Title: The MenSS (Mens Safer Sex) website to increase condom use: intervention development and pilot trial
Funder: Department of Health (England)

Abstract: Aims:1) To design an interactive computer-based intervention to increase correct condom use in men 16 years and over recently diagnosed with a sexually transmitted infection (STI)2) To assess the feasibility and optimum design of a randomised controlled trial to test the interventionDetailed objectives:• To clarify the barriers and facilitators affecting condom use for men 16 years and over• To develop and optimise a targeted theoretically-informed interactive computer-based intervention (ICBI) to increase correct condom use in men recently diagnosed with STI• To refine our existing sexual health outcome measure (for self-reported sexual health behavioural outcomes)• To conduct a pilot randomised controlled trial (RCT) to optimise the parameters for a Phase 3 trial of usual clinical care plus the ICBI compared to usual care only• To conduct a qualitative process evaluation to explore mens experiences of participating in the pilot RCT• To optimise the data collection and analysis procedures for a health economic analysis for a future Phase 3 RCTOur team have already developed an interactive website for sexual health promotion for young people (Sexunzipped) and this will form the basis of a computer-based intervention targeting condom use skills for men. We also already have the software frameworks for online registration randomisation sexual health outcome measurement and automated follow-up by email.Setting: Participating genitourinary medicine clinics (GUM) which serve a diverse range of patients in terms of sexuality socio-economic status and ethnicity. Target Population: Men 16 years and over recently diagnosed with STI including men who have sex with men and men who have sex with womenPart 1- Intervention development and pilot trial set-up (12 months)A. Health advisor workshop: expert views on intervention contentB. Interviews: to ascertain experiences and perceptions of barriers and facilitators to condom use with a sample of men recently diagnosed with STI recruited from participating GUM clinics; also to obtain views on trial procedures including outcome measurementC. Focus groups: Mens views on the design and content of a computer-based interventionHealth Technology Being Assessed: A targeted theoretically-informed interactive computer-based intervention (ICBI) to encourage condom use in men recently diagnosed with STI delivered via: 1) a touch-screen laptop in clinics 2) online and 3) mobile phone. The intervention will include activities to increase motivation to use condoms; condom use and communication skills training; and exercises to boost self-esteem and self-efficacy. Consultation with users will ensure that the intervention is engaging and addresses mens views on content and design.Part 2- Phase 2 pilot randomised controlled trial (21 months)Setting target population and intervention as described above. Comparator = usual clinical care.Recruitment: Clinic staff will refer potentially eligible men to the researcher who will obtain informed consent and collect baseline data on a laptop prior to automated randomisation to an online trial (n=172: 86 intervention 86 control).Measurement of cost and outcomes: We will report development costs and recruitment and retention rates. We will measure changes in self-reported condom use and also mediators of behaviour change (e.g. intention and self-efficacy in communication with partners and condom use); measures of sexual wellbeing and satisfaction; and self-reported STI. Self-reported outcomes will be collected online at 12 months using automated email reminders with links to our online outcome measure. STI diagnoses will be recorded from GU clinical notes at 12 months as well as urinary Chlamydia and Gonorrhoea sampling by post. We will also define suitable ways of measuring the economic costs and benefits of increased condom use and undertake a parallel qualitative evaluation of the trial procedures to optimise future recruitment and retention.


Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;6.6 PSYCHOLOGICAL AND BEHAVIOURAL
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH