Clinical trial NCT02280967: Prevention of HPV in the School Health Service
Official title: Prevention of Human Papillomavirus (HPV) Associated Cancer by Intervention Studies in Teenagers Attending School Health
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Human Papillomavirus
Cervix Cancer
Keywords: Adolescent
Attitude
Condom
Human Papillomavirus Vaccines
Primary prevention
School Health
Lead sponsor: Uppsala University
Sponsor class: OTHER
Collaborators: name: Swedish Cancer Society
name: Uppsala-Örebro Regional Research Council
First posted: 2014-11-02
Enrollment: 832
Sex: ALL
Minimum age (years): 15
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Intention to use condom if new partner
timeFrame: Change from Baseline Intention at 3 months
measure: Intention to use condom if new partner
timeFrame: Change from Baseline Intention at 12 months
measure: Intention to use condom if new partner
timeFrame: Change from Baseline Intention at 24 months
measure: Attitude to prevention about HPV
timeFrame: Change from Baseline Attitude at 3 months
measure: Attitude to prevention about HPV
timeFrame: Change from Baseline Attitude at 12 months
measure: Attitude to prevention about HPV
timeFrame: Change from Baseline Attitude at 24 months
Secondary outcomes:
measure: Behavioural outcomes: Increased HPV vaccination and increased condom use.
timeFrame: Change from Baseline Behaviour at 3 months.
measure: Behavioural outcomes: Increased HPV vaccination and increased condom use.
timeFrame: Change from Baseline Behaviour at 12 months.
measure: Behavioural outcomes: Increased HPV vaccination and increased condom use.
timeFrame: Change from Baseline Behaviour at 24 months.
Other outcomes:
measure: Knowledge about HPV
timeFrame: Change from Baseline Knowledge at 3 months
measure: Knowledge about HPV
timeFrame: Change from Baseline Knowledge at 12 months
measure: Knowledge about HPV
timeFrame: Change from Baseline Knowledge at 24 months
Locations:
city: Uppsala
country: Sweden
facility: Uppsala University, Public Health and Caring Sciences
Study officials:
affiliation: Uppsala University
name: Tanja Tydén, Professor
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.