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Prevention of HPV in the School Health Service

Primary Purpose

Human Papillomavirus, Cervix Cancer

Status
Completed
Phase
Not Applicable
Locations
Sweden
Study Type
Interventional
Intervention
Education about HPV by school nurse
Sponsored by
Uppsala University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Human Papillomavirus focused on measuring Adolescent, Attitude, Condom, Human Papillomavirus Vaccines, Primary prevention, School Health

Eligibility Criteria

15 Years - 18 Years (Child, Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Uppsala University, Public Health and Caring Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Education about HPV by school nurse

Control group 1

Arm Description

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)

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).

Outcomes

Primary Outcome Measures

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".
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".
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".
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".
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".
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".

Secondary Outcome Measures

Behavioural outcomes: Increased HPV vaccination and increased condom use.
Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?
Behavioural outcomes: Increased HPV vaccination and increased condom use.
Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?
Behavioural outcomes: Increased HPV vaccination and increased condom use.
Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?

Full Information

First Posted
October 21, 2014
Last Updated
September 1, 2017
Sponsor
Uppsala University
Collaborators
Swedish Cancer Society, Uppsala-Örebro Regional Research Council
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1. Study Identification

Unique Protocol Identification Number
NCT02280967
Brief Title
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

2. Study Status

Record Verification Date
September 2017
Overall Recruitment Status
Completed
Study Start Date
January 2014 (undefined)
Primary Completion Date
August 2017 (Actual)
Study Completion Date
August 1, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Uppsala University
Collaborators
Swedish Cancer Society, Uppsala-Örebro Regional Research Council

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Papillomavirus, Cervix Cancer
Keywords
Adolescent, Attitude, Condom, Human Papillomavirus Vaccines, Primary prevention, School Health

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
Randomized
Enrollment
832 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Education about HPV by school nurse
Arm Type
Experimental
Arm Description
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)
Arm Title
Control group 1
Arm Type
No Intervention
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Education about HPV by school nurse
Intervention Description
Information about prevention of HPV among adolescents aged 16 at time for the regular health interview with the school nurse.
Primary Outcome Measure Information:
Title
Intention to use condom if new partner
Description
Intention to use condom if new partner measured by questionnaire, five-point Likert scale ranging from "totally agree" to "totally disagree".
Time Frame
Change from Baseline Intention at 3 months
Title
Intention to use condom if new partner
Description
Intention to use condom if new partner measured by questionnaire, five-point Likert scale ranging from "totally agree" to "totally disagree".
Time Frame
Change from Baseline Intention at 12 months
Title
Intention to use condom if new partner
Description
Intention to use condom if new partner measured by questionnaire, five-point Likert scale ranging from "totally agree" to "totally disagree".
Time Frame
Change from Baseline Intention at 24 months
Title
Attitude to prevention about HPV
Description
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".
Time Frame
Change from Baseline Attitude at 3 months
Title
Attitude to prevention about HPV
Description
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".
Time Frame
Change from Baseline Attitude at 12 months
Title
Attitude to prevention about HPV
Description
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".
Time Frame
Change from Baseline Attitude at 24 months
Secondary Outcome Measure Information:
Title
Behavioural outcomes: Increased HPV vaccination and increased condom use.
Description
Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?
Time Frame
Change from Baseline Behaviour at 3 months.
Title
Behavioural outcomes: Increased HPV vaccination and increased condom use.
Description
Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?
Time Frame
Change from Baseline Behaviour at 12 months.
Title
Behavioural outcomes: Increased HPV vaccination and increased condom use.
Description
Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?
Time Frame
Change from Baseline Behaviour at 24 months.
Other Pre-specified Outcome Measures:
Title
Knowledge about HPV
Description
Knowledge about HPV measured by questionnaire. (Facts about the virus, transmission, what HPV can cause. Heard of HPV vaccine?)
Time Frame
Change from Baseline Knowledge at 3 months
Title
Knowledge about HPV
Description
Knowledge about HPV measured by questionnaire. (Facts about the virus, transmission, what HPV can cause. Heard of HPV vaccine?)
Time Frame
Change from Baseline Knowledge at 12 months
Title
Knowledge about HPV
Description
Knowledge about HPV measured by questionnaire. (Facts about the virus, transmission, what HPV can cause. Heard of HPV vaccine?)
Time Frame
Change from Baseline Knowledge at 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
15 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tanja Tydén, Professor
Organizational Affiliation
Uppsala University
Official's Role
Study Director
Facility Information:
Facility Name
Uppsala University, Public Health and Caring Sciences
City
Uppsala
ZIP/Postal Code
751 22
Country
Sweden

12. IPD Sharing Statement

Citations:
PubMed Identifier
20178696
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.
Results Reference
background
PubMed Identifier
24530401
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.
Results Reference
background
PubMed Identifier
23238407
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.
Results Reference
result
PubMed Identifier
23777602
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.
Results Reference
result
PubMed Identifier
24460679
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.
Results Reference
result
PubMed Identifier
24886332
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.
Results Reference
result
PubMed Identifier
21491379
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.
Results Reference
result
PubMed Identifier
26817639
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.
Results Reference
derived
Links:
URL
http://www.folkhalsomyndigheten.se/nyheter-och-press/nyhetsarkiv/2016/mars/atta-av-tio-flickor-vaccinerade-mot-hpv/
Description
Public Health Agency of Sweden

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Prevention of HPV in the School Health Service

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