Plain English Summary
Background and study aims
Mobile phones offer a low cost way of helping people change their behaviour. New results from a smoking cessation trial show that text message support can help people sustain behaviour change in the long term, doubling smokers chances of stopping at six months. Mobile phones may be a particularly good way of providing safer sex support for young people. Text message support is likely to be acceptable to young people and may be able to change safer sex behaviours. Support via mobile phones is confidential and the content can be personalised according to the issues young people face. Young people can text for advice and support at any time of day or night. In this initial study, we will develop a text message intervention for young people and evaluate how well this works in promoting safer sexual health behaviour in this population. The intervention aims to encourage: condom use; testing of sexually transmitted infections (STIs) prior to unprotected sex; correct follow up for STI treatment and partner notification about infection.
Who can participate?
Participants will be male & female aged 16-24 who have been diagnosed with Chlamydia and/or who have had unsafe sex in the last year (more than one partner and at least one occasion of unprotected sex) and who own a mobile phone.
What does the study involve?
With the input of young people, sexual health counsellors, experts in sexual health and behaviour change, we will develop text messages to reduce sexual risk behaviours. After obtaining written informed consent, we will ask panels of young people about the acceptability, comprehensibility and appropriateness of the text messages. We will also ask 100 participants to score text messages and interview up to 15 participants about the messages after they have had a chance to implement the advice in them. According to their feedback, we will retain, discard or modify the messages.
We will then conduct a initial study (called a pilot randomized controlled trial) with 200 young people in the Chlamydia screening programme/ Participants will be randomly allocated to either receive the intervention or to be in a control group (who do not receive the intervention) in order to test all trial methods and procedures. A web-based link to an independent randomisation service will allocate participants to intervention or control groups. The system will automatically generate text messages according to allocation. The control group will receive a monthly message about the importance of being in a study.
The pilot study will test the computerised systems that will send the text messages to participants. It will also test recruitment, follow up procedures, acceptability of the intervention, message frequency and timing.
We will also undertake qualitative interviews with 25 participants to find out about their experiences of the study. According to their preferences these will be conducted either face-to-face or over the phone.
What are the possible benefits and risks of participating?
The intervention provides support and is unlikely to cause any harmful effects. Even small changes in sexual health behaviour will outweigh any plausible risks from using mobile phones. The support might make some participants more aware that they are in abusive sexual relationships. To address this, we will provide clear information about how to access appropriate counselling services for people in abusive relationships.
Where is the study run from?
The study is run from the Department of Population Health at the London School of Hygiene and Tropical Medicine (UK).
When is the study starting and how long is it expected to run for?
The study started in March 2013 and is anticipated to end in March 2015.
Who is funding the study?
The National Institute for Health Research (NIHR), Health Technology Assessment (HTA) Programme (UK)
Who is the main contact?
Ona McCarthy
ona.mccarthy@lshtm.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Ms Ona McCarthy
ORCID ID
Contact details
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
+44 (0)20 7927 2581
ona.mccarthy@lshtm.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
HTA 10/93/04
Study information
Scientific title
Can text messages increase safer sexual health behaviours in young people?: qualitative research & pilot randomized controlled trial
Acronym
Study hypothesis
Can text messages increase safer sexual health behaviours in young people?
Ethics approval
London-Bentham, Development ethical approval granted 06/11/2012, REC ref 12/LO/1329; Pilot ethical approval anticipated April 2013
Study design
Mixed methods: Qualitative research & Pilot Randomized controlled trial
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 to request a patient information sheet
Condition
Sexual health
Intervention
Mobile phone texting intervention (supportive safer sex text messages using behaviour change techniques) vs. control (fortnightly messages about the importance of being in the trial)
Intervention type
Other
Phase
Not Applicable
Drug names
Primary outcome measure
The main factors relating to the design of the main trial we will be collecting include: recruitment rates (number of people randomised per month) and completeness of follow up. We will assess the number of young people recruited at the time of 1) testing, 2) provision of test results or 3) treatment collection. We will assess the number of people enrolled face to face from services or opting to enrol on line.
Secondary outcome measures
Condom use at last sex; condom use with new partners; Chlamydia infection; number of sexual partners in last 12 months; STI testing prior to unprotected sex with new partners; participants' report of partner testing for STIs prior to unprotected sex with them.
At 1 month we will assess:
Condom use at last sex for Chlamydia tests and self reported data
For those diagnosed with Chlamydia at the time of recruitment we will assess treatment compliance (did they take the medication), abstinence or protected sex for one week and until the partner is treated and partner notification of sexually transmitted infection.
At 12 months, we will assess:
Chlamydia infection for men through a urine test and for women using a self taken vaginal swab
condom use at last sex
condom use with new partners
the number of sexual partners in last 12 months
sexually transmitted infection testing for self prior to unprotected sex with new partner(s).
participants report that the partner was tested for sexually transmitted infection prior to unprotected sex with them.
Overall trial start date
01/03/2013
Overall trial end date
01/03/2015
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
Chlamydia screening programme participants diagnosed with Chlamydia and/or who have had unsafe sex in the last year (more than one or more partner and at least one occasion of unprotected sex); owner of a mobile phone.
Participant type
Patient
Age group
Adult
Gender
Both
Target number of participants
300
Participant exclusion criteria
Eligible participants who are non-English language speakers will be excluded from the study as the text messages will be delivered in English. Those that are unable to provide informed consent (e.g. people with severe learning difficulties) will be excluded from this study.
Recruitment start date
01/03/2013
Recruitment end date
01/03/2015
Locations
Countries of recruitment
United Kingdom
Trial participating centre
London School of Hygiene and Tropical Medicine
London
WC1E 7HT
United Kingdom
Funders
Funder type
Government
Funder name
Health Technology Assessment Programme
Alternative name(s)
NIHR Health Technology Assessment Programme, HTA
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
2016 development of follow-up procedures in: http://www.ncbi.nlm.nih.gov/pubmed/26767413
2016 results in: http://www.ncbi.nlm.nih.gov/pubmed/28011811