Prevention of HPV in the School Health Service

September 1, 2017 updated by: Uppsala University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

832

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
      • Uppsala, Sweden, 751 22
        • Uppsala University, Public Health and Caring Sciences

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / 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).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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".
Change from Baseline Intention at 3 months
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".
Change from Baseline Intention at 12 months
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".
Change from Baseline Intention at 24 months
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".
Change from Baseline Attitude at 3 months
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".
Change from Baseline Attitude at 12 months
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".
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.
Time Frame: Change from Baseline Behaviour at 3 months.
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.
Time Frame: Change from Baseline Behaviour at 12 months.
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.
Time Frame: Change from Baseline Behaviour at 24 months.
Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?
Change from Baseline Behaviour at 24 months.

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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?)
Change from Baseline Knowledge at 3 months
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?)
Change from Baseline Knowledge at 12 months
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?)
Change from Baseline Knowledge at 24 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Uppsala University

Collaborators

Uppsala-Örebro Regional Research Council
Swedish Cancer Society

Investigators

  • Study Director: Tanja Tydén, Professor, Uppsala University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (Actual)

August 1, 2017

Study Completion (Actual)

August 1, 2017

Study Registration Dates

First Submitted

October 21, 2014

First Submitted That Met QC Criteria

October 29, 2014

First Posted (Estimate)

November 2, 2014

Study Record Updates

Last Update Posted (Actual)

September 5, 2017

Last Update Submitted That Met QC Criteria

September 1, 2017

Last Verified

September 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RFR-387561

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Cervix Cancer

Clinical Trials on Education about HPV by school nurse

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe