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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.
BMJ Open. 2015 Feb 16; 5(2):e007552.BO

Abstract

INTRODUCTION

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.

PARTICIPANTS

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.

ETHICS AND DISSEMINATION

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.

TRIAL REGISTRATION NUMBER

Current Controlled Trials. ISRCTN18649610. Registered 15 October 2013 http://www.controlled-trials.com/ISRCTN18649610.

Authors+Show Affiliations

eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, UK.eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, UK.PRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UK.PRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UK.PRIMENT Clinical Trials Unit, Research Department of Primary Care and Population Health, University College London, London, UK.Research Department of Clinical, Educational, and Health Psychology, University College London, London, UK.BICMS, Barts and The London School of Medicine & Dentistry, Barts Sexual Health Centre, St Bartholomew's Hospital, London, UK.Homerton Sexual Health Services, Homerton University Hospital, London, UK.Centre for Sexual Health and HIV Research, University College London, London, UK.Centre for Sexual Health and HIV Research, University College London, London, UK.School of Engineering and Digital Arts, University of Kent, Canterbury, UK.Department of Infection & Population Health, University College London, London, UK.eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, UK.eHealth Unit, Research Department of Primary Care and Population Health, University College London, London, UK.

Pub Type(s)

Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

25687900

Citation

Bailey, Julia V., et al. "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." BMJ Open, vol. 5, no. 2, 2015, pp. e007552.
Bailey JV, Webster R, Hunter R, et al. 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. BMJ Open. 2015;5(2):e007552.
Bailey, J. V., Webster, R., Hunter, R., Freemantle, N., Rait, G., Michie, S., Estcourt, C., Anderson, J., Gerressu, M., Stephenson, J., Ang, C. S., Hart, G., Dhanjal, S., & Murray, E. (2015). 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. BMJ Open, 5(2), e007552. https://doi.org/10.1136/bmjopen-2014-007552
Bailey JV, et al. 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. BMJ Open. 2015 Feb 16;5(2):e007552. PubMed PMID: 25687900.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - 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. AU - Bailey,Julia V, AU - Webster,Rosie, AU - Hunter,Rachael, AU - Freemantle,Nick, AU - Rait,Greta, AU - Michie,Susan, AU - Estcourt,Claudia, AU - Anderson,Jane, AU - Gerressu,Makeda, AU - Stephenson,Judith, AU - Ang,Chee Siang, AU - Hart,Graham, AU - Dhanjal,Sacha, AU - Murray,Elizabeth, Y1 - 2015/02/16/ PY - 2015/2/18/entrez PY - 2015/2/18/pubmed PY - 2015/10/1/medline KW - behavior change KW - complex intervention KW - interactive digital intervention KW - online trial KW - randomized controlled trial KW - sexual health SP - e007552 EP - e007552 JF - BMJ open JO - BMJ Open VL - 5 IS - 2 N2 - INTRODUCTION: 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. PARTICIPANTS: 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. ETHICS AND DISSEMINATION: 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. TRIAL REGISTRATION NUMBER: Current Controlled Trials. ISRCTN18649610. Registered 15 October 2013 http://www.controlled-trials.com/ISRCTN18649610. SN - 2044-6055 UR - https://www.unboundmedicine.com/medline/citation/25687900/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_ L2 - https://bmjopen.bmj.com/lookup/pmidlookup?view=long&pmid=25687900 DB - PRIME DP - Unbound Medicine ER -