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...

Full description

Bibliographic Details
Main Authors: 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
Format: Article
Language:English
Published: SAGE Publishing 2016-11-01
Series:Digital Health
Online Access:https://doi.org/10.1177/2055207616679002
id doaj-eb2b3c004d1d48179adc79d7d24b75f1
record_format Article
spelling 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
work_keys_str_mv AT juliavbailey themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT rosiewebster themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT markgriffin themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT nickfreemantle themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT rachaelhunter themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT gretarait themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT claudiaestcourt themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT janeanderson themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT makedagerressu themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT judithstephenson themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT susanmichie themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT elizabethmurray themenssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT juliavbailey menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT rosiewebster menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT markgriffin menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT nickfreemantle menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT rachaelhunter menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT gretarait menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT claudiaestcourt menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT janeanderson menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT makedagerressu menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT judithstephenson menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT susanmichie menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
AT elizabethmurray menssafersextrialafeasibilityrandomisedcontrolledtrialofaninteractivedigitalinterventiontoincreasecondomuseinmen
_version_ 1724729691634401280