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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

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.


Condition or disease Intervention/treatment Phase
Human Papillomavirus Cervix Cancer Behavioral: Education about HPV by school nurse Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 832 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: Open label
Primary Purpose: Prevention
Official Title: Prevention of Human Papillomavirus (HPV) Associated Cancer by Intervention Studies in Teenagers Attending School Health
Study Start Date : January 2014
Actual Primary Completion Date : August 2017
Actual Study Completion Date : August 1, 2017

Arm Intervention/treatment
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)
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.

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).



Primary Outcome Measures :
  1. 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".

  2. 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".

  3. 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".

  4. 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".

  5. 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".

  6. 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".


Secondary Outcome Measures :
  1. 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?

  2. 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?

  3. 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?


Other Outcome Measures:
  1. 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?)

  2. 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?)

  3. 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?)



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Ages Eligible for Study:   15 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02280967


Locations
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Sweden
Uppsala University, Public Health and Caring Sciences
Uppsala, Sweden, 751 22
Sponsors and Collaborators
Uppsala University
Swedish Cancer Society
Uppsala-Örebro Regional Research Council
Investigators
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Study Director: Tanja Tydén, Professor Uppsala University
Additional Information:
Publications of Results:
Other Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Uppsala University
ClinicalTrials.gov Identifier: NCT02280967    
Other Study ID Numbers: RFR-387561
First Posted: November 2, 2014    Key Record Dates
Last Update Posted: September 5, 2017
Last Verified: September 2017
Keywords provided by Uppsala University:
Adolescent
Attitude
Condom
Human Papillomavirus Vaccines
Primary prevention
School Health
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female