Plain English 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

Trial website

Contact information

Type

Scientific

Primary contact

Mrs Katie Newby

ORCID ID

Contact details

Coventry University
Faculty of Health and Life Sciences
ARC-HLI / WF121
Priory Street
Coventry
CV1 5FB
United Kingdom
k.newby@coventry.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

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

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)?

Ethics approval

Coventry University Ethics Committee approval pending

Study design

Two-arm cluster randomised controlled trial with a waiting-list control

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Chlamydia trachomatis

Intervention

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.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

Intention to use condoms during vaginal sex with casual sexual partners over the next three months

Secondary outcome measures

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

Overall trial start date

01/01/2013

Overall trial end date

31/12/2013

Reason abandoned

Eligibility

Participant 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

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

770

Participant exclusion criteria

Does not meet inclusion criteria

Recruitment start date

01/01/2013

Recruitment end date

31/12/2013

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Coventry University
Coventry
CV1 5FB
United Kingdom

Sponsor information

Organisation

Coventry University (UK)

Sponsor details

Priory Street
Coventry
CV1 5FB
United Kingdom
+44 (0)24 7688 7688
genenq.hls@coventry.ac.uk

Sponsor type

University/education

Website

http://www.coventry.ac.uk

Funders

Funder type

University/education

Funder name

Coventry University (UK)

Alternative name(s)

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Editorial Notes