Title: Safetxt: A randomised controlled trial of an intervention delivered by mobile phone messaging to reduce sexually transmitted infections (STI) by increasing sexual health precaution behaviours in young people
Funder: Department of Health and Social Care

Abstract: Objective: To establish the effectiveness of a safer sex intervention delivered by mobile phone messaging on STI infection at one year. To establish the effect of the intervention on partner notification, condom use and STI testing at one month & one year. To explore which components of the intervention are effective. To establish the costs and cost-effectiveness of the intervention. Design: A randomised controlled trial. Setting: The intervention is delivered by mobile phone messaging to participants in the community. Participants are recruited from services testing for STI across the UK. Strategy for reviewing the literature: We searched MEDLINE, EMBASE, Global health, Web of Science, PsycINFO and the Cochrane library. (Jan 1990- Nov 2014) to identify trials of mobile phone based support to increase safer sex behaviours and reduce STI. Target population: People aged 16-24 diagnosed with gonorrhoea, chlamydia or non-specific urethritis (NSU) in the last month. Recruitment and randomisation procedures: We will provide trial information, confirm eligibility and obtain consent by post, email or on the trial website. The researcher or participant will enter base-line data. A web-based link to an independent randomisation service will allocate the participants to receive the safer sex intervention or to a control group (see trial flow chart). The system will automatically generate text messages according to the allocation. Intervention: A safer sex intervention designed to reduce STIs by increasing correct treatment of STI, partner notification, condom use and STI testing before unprotected sex with a new partner. The intervention is delivered over 12 months from an automated IT system based at the trial co-ordinating centre. Comparator: A monthly text message checking contact details. Measurement of costs and outcome: The primary outcome at one year is chlamydia or gonorrhoea infection using NAAT tests. Secondary outcomes at one month & one year: safer sex behaviours (partner notification, condom use and testing for STI before unprotected sex with a new partner) and the theoretical constructs linked to the effects of intervention components (behaviour change techniques). We will collect one year data on STI infection by postal testing/ clinic data. We will collect self-reported data by post, text message, email or phone and partner attendance for treatment by clinic data. Costs of intervention delivery will be collected for economic modelling. Project timetable: Months 1-4 Trial set up Months 5-37 Recruitment Months 6-50 Follow up Months 51-54 Data analysis & writing up Sample size: Because the intervention can be delivered to large numbers of people at low cost, even a modest reduction in STI would deliver public health benefit. The trial has been designed to detect a reduction in incidence of STI of 3.4%. If the real difference in STI at 12 months is 17% vs 13.6% (RR 0.8) then there is a 90% chance that a trial with 6250 patients would achieve p = 0.05, even allowing for 20% loss to follow up. Expertise in the team: Members have strong expertise in sexual health, behaviour change, health promotion, mobile phone based interventions, sexual diversity and equality, conducting large randomised controlled trials, systematic reviews, health economics, statistics and epidemiology.

Lay abstract: Sexually transmitted infections are common in young people. They can cause important health problems, like infertility. People are less likely to get an infection if they use condoms and get tested before they stop using condoms with a new partner. People with an infection are less likely to get another infection if they tell their partner. Young people can find it hard to do these things. Health education can help people use condoms and get tested. Using condoms and getting tested can reduce sexually transmitted infections. But many forms of current health education do not appeal to young people. Few approaches have been carefully tested so, we don’t know if they work. Mobile phones are popular with young people. Support delivered by text message could help young people use condoms and get tested. The support could help them to tell partner(s) about an infection. Text messages are cheap. Young people could get the support, wherever they are. We know that these messages work to help people stop smoking, but we don’t know if they work for sexual health. In sexual health, until now, studies of the use of text messages have not been high quality. For example, they have not tried to help people tell partners about an infection or been based on tried and tested approaches to changing behaviour. We have developed support for young people delivered by text message aimed at reducing sexually transmitted infections. It is designed to help young people use condoms, get tested and tell a partner about an infection. This approach was developed with young people and experts. We have used tried and tested approaches to changing behaviour. We conducted a pilot study which showed it is possible to do a large scale study. Young people were happy to join the study and we recruited ahead of schedule. We were able to collect the samples we needed to test for sexually transmitted infection, one year later. Young people liked the messages. They felt that the messages increased their knowledge in how to use condoms. They said the messages helped them to tell a partner about an infection. Some women said they shared the messages with their partner to get them to use condoms. Our study will tell us if this form of health education reduces sexually transmitted infections. We will find out if it helps young people tell a partner about an infection and if it helps them use condoms and get tested. We will recruit 6250 young people. We will randomly (by chance) send people either the support messages, or not. This will allow us to find out whether it is the messages that are making a difference. The research team includes experts in the design and management of trials, statistics, behaviour change and sexual health. The team has specific experience in designing, delivering and evaluating mobile phone based health education.

Research activity codes: 6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: INFECTION;REPRODUCTIVE HEALTH AND CHILDBIRTH