Prevention of HPV in the School Health Service

NCT ID: NCT02280967

Last Updated: 2017-09-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

832 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-01-31

Study Completion Date

2017-08-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The last ten years sexually transmitted infections (STI) have substantially increased among adolescents. STI can lead to individual suffering and have a negative effect on the future reproductive health and also increase the need for health care, thus it is important to reduce the number of STIs. HPV vaccination is included in the school-based vaccination program since 2012, a catch-up vaccination is offered to older girls and young women aged 13-25. School nurses have a key role regarding information about HPV and HPV vaccine, and the school-based vaccination program has a substantial higher coverage rate. Knowledge is an important factor associated with attitude to preventive methods against HPV. In previous studies the results indicate that young people have low awareness of HPV and the HPV vaccine. Interventions can decrease sexual risk taking and influence the intention to receive HPV vaccination and increase the use of condom.

The aim of this study is to increase primary prevention of human papillomavirus (HPV) by promoting HPV vaccination and increase condom use among upper secondary students. The aim is also to increase the knowledge about HPV, risk and prevention.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Human Papillomavirus Cervix Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Open label

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Education about HPV by school nurse

The educational intervention consists of education about HPV and a special designed leaflet and self-reported questionnaires. The educational intervention is included in the regular health interview with the school nurse (scheduled for about one hour) and includes information about HPV; facts about the virus, transmission, what it can cause and prevention (i.e. safe sex with condom use and HPV vaccination), facts about HPV vaccine and the importance of attending future cervical cancer screening controls. Students complete questionnaires before the health interview at baseline and after three months. A follow-up with parts of the boys will be performed with qualitative interviews. Participants (n=40)

Group Type EXPERIMENTAL

Education about HPV by school nurse

Intervention Type BEHAVIORAL

Information about prevention of HPV among adolescents aged 16 at time for the regular health interview with the school nurse.

Control group 1

Students allocated to control group 1 receives standard treatment, the regular health interview with the school nurse. Students complete questionnaires before the health interview at baseline and after three months (n=400).

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Education about HPV by school nurse

Information about prevention of HPV among adolescents aged 16 at time for the regular health interview with the school nurse.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* First year students in upper secondary school who visit the school nurse for the regular health interview.
* Master Swedish in speech and writing.

Exclusion Criteria

* Students with cognitive disabilities.
Minimum Eligible Age

15 Years

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Swedish Cancer Society

OTHER

Sponsor Role collaborator

Uppsala-Örebro Regional Research Council

OTHER

Sponsor Role collaborator

Uppsala University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Tanja Tydén, Professor

Role: STUDY_DIRECTOR

Uppsala University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Uppsala University, Public Health and Caring Sciences

Uppsala, , Sweden

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Sweden

References

Explore related publications, articles, or registry entries linked to this study.

Shepherd J, Kavanagh J, Picot J, Cooper K, Harden A, Barnett-Page E, Jones J, Clegg A, Hartwell D, Frampton GK, Price A. The effectiveness and cost-effectiveness of behavioural interventions for the prevention of sexually transmitted infections in young people aged 13-19: a systematic review and economic evaluation. Health Technol Assess. 2010 Feb;14(7):1-206, iii-iv. doi: 10.3310/hta14070.

Reference Type BACKGROUND
PMID: 20178696 (View on PubMed)

Fu LY, Bonhomme LA, Cooper SC, Joseph JG, Zimet GD. Educational interventions to increase HPV vaccination acceptance: a systematic review. Vaccine. 2014 Apr 7;32(17):1901-20. doi: 10.1016/j.vaccine.2014.01.091. Epub 2014 Feb 14.

Reference Type BACKGROUND
PMID: 24530401 (View on PubMed)

Danielsson M, Berglund T, Forsberg M, Larsson M, Rogala C, Tyden T. Sexual and reproductive health: Health in Sweden: The National Public Health Report 2012. Chapter 9. Scand J Public Health. 2012 Dec;40(9 Suppl):176-96. doi: 10.1177/1403494812459600. No abstract available.

Reference Type RESULT
PMID: 23238407 (View on PubMed)

Gottvall M, Grandahl M, Hoglund AT, Larsson M, Stenhammar C, Andrae B, Tyden T. Trust versus concerns-how parents reason when they accept HPV vaccination for their young daughter. Ups J Med Sci. 2013 Nov;118(4):263-70. doi: 10.3109/03009734.2013.809039. Epub 2013 Jun 19.

Reference Type RESULT
PMID: 23777602 (View on PubMed)

Grandahl M, Oscarsson M, Stenhammar C, Neveus T, Westerling R, Tyden T. Not the right time: why parents refuse to let their daughters have the human papillomavirus vaccination. Acta Paediatr. 2014 Apr;103(4):436-41. doi: 10.1111/apa.12545. Epub 2014 Jan 8.

Reference Type RESULT
PMID: 24460679 (View on PubMed)

Grandahl M, Tyden T, Rosenblad A, Oscarsson M, Neveus T, Stenhammar C. School nurses' attitudes and experiences regarding the human papillomavirus vaccination programme in Sweden: a population-based survey. BMC Public Health. 2014 May 31;14:540. doi: 10.1186/1471-2458-14-540.

Reference Type RESULT
PMID: 24886332 (View on PubMed)

Shepherd JP, Frampton GK, Harris P. Interventions for encouraging sexual behaviours intended to prevent cervical cancer. Cochrane Database Syst Rev. 2011 Apr 13;2011(4):CD001035. doi: 10.1002/14651858.CD001035.pub2.

Reference Type RESULT
PMID: 21491379 (View on PubMed)

Grandahl M, Rosenblad A, Stenhammar C, Tyden T, Westerling R, Larsson M, Oscarsson M, Andrae B, Dalianis T, Neveus T. School-based intervention for the prevention of HPV among adolescents: a cluster randomised controlled study. BMJ Open. 2016 Jan 27;6(1):e009875. doi: 10.1136/bmjopen-2015-009875.

Reference Type DERIVED
PMID: 26817639 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

RFR-387561

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Promoting HPV Vaccination Among Young Adults in Texas
NCT05057312 ACTIVE_NOT_RECRUITING NA
Stories to Prevent (StoP) HPV Cancers
NCT06808776 RECRUITING NA