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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02280967
Other study ID # RFR-387561
Secondary ID
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
Health authority
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.

Study Design


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.
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