Plain English Summary
Not provided at time of registration
Trial website
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 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 trial start date
01/11/2010
Overall trial end date
30/09/2011
Reason abandoned (if study stopped)
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
Funders
Funder type
Research council
Funder name
Medical Research Council (MRC) (UK) (ref: G0701749)
Alternative name(s)
MRC
Funding Body Type
government organisation
Funding Body Subtype
Federal/National Government
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 results in: http://www.ncbi.nlm.nih.gov/pubmed/24334216
2013 results in: http://www.ncbi.nlm.nih.gov/pubmed/24334198
Publication citations
-
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.
-
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.