An Intervention to Increase Condom Use Among Users of Sexually Transmitted Infection Self-sampling Websites (Wrapped): Protocol for a Randomized Controlled Feasibility Trial.

BACKGROUND: Reducing the rates of sexually transmitted infections (STIs) among young people is a public health priority. The best way to avoid STIs from penetrative sex is to use a condom, but young people report inconsistent use. A missed opportunity to intervene to increase condom use is when young people access self-sampling kits for STIs through the internet. The potential of this opportunity is enhanced by the increasing numbers of young people being tested through this route every year in England. Hence, in a cocreation by young people, stakeholders, and researchers, Wrapped was developed--a fully automated, multicomponent, and interactive digital behavior change intervention developed for users of STI self-sampling websites, who are aged 16-24 years. OBJECTIVE: This paper is a protocol for a feasibility randomized controlled trial (fRCT). The fRCT seeks to establish whether it is feasible to run a randomized controlled trial to test the effectiveness and cost-effectiveness of Wrapped. Wrapped aims to reduce the incidence of STIs through increasing correct and consistent use of condoms among users of STI self-sampling websites, who are aged 16-24 years. METHODS: A 2-arm parallel-group randomized fRCT of Wrapped plus usual care, compared to usual care only (basic information on STIs and condom use), with a nested qualitative study. A minimum of 230 participants (aged 16-24 years) are recruited from an existing chlamydia self-sampling website. Participants are randomized into 1 of 2 parallel groups (1:1 allocation). Primary outcomes are the percentage of users recruited to the fRCT and the percentage of randomized participants who return a chlamydia self-sampling kit at month 12. Additionally, besides chlamydia positivity based on biological samples, surveys at baseline, month 3, month 6, and month 12, are used to assess condom use attitude, behavioral capability, self-efficacy, and intention, along with details of any partnered sexual activity and condom use, and health economic data. Nested qualitative interviews with trial participants are used to gain insight into the factors affecting recruitment and attrition. RESULTS: Recruitment to the fRCT began in March 2021 and was completed in October 2021. Data collection was completed in December 2022. CONCLUSIONS: This feasibility study will provide data to inform the design of a future-definitive trial. This work is timely given a rapid rise in the use of internet testing for STIs and the sustained high levels of STIs among young people. TRIAL REGISTRATION: ISRCTN Registry ISRCTN17478654; http://www.isrctn.com/ISRCTN17478654. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/43645.

Do automated digital health behaviour change interventions have a positive effect on self-efficacy? A systematic review and meta-analysis.

Self-efficacy is an important determinant of health behaviour. Digital interventions are a potentially acceptable and cost-effective way of delivering programmes of health behaviour change at scale. Whether behaviour change interventions work to increase self-efficacy in this context is unknown. This systematic review and meta-analysis sought to identify whether automated digital interventions are associated with positive changes in self-efficacy amongst non-clinical populations for five major health behaviours, and which BCTs are associated with that change. A systematic literature search identified 20 studies (n = 5624) that assessed changes in self-efficacy and were included in a random-effects meta-analysis. Interventions targeted: healthy eating (k = 4), physical activity (k = 9), sexual behaviour (k = 3) and smoking (k = 4). No interventions targeting alcohol use were identified. Overall, interventions had a small, positive effect on self-efficacy (g¯=0.190,CI[0.078;0.303]). The effect of interventions on self-efficacy did not differ as a function of health behaviour type (Q-between = 7.3704, p = .061, df = 3). Inclusion of the BCT 'information about social and environmental consequences' had a small, negative effect on self-efficacy (Δg¯=-0.297,Q=7.072,p=.008). Whilst this review indicates that digital interventions can be used to change self-efficacy, which techniques work best in this context is not clear.

Tailored digital behaviour change intervention with e-referral system to increase attendance at NHS stop smoking services (the MyWay project): study protocol for a randomised controlled feasibility trial.

INTRODUCTION: In the UK, smokers who use stop smoking services (SSSs) are four times more likely to stop smoking than smokers who do not. Attendance has declined, warranting the development of interventions to address this. StopApp is a novel, brief online behaviour change intervention designed to address common barriers to SSS attendance. It links to widely commissioned service management software that enables instant appointment booking at a user's location and time of choice. METHODS AND ANALYSIS: A two-arm parallel group, individual participant feasibility randomised controlled trial of StopApp (intervention) compared with the standard promotion of and referral to SSSs (control). The study includes a nested qualitative process evaluation to assess the acceptability of the research processes, with a subsample of participants. Smokers aged over 16 years will be recruited via three routes: General Practice (GP), community settings and online. After consenting and the collection of baseline data, participants will be randomised to control or intervention groups. Participants in the intervention group receive a link to StopApp and those in the control group receive standard web-based information about the SSSs. All participants are told they can book a SSS appointment but are under no obligation to do so. Online follow-up 2 months post randomisation includes data on SSS use and carbon monoxide verified 4-week quit rates. The study aims to recruit 162 smokers. ETHICS AND DISSEMINATION: Ethics approval has been granted by the West Midlands-Edgbaston NHS Research Ethics Committee. The findings will be reported in conferences and peer-reviewed publications; and will be used to design the parameters necessary for a definitive trial to ascertain the effectiveness of StopApp at increasing booking and attendance at SSSs compared with existing methods for encouraging uptake.

Lost in Translation: Transforming Behaviour Change Techniques into Engaging Digital Content and Design for the StopApp.

Frameworks to support the application of behaviour change theory to the choice of behaviour change techniques (BCTs) in designing digital behaviour change interventions (DBCIs) are becoming well established, and have been employed by the authors in the development of StopApp. However, guidance on the next stage—effective operationalisation (translation) of these BCTs to a digital context, including the precise delivery and design of “behavioural intervention technology” (BIT) elements, is still in its infancy. This is despite growing recognition of the need to optimise engagement and usability, alongside a theoretical basis, for intervention effectiveness. The aim of this study was to explore methods to translate BCTs into digital content in an accurate and systematic manner. We describe the process of using co-creation (user-led) rather than expert-driven methods in the development of user-facing features and design in StopApp, including the iterative “bottom-up” and “top-down processes” necessary for accurate BCT translation. We found a small disparity between the intended and actual BCT content, reflecting the difficulties of translating BCTs into digital intervention content and the need for better guidance and methodical approaches to enhance this under-researched process. The involvement of our Patient and Public Involvement (PPI) group throughout these processes is described.

StopApp: Using the Behaviour Change Wheel to Develop an App to Increase Uptake and Attendance at NHS Stop Smoking Services.

Smokers who attend NHS Stop Smoking Services (SSS) are four times more likely to stop smoking; however, uptake has been in decline. We report the development of an intervention designed to increase uptake of SSS, from a more motivated self-selected sample of smokers. In Phase 1 we collected data to explore the barriers and facilitators to people using SSS. In Phase 2, data from extant literature and Phase 1 were subject to behavioural analysis, as outlined by the Behaviour Change Wheel (BCW) framework. Relevant Behaviour Change Techniques (BCTs) were identified in order to address these, informing the content of the StopApp intervention. In Phase 3 we assessed the acceptability of the StopApp. Smokers and ex-smokers identified a number of barriers to attending SSS, including a lack of knowledge about what happens at SSS (Capability); the belief that SSS is not easy to access (Opportunity); that there would be 'scare tactics' or 'nagging'; and not knowing anyone who had been and successfully quit (Motivation). The 'StopApp' is in development and will link in with the commissioned SSS booking system. Examples of the content and functionality of the app are outlined. The next phase will involve a full trial to test effectiveness.