Condition category
Urological and Genital Diseases
Date applied
12/01/2011
Date assigned
22/03/2011
Last edited
06/01/2014
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

http://www.sexunzipped.co.uk

Contact information

Type

Scientific

Primary contact

Dr Julia Bailey

ORCID ID

Contact details

e-Health Unit
UCL Research Department of Primary Care & Population Health
Upper 3rd Floor
Royal Free Hospital
Rowland Hill Street
London
NW3 2PF
United Kingdom
+44 (0)20 7794 0500 ext 36747
julia.bailey@ucl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

G0701749

Study information

Scientific title

An interactive computer-based intervention for sexual behaviour change: Sexunzipped pilot online trial

Acronym

Study hypothesis

That an interactive, tailored online intervention for sexual health promotion will be more effective in promoting sexual health in young people than an information-only website.

Ethics approval

UCL Ethics Committee approved on the 4th August 2010 (ref: 1023/002)

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Other

Trial type

Quality of life

Patient information sheet

Supplied online via www.sexunzipped.co.uk ('sign up')

Condition

Sexual Health

Intervention

1. Interactive website containing sexual health information and activities based on psychological theories of behaviour change and a holistic conception of sexual wellbeing which includes a focus on pleasure
2. Quizzes and decision-making activities with tailored feedback
3. Control - brief, information-only website with content which focuses mainly on sexually transmitted infection and contraception
4. No interactive activities

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. This pilot study will help to determine which outcome should be the primary outcome for a substantive trial. We will report on all measured outcomes including:
1.1. Knowledge
1.2. Self-efficacy
1.3. Intention
1.4. Affective outcomes
1.5. Communication in relationships
1.6. Sexual behaviour (especially condom use for vaginal or anal sex)
1.7. Genital chlamydia (postal sample)

Secondary outcome measures

No secondary outcome measures

Overall trial start date

01/11/2010

Overall trial end date

30/09/2011

Reason abandoned

Eligibility

Participant inclusion criteria

1. Young people aged 16 - 20 years, either sex
2. Living in the UK
3. Able to read English

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

2000

Participant exclusion criteria

People aged under 16 or over 21

Recruitment start date

01/11/2010

Recruitment end date

30/09/2011

Locations

Countries of recruitment

United Kingdom

Trial participating centre

e-Health Unit
London
NW3 2PF
United Kingdom

Sponsor information

Organisation

University College London (UCL) (UK)

Sponsor details

Joint UCL
UCLH and Royal Free Biomedical Research Unit
1st Floor
Maple House
149 Tottenham Court Road
London
W1T 7NF
United Kingdom

Sponsor type

University/education

Website

http://www.ucl.ac.uk/joint-rd-unit/

Funders

Funder type

Research council

Funder name

Medical Research Council (MRC) (UK) (ref: G0701749)

Alternative name(s)

MRC

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

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

2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24334216
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24334198

Publication citations

  1. Results

    Bailey JV, Pavlou M, Copas A, McCarthy O, Carswell K, Rait G, Hart G, Nazareth I, Free C, French R, Murray E, The Sexunzipped trial: optimizing the design of online randomized controlled trials., J. Med. Internet Res., 2013, 15, 12, e278, doi: 10.2196/jmir.2668.

  2. Results

    Nicholas A, Bailey JV, Stevenson F, Murray E, The Sexunzipped trial: young people's views of participating in an online randomized controlled trial., J. Med. Internet Res., 2013, 15, 12, e276, doi: 10.2196/jmir.2647.

Additional files

Editorial Notes