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Sexual health
Protocol
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
  1. Caroline Free1,
  2. Ona L McCarthy1,
  3. Melissa J Palmer1,
  4. Rosemary Knight2,
  5. Phil Edwards1,
  6. Rebecca French3,
  7. Paula Baraitser4,
  8. Ford Colin Ian Hickson5,
  9. Kaye Wellings3,
  10. Ian Roberts1,
  11. Julia V Bailey6,
  12. Graham Hart7,
  13. Susan Michie8,
  14. Tim Clayton9,
  15. George B Ploubidis10,
  16. James R Carpenter9,
  17. Katy M E Turner11,
  18. Karen Devries9,
  19. Kimberley Potter9
  1. 1Population Health, London School of Hygiene and Tropical Medicine, London, London, UK
  2. 2Clinical Trials Unit, MSD, London School of Hygiene and Tropical Medicine, London, London, UK
  3. 3Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, London, UK
  4. 4Centre for Global Health, King's College London, London, London, UK
  5. 5Sigma Research, London School of Hygiene and Tropical Medicine, London, London, UK
  6. 6Primary Care and Population Health, University College London, London, London, UK
  7. 7Department of Infection and Population Health, University College London, London, London, UK
  8. 8Centre for Outcomes Research and Effectivenes, University College London, London, London, UK
  9. 9Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK
  10. 10Department of Social Science, University College London Institute of Education, London, London, UK
  11. 11Bristol Vetinary School, University of Bristol, Bristol, UK
  1. Correspondence to Dr Caroline Free; caroline.free{at}lshtm.ac.uk

Abstract

Introduction Young 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 analysis A 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 dissemination Ethics 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 number International Standard Randomised Controlled Trials Number: ISRCTN64390461. Registered on 17th March 2016. WHO trial registration data set available at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461.

Trial protocol version 12, 19th July 2018.

  • sexually transmitted infection
  • sexual behaviour
  • text message
  • mHealth
  • randomised controlled trial
  • young people
https://creativecommons.org/licenses/by/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution 4.0 Unported (CC BY 4.0) license, which permits others to copy, redistribute, remix, transform and build upon this work for any purpose, provided the original work is properly cited, a link to the licence is given, and indication of whether changes were made. See: https://creativecommons.org/licenses/by/4.0/.

https://doi.org/10.1136/bmjopen-2019-031635

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    Footnotes

    • Twitter @juliavbailey, @katymeturner

    • Collaborators The Trial Steering Committee (TSC) may recommend changes to the overall trial management processes for which there is evidence the current process may compromise the conduct of the trial or the safety of participants. The members of the TSC are: Professor Pippa Oakeshott (Chair), Dr Andrew Copas, Professor Michael Ussher, Mr Colum McGrady, Dr Michael Brady and Professor Caroline Free.

    • Contributors CF conceived the study, contributed to the development of the intervention and statistical analysis plan, is a member of the Trial Management Group and had overall responsibility for the design and conduct of the trial and writing the protocol. OM contributed to the development of the intervention, contributed to the statistical analysis plan, is a member of the Trial Management Group, contributed to the trial design, the refinement of the study protocol and approved the manuscript. MP contributed to the statistical analysis plan, is a member of the Trial Management Group, contributed to the process evaluation design, contributed to the trial design, the refinement of the study protocol and approved the manuscript. RK is a member of the Trial Management Group, is responsible for the day-to-day management of the trial, contributed to the trial design, the refinement of the study protocol and approved the manuscript. PE is the trial statistician who provides general statistical oversight, contributed to the statistical analysis plan, contributed to the trial design, the refinement of the study protocol and approved the manuscript. RF contributed to the development of the intervention, provided input on the trial outcome measures, contributed to the trial design, the refinement of the study protocol and approved the manuscript. PB contributed to the development of the intervention, contributed to the trial design, the refinement of the study protocol and approved the manuscript. FH adapted the intervention messages for men who have sex with men, contributed to the trial design, the refinement of the study protocol and approved the manuscript. KW contributed to the development of the intervention, provided input on the trial outcome measures, contributed to the trial design, the refinement of the study protocol and approved the manuscript. IR provided expertise on trial design, contributed to the refinement of the study protocol and approved the manuscript. JB contributed to the development of the intervention, the trial design, the refinement of the study protocol and approved the manuscript. GH provided fundamental intellectual input into the design of the trial, the refinement of the study protocol and approved the manuscript. SM provided behavioural science expertise, which informed the development of the intervention, contributed to the trial design, the refinement of the study protocol and approved the manuscript. TC provided statistical expertise regarding the supplementary and subgroup analyses, provided general statistical advice, contributed to the trial design, the refinement of the study protocol and approved the manuscript. GP provided statistical expertise for the Generalised Latent Variable Modelling framework, contributed to the trial design, the refinement of the study protocol and approved the manuscript. JC provided statistical expertise regarding multiple imputation, contributed to the trial design, the refinement of the study protocol and approved the manuscript. KT leads the economic evaluation, contributed to the trial design, the refinement of the study protocol and approved the manuscript. KD contributed to the development of the intervention, contributed to the trial design, the refinement of the study protocol and approved the manuscript. KP is a member of the Trial Management Group, is responsible for the day-to-day management of the trial, contributed to the trial design, the refinement of the study protocol and approved the manuscript.

    • Funding This trial is funded by the National Institute for Health Research Public Health Research (NIHR PHR) Programme (project number 14/182/07). London School of Hygiene & Tropical Medicine is the main research sponsor for this trial. For further information regarding the sponsorship conditions, please contact the Research Governance and Integrity Office: London School of Hygiene & Tropical Medicine, Keppel Street, London, WC1E 7HT Tel: +44 207 927 2626 Email: patricia.henley@lshtm.ac.uk.

    • Disclaimer The funding body has no role in any aspect of the design and conduct of this study, or the decision to submit the report for publication. The sponsor had no role in any aspect of the design and conduct of this study, or the decision to submit the report for publication.

    • Competing interests None declared.

    • Patient consent for publication Not required.

    • Ethics approval Ethics approval for this trial was provided by the NHS Health Research Authority - London – Riverside Research Ethics Committee (REC reference: 15/LO/1665) and the London School of Hygiene & Tropical Medicine.

    • Provenance and peer review Not commissioned; externally peer reviewed.