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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.
BMJ Open. 2020 03 08; 10(3):e031635.BO

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 17[th] March 2016. WHO trial registration data set available at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461.

TRIAL PROTOCOL VERSION

12, 19[th] July 2018.

Authors+Show Affiliations

Population Health, London School of Hygiene and Tropical Medicine, London, London, UK caroline.free@lshtm.ac.uk.Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.Clinical Trials Unit, MSD, London School of Hygiene and Tropical Medicine, London, London, UK.Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, London, UK.Centre for Global Health, King's College London, London, London, UK.Sigma Research, London School of Hygiene and Tropical Medicine, London, London, UK.Social and Environmental Health Research, London School of Hygiene and Tropical Medicine, London, London, UK.Population Health, London School of Hygiene and Tropical Medicine, London, London, UK.Primary Care and Population Health, University College London, London, London, UK.Department of Infection and Population Health, University College London, London, London, UK.Centre for Outcomes Research and Effectivenes, University College London, London, London, UK.Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.Department of Social Science, University College London Institute of Education, London, London, UK.Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.Bristol Vetinary School, University of Bristol, Bristol, UK.Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.Department of Medical Statistics, London School of Hygiene and Tropical Medicine, London, London, UK.

Pub Type(s)

Clinical Trial Protocol
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32152156

Citation

Free, Caroline, et al. "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." BMJ Open, vol. 10, no. 3, 2020, pp. e031635.
Free C, McCarthy OL, Palmer MJ, et al. 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. BMJ Open. 2020;10(3):e031635.
Free, C., McCarthy, O. L., Palmer, M. J., Knight, R., Edwards, P., French, R., Baraitser, P., Hickson, F. C. I., Wellings, K., Roberts, I., Bailey, J. V., Hart, G., Michie, S., Clayton, T., Ploubidis, G. B., Carpenter, J. R., Turner, K. M. E., Devries, K., & Potter, K. (2020). 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. BMJ Open, 10(3), e031635. https://doi.org/10.1136/bmjopen-2019-031635
Free C, et al. 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. BMJ Open. 2020 03 8;10(3):e031635. PubMed PMID: 32152156.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Free,Caroline, AU - McCarthy,Ona L, AU - Palmer,Melissa J, AU - Knight,Rosemary, AU - Edwards,Phil, AU - French,Rebecca, AU - Baraitser,Paula, AU - Hickson,Ford Colin Ian, AU - Wellings,Kaye, AU - Roberts,Ian, AU - Bailey,Julia V, AU - Hart,Graham, AU - Michie,Susan, AU - Clayton,Tim, AU - Ploubidis,George B, AU - Carpenter,James R, AU - Turner,Katy M E, AU - Devries,Karen, AU - Potter,Kimberley, Y1 - 2020/03/08/ PY - 2020/3/11/entrez PY - 2020/3/11/pubmed PY - 2021/4/14/medline KW - mHealth KW - randomised controlled trial KW - sexual behaviour KW - sexually transmitted infection KW - text message KW - young people SP - e031635 EP - e031635 JF - BMJ open JO - BMJ Open VL - 10 IS - 3 N2 - 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 17[th] March 2016. WHO trial registration data set available at: http://apps.who.int/trialsearch/Trial2.aspx?TrialID=ISRCTN64390461. TRIAL PROTOCOL VERSION: 12, 19[th] July 2018. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/32152156/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_ DB - PRIME DP - Unbound Medicine ER -