lauren Rockliffe
Public

Health Behaviour Research Centre
UCL, Gower Street
London
WC1E 6BT
United Kingdom

Dr Alice Forster
Scientific

Health Behaviour Research Centre
UCL, Gower Street
London
WC1E 6BT
United Kingdom

ORCID ID	0000-0002-9933-7919

Study information

Study design	Two-arm single-blind cluster randomized feasibility trial
Primary study design	Interventional
Secondary study design	Cluster randomised trial
Study setting(s)	School
Study type	Prevention
Participant information sheet	Not available in web format, please use contact details to request a participant information sheet.
Scientific title	A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination among girls
Study acronym	reWARD off HPV
Study objectives	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.
Ethics approval(s)	UCL Research Ethics Committee, 09/06/2016, ref: 6615/002
Health condition(s) or problem(s) studied	Human papillomavirus (HPV)
Intervention	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.
Intervention type	Behavioural
Primary outcome measure	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 study start date	01/07/2016
Completion date	31/01/2017

Eligibility

Participant type(s)	Learner/student
Age group	Mixed
Sex	Both
Target number of participants	At least 6 clusters (schools), with approximately 100 adolescent girls per cluster. Questionnaire data is collected from parents/guardians of participating adolescent girls. Interviews are conducted with 18 members of school staff.
Key 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
Key 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
Date of first enrolment	01/07/2016
Date of final enrolment	20/01/2017

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

University College London

Health Behaviour Research Centre
Gower Street
London
WC1E 6BT
United Kingdom

Sponsor information

University College London
University/education

Gower Street
London
WC1E 6BT
England
United Kingdom

"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Charity

Cancer Research UK
Private sector organisation / Other non-profit organizations

Alternative name(s): CR_UK, Cancer Research UK - London, CRUK
Location: United Kingdom

Results and Publications

Intention to publish date	31/03/2017
Individual participant data (IPD) Intention to share	Yes
IPD sharing plan summary	Available on request
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)
IPD sharing plan	The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Alice Forster (alice.forster@ucl.ac.uk).

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	protocol	06/03/2017		Yes	No
Results article	results	10/10/2017		Yes	No
Results article	results	20/03/2018		Yes	No
Results article	qualitative results	21/08/2020	10/10/2023	Yes	No

Editorial Notes

10/10/2023: Publication reference added.
22/03/2018: Publication reference added.
25/08/2017: IPD sharing statement and publication references added.
14/02/2017: The overall trial end date has been updated from 31/03/2017 to 31/01/2017 and the recruitment end date has been updated from 28/02/2017 to 20/01/2017.
14/11/2016: Cancer Help UK lay summary link added.