Condition category
Infections and Infestations
Date applied
22/11/2012
Date assigned
28/12/2012
Last edited
14/12/2017
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
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. Increasing young peoples' knowledge and understanding of this STI may 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

What does the study involve?
Schools are selected at random to give either just their usual teaching on STIs, or their usual teaching on STIs plus a specially designed lesson on chlamydia. All pupils are 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 get the opportunity to be involved in shaping future sex education on STIs. Schools receive a £60 Amazon voucher in recognition of the time and support they have given to the study. There are not thought to be 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?
January 2013 to December 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

Cluster randomised trial

Trial setting

Schools

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details 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

Behavioural

Phase

Drug names

Primary outcome measure

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 (if study stopped)

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

Other

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

01/03/2013

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

Basic results (scientific)

Publication list

2013 protocol in: https://www.ncbi.nlm.nih.gov/pubmed/23721352

Publication citations

Additional files

Editorial Notes

14/12/2017: Publication reference added.