Prevention of HPV in the School Health Service

Cervix Cancer Clinical Trial

Official title:

Prevention of Human Papillomavirus (HPV) Associated Cancer by Intervention Studies in Teenagers Attending School Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02280967
• Other study ID #: RFR-387561
• Status: Completed
• Phase: N/A
• First received: October 21, 2014
• Last updated: September 1, 2017
• Start date: January 2014
• Est. completion date: August 1, 2017

Study information

• Verified date: September 2017
• Source: Uppsala University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 832
• Est. completion date: August 1, 2017
• Est. primary completion date: August 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 15 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cervix Cancer
• Human Papillomavirus
• Uterine Cervical Neoplasms

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
Sweden	Uppsala University, Public Health and Caring Sciences	Uppsala

Sponsors (3)

Lead Sponsor	Collaborator
Uppsala University	Swedish Cancer Society, Uppsala-Örebro Regional Research Council

Country where clinical trial is conducted

Sweden, 

References & Publications (7)

Danielsson M, Berglund T, Forsberg M, Larsson M, Rogala C, Tydén 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. — View 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. Review. — View Citation

Gottvall M, Grandahl M, Höglund AT, Larsson M, Stenhammar C, Andrae B, Tydén 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. E — View Citation

Grandahl M, Oscarsson M, Stenhammar C, Nevéus T, Westerling R, Tydén 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 — View Citation

Grandahl M, Tydén T, Rosenblad A, Oscarsson M, Nevéus 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: 10.1 — View 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. Review. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Knowledge about HPV	Knowledge about HPV measured by questionnaire. (Facts about the virus, transmission, what HPV can cause. Heard of HPV vaccine?)	Change from Baseline Knowledge at 3 months
Other	Knowledge about HPV	Knowledge about HPV measured by questionnaire. (Facts about the virus, transmission, what HPV can cause. Heard of HPV vaccine?)	Change from Baseline Knowledge at 12 months
Other	Knowledge about HPV	Knowledge about HPV measured by questionnaire. (Facts about the virus, transmission, what HPV can cause. Heard of HPV vaccine?)	Change from Baseline Knowledge at 24 months
Primary	Intention to use condom if new partner	Intention to use condom if new partner measured by questionnaire, five-point Likert scale ranging from "totally agree" to "totally disagree".	Change from Baseline Intention at 3 months
Primary	Intention to use condom if new partner	Intention to use condom if new partner measured by questionnaire, five-point Likert scale ranging from "totally agree" to "totally disagree".	Change from Baseline Intention at 12 months
Primary	Intention to use condom if new partner	Intention to use condom if new partner measured by questionnaire, five-point Likert scale ranging from "totally agree" to "totally disagree".	Change from Baseline Intention at 24 months
Primary	Attitude to prevention about HPV	Attitude to HPV vaccine. Intention to be vaccinated against HPV. Condom use and intention to attend future cervical cancer screening programmes. Measured by questionnaire, five-point Likert scale ranging from "totally agree" to "totally disagree".	Change from Baseline Attitude at 3 months
Primary	Attitude to prevention about HPV	Attitude to HPV vaccine. Intention to be vaccinated against HPV. Condom use and intention to attend future cervical cancer screening programmes. Measured by questionnaire, five-point Likert scale ranging from "totally agree" to "totally disagree".	Change from Baseline Attitude at 12 months
Primary	Attitude to prevention about HPV	Attitude to HPV vaccine. Intention to be vaccinated against HPV. Condom use and intention to attend future cervical cancer screening programmes. Measured by questionnaire, five-point Likert scale ranging from "totally agree" to "totally disagree".	Change from Baseline Attitude at 24 months
Secondary	Behavioural outcomes: Increased HPV vaccination and increased condom use.	Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?	Change from Baseline Behaviour at 3 months.
Secondary	Behavioural outcomes: Increased HPV vaccination and increased condom use.	Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?	Change from Baseline Behaviour at 12 months.
Secondary	Behavioural outcomes: Increased HPV vaccination and increased condom use.	Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?	Change from Baseline Behaviour at 24 months.

External Links

•   Public Health Agency of Sweden