Title: Evaluating the Home-based Intervention Strategy (HIS-UK) to reduce new chlamydia infection among young men aged 16-25 years by promoting correct and consistent condom use: What is the cost effectiveness of two different delivery models (face-to-face and digital delivery)?
Funder: Department of Health and Social Care

Abstract: WHAT IS THE PROBLEM? Poor sexual health is not shared equally across the UK population. The Department of Health has identified the need to reduce sexually transmitted infection (STI) rates as a priority for reducing SH inequalities and have recognised men who have sex with men and young people as target ‘at-risk’ groups. The health, social, and economic costs of STIs are huge. The current cost of STI treatment to the NHS is £620 million per year. Recent guidelines from the National Institute for Health and Care Excellence include the need to teach young people to use condoms effectively and safely before providing them._x000D_ _x000D_ WHY DO WE NEED TO DO SOMETHING? Condoms remain the main protection against STIs when used correctly and consistently, yet there are many barriers to their use such as reduced sexual pleasure, fit-and-feel problems, lubrication issues and erection difficulties. Many health promotion programmes try to improve knowledge and skills to increase condom use, but do not address the barriers. There is a need to develop effective programmes to reduce barriers and improve condom use experiences to help reduce sexual risk among young people. Furthermore, given the increasing use of the internet by young people, designing programmes using digital technology is seen as a key delivery strategy._x000D_ _x000D_ WHAT HAS ALREADY BEEN DONE? We have developed a condom promotion programme for use among young men in the UK. The programme gives out condom kits (containing different types of condoms and lubricants) and asks men to experiment with the contents at home by themselves following condom use education and training. The education and training can either be delivered online (eHIS) or face-to-face by a health professional (proHIS). As men test each condom and lubricant they are asked to think about their own pleasure and which they like. An online rating exercise helps men to identify the ‘best’ condoms and lubricants for them. Men who have already tested the programme said that they have enjoyed it and would recommend it to others._x000D_ _x000D_ WHAT NOW? We want to see if men who experiment with different types of condoms report more enjoyable, correct and consistent condom use, and are less likely to have chlamydia at follow-up than men who do not. We also want to find out if it is more effective, acceptable and cost effective to deliver the programme face-to-face or online. To do this we will recruit 2231 men aged between 16-25 years who are at risk of STIs because they do not use condoms during sex with casual and/or new partners. Young men will be recruited via adverts on social media, from young people’s information and advice services, and from specialist sexual health services at selected sites across England. Men will be assigned at random to receive either the digital eHIS programme, the face-to-face proHIS programme or usual condom care and will be followed up for 12 months during which they will be asked at various times about their sexual behaviour, condom use experiences and to take Chlamydia tests. We will then be able to see if Chlamydia rates and/or condom use behaviours differ between the groups of young men._x000D_ _x000D_ We will share the findings widely to help ensure that the findings are used to improve the health and wellbeing of young people through reducing risk to STIs. Engagement of health professionals and policy makers will support adoption of the programme into mainstream practice and help reduce Public Health and NHS costs.

Lay abstract: The UK Home-Based Intervention Strategy (HIS-UK) is a behaviour change condom promotion intervention for young men designed to enhance enjoyment of condom-protected intercourse, improve attitudes towards condoms, improve the correct and consistent use of condoms, and thereby reduce the risk of sexually transmitted infections. HIS-UK is an adapted version of The Kinsey Institute Homework Intervention Strategy® originally developed in the US and which is based on the behavioural therapy directed practice approach most commonly used to treat sexual problems. HIS-UK has two delivery models; digital delivery using an interactive website (eHIS), and face-to-face delivered by a trained health professional (proHIS). This study will build on the previous work of, and lessons learned from, a) the MRC-funded feasibility study of the HIS-UK face-to-face intervention and b) the feasibility and pilot study of the digital version of the intervention._x000D_ _x000D_ Aim_x000D_ To assess the effectiveness and cost-effectiveness of HIS-UK delivered by proHIS and eHIS to reduce test positivity of Chlamydia among young men aged 16-25 years as compared to usual condom distribution care._x000D_ _x000D_ Objectives_x000D_ _x000D_ 1) To assess the effectiveness of HIS-UK among young men aged 16-25 years by comparing between the intervention and control arms:_x000D_ • Chlamydia test positivity (6 & 12 months) _x000D_ • episodes of condomless anal and/or vaginal sexual intercourse (1-12 months)_x000D_ • reported condom use errors and problems (1-12 months)_x000D_ • enhanced condom use experiences (1-12months)_x000D_ • positive condom use attitudes (1-12 months)_x000D_ _x000D_ 2) To conduct a process evaluation and mediation analysis to explore the way in which the HIS-UK delivered by proHIS and eHIS may work and the possible mediators and mechanisms of change._x000D_ _x000D_ 3) To estimate the costs associated with proHIS and eHIS and their cost effectiveness as compared to usual condom distribution care._x000D_ _x000D_ Methods_x000D_ _x000D_ To compare the effectiveness of HIS-UK delivered by proHIS and eHIS-UK to usual care we propose a randomised, controlled, superiority trial with three-parallel groups (two intervention and one control arm, 1:1:1 allocation), with an internal pilot phase. We will use a repeated measures study design with baseline measurement (T0) and follow-up monthly online questionnaires to 12 months (T1-12) post intervention and three STI screening points (T0,T6,T12) for chlamydia. We will collect health economic data to compare the resource use and cost effectiveness of delivering HIS-UK by the two delivery models to usual condom distribution care._x000D_ _x000D_ 2231 young men who are ‘at-risk’ of STIs - defined as men, aged 16-25 years, who report condomless penile-vaginal/anal intercourse with casual or new sexual partners during the previous 3 months – will be recruited over 30 months and randomised to either the control or intervention arms. _x000D_ _x000D_ Impact and Dissemination_x000D_ _x000D_ The beneficiaries of this research will be young men who are at risk of STIs; young men's sexual partners; clinicians, youth organisations, Local Authorities and SH service providers; health promotion specialists and SH advisers; policy makers and Local Authority, Public Health and NHS commissioners; condom distributors; the academic community; the public and wider society; and the public purse.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING
Health categories: INFECTION