Overview

This trial is active, not recruiting.

Conditions human papillomavirus, cervix cancer
Treatment education about hpv by school nurse
Sponsor Uppsala University
Collaborator Swedish Cancer Society
Start date January 2014
End date March 2016
Trial size 1050 participants
Trial identifier NCT02280967, RFR-387561

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking open label
Primary purpose prevention
Arm
(Experimental)
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 (short term follow-up) and also after one and two years (long term follow-up). Participants (n=400)
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)
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 (short term follow-up) and also after one and two years (long term follow-up). Participants (n=400)
(No Intervention)
Students allocated to control group 2 (bias group) receives standard treatment, the regular health interview with the school nurse. Students complete the follow-up questionnaire after two years. Participants (n=250)

Primary Outcomes

Measure
Intention to use condom if new partner
time frame: 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
time frame: Change from Baseline Intention at 24 months
Attitude to prevention about HPV
time frame: Change from Baseline Attitude at 3 months
Attitude to prevention about HPV
time frame: Change from Baseline Attitude at 12 months
Attitude to prevention about HPV
time frame: Change from Baseline Attitude at 24 months

Secondary Outcomes

Measure
Behavioural outcomes: Increased HPV vaccination and increased condom use.
time frame: 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.
Behavioural outcomes: Increased HPV vaccination and increased condom use.
time frame: Change from Baseline Behaviour at 24 months.

Eligibility Criteria

Male or female participants from 15 years up to 18 years old.

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.

Additional Information

Official title Prevention of Human Papillomavirus (HPV) Associated Cancer by Intervention Studies in Teenagers Attending School Health
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Uppsala University.