Title: An interactive digital behaviour change intervention (Wrapped) to decrease incidence of sexually transmitted infections (STIs) amongst users of STI self-sampling websites: A randomised controlled feasibility trial
Funder: Department of Health and Social Care

Abstract: What is the problem?_x000D_ Last year in England, 210,000 15-24 year olds were diagnosed with a Sexually Transmitted Infection (STI), half of all total diagnoses. If individuals experience symptoms, they can be unpleasant and painful. Often though, STIs have no symptoms and individuals unknowingly pass them on to others. Without treatment, STIs can have serious consequences such as infertility which negatively impact on quality of life. The cost to the National Health Service (NHS) of treating STIs is estimated to be £620 million per year. Each individual case of STI is preventable. The only way for sexually active people to avoid STIs is to use a condom, but young people report inconsistent use. _x000D_ _x000D_ It is important that we look for ways to reach young people at risk of future STIs and identify what will help them to increase their condom use. One way of reaching large numbers of young people at risk of STIs, that has been almost entirely overlooked, is through STI self-sampling websites. Through these sites, young people can request a free self-sampling kit that is received and returned via post. Demand for this service is rising rapidly. Users include groups known to be most at risk of future STIs, such as those from poorer backgrounds. _x000D_ _x000D_ What have we done so far?_x000D_ Together with young people and health professionals, we have developed a website called ‘Wrapped’. It aims to reduce future STI diagnoses amongst users of STI self-sampling websites through increasing their condom use. After placing an order for a self-sampling kit, users are immediately directed to Wrapped. Here they are asked to identify their main barriers to condom use before being allocated up to six different components. Components include a condom sample pack, access to a free monthly condom ordering service, a free condom carrier, a condom demonstration video, videos of young people giving tips on communicating about condoms, and videos of real couples discussing and using condoms. _x000D_ _x000D_ What are we going to do?_x000D_ What we want to know is whether Wrapped works. To find this out, we need to run a type of experiment called a Randomised Controlled Trial (RCT). RCTs are time consuming and expensive, often involving thousands of participants. In line with good practice, to prepare for this we are going to run a feasibility study. The primary aim is to identify whether we can recruit and retain the numbers of participants required for an RCT. _x000D_ _x000D_ How are we going to do it?_x000D_ Throughout this study we will work with users of a chlamydia self-sampling website (our Patient and Public Involvement (PPI) group). Initially, we will work with this group to develop materials and procedures that we think will work well to attract people to an RCT and keep them engaged throughout. The materials and procedures we select will be based on evidence of what has worked in the past but also on feedback from other young people sought via focus groups. We will then test these out by running a mini version of a full RCT. Throughout, we will carefully monitor engagement and interview participants, including those who drop-out, to see what we can learn about what it is like to be a participant in our study. Working again with our PPI group, we will use this evidence to adapt our materials and procedures so that we are ready to carry out a full RCT.

Lay abstract: Research question_x000D_ Is it feasible to run a RCT to test the effectiveness and cost-effectiveness of Wrapped (a fully automated, multi-component and interactive digital behaviour change intervention that aims to reduce the incidence of STIs through increasing correct and consistent condom use amongst users of STI self-sampling websites aged 16-24 years old)? _x000D_ _x000D_ Background_x000D_ Reducing the rates of Sexually Transmitted Infections (STIs) amongst young people is a public health priority. The best way for sexually active people to avoid STIs is to use a condom but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when they access self-sampling kits for STIs via the internet; young people are increasingly being tested via this route every year in England. _x000D_ _x000D_ Aim: to assess whether and how it is possible to carry out a future full RCT to evaluate the effectiveness and cost effectiveness of Wrapped in comparison to usual care._x000D_ _x000D_ Primary Objectives:_x000D_ To estimate for the main RCT: _x000D_ i. the rate of recruitment of eligible participants_x000D_ ii. the rate of participant follow-up for the main RCT primary outcome measure (cumulative incidence of chlamydia measured using biological samples) at 12 months_x000D_ _x000D_ Methods_x000D_ Research design: a two-arm parallel group randomised feasibility RCT of Wrapped compared to usual care (basic information on STIs and condom use), with preceding and nested qualitative studies. The preceding qualitative study will be used to develop and refine a participant recruitment and retention strategy for the feasibility RCT. A draft version of the strategy will be developed with our Participant and Patient Involvement (PPI) group and then revised/finalised following feedback obtained through a series of three focus groups with young people (16-24 years old). For the feasibility RCT, we will recruit a minimum of 230 participants (aged 16-24 years) over 3 months from an existing chlamydia self-sampling website. Participants will be randomised into one of two parallel groups (1:1 allocation). Repeated measures will be surveys at baseline (M0) and then M3, M6 and M12, and chlamydia screening at T0, T3 and T12. We will collect health economic data to compare the resource costs and cost effectiveness of delivering Wrapped compared to usual care. Nested qualitative interviews with trial participants will be used to gain insight into factors affecting recruitment and attrition. _x000D_ _x000D_ Timelines for delivery_x000D_ 0-6 months – development of recruitment/retention strategy and focus groups_x000D_ 7-9 months – recruitment to feasibility RCT_x000D_ 7-21 months – data collection: surveys and chlamydia screening _x000D_ 9-22 months – nested qualitative interviews_x000D_ 22-28 months – data analysis, report writing, dissemination _x000D_ _x000D_ Anticipated impact and dissemination_x000D_ We have a robust plan for project dissemination which we expect to lead to some short-term limited impact in terms of an increase in public engagement with research and related societal issues, and an increase in the knowledge economy. This includes multi-media communication with stakeholders, academics and the public. To ensure the potential for more long-term and meaningful impact (a reduction in STIs amongst the at-risk group and associated improvements in health/wellbeing), this project seeks to establish what evidence is required to make an economic case for investment in the intervention and make recommendations for routes to implementation and sustainability.

Research activity codes: 3.1 PRIMARY PREVENTION INTERVENTIONS TO MODIFY BEHAVIOURS OR PROMOTE WELL-BEING;8.4 RESEARCH DESIGN AND METHODOLOGIES (HEALTH SERVICES)
Health categories: REPRODUCTIVE HEALTH AND CHILDBIRTH