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Prevention of HPV in the School Health Service

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02280967
Recruitment Status : Completed
First Posted : November 2, 2014
Last Update Posted : September 5, 2017
Sponsor:
Collaborators:
Swedish Cancer Society
Uppsala-Örebro Regional Research Council
Information provided by (Responsible Party):
Uppsala University

Tracking Information
First Submitted Date  ICMJE October 21, 2014
First Posted Date  ICMJE November 2, 2014
Last Update Posted Date September 5, 2017
Study Start Date  ICMJE January 2014
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
  • Intention to use condom if new partner [ Time Frame: Change from Baseline Intention at 3 months ]
    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 [ Time Frame: Change from Baseline Intention at 12 months ]
    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 [ Time Frame: Change from Baseline Intention at 24 months ]
    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 [ Time Frame: Change from Baseline Attitude at 3 months ]
    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 [ Time Frame: Change from Baseline Attitude at 12 months ]
    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 [ Time Frame: Change from Baseline Attitude at 24 months ]
    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".
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 29, 2014)
  • Behavioural outcomes: Increased HPV vaccination and increased condom use. [ Time Frame: Change from Baseline Behaviour at 3 months. ]
    Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?
  • Behavioural outcomes: Increased HPV vaccination and increased condom use. [ Time Frame: Change from Baseline Behaviour at 12 months. ]
    Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?
  • Behavioural outcomes: Increased HPV vaccination and increased condom use. [ Time Frame: Change from Baseline Behaviour at 24 months. ]
    Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: October 29, 2014)
  • Knowledge about HPV [ Time Frame: Change from Baseline Knowledge at 3 months ]
    Knowledge about HPV measured by questionnaire. (Facts about the virus, transmission, what HPV can cause. Heard of HPV vaccine?)
  • Knowledge about HPV [ Time Frame: Change from Baseline Knowledge at 12 months ]
    Knowledge about HPV measured by questionnaire. (Facts about the virus, transmission, what HPV can cause. Heard of HPV vaccine?)
  • Knowledge about HPV [ Time Frame: Change from Baseline Knowledge at 24 months ]
    Knowledge about HPV measured by questionnaire. (Facts about the virus, transmission, what HPV can cause. Heard of HPV vaccine?)
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Prevention of HPV in the School Health Service
Official Title  ICMJE Prevention of Human Papillomavirus (HPV) Associated Cancer by Intervention Studies in Teenagers Attending School Health
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description:
Open label
Primary Purpose: Prevention
Condition  ICMJE
  • Human Papillomavirus
  • Cervix Cancer
Intervention  ICMJE 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.
Study Arms  ICMJE
  • Experimental: 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)
    Intervention: Behavioral: Education about HPV by school nurse
  • No Intervention: 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).
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: September 1, 2017)
832
Original Estimated Enrollment  ICMJE
 (submitted: October 29, 2014)
1050
Actual Study Completion Date  ICMJE August 1, 2017
Actual Primary Completion Date August 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 15 Years to 18 Years   (Child, Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Sweden
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02280967
Other Study ID Numbers  ICMJE RFR-387561
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Uppsala University
Study Sponsor  ICMJE Uppsala University
Collaborators  ICMJE
  • Swedish Cancer Society
  • Uppsala-Örebro Regional Research Council
Investigators  ICMJE
Study Director: Tanja Tydén, Professor Uppsala University
PRS Account Uppsala University
Verification Date September 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP