Sexunzipped pilot online trial

ISRCTN	ISRCTN55651027
DOI	https://doi.org/10.1186/ISRCTN55651027
Secondary identifying numbers	G0701749

Submission date: 12/01/2011
Registration date: 22/03/2011
Last edited: 06/01/2014

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Urological and Genital Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Study website

Contact information

Dr Julia Bailey
Scientific

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

Phone	+44 (0)20 7794 0500 ext 36747
Email	julia.bailey@ucl.ac.uk

Study information

Study design	Randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Other
Study type	Quality of life
Participant information sheet	Supplied online via www.sexunzipped.co.uk ('sign up')
Scientific title	An interactive computer-based intervention for sexual behaviour change: Sexunzipped pilot online trial
Study objectives	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(s)	UCL Ethics Committee approved on the 4th August 2010 (ref: 1023/002)
Health condition(s) or problem(s) studied	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
Primary outcome measure	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 study start date	01/11/2010
Completion date	30/09/2011

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Both
Target number of participants	2000
Key inclusion criteria	1. Young people aged 16 - 20 years, either sex 2. Living in the UK 3. Able to read English
Key exclusion criteria	People aged under 16 or over 21
Date of first enrolment	01/11/2010
Date of final enrolment	30/09/2011

Locations

Countries of recruitment

England
United Kingdom

Study participating centre

e-Health Unit

London
NW3 2PF
United Kingdom

Sponsor information

University College London (UCL) (UK)
University/education

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

Website	http://www.ucl.ac.uk/joint-rd-unit/
"ROR"	https://ror.org/02jx3x895

Funders

Funder type

Research council

Medical Research Council (MRC) (UK) (ref: G0701749)
Government organisation / National government

Alternative name(s): Medical Research Council (United Kingdom), UK Medical Research Council, MRC
Location: United Kingdom

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	11/12/2013		Yes	No
Results article	results	12/12/2013		Yes	No