Safetxt: a safer sex intervention delivered by mobile phone messaging on sexually transmitted infections (STI) among young people in the UK - protocol for a randomised controlled trial

Abstract

IntroductionYoung people aged 16 to 24 have the highest prevalence of genital chlamydia and gonorrhoea compared with other age groups and re-infection rates following treatment are high. Long-term adverse health effects include subfertility and ectopic pregnancy, particularly among those with repeated infections. We developed the safetxt intervention delivered by text message to reduce sexually transmitted infection (STI) by increasing partner notification, condom use and (STI) testing among young people in the UK.Methods and analysisA single-blind randomised trial to reliably establish the effect of the safetxt intervention on chlamydia and gonorrhoea infection at 1 year. We will recruit 6250 people aged 16 to 24 years who have recently been diagnosed with chlamydia, gonorrhoea or non-specific urethritis from health services in the UK. Participants will be allocated to receive the safetxt intervention (text messages designed to promote safer sexual health behaviours) or to receive the control text messages (monthly messages asking participants about changes in contact details) by an automated remote online randomisation system. The primary outcome will be the cumulative incidence of chlamydia and gonorrhoea infection at 1 year assessed by nucleic acid amplification tests. Secondary outcomes include partner notification, correct treatment of infection, condom use and STI testing prior to sex with new partners.Ethics and disseminationEthics approval was obtained from NHS Health Research Authority - London – Riverside Research Ethics Committee (REC reference: 15/LO/1665) and the London School of Hygiene & Tropical Medicine. We will submit the results of the trial for publication in peer-reviewed journals.Trial registration numberInternational Standard Randomised Controlled Trials Number:ISRCTN64390461. Registered on 17thMarch 2016.WHO trial registration data setavailable at:http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461.Trial protocol version12, 19thJuly 2018.

Effectiveness of a behavioural intervention delivered by text messages (safetxt) on sexually transmitted reinfections in people aged 16-24 years: randomised controlled trial

“…Our methods were prespecified and are published in the trial protocol. 10 Eligible participants were aged 16-24 years, owned a mobile phone, were able to provide informed consent, and either had a diagnosis of or had started treatment for chlamydia or gonorrhoea or non-specific urethritis in the past two weeks. We excluded those known to be a sexual partner of someone already recruited to the trial.…”

“…Recipients could request additional messages on specific topics. Participants were sent text messages starting on the day of randomisation: four texts daily for days 1-3, one or two daily for days 4-28, two or three weekly for month 2, and 2-5 monthly for months [3][4][5][6][7][8][9][10][11][12] (see examples of messages in appendix 1).…”

“…Participants were recruited from 92 sexual health clinics in the United Kingdom, and the intervention was delivered in the community by mobile phone. Our methods were prespecified and are published in the trial protocol 10…”

Adapting an evidence-based contraceptive behavioural intervention delivered by mobile phone for young people in Zimbabwe

“…Messages regarding correct condom use (e.g. how to use condoms so they are less likely to break), taken from an existing SMS intervention [ 10 ] were added. Three messages for non-sexually active people were condensed into one message in the main adapted Zimbabwean message set to account for periods of sexually active and inactivity (for both the male and female sets).…”

A dynamic and collaborative approach to trial recruitment in safetxt, a UK sexual health randomised controlled trial

“…A detailed trial protocol has been published elsewhere previously. 9 We did not pre-specify the number of sites we would open for recruitment, instead sexual health services were opened as recruiting sites if they saw at least five eligible patients per month, and believed they could recruit to at least this target. We originally planned to recruit 5000 participants by April 2018, but due to a lower than expected event rate (sexually transmitted infection positivity) the trial steering committee recommended we increase our sample size and extend recruitment to 6250 participants by December 2018.…”