Prevention of HPV in the School Health Service

Study Overview
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Brief Summary
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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.

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

Conditions
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Human Papillomavirus, Cervix Cancer

Intervention / Treatment
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* Behavioral: Education about HPV by school nurse


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Education about HPV by school nurse<br>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<br>* Information about prevention of HPV among adolescents aged 16 at time for the regular health interview with the school nurse.<br>|
| No Intervention: Control group 1<br>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). | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 
| 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. | 
| 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Adolescent, Attitude, Condom, Human Papillomavirus Vaccines, Primary prevention, School Health