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AzTrials

Human PapillomavirusNCT02280967

Prevention of HPV in the School Health Service

A study testing Education about HPV by school nurse in people with Human Papillomavirus and Cervix Cancer, run by Uppsala University at 1 site in Sweden.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 15 to 18 yearsHealthy volunteers can take part
Conditions the study is for
Human Papillomavirus, Cervix Cancer
What is being tested?
Education about HPV by school nurse
Could I receive a placebo?
No, everyone receives an active treatment
How many people
832 participants
Where
1 siteSweden
Study dates
Jan 2014to 1 Aug 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 15 to 18 years
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult

Who may be able to join

  • First year students in upper secondary school who visit the school nurse for the regular health interview.
  • Master Swedish in speech and writing.

Who cannot join

  • Students with cognitive disabilities.

Trial locations and contacts

1 site in 1 country.

Sweden1 site

  • Uppsala University, Public Health and Caring Sciences

    Uppsala, 751 22

Other trials in Sweden

About this study

Official title: 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.

Being tested
Education about HPV by school nurse
Keywords
Adolescent, Attitude, Condom, Human Papillomavirus Vaccines, Primary prevention, School Health
Medical subject headings
Uterine Cervical Neoplasms, Behavior

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Education about HPV by school nurseBehavioural

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

Study groups in NCT02280967
Study groupRoleWhat they receive
Education about HPV by school nurseExperimentalThe 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)
Receives: Behavioral: Education about HPV by school nurse
Control group 1No interventionStudents 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 being measured

The primary outcome is the main question the study is designed to answer.

  1. 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".

    Measured: Change from Baseline Intention at 3 months

  2. 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".

    Measured: Change from Baseline Intention at 12 months

  3. 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".

    Measured: Change from Baseline Intention at 24 months

  4. 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".

    Measured: Change from Baseline Attitude at 3 months

  5. 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".

    Measured: Change from Baseline Attitude at 12 months

  6. 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".

    Measured: Change from Baseline Attitude at 24 months

Secondary outcomes (3)

  1. Behavioural outcomes: Increased HPV vaccination and increased condom use.

    Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?

    Measured: Change from Baseline Behaviour at 3 months.

  2. Behavioural outcomes: Increased HPV vaccination and increased condom use.

    Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?

    Measured: Change from Baseline Behaviour at 12 months.

  3. Behavioural outcomes: Increased HPV vaccination and increased condom use.

    Measured by questionnaire. Vaccinated against HPV? Condom use at last sexual intercourse?

    Measured: Change from Baseline Behaviour at 24 months.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Nov 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionAug 2017
  4. Study completion1 Aug 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
832 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02280967
Sponsor's protocol ID
RFR-387561
Status last verified
Sep 2017
First submitted
21 Oct 2014
Last updated
5 Sep 2017
Results posted
No
Data monitoring committee
No

Publications

  • Shepherd J, Kavanagh J, Picot J, Cooper K, Harden A, Barnett-Page E, Jones J, Clegg A, Hartwell D, Frampton GK, Price A. The effectiveness and cost-effectiveness of behavioural interventions for the prevention of sexually transmitted infections in young people aged 13-19: a systematic review and economic evaluation. Health Technol Assess. 2010 Feb;14(7):1-206, iii-iv. doi: 10.3310/hta14070.

    PubMed 20178696

  • Fu LY, Bonhomme LA, Cooper SC, Joseph JG, Zimet GD. Educational interventions to increase HPV vaccination acceptance: a systematic review. Vaccine. 2014 Apr 7;32(17):1901-20. doi: 10.1016/j.vaccine.2014.01.091. Epub 2014 Feb 14.

    PubMed 24530401

  • Danielsson M, Berglund T, Forsberg M, Larsson M, Rogala C, Tyden T. Sexual and reproductive health: Health in Sweden: The National Public Health Report 2012. Chapter 9. Scand J Public Health. 2012 Dec;40(9 Suppl):176-96. doi: 10.1177/1403494812459600. No abstract available.

    PubMed 23238407

  • Gottvall M, Grandahl M, Hoglund AT, Larsson M, Stenhammar C, Andrae B, Tyden T. Trust versus concerns-how parents reason when they accept HPV vaccination for their young daughter. Ups J Med Sci. 2013 Nov;118(4):263-70. doi: 10.3109/03009734.2013.809039. Epub 2013 Jun 19.

    PubMed 23777602

  • Grandahl M, Oscarsson M, Stenhammar C, Neveus T, Westerling R, Tyden T. Not the right time: why parents refuse to let their daughters have the human papillomavirus vaccination. Acta Paediatr. 2014 Apr;103(4):436-41. doi: 10.1111/apa.12545. Epub 2014 Jan 8.

    PubMed 24460679

  • Grandahl M, Tyden T, Rosenblad A, Oscarsson M, Neveus T, Stenhammar C. School nurses' attitudes and experiences regarding the human papillomavirus vaccination programme in Sweden: a population-based survey. BMC Public Health. 2014 May 31;14:540. doi: 10.1186/1471-2458-14-540.

    PubMed 24886332

  • Shepherd JP, Frampton GK, Harris P. Interventions for encouraging sexual behaviours intended to prevent cervical cancer. Cochrane Database Syst Rev. 2011 Apr 13;2011(4):CD001035. doi: 10.1002/14651858.CD001035.pub2.

    PubMed 21491379

  • Grandahl M, Rosenblad A, Stenhammar C, Tyden T, Westerling R, Larsson M, Oscarsson M, Andrae B, Dalianis T, Neveus T. School-based intervention for the prevention of HPV among adolescents: a cluster randomised controlled study. BMJ Open. 2016 Jan 27;6(1):e009875. doi: 10.1136/bmjopen-2015-009875.

    PubMed 26817639

Questions about this trial

What is this clinical trial studying?

A study testing Education about HPV by school nurse in people with Human Papillomavirus and Cervix Cancer, run by Uppsala University at 1 site in Sweden.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Intention to use condom if new partner (time frame: Change from Baseline Intention at 3 months). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02280967, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2017.

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