title: The Men's Safer Sex (MenSS) trial: protocol for a pilot randomised controlled trial of an interactive digital intervention to increase condom use in men.
abstract: BACKGROUND
  Sexually transmitted infections (STI) are a major public health problem. Condoms provide effective protection but there are many barriers to use. Face-to-face health promotion interventions are resource-intensive and show mixed results. Interactive digital interventions may provide a suitable alternative, allowing private access to personally tailored behaviour change support. We have developed an interactive digital intervention (the Men's Safer Sex (MenSS) website) which aims to increase condom use in men. We describe the protocol for a pilot trial to assess the feasibility of a full-scale randomised controlled trial of the MenSS website in addition to usual sexual health clinical care.
  
  
  METHODS
  
  
  
  METHODS
  Men aged 16 or over who report female sexual partners and recent unprotected sex or suspected acute STI. PARTICIPANTS (N=166) will be enrolled using a tablet computer in clinic waiting rooms. All trial procedures will be online, that is, eligibility checks; study consent; trial registration; automated random allocation; and data submission. At baseline and at 3, 6 and 12 months, an online questionnaire will assess condom use, self-reported STI diagnoses, and mediators of condom use (eg, knowledge, intention). Reminders will be by email and mobile phone. The primary outcome is condom use, measured at 3 months. STI rates will be recorded from sexual health clinic medical records at 12 months. The feasibility of a cost-effectiveness analysis will be assessed, to calculate incremental cost per STI prevented (Chlamydia or Gonorrhoea), from the NHS perspective.
  
  
  BACKGROUND
  Ethical approval: City and East NHS Research Ethics Committee (reference number 13 LO 1801). Findings will be made available through publication in peer-reviewed journals, and to participants and members of the public via Twitter and from the University College London eHealth Unit website. Raw data will be made available on request.
  
  
  BACKGROUND
  Current Controlled Trials. ISRCTN18649610. Registered 15 October 2013 http://www.controlled-trials.com/ISRCTN18649610.
authors: eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, UK.
authors: Julia V
authors: JV
authors: Bailey
authors: eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, UK.
authors: Rosie
authors: R
authors: Webster
authors: PRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UK.
authors: Rachael
authors: R
authors: Hunter
authors: PRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UK.
authors: Nick
authors: N
authors: Freemantle
authors: PRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UK.
authors: Greta
authors: G
authors: Rait
authors: Research Department of Clinical, Educational, and Health Psychology, University College London, London, UK.
authors: Susan
authors: S
authors: Michie
authors: BICMS, Barts and The London School of Medicine & Dentistry, Barts Sexual Health Centre, St Bartholomew's Hospital, London, UK.
authors: Claudia
authors: C
authors: Estcourt
authors: Homerton Sexual Health Services, Homerton University Hospital, London, UK.
authors: Jane
authors: J
authors: Anderson
authors: Centre for Sexual Health and HIV Research, University College London, London, UK.
authors: Makeda
authors: M
authors: Gerressu
authors: Centre for Sexual Health and HIV Research, University College London, London, UK.
authors: Judith
authors: J
authors: Stephenson
authors: School of Engineering and Digital Arts, University of Kent, Canterbury, UK.
authors: Chee Siang
authors: CS
authors: Ang
authors: Department of Infection & Population Health, University College London, London, UK.
authors: Graham
authors: G
authors: Hart
authors: eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, UK.
authors: Sacha
authors: S
authors: Dhanjal
authors: eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, UK.
authors: Elizabeth
authors: E
authors: Murray
mesh_terms: D000293:Adolescent; D000328:Adult; D040421:Cell Phone; D003201:Computers; D017280:Condoms / Q000706:statistics & numerical data*; D034742:Electronic Mail; D005260:Female; D006293:Health Promotion / Q000379:methods*; D006801:Humans; D008297:Male; D008571:Men; D010865:Pilot Projects; D012107:Research Design; D021841:Safe Sex; D012749:Sexually Transmitted Diseases / Q000517:prevention & control*; D011795:Surveys and Questionnaires
keywords: behavior change; complex intervention; interactive digital intervention; online trial; randomized controlled trial; sexual health