The Men’s Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men
Objectives We aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men’s Safer Sex website, measuring condom use and sexually transmitted infection (STI). Methods For this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected ST...
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doaj-eb2b3c004d1d48179adc79d7d24b75f12020-11-25T02:52:29ZengSAGE PublishingDigital Health2055-20762016-11-01210.1177/2055207616679002The Men’s Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in menJulia V Bailey0Rosie Webster1Mark Griffin2Nick Freemantle3Rachael Hunter4Greta Rait5Claudia Estcourt6Jane Anderson7Makeda Gerressu8Judith Stephenson9Susan Michie10Elizabeth Murray11eHealth unit, Research Department of Primary Care and Population Health, University College London, London, UKeHealth unit, Research Department of Primary Care and Population Health, University College London, London, UKPRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UKPRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UKPRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UKPRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UKBICMS, Bart’s and The London School of Medicine & Dentistry, Bart’s Sexual Health Centre, Queen Mary University of London, St Bartholomew’s Hospital, London, UKCentre for the Study of Sexual Health and HIV, Homerton University Hospital, London, UKDepartment of Infection and Population Health, University College London, London, UKDepartment of Reproductive Health, Institute for Women’s Health, University College London, London, UKResearch Department of Clinical, Educational, and Health Psychology, University College London, London, UKeHealth unit, Research Department of Primary Care and Population Health, University College London, London, UKObjectives We aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men’s Safer Sex website, measuring condom use and sexually transmitted infection (STI). Methods For this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected STI were recruited from three UK sexual health clinics. Participants were randomised to the intervention website plus usual clinic care ( n = 84), or usual clinic care only ( n = 75). Online outcome data were solicited at 3, 6, and 12 months. Results Men were enrolled via tablet computers in clinic waiting rooms. Software errors and clinic Wi-Fi access presented significant challenges, and online questionnaire response rates were poor (36% at 3 months with a £10 voucher; 50% at 12 months with £30). Clinical records (for STI diagnoses) were located for 94% of participants. Some 37% of the intervention group did not see the intervention website ( n = 31/84), and (as expected) there was no detectable difference in condomless sex with female partners (IRR = 1.01, 95% CI 0.52 to 1.96). New acute STI diagnoses were recorded for 8.8% (7/80) of the intervention group, and 13.0% (9/69) of the control group over 12 months (IRR = 0.75, 95% CI 0.29 to 1.90). Conclusion It is likely to be feasible to conduct a future large-scale RCT to assess the impact of an online intervention using clinic STI diagnoses as a primary outcome. However, practical and technical challenges need to be addressed before the potential of digital media interventions can be realised in sexual health settings. Trial registration number: ISRCTN18649610https://doi.org/10.1177/2055207616679002 |
collection |
DOAJ |
language |
English |
format |
Article |
sources |
DOAJ |
author |
Julia V Bailey Rosie Webster Mark Griffin Nick Freemantle Rachael Hunter Greta Rait Claudia Estcourt Jane Anderson Makeda Gerressu Judith Stephenson Susan Michie Elizabeth Murray |
spellingShingle |
Julia V Bailey Rosie Webster Mark Griffin Nick Freemantle Rachael Hunter Greta Rait Claudia Estcourt Jane Anderson Makeda Gerressu Judith Stephenson Susan Michie Elizabeth Murray The Men’s Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men Digital Health |
author_facet |
Julia V Bailey Rosie Webster Mark Griffin Nick Freemantle Rachael Hunter Greta Rait Claudia Estcourt Jane Anderson Makeda Gerressu Judith Stephenson Susan Michie Elizabeth Murray |
author_sort |
Julia V Bailey |
title |
The Men’s Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men |
title_short |
The Men’s Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men |
title_full |
The Men’s Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men |
title_fullStr |
The Men’s Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men |
title_full_unstemmed |
The Men’s Safer Sex Trial: A feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men |
title_sort |
men’s safer sex trial: a feasibility randomised controlled trial of an interactive digital intervention to increase condom use in men |
publisher |
SAGE Publishing |
series |
Digital Health |
issn |
2055-2076 |
publishDate |
2016-11-01 |
description |
Objectives We aimed to determine the feasibility of an online randomised controlled trial (RCT) of the Men’s Safer Sex website, measuring condom use and sexually transmitted infection (STI). Methods For this study 159 men aged ≥16 with female sexual partners and recent condomless sex or suspected STI were recruited from three UK sexual health clinics. Participants were randomised to the intervention website plus usual clinic care ( n = 84), or usual clinic care only ( n = 75). Online outcome data were solicited at 3, 6, and 12 months. Results Men were enrolled via tablet computers in clinic waiting rooms. Software errors and clinic Wi-Fi access presented significant challenges, and online questionnaire response rates were poor (36% at 3 months with a £10 voucher; 50% at 12 months with £30). Clinical records (for STI diagnoses) were located for 94% of participants. Some 37% of the intervention group did not see the intervention website ( n = 31/84), and (as expected) there was no detectable difference in condomless sex with female partners (IRR = 1.01, 95% CI 0.52 to 1.96). New acute STI diagnoses were recorded for 8.8% (7/80) of the intervention group, and 13.0% (9/69) of the control group over 12 months (IRR = 0.75, 95% CI 0.29 to 1.90). Conclusion It is likely to be feasible to conduct a future large-scale RCT to assess the impact of an online intervention using clinic STI diagnoses as a primary outcome. However, practical and technical challenges need to be addressed before the potential of digital media interventions can be realised in sexual health settings. Trial registration number: ISRCTN18649610 |
url |
https://doi.org/10.1177/2055207616679002 |
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