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

Bailey

Brafford

Carr-Hill

Crosby

Curtis

Exner

Fortenberry

Free

French

Glick

Green

Joint Formulary Committee

Kanuga

Kelly

Lustria

Marston

Michie

Milhausen

Murray

National Institute for Clinical Excellence

Nicholas

Noar

Ratcliffe

Seymour-Smith

Sheeran

St Lawrence

The EuroQoL group

Townsend

Weatherly

Webster

West

BMJ Open

English

PubMed

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.Methods and analysis: 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

Bailey, Julia V.

Webster, Rosie

Hunter, Rachael

Freemantle, Nick

Rait, Greta

Michie, Susan

Estcourt, Claudia

Anderson, Jane

Gerressu, Makeda

Stephenson, Judith

Ang, Chee Siang

Hart, Graham

Dhanjal, Sacha

Murray, Elizabeth

ResearchOnline@GCU

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

Bailey, J. V.

Webster, R.

Hunter, R.

Freemantle, N.

Rait, G.

Michie, S.

Estcourt, C.

Anderson, J.

Gerressu, M.

Stephenson, J.

Hart, G.

Dhanjal, S.

Murray, E.

Kent Academic Repository

A Comparison of Sexual Behavior Patterns Among Men Who Have Sex With Men and Heterosexual Men and Women.

A Systematic Review of Behavioral Interventions to Prevent HIV Infection and Transmission among Heterosexual, Adult Men in Low-and Middle-Income Countries. Prev Sci

Adolescent sexuality and the internet: the good, the bad, and the URL.

Agency. Infection Report. Health Protection Report: Weekly Report

Can computer mediated interventions change theoretical mediators of safer sex? A meta-analysis.

Computer-tailored health interventions delivered over the web: Review and analysis of key components.

Condom 'turn offs' among adults: an exploratory study.

Condom use as a function of time in new and established adolescent sexual relationships.

Condom-use errors and problems: A neglected aspect of studies assessing condom effectiveness.

ÇÿMy Wife Ordered Me to Come!*ÇÖ: A Discursive Analysis of Doctors*ÇÖ and Nurses*ÇÖ Accounts of Men*ÇÖs Use of General Practitioners.

Development and validation of a condom self-efficacy scale for college students.

Development of a theory-based interactive digital intervention to improve condom use in men in sexual health clinics: an application of qualitative methods using the behaviour change wheel. The Lancet 2013;382:S102.

Do minutes count? Consultation lengths in general practice.

Economic appraisal of public health interventions. Health Development Agency London;

Efficacy of computer technology-based HIV prevention interventions: a meta-analysis. AIDS 23(1):107-15,

Factors that shape young people's sexual behaviour: a systematic review. Lancet

for Clinical Excellence. Guide to the methods of technology appraisal. National Institute for Clinical Excellence

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.

HIV Sexual Risk Reduction Interventions With Heterosexual Men: The Forgotten Group.

Interactive computerbased interventions for sexual health promotion (Review).

Joint Formulary Committee. British national formulary. 65 ed.

Measurement of condom use in 72 studies of HIV-preventive behaviour: a critical review. Patient education and counseling

Measuring perceived barriers to condom use: Psychometric evaluation of the Condom Barriers Scale. Assessment

Methodological Challenges in Online Trials.

Methods for assessing the cost-effectiveness of public health interventions: Key challenges and recommendations.

National survey of sexual attitudes and lifestyles II: Technical report. National Centre for Social Research London;

psychosocial factors and the use of medical services: a longitudinal analysis.

Reactivity of measurement in health psychology: How much of a problem is it? What can be done about it? British journal of health psychology

Smoking cessation support delivered via mobile phone text messaging (txt2stop): A single-blind, randomised trial.

The behaviour change wheel: A new method for characterising and designing behaviour change interventions.

The EuroQoL group. EuroQol - a new facility for the measurement of health-related quality of life. Health policy

The Sexunzipped pilot trial: optimizing the design of online randomized controlled trials.

The Sexunzipped Trial: Young People*ÇÖs Views of Participating in an Online Randomized Controlled Trial.

Theory of addiction. Wiley-Blackwell;

Unit Costs of Health and Social Care.

Using DCE and ranking data to estimate cardinal values for health states for deriving a preference-based single index from the sexual quality of life questionnaire. Health Econ

Validation of a partner sexual communication scale for use in HIV/AIDS prevention interventions.

J. V. Bailey

R. Webster

R. Hunter

N. Freemantle

G. Rait

S. Michie

C. Estcourt

J. Anderson

M. Gerressu

J. Stephenson

C. S. Ang

G. Hart

S. Dhanjal

E. Murray

Crossref

Bailey, JV

Webster, R

Hunter, R

Freemantle, N

Rait, G

Michie, S

Estcourt, C

Anderson, J

Gerressu, M

Stephenson, J

Ang, CS

Hart, G

Dhanjal, S

Murray, E

UCL Discovery

A comparison of sexual behavior patterns among men who have sex with men and heterosexual men and women.

A systematic review of behavioral interventions to prevent HIV infection and transmission among heterosexual, adult men in low- and middle-income countries. Prev Sci 2013;14:88–105.

Agency. Infection report. Health Protection Report: Weekly Report

Committee. British national formulary. 65th edn.

Computer-tailored health interventions delivered over the web: review and analysis of key components. Patient Educ Couns

Condom ‘turn offs’ among adults: an exploratory study.

Condom-use errors and problems: a neglected aspect of studies assessing condom effectiveness.

Development and validation of a condom selfefficacy scale for college students.

Development of a theory-based interactive digital intervention to improve condom use in men in sexual health clinics: an application of qualitative methods using the behaviour change wheel. Lancet 2013;382:S102.

Economic appraisal of public health interventions. London: Health Development Agency,

Efficacy of computer technologybased HIV prevention interventions: a meta-analysis.

Factors that shape young people’s sexual behaviour: a systematic review. Lancet

HIV Sexual risk reduction interventions with heterosexual men: the forgotten group.

Interactive computer-based interventions for sexual health promotion. Cochrane Database Syst Rev 2010;(9):CD006483.

Measurement of condom use in 72 studies of HIV-preventive behaviour: a critical review. Patient Educ Couns

Measuring perceived barriers to condom use: psychometric evaluation of the Condom Barriers Scale. Assessment

Methodological challenges in online trials.

Methods for assessing the cost-effectiveness of public health interventions: key challenges and recommendations. Health Policy

My wife ordered me to come!’: a discursive analysis of doctors’ and nurses’ accounts of men’s use of general practitioners.

National survey of sexual attitudes and lifestyles II: Technical report. National Centre for Social Research London,

psychosocial factors and the use of medical services: a longitudinal analysis. Soc Sci Med 1999;48:1363–72.

Reactivity of measurement in health psychology: how much of a problem is it? What can be done about it?

Smoking cessation support delivered via mobile phone text messaging (txt2stop): a single-blind, randomised trial.

The behaviour change wheel: a new method for characterising and designing behaviour change interventions. Implement Sci 2011;6:1–12.

The EuroQoL group. EuroQol—a new facility for the measurement of health-related quality of life. Health Policy

The Sexunzipped trial: young people’s views of participating in an online randomized controlled trial.

Theory of addiction.

Unit costs of health and social care. Personal Social Services Research Unit,

Using DCE and ranking data to estimate cardinal values for health states for deriving a preference-based single index from the sexual quality of life questionnaire.

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.

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

Similar works

Full text

Available Versions

ResearchOnline@GCU

Kent Academic Repository

Crossref

UCL Discovery