Plain English Summary
Background and study aims
Sexually transmitted infections (STI) and unwanted pregnancy are major public health problems. Condoms are effective for prevention, but there are many barriers to successful use such as decrease in sensation, interruption of sex, incorrect size or fit, use of alcohol/recreational drugs, anxiety, and stigma. Face-to-face condom-use interventions are expensive and not very effective. Interactive digital interventions (IDI) such as websites are highly suitable for sexual health issues: access can be private and self-paced, and programmes can be tailored for individuals. Evidence shows that IDI can improve sexual behaviour (condom use) as well as increasing knowledge. Men who are engaging in unprotected sex are at high risk of future infection, so targeting this measure at these men will increase the impact of IDI. This initial study aims to find out how we should plan a future larger study regarding an interactive, theory-based website to increase condom use.
Who can participate?
We will recruit men, aged 18 years and over who are at risk of sexually transmitted infection, from three sexual health clinics.
What does the study involve?
Men will be invited to register for the study using a laptop which will be available in clinic waiting rooms. Study information and consent will be offered on the laptop, with participants submitting contact details and demographic details and answering sexual health questions online, directly onto the laptop. A programme on the laptop will automatically allocate eligible men either to usual sexual health clinic care plus the website, or to usual care only, and measuring any changes in outcomes such as knowledge, confidence and condom use at 12 months. We will collect data online at 3, 6, 9 and 12 months, and ask participants for permission to check their clinic notes after one year. We will also collect data on costs and possible benefits of this method. We will interview some participants to understand how the method was used, and to work out the best design for a future large scale study.
What are the possible benefits and risks of participating?
This project aims to encourage behaviour change (i.e. safer sex) to reduce the incidence of sexually transmitted infections. This will benefit the participants as well as wider society. The tone of the intervention website is non-judgemental about choices of lifestyle or behaviour, however, there is a risk that the study may unintentionally aggravate the stigma of STI or of particular sexual behaviours. It could be that the content embarrasses or upsets some participants. The website itself will provide links to helpful resources, for example regarding domestic violence, HIV, sexual problems etc. We will also refer on to support organisations any participants who contact the research team directly with any concerns. It could be that participants partners or others see the intervention website, texts or email messages (which will be sent as prompts to complete the follow-up assessments and to re-visit the website) and that this leads to embarrassment or relationship difficulties in some way. A component of the intervention will focus on communication with partners, so it is hoped that the intervention will improve the quality of relationships rather than cause harm.
Where is the study run from?
We will recruit from three sexual health clinics in England: Homerton Department of Sexual Health in East London, Barts Sexual Health Centre at St. Bartholomew's hospital, and Coventry Integrated Sexual Health Services at the City of Coventry Health Centre.
When is the study starting and how long is it expected to run for?
The study runs between January 2014 to September 2015, recruiting men from January 2014 to June 2014.
Who is funding the study?
The National Institute for Health Research (NIHR), UK.
Who is the main contact?
Dr Julia Bailey
Julia.bailey@ucl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Julia Bailey
ORCID ID
Contact details
e-Health Unit
Research Department of Primary Care and Population Health
Upper third floor
Royal free Hospital
Rowland Hill Street
London
NW3 2PF
United Kingdom
-
julia.bailey@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 10/131/01
Study information
Scientific title
An interactive digital intervention to increase condom use in heterosexual men in sexual health clinics: a pilot trial and qualitative evaluation of trial procedures
Acronym
MenSS
Study hypothesis
That an interactive, theory-based website plus usual sexual health clinic care will be more effective in increasing men's condom use than usual care only.
More details can be found at: http://www.nets.nihr.ac.uk/projects/hta/1013101
Protocol can be found at: http://www.nets.nihr.ac.uk/__data/assets/pdf_file/0003/81138/PRO-10-131-01.pdf
Ethics approval
NRES Committee London - City & East, 14/02/2014, REC ref: 13/LO/1801
Study design
Randomised controlled trial with linked qualitative process evaluation
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
1. Sexually transmitted infections
2. Sexual health promotion
Intervention
Participants will be allocated by computer algorithm to either usual care (the control condition) or usual care plus the interactive digital intervention (intervention condition). Those in the intervention condition will be asked to spend time interacting with the intervention whilst in the clinic waiting room, and will then have access to the intervention for the next 12 months. The intervention is an interactive, theory-based website to promote condom use in men. Sexual health outcomes (e.g., condom use, STI diagnoses) will be assessed at baseline (before randomisation), and 3, 6, 9, and 12 months later.
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The primary outcome is self-reported condom use for penetrative sex over the previous three months. This is a small-scale pilot trial to test the procedures for a future full-scale trial, so we will also assess the success of recruitment, trial procedures and retention over one year.
Secondary outcome measures
Pilot trial:
1. We will measure outcomes such as knowledge, confidence in ability, and motivation, which contribute to behaviour change (increased condom use). We will also measure self-reported sexually transmitted infection (STI) and record STI diagnoses from sexual health clinic notes.
2. Qualitative process evaluation:
2.1. Men's experiences and views of participating in the pilot trial, and views of the website to increase condom use
2.2. Sexual health clinic staff members' views of the trial procedures and the role of interactive digital interventions (e.g. websites) in sexual health clinical care
3. We will also work out the best methods of data collection and analysis for a cost effectiveness analysis analysis for a future full scale randomised controlled trial
Overall trial start date
06/01/2014
Overall trial end date
30/09/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Male
2. Aged 18 years and over (with no upper age limit)
3. Able to read English
4. Heterosexual and sexually active
5. Possession of an active email account and access to the internet
6. Reporting 2 or more sexual partners in the last year, and unprotected sex in the last 3 months
7. Predominantly female partners, or an equal number of male and female partners
Participant type
Healthy volunteer
Age group
Adult
Gender
Male
Target number of participants
172 for the trial, 24 for the qualitative process evaluation (participant interviews)
Participant exclusion criteria
1. HIV positive men
2. Men with hepatitis B or C
3. We will exclude men who have had sexual experience only ever with males, more often with males and at least once with a female or no sexual experience at all
Recruitment start date
06/01/2014
Recruitment end date
01/06/2014
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
-
david.wilson@ucl.ac.uk
Sponsor type
University/education
Website
Funders
Funder type
Government
Funder name
NIHR Health Technology Assessment Programme - HTA (UK); HTA 10/131/01
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
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
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25687900