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Evaluation of a sex education lesson on chlamydia to see whether it increases the likelihood that young adults will use condoms to protect against this sexually transmitted infection (STI)
ISRCTN ISRCTN54091015
DOI 10.1186/ISRCTN54091015
ClinicalTrials.gov identifier
EudraCT number
Public title Evaluation of a sex education lesson on chlamydia to see whether it increases the likelihood that young adults will use condoms to protect against this sexually transmitted infection (STI)
Scientific title Increasing young adults’ condom use intentions and behaviour through changing chlamydia risk and coping appraisals: A cluster randomised controlled trial of efficacy
Acronym N/A
Serial number at source N/A
Study hypothesis Primary research question
1. Is the lesson effective in increasing young people’s intentions to use condoms during vaginal sex with casual sexual partners?

Secondary research questions
2. Is the lesson effective in increasing young people’s condom use during vaginal sex with casual sexual partners?
3. If the lesson is effective, are changes in young people’s condom use intentions or behaviour due to changes in their chlamydia risk appraisals (perceived likelihood and severity) and/or coping appraisals (condom use response efficacy and self-efficacy)?
Lay summary Background and study aims
We think that young people may underestimate their risk of getting a sexually transmitted infection (STI) called ‘chlamydia’. This infection can be serious if untreated, leading to conditions such as infertility. We want to increase young peoples’ knowledge and understanding of this STI, and see whether in doing this we can also increase their motivation to use condoms to protect themselves against it.
The study aims to find out if after having a sex education lesson on chlamydia, young peoples’ beliefs about the risk of chalmydia have changed and whether they are then more likely to use condoms during sexual intercourse.

Who can participate?
Pupils aged 13-16 from selected secondary schools across England will be taking part.

What does the study involve?
Schools will be selected at random to be given either:
• Their usual teaching on STIs plus a specially designed lesson on chlamydia
• Just their usual teaching on STIs
All pupils will be asked to complete three short questionnaires: one before the lessons, one straight after, and one three months later.

What are the possible benefits and risks of participating?
Pupils will get the opportunity to be involved in shaping future sex education on STIs. Schools will receive a £60 Amazon voucher in recognition of the time and support they have given to the study.
We are not aware of any risks involved with taking part.

Where is the study run from?
Coventry University (Applied research Centre in Heath and Lifestyle Interventions (ARC-HLI)) and the Health Protection Agency (Primary Care Unit) are running this study. Coventry University is the lead organisation.

When is the study starting and how long is it expected to run for?
The study will start in January 2013 and end in December 2013. Participants will be recruited until March 2013. Data collection will end in August 2013.

Who is funding the study?
The study has no funding. Researchers’ time and overheads are being funded by their respective organisations.

Who is the main contact?
Katie Newby
k.newby@coventry.ac.uk
Ethics approval Coventry University Ethics Committee approval pending
Study design Two-arm cluster randomised controlled trial with a waiting-list control
Countries of recruitment United Kingdom
Disease/condition/study domain Chlamydia trachomatis
Participants - inclusion criteria 1. Aged 13-16 years old
2. Attending a secondary school in England which has a Sex and Relationships Education (SRE) protocol and curriculum
3. Have not received any previous formal education on STIs through school
Participants - exclusion criteria Does not meet inclusion criteria
Anticipated start date 01/01/2013
Anticipated end date 31/12/2013
Status of trial Completed
Patient information material Not available in web format, please use the contact details below to request a patient information sheet
Target number of participants 770
Interventions In the experimental group, participants will receive the school's standard teaching on STIs plus a theory- and evidence-based lesson on chlamydia.

In the control group participants will receive just their school's usual teaching on STIs.

The teaching will last 40 minutes. The duration of follow-up is three months.
Primary outcome measure(s) Intention to use condoms during vaginal sex with casual sexual partners over the next three months
Secondary outcome measure(s) 1. Use of condoms during vaginal sex with casual sexual partners over three months post delivery
2. Perceived likelihood of chlamydia
3. Perceived severity of chlamydia
4. Response efficacy for condom use
5. Self-efficacy for using condoms during vaginal sex with casual sexual partners over the next three months
Sources of funding Coventry University (UK)
Trial website
Publications
Contact name Mrs  Katie  Newby
  Address Coventry University
Faculty of Health and Life Sciences
ARC-HLI / WF121
Priory Street
  City/town Coventry
  Zip/Postcode CV1 5FB
  Country United Kingdom
  Email k.newby@coventry.ac.uk
Sponsor Coventry University (UK)
  Address Priory Street
  City/town Coventry
  Zip/Postcode CV1 5FB
  Country United Kingdom
  Tel +44 (0)24 7688 7688
  Email genenq.hls@coventry.ac.uk
  Sponsor website: http://www.coventry.ac.uk
Date applied 22/11/2012
Last edited 28/12/2012
Date ISRCTN assigned 28/12/2012
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