ISRCTN ISRCTN86240771
DOI https://doi.org/10.1186/ISRCTN86240771
Protocol serial number N/A
Sponsor University of Hamburg (Germany)
Funder University of Hamburg (Germany) - paid the salary of the PI
Submission date
31/01/2011
Registration date
25/03/2011
Last edited
30/06/2014
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

Not provided at time of registration

Contact information

Dr Anke Steckelberg
Scientific

Martin-Luther King Platz 6
Hamburg
20146
Germany

Email asteckelberg@uni-hamburg.de

Study information

Primary study designInterventional
Study designDouble-blind randomised controlled trial
Secondary study designRandomised controlled trial
Study type Participant information sheet
Scientific titleImpact of an evidence-based leaflet on 'risk knowledge' of human papillomavirus (HPV) vaccination in disadvantaged pupils: a randomised controlled trial
Study acronymHPV-Eva
Study objectivesEvidence-based patient information leads to better risk knowledge in human papillomavirus (HPV) vaccination compared to standard information.
Ethics approval(s)1. The Ministry of Education and Culture, 30/10/2009
2. The Ethics Committee in Hamburg, 11/01/2011, ref: PV3344
Health condition(s) or problem(s) studiedHuman papillomavirus (HPV) vaccination
InterventionIntervention: evidence-based patient information
Control treatment: standard patient information

Pupils received either the evidence-based leaflet or the standard one in the beginning of a 1.5 hour session.
Intervention typeDrug
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Human papillomavirus (HPV) vaccination
Primary outcome measure(s)

Risk-knowledge, measured immediately after the intervention

Key secondary outcome measure(s)

No secondary outcome measures

Completion date01/05/2010

Eligibility

Participant type(s)Patient
Age groupChild
SexFemale
Target sample size at registration94
Key inclusion criteriaParticipants were vocational school pupils who were preparing for grade 10 graduation and who were members of the target group for HPV vaccination.
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/01/2010
Date of final enrolment01/05/2010

Locations

Countries of recruitment

  • Germany

Study participating centre

Martin-Luther King Platz 6
Hamburg
20146
Germany

Results and Publications

Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
IPD sharing plan

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?
Results article results 17/10/2013 Yes No
Participant information sheet Participant information sheet 11/11/2025 11/11/2025 No Yes