Condition category
Infections and Infestations
Date applied
16/08/2016
Date assigned
26/09/2016
Last edited
14/11/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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

31/03/2017

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

Healthy volunteer

Age group

Mixed

Gender

Both

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

01/07/2016

Recruitment end date

28/02/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

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

Sponsor information

Organisation

University College London

Sponsor details

Gower Street
London
WC1E 6BT
United Kingdom

Sponsor type

University/education

Website

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)

Intention to publish date

31/03/2017

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

14/11/2016: Cancer Help UK lay summary link added.