Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
Randomized Controlled Trial
. 2015 Feb 16;5(2):e007552.
doi: 10.1136/bmjopen-2014-007552.

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

Julia V Bailey  1 , Rosie Webster  1 , Rachael Hunter  2 , Nick Freemantle  2 , Greta Rait  2 , Susan Michie  3 , Claudia Estcourt  4 , Jane Anderson  5 , Makeda Gerressu  6 , Judith Stephenson  6 , Chee Siang Ang  7 , Graham Hart  8 , Sacha Dhanjal  1 , Elizabeth Murray  1
Affiliations
Randomized Controlled Trial

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

Julia V Bailey et al. BMJ Open. .

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.

Keywords: behavior change; complex intervention; interactive digital intervention; online trial; randomized controlled trial; sexual health.

PubMed Disclaimer

Figures

Figure 1
Figure 1
Men's Safer Sex trial software framework: online study information, consent, registration, data collection and randomisation.
See this image and copyright information in PMC

References

    1. National Institute for Health and Clinical Excellence. One to one interventions to reduce the transmission of sexually transmitted infections (STIs) including HIV, and to reduce the rate of under 18 conceptions, especially among vulnerable and at risk groups London: National Institute for Health and Clinical Excellence, 2007.
    1. Health Protection Agency. Infection report. Health Protection Report: Weekly Report 2013 June 5;7(23) http://www.hpa.org.uk/hpr/archives/2013/hpr2313.pdf
    1. Crosby R, Milhausen R, Yarber WL et al. . Condom ‘turn offs’ among adults: an exploratory study. Int J STD AIDS 2008;19:590–4. 10.1258/ijsa.2008.008120 - DOI - PubMed
    1. Marston C, King E. Factors that shape young people's sexual behaviour: a systematic review. Lancet 2006;368:1581–6. 10.1016/S0140-6736(06)69662-1 - DOI - PubMed
    1. Sheeran P, Abraham C. Measurement of condom use in 72 studies of HIV-preventive behaviour: a critical review. Patient Educ Couns 1994;24:199–216. 10.1016/0738-3991(94)90065-5 - DOI - PubMed

Publication types

LinkOut - more resources