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Completed

NCT Number: NCT02280967

Prevention of HPV in the School Health Service

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.

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Key information

Conditions

Human Papillomavirus Behavior Cervix Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Cervical Diseases Uterine Cervical Neoplasms Uterine Diseases Uterine Neoplasms

Age range

15 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Uppsala University, Public Health and Caring Sciences

Uppsala, 751 22, Sweden

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Education about HPV by school nurse

Behavioral

Information about prevention of HPV among adolescents aged 16 at time for the regular health interview with the school nurse.

Primary outcomes

  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 outcomes

  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 outcomes

  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?)

Sponsors and collaborators

Lead sponsor

Uppsala University

Other

Collaborators

  • Swedish Cancer Society
  • Uppsala-Örebro Regional Research Council

Registry information

Official study title

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

Important dates

Study start
2014
Primary completion
2017
Study completion
2017
First posted
Nov 3, 2014
Registry last updated
Sep 5, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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