Human papillomavirus (HPV) Infections and Infestations
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
Exclusion criteria
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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
| Measure | Time frame |
|---|---|
| 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 vaccinatio | — |
Countries
England, United Kingdom