Condition category
Infections and Infestations
Date applied
31/01/2011
Date assigned
25/03/2011
Last edited
30/06/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Dr Anke Steckelberg

ORCID ID

Contact details

Martin-Luther King Platz 6
Hamburg
20146
Germany
asteckelberg@uni-hamburg.de

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Impact of an evidence-based leaflet on 'risk knowledge' of human papillomavirus (HPV) vaccination in disadvantaged pupils: a randomised controlled trial

Acronym

HPV-Eva

Study hypothesis

Evidence-based patient information leads to better risk knowledge in human papillomavirus (HPV) vaccination compared to standard information.

Ethics approval

1. The Ministry of Education and Culture, 30/10/2009
2. The Ethics Committee in Hamburg, 11/01/2011, ref: PV3344

Study design

Double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request the patient information

Condition

Human papillomavirus (HPV) vaccination

Intervention

Intervention: 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 type

Drug

Phase

Not Applicable

Drug names

Human papillomavirus (HPV) vaccination

Primary outcome measures

Risk-knowledge, measured immediately after the intervention

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/01/2010

Overall trial end date

01/05/2010

Reason abandoned

Eligibility

Participant inclusion criteria

Participants were vocational school pupils who were preparing for grade 10 graduation and who were members of the target group for HPV vaccination.

Participant type

Patient

Age group

Child

Gender

Female

Target number of participants

94

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2010

Recruitment end date

01/05/2010

Locations

Countries of recruitment

Germany

Trial participating centre

Martin-Luther King Platz 6
Hamburg
20146
Germany

Sponsor information

Organisation

University of Hamburg (Germany)

Sponsor details

Martin-Luther King Platz 6
Hamburg
20146
Germany
asteckelberg@uni-hamburg.de

Sponsor type

University/education

Website

http://www.uni-hamburg.de/

Funders

Funder type

University/education

Funder name

University of Hamburg (Germany) - paid the salary of the PI

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24198750

Publication citations

  1. Results

    Steckelberg A, Albrecht M, Kezle A, Kasper J, Mühlhauser I, Impact of numerical information on risk knowledge regarding human papillomavirus (HPV) vaccination among schoolgirls: a randomised controlled trial., Ger Med Sci, 2013, 11, Doc15, doi: 10.3205/000183.

Additional files

Editorial Notes