Contact information
Type
Public
Primary contact
Ms Lauren Rockliffe
ORCID ID
Contact details
Health Behaviour Research Centre
UCL
Gower Street
London
WC1E 6BT
United Kingdom
Type
Scientific
Additional contact
Dr Alice Forster
ORCID ID
http://orcid.org/0000-0002-9933-7919
Contact details
Health Behaviour Research Centre
UCL
Gower Street
London
WC1E 6BT
United Kingdom
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
A cluster randomised feasibility study of an adolescent incentive intervention to increase uptake of HPV vaccination among girls
Acronym
reWARD off HPV
Study hypothesis
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
UCL Research Ethics Committee, 09/06/2016, ref: 6615/002
Study design
Two-arm single-blind cluster randomised feasibility trial
Primary study design
Interventional
Secondary study design
Cluster randomised trial
Trial setting
Schools
Trial type
Prevention
Patient information sheet
Not available in web format, please use contact details to request a participant information sheet.
Condition
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
Phase
Drug names
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
01/07/2016
Overall trial end date
31/01/2017
Reason abandoned
Eligibility
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
Participant type
Mixed
Age group
Mixed
Gender
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.
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
01/07/2016
Recruitment end date
20/01/2017
Locations
Countries of recruitment
United Kingdom
Trial participating centre
University College London
Health Behaviour Research Centre
Gower Street
London
WC1E 6BT
United Kingdom
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
other non-profit
Location
United Kingdom
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)
IPD sharing statement
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).
Intention to publish date
31/03/2017
Participant level data
Available on request
Results - basic reporting
Publication summary
2017 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/28286668
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/28829766
2018 results in: https://www.ncbi.nlm.nih.gov/pubmed/29558923