A Virtual Reality Exergame to Engage Adolescents in Physical Activity: Mixed Methods Study Describing the Formative Intervention Development Process.

BACKGROUND: Early adolescence (13-17 years) is a critical developmental stage for physical activity promotion. Virtual reality (VR) exergaming is a promising intervention strategy to engage adolescents in physical activity. OBJECTIVE: The vEngage project aims to develop a physical activity intervention for adolescents using VR exergaming. Here, we describe the formative intervention development work and process of academic-industry collaboration. METHODS: The formative development was guided by the Medical Research Council framework and included recruiting an adolescent user group to provide iterative feedback, a literature review, a quantitative survey of adolescents, qualitative interviews with adolescents and parents, inductive thematic analysis of public reviews of VR exergames, a quantitative survey and qualitative interviews with users of the augmented reality running app Zombies, Run!, and building and testing a prototype with our adolescent user group. RESULTS: VR exergaming was appealing to adolescents and acceptable to parents. We identified behavior change techniques that users would engage with and features that should be incorporated into a VR exergame, including realistic body movements, accurate graphics, stepped levels of gameplay difficulty, new challenges, in-game rewards, multiplayer options, and the potential to link with real-world aspects such as physical activity trackers. We also identified some potential barriers to use, such as cost, perceived discomfort of VR headsets, and motion sickness concerns. A prototype game was developed and user-tested with generally positive feedback. CONCLUSIONS: This is the first attempt to develop a VR exergame designed to engage adolescents in physical activity that has been developed within a public health intervention development framework. Our formative work suggests that this is a very promising avenue. The benefit of the design process was the collaborative parallel work between academics and game designers and the involvement of the target population in the game (intervention) design from the outset. Developing the game within an intervention framework allowed us to consider factors, such as parental support, that would be important for future implementation. This study also serves as a call to action for potential collaborators who may wish to join this endeavor for future phases and an example of how academic-industry collaboration can be successful and beneficial.

What Players of Virtual Reality Exercise Games Want: Thematic Analysis of Web-Based Reviews.

BACKGROUND: Physical activity (PA) is associated with a variety of physical and psychosocial health benefits, but levels of moderate-to-vigorous intensity PA remain low worldwide. Virtual reality (VR) gaming systems involving movement (VR exergames) could be used to engage people in more PA. OBJECTIVE: This study aimed to synthesize public reviews of popular VR exergames to identify common features that players liked or disliked to inform future VR exergame design. METHODS: We conducted a thematic analysis of 498 reviews of the 29 most popular exergames sold in the top 3 VR marketplaces: Steam (Valve Corporation), Viveport (Valve Corporation), and Oculus (Oculus VR). We categorized reviews as positive and negative as they appeared in the marketplaces and identified the most common themes using an inductive thematic analysis. RESULTS: The reviews were often mixed, reporting a wide variety of expectations, preferences, and gaming experiences. Players preferred highly realistic games (eg, closely simulated real-world sport), games that were intuitive (in terms of body movement and controls), and games that provided gradual increases in skill acquisition. Players reported feeling that they reached a high level of exertion when playing and that the immersion distracted them from the intensity of the exercise. Some preferred features included music and social aspects of the games, with multiplayer options to include friends or receive help from experienced players. There were 3 main themes in negative reviews. The first concerned bugs that rendered games frustrating. Second, the quality of graphics had a particularly strong impact on perceived enjoyment. Finally, reviewers disliked when games had overly complex controls and display functions that evoked motion sickness. CONCLUSIONS: Exergames prove to be a stimulating avenue for players to engage in PA and distract themselves from the negative perceptions of performing exercise. The common negative aspects of VR exergames should be addressed for increased uptake and continued engagement.

Evidence for behavioural interventions addressing condom use fit and feel issues to improve condom use: a systematic review.

Continuing high rates of sexually transmissible infections (STIs) in many countries highlight the need to identify effective behavioural interventions. Consistent and correct use of male condoms is a key strategy for the prevention of STIs. However, some men report problems with condom fit (e.g. the size and shape of the condom) and feel (e.g. tightness, irritation, sensitivity), which inhibits their use. We conducted a systematic review to identify existing interventions addressing condom use fit and feel problems. We searched electronic databases for peer-reviewed articles and searched reference lists of retrieved studies. Five studies met the inclusion criteria. These were generally small-scale pilot studies evaluating behavioural interventions to promote safer sex with men aged under 30 years, addressing, among other things, barriers to condom use relating to fit and feel. There were significant increases in the reported use of condoms, including condom use with no errors and problems. Improvements in some condom use mediators were reported, such as condom use self-efficacy, knowledge, intentions and condom use experience. There were mixed findings in terms of the ability of interventions to reduce STI acquisition. Behavioural interventions addressing condom fit and feel are promising in terms of effectiveness but require further evaluation.

Development of an Intervention to Increase Sexual Health Service Uptake by Young People.

This study aimed to develop and implement an intervention, delivered via a website and Web app, to increase the uptake of sexual health services by young people. The intervention was co-designed with a group of 10 young people. Intervention mapping was used to guide development. To identify barriers and facilitators of access to sexual health services, three focus groups with 24 young people aged 13 to 19 years, and interviews with 12 professionals recruited from across a range of health and social services, were conducted. Data were analyzed using content analysis. Evidence was supplemented through a literature review. Barriers and facilitators were categorized as theoretical determinants and then suitable behavior change techniques (BCTs) for targeting them were selected. Targeted determinants were attitude, subjective norm, perceived behavioral control, and knowledge. Selected BCTs included "information about others' approval," "framing/reframing," and "credible source." The website/app enable users to search for services, access key information about them, watch videos about what to expect, and have key concerns removed/addressed. This is the first known digital evidence-based intervention to target this behavior described in the literature. A clear and full description of intervention development and content, including of theorized causal pathways, is provided to aid interpretation of future outcome evaluations.

Identifying strategies to increase influenza vaccination in GP practices: a positive deviance approach.

BACKGROUND: Influenza (flu) is an acute viral infection of the respiratory tract, which can lead to serious complications for individuals within at-risk groups. Evidence indicates that aspects of organization and delivery within GP practices can have an influence on the rates of flu vaccination uptake. Positive deviance is a methodological approach that facilitates identification of factors associated with high performance. OBJECTIVE: To use positive deviance to isolate factors associated with high performance by comparing GP practices achieving high and low flu vaccination uptake. METHODS: This was a qualitative study. A total of 18 practice managers and 2 GPs from 20 GP practices participated, 10 with high and low vaccination rates, respectively. Telephone interviews were conducted, audio recorded and fully transcribed. Framework Analysis was used to analyse the data. RESULTS: High uptake practices were more likely than low uptake practices to have a lead member of staff who demonstrated tenacity, have aspirational uptake targets, have developed and used additional prompts within their IT systems to identify eligible patients, have GPs who were opportunistically vaccinating and use phone calls as a first-line strategy to invite patients for vaccination. CONCLUSIONS: This is the first known qualitative study to identify strategies used by UK GP practices to deliver seasonal flu vaccination programmes. It is one of few studies using the robust and novel approach of positive deviance to inform health care recommendations. This approach has offered new and more nuanced insights into GP practice factors associated high flu vaccination uptake beyond those captured through large-scale survey research.

Which outcome expectancies are important in determining young adults' intentions to use condoms with casual sexual partners?: a cross-sectional study.

BACKGROUND: The prevalence of unwanted pregnancy and sexually transmitted infection amongst young adults represents an important public health problem in the UK. Individuals' attitude towards the use of condoms has been identified as an important determinant of behavioural intentions and action. The Theory of Planned Behaviour has been widely used to explain and predict health behaviour. This posits that the degree to which an individual positively or negatively values a behaviour (termed 'direct attitude') is based upon consideration of the likelihood of a number of outcomes occurring (outcome expectancy) weighted by the perceived desirability of those outcomes (outcome evaluation). Outcome expectancy and outcome evaluation when multiplied form 'indirect attitude'. The study aimed to assess whether positive outcome expectancies of unprotected sex were more important for young adults with lower safe sex intentions, than those with safer sex intentions, and to isolate optimal outcomes for targeting through health promotion campaigns. METHODS: A cross-sectional survey design was used. Data was collected from 1051 school and university students aged 16-24 years. Measures of intention, direct attitude and indirect attitude were taken. Participants were asked to select outcome expectancies which were most important in determining whether they would use condoms with casual sexual partners. RESULTS: People with lower safe sex intentions were more likely than those with safer sex intentions to select all positive outcome expectancies for unprotected sex as salient, and less likely to select all negative outcome expectancies as salient. Outcome expectancies for which the greatest proportion of participants in the less safe sex group held an unfavourable position were: showing that I am a caring person, making sexual experiences less enjoyable, and protecting against pregnancy. CONCLUSIONS: The findings point to ways in which the attitudes of those with less safe sex intentions could be altered in order to motivate positive behavioural change. They suggest that it would be advantageous to highlight the potential for condom use to demonstrate a caring attitude, to challenge the potential for protected sex to reduce sexual pleasure, and to target young adults' risk appraisals for pregnancy as a consequence of unprotected sex with casual sexual partners.

Increasing young adults' condom use intentions and behaviour through changing chlamydia risk and coping appraisals: study protocol for a cluster randomised controlled trial of efficacy.

BACKGROUND: Chlamydia is the most commonly diagnosed sexually transmitted infection (STI) in England and has serious public health consequences. Young people carry a disproportionate burden of infection. A number of social cognition models identify risk appraisal as a primary motivator of behaviour suggesting that changing risk appraisals for STIs may be an effective strategy in motivating protective behaviour. Meta-analytic evidence indicates that the relationship between risk appraisal and health behaviour is small, but studies examining this relationship have been criticised for their many conceptual and methodological weaknesses. The effect of risk appraisal on health behaviour may therefore be of larger size. The proposed study aims to examine the efficacy of an intervention to increase condom use intentions and behaviour amongst young people through changing chlamydia risk and coping appraisals. Coping appraisal is targeted to avoid the intervention being counterproductive amongst recipients who do not feel able to perform the behaviour required to reduce the threat. An experimental design with follow-up, a conditional measure of risk appraisal, and analysis which controls for past behaviour, enable the relationship between risk appraisal and protective behaviour to be accurately assessed. METHODS/DESIGN: The proposed study is a two-arm cluster randomised controlled trial using a waiting-list control design to test the efficacy of the intervention compared to a control group. Participants will be school pupils aged 13-16 years old recruited from approximately ten secondary schools. Schools will be randomised into each arm. Participants will receive their usual teaching on STIs but those in the intervention condition will additionally receive a single-session sex education lesson on chlamydia. Measures will be taken at baseline, post-intervention and at follow-up three months later. The primary outcome measure is intention to use condoms with casual sexual partners. DISCUSSION: As far as the authors are aware, this is the first controlled trial testing the efficacy of an intervention to increase condom use intentions and behaviour through changing chlamydia risk appraisals. It is one of few experimental studies to accurately test the relationship between risk appraisal and precautionary sexual behaviour using a conditional measure of risk appraisal and controlling for past behaviour.

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.

Findings from the Tushirikiane mobile health (mHealth) HIV self-testing pragmatic trial with refugee adolescents and youth living in informal settlements in Kampala, Uganda.

INTRODUCTION: Urban refugee youth remain underserved by current HIV prevention strategies, including HIV self-testing (HIVST). Examining HIVST feasibility with refugees can inform tailored HIV testing strategies. We examined if HIVST and mobile health (mHealth) delivery approaches could increase HIV testing uptake and HIV status knowledge among refugee youth in Kampala, Uganda. METHODS: We conducted a three-arm pragmatic controlled trial across five informal settlements grouped into three sites in Kampala from 2020 to 2021 with peer-recruited refugee youth aged 16-24 years. The intervention was HIVST and HIVST + mHealth (HIVST with bidirectional SMS), compared with standard of care (SOC). Primary outcomes were self-reported HIV testing uptake and correct status knowledge verified by point-of-care testing. Some secondary outcomes included: depression, HIV-related stigma, and adolescent sexual and reproductive health (SRH) stigma at three time points (baseline [T0], 8 months [T1] and 12 months [T2]). We used generalized estimating equation regression models to estimate crude and adjusted odds ratios comparing arms over time, adjusting for age, gender and baseline imbalances. We assessed study pragmatism across PRECIS-2 dimensions. RESULTS: We enrolled 450 participants (50.7% cisgender men, 48.7% cisgender women, 0.7% transgender women; mean age: 20.0, standard deviation: 2.4) across three sites. Self-reported HIV testing uptake increased significantly from T0 to T1 in intervention arms: HIVST arm: (27.6% [n = 43] at T0 vs. 91.2% [n = 135] at T1; HIVST + mHealth: 30.9% [n = 47] at T0 vs. 94.2% [n = 113] at T1]) compared with SOC (35.5% [n = 50] at T0 vs. 24.8% [ = 27] at T1) and remained significantly higher than SOC at T2 (p<0.001). HIV status knowledge in intervention arms (HIVST arm: 100% [n = 121], HIVST + mHealth arm: 97.9% [n = 95]) was significantly higher than SOC (61.5% [n = 59]) at T2. There were modest changes in secondary outcomes in intervention arms, including decreased depression alongside increased HIV-related stigma and adolescent SRH stigma. The trial employed both pragmatic (eligibility criteria, setting, organization, outcome, analysis) and explanatory approaches (recruitment path, flexibility of delivery flexibility, adherence flexibility, follow-up). CONCLUSIONS: Offering HIVST is a promising approach to increase HIV testing uptake among urban refugee youth in Kampala. We share lessons learned to inform future youth-focused HIVST trials in urban humanitarian settings.

Stool submission by general practitioners in SW England - when, why and how? A qualitative study.

BACKGROUND: We know little about when and why general practitioners (GPs) submit stool specimens in patients with diarrhoea. The recent UK-wide intestinal infectious disease (IID2) study found ten GP consultations for every case reported to national surveillance. We aimed to explore what factors influence GP's decisions to send stool specimens for laboratory investigation, and what guidance, if any, informs them. METHODS: We used qualitative methods that enabled us to explore opinions and ask open questions through 20 telephone interviews with GPs with a range of stool submission rates in England, and a discussion group with 24 GPs. Interviews were transcribed and subjected to content analysis. RESULTS: Interviews: GPs only sent stool specimens to microbiology if diarrhoea persisted for over one week, after recent travel, or the patient was very unwell. Very few had a systematic approach to determine the clinical or public health need for a stool specimen. Only two GPs specifically asked patients about blood in their stool; only half asked about recent antibiotics, or potential food poisoning, and few asked about patients' occupations. Few GPs gave patients advice on how to collect specimens.Results from interviews and discussion group in relation to guidance: All reported that the HPA stool guidance and patient collection instructions would be useful in their clinical work, but only one GP (an interviewee) had previously accessed them. The majority of GPs would value links to guidance on electronic requests. Most GPs were surprised that a negative stool report did not exclude all the common causes of IID. CONCLUSIONS: GPs value stool culture and laboratories should continue to provide it. Patient instructions on how to collect stool specimens should be within stool collection kits. Through readily accessible guidance and education, GPs need to be encouraged to develop a more systematic approach to eliciting and recording details in the patient's history that indicate greater risk of severe infection or public health consequences. Mild or short duration IID (under one week) due to any cause is less likely to be picked up in national surveillance as GPs do not routinely submit specimens in these cases.

Tackling sensitive issues using a game-based environment: serious game for relationships and sex education (RSE).

Experiencing sexual coercion during adolescence can lead to adverse psychological and physical health outcomes for those affected. Eliminating such experiences is important for enhancing adolescent wellbeing, and the provision of good quality relationships and sex education (RSE) is needed. Engaging young people in sensitive subject matters in RSE can be challenging, and using Serious Gaming technology may support young people and educators in this process. This paper describes the use of Intervention mapping (IM) in the development of a serious game on the topic of sexual coercion for use in RSE. IM is a process that draws on stakeholder engagement and the theory and evidence base to support health improvement intervention planning. Serious game developers transformed the game concept 'flat plan' into an interactive gameshow. The game is teacher led and aims to engage students in game play and discussion around the issue of sexual coercion. The final product known as PR:EPARe (Positive Relationships: Eliminating Coercion and Pressure in Adolescent Relationships) is the subject of an ongoing cluster Randomised Controlled Trial (RCT) in local schools. Early data analysis shows improvements in psychological preparedness for dealing with sexual coercion against some change objectives. This work represents the first attempt to use IM in the development of a Serious Game and the use of Serious Gaming for RSE delivery. RCT work is ongoing and PR:EPARe will become part of local RSE delivery in the new school year. Plans for ensuring broader impact of the game are in development.

Effectiveness of a Digital Intervention in Increasing Flu Vaccination-Related Risk Appraisal, Intention to Vaccinate and Vaccination Behaviour Among Pregnant Women.

BACKGROUND: Pregnant women are at increased risk of complications from flu, but uptake of flu vaccination is below 75% targets. Evidence suggests that changing illness risk appraisals may increase vaccination behaviour. In 2018-2019, researchers, public health specialists, and pregnant women co-designed a short animation targeting (unhelpful) beliefs underlying pregnant women's flu risk appraisals aiming to promote vaccination uptake. AIMS: This study aimed to examine effectiveness of a digital intervention (animation) in increasing flu vaccination among pregnant women through changing illness risk appraisals. METHOD: A prospective study design was used, involving convenience sampling of unvaccinated pregnant women recruited via a Qualtrics Online Panel. Participants received small payments via the panel for survey completion. Risk appraisals and intention to vaccinate were measured at baseline and immediately after intervention presentation (follow-up one). Six months later, a further survey (follow-up two) was administered measuring vaccination behaviour. RESULTS: Baseline and first follow-up surveys were completed by 411 participants. Watching the animation led to increased appraisals of likelihood of getting flu while pregnant and severity of flu during pregnancy, and increased intentions to accept flu vaccination during pregnancy. Of the 67 respondents who completed follow-up survey two, 38 reported having the vaccination while pregnant. CONCLUSIONS: This study provides evidence supporting the promise of the intervention. Randomized controlled trials are required to produce definitive efficacy evidence. Should such a study prove intervention effectiveness, it could be readily embedded within existing campaigns at national and local levels by public health organizations.

Evaluation of the move to remote delivery of drug and alcohol services during the COVID-19 pandemic: A study protocol.

Background: Substance misuse is a significant global health concern. In the UK, the prevalence of substance misuse has increased over the past decade and the number of alcohol and drug related deaths are increasing. Individuals with substance dependency issues are entitled to access treatment services. However, the COVID-19 pandemic created significant challenges for public services, including drug and alcohol treatment, and resulted in significant service reconfiguration and a shift from in-person to remote delivery. This study aims to evaluate the delivery of drug and alcohol services in a large metropolitan area in Northern England during the COVID-19 pandemic. It aims to understand the impact of service reconfiguration for services, staff and service users, and to use this understanding to inform the future optimised design of services. Design and methods: The study has five workstreams within a mixed methods framework: (1) Systematic review of literature; (2) Qualitative process evaluation with service providers (digital timelines, focus groups and interviews); (3) Qualitative process evaluation with service users (interviews, focus groups, text based conversations and case studies); (4) Quantitative outcomes and health economic analysis; and (5) Data synthesis and dissemination. Expected Impact of the study for Public Health: The breadth of the study, its novel nature, and the importance of substance misuse as a public health issue, mean that this study will provide valuable findings for those who commission, deliver and use drug and alcohol treatment services nationally and internationally. There will also be important learning for the effective remote delivery of services in sectors beyond drug and alcohol treatment.

Reducing New Chlamydia Infection Among Young Men by Promoting Correct and Consistent Condom Use: Protocol for a Randomized Controlled Trial.

BACKGROUND: The health, social, and economic costs of sexually transmitted infections (STIs) represent a major public health concern. Young people are considered one of the groups most at risk for acquiring and transmitting STIs. Correct and consistent condom use has been shown to be the most effective method for reducing STIs; however, condoms are often not used properly. Evidence shows that brief behavior change interventions that focus on skills, communication, and motivation to acquire safe sex practices should be adopted into routine care to reduce STIs. Funding for sexual health services in England has declined dramatically, so novel ways of reducing clinic attendance are being sought. The home-based intervention strategy (HIS-UK) to promote condom use among young men has shown promise in feasibility and pilot studies by demonstrating high acceptability of the intervention in participant and health professional feedback, including aiding men to find condoms they like and feel more confident when using condoms. OBJECTIVE: The aim of this study is to determine the effectiveness and cost-effectiveness of HIS-UK when compared to usual condom distribution care among young men. METHODS: The 3 trial arms consisting of "e-HIS" (HIS-UK delivered digitally), "ProHIS" (HIS-UK delivered face-to-face), and control condition (usual National Health Service [NHS] care) will be compared against the following 3 primary outcomes: the extent to which correct and consistent condom use is increased; improvement of condom use experiences (pleasure as well as fit and feel); and decrease in chlamydia test positivity. Eligibility criteria include men aged 16-25 years at risk of STIs through reporting of condom use errors (ie, breakage or slippage) or condomless penile-vaginal or penile-anal intercourse with casual or new sexual partners during the previous 3 months. Prospective participants will be recruited through targeted advertisements and an opportunistic direct approach at selected sexual health and genitourinary medicine services and university-associated health centers and general practitioner practices. Community and educational establishments will be used to further advertise the study and signpost men to recruitment sites. Participants will be randomly allocated to 1 of 3 trial arms. A repeated measures design will assess the parallel arms with baseline and 12 monthly follow-up questionnaires after intervention and 3 chlamydia screening points (baseline, 6, and 12 months). RESULTS: Recruitment commenced in March 2020. Due to the COVID-19 pandemic, the study was halted and has since reopened for recruitment in Summer 2021. A 30-month recruitment period is planned. CONCLUSIONS: If effective and cost-effective, HIS-UK can be scaled up into routine NHS usual care to reduce both STI transmission in young people and pressure on NHS resources. This intervention may further encourage sexual health services to adopt digital technologies, allowing for them to become more widely available to young people while decreasing health inequalities and fear of stigmatization. TRIAL REGISTRATION: ISRCTN Registry ISRCTN11400820; https://www.isrctn.com/ISRCTN11400820.

Evaluation of a whole system approach to diet and healthy weight in the east of Scotland: Study protocol.

Obesity is a global epidemic affecting all age groups, populations and income levels across continents. The causes of obesity are complex and are routed in health behaviours, environmental factors, government policy and the cultural and built environment. Consequently, a Whole System Approach (WSA) which considers the many causes of obesity and shifts the focus away from individuals as points of intervention and puts an emphasis on understanding and improving the system in which people live in is required. This protocol describes a programme of research that will: critically evaluate the evidence for WSAs; assess longitudinally the implementation of a WSA to diet and healthy weight to explore the range of levers (drivers) and opportunities to influence relevant partnerships and interventions to target obesity in East Scotland. The programme consists of four workstreams within a mixed methods framework: 1) Systematic review of reviews of WSAs to diet and healthy weight; 2) Longitudinal qualitative process evaluation of implementing two WSAs in Scotland; 3) Quantitative and Qualitative momentary analysis evaluation of a WSA; and 4) the application of System Dynamics Modelling (SDM) methodology to two council areas in Scotland. A Public Involvement in Research group (PIRg) have informed each stage of the research process. The research programme's breadth and its novel nature, mean that it will provide valuable findings for the increasing numbers who commission, deliver, support and evaluate WSAs to diet and healthy weight nationally and internationally.

"What Should We Tell the Children About Relationships and Sex?"©: development of a program for parents using intervention mapping.

This article describes the development of an intervention that aims to increase the quantity and quality of parent-child communication about sex and relationships. The intervention has been designed as part of a local strategic approach to teenage pregnancy and sexual health. The process and findings of Intervention Mapping (IM), a tool for the development of theory-and evidence-based interventions, are presented. The process involves a detailed assessment of the difficulties parents experience in communicating with their children about sex and relationships. The findings are translated into program and change objectives that specify what parents need to do to improve their communication. Theory-based practical strategies most likely to bring about the desired behavioral change are then identified and pretested. The intervention developed consists of a six-session facilitator-led program that targets parents' attitudes, knowledge, communication skills, and self-efficacy. Following on from Bartholomew's seminal work on IM, this article develops and extends the application of this process by presenting explicit detail on the behavioral change techniques used and their theoretical underpinnings. The strengths and weaknesses of IM as a process for the development of health behavior interventions are discussed.

The development of a digital intervention to increase influenza vaccination amongst pregnant women.

OBJECTIVE: Pregnant women and unborn babies are at increased risk of complications from influenza, including pneumonia, yet in the UK, uptake of flu vaccination amongst this population remains <50%. Pregnant women hold beliefs about risks of flu and efficacy of vaccination that consistently predict them to decline vaccination. This study aimed to develop a theory and evidence-based intervention addressing these beliefs to promote flu vaccine uptake. METHODS: The intervention was developed by behavioural scientists, pregnant women, midwives, clinicians and Public Health professionals, informed by Intervention Mapping. Six predefined steps were performed in line with Intervention Mapping. RESULTS: The intervention is an animation addressing beliefs about risks of flu and efficacy of vaccination. Preliminary testing using qualitative methodology indicates the information within the animation is appropriate, and the animation is acceptable to pregnant women. CONCLUSIONS: This is the first known intervention for pregnant women, aiming to increase flu vaccination through addressing risk and efficacy appraisals. It has been implemented within seasonal flu vaccination campaigns during 2018/19 and 2019/20 within one geographically and ethnically diverse area of the UK.

Feasibility study of the Home-based Exercises for Responsible Sex (HERS) intervention to promote correct and consistent condom use among young women.

BACKGROUND: Male condoms are effective in preventing common sexually transmitted infections (STIs) and unintended pregnancy, if used correctly and consistently. However, condom use errors and problems are common and young people report negative experiences, such as reduced pleasure. The Kinsey Institute Home-Based Exercises for Responsible Sex (KIHERS) is a novel condom promotion intervention for young women, which aims to reduce condom errors and problems, increase self-efficacy and improve attitudes towards condoms, using a pleasure-focussed approach. The study objective was to test the operability, viability and acceptability of an adapted version of the KIHERS intervention with young women aged 16-25 years in the United Kingdom (UK) (Home-Based Exercises for Responsible Sex-UK (HERS-UK). METHODS: A repeated-measures single-arm design was used, with a baseline (T1) and two follow-up assessments (T2 and T3), conducted 4 weeks and 8 weeks post intervention over a 3-month period. Participants were provided a condom kit containing different condoms and lubricants and were asked to experiment with condoms alone using a dildo and/or with a sexual partner. Ten process evaluation interviews were conducted post intervention. RESULTS: Fifty-five young women received the intervention; 36 (65%) completed T2 and 33 (60%) completed T3. Condom use errors and problems decreased, self-efficacy increased and attitudes towards condoms improved significantly. The proportion of participants who reported using a condom for intercourse in the past 4 weeks increased from T1 (20; 47%) to T2 (27; 87%) and T3 (23; 77%) and using lubricant with a condom for intercourse increased from T1 (6; 30%) to T2 (13; 48%)) and T3 (16; 70%). However, motivation to use condoms did not change. Cronbach's alpha scores indicated good internal consistency of measures used. Qualitative data provided strong evidence for the acceptability of the intervention. CONCLUSIONS: HERS-UK was implemented as intended and the recruitment strategy was successful within a college/university setting. This feasibility study provided an early indication of the potential effectiveness and acceptability of the intervention, and the benefits of using a pleasure-focussed approach with young women. Measures used captured change in outcome variables and were deemed fit for purpose. Future research should explore cost-effectiveness of this intervention, in a large-scale controlled trial using a diverse sample and targeting young women most at risk of STIs.

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.

Mobile Health-Supported HIV Self-Testing Strategy Among Urban Refugee and Displaced Youth in Kampala, Uganda: Protocol for a Cluster Randomized Trial (Tushirikiane, Supporting Each Other).

BACKGROUND: HIV is the leading cause of mortality among youth in sub-Saharan Africa. Uganda hosts over 1.43 million refugees, and more than 83,000 live in Kampala, largely in informal settlements. There is limited information about HIV testing uptake and preferences among urban refugee and displaced youth. HIV self-testing is a promising method for increasing testing uptake. Further, mobile health (mHealth) interventions have been effective in increasing HIV testing uptake and could be particularly useful among youth. OBJECTIVE: This study aims to evaluate the feasibility and effectiveness of two HIV self-testing implementation strategies (HIV self-testing intervention alone and HIV self-testing combined with an mHealth intervention) in comparison with the HIV testing standard of care in terms of HIV testing outcomes among refugee/displaced youth aged 16 to 24 years in Kampala, Uganda. METHODS: A three-arm cluster randomized controlled trial will be implemented across five informal settlements grouped into three sites, based on proximity, and randomization will be performed with a 1:1:1 method. Approximately 450 adolescents (150 per cluster) will be enrolled and followed for 12 months. Data will be collected at the following three time points: baseline enrollment, 8 months after enrollment, and 12 months after enrollment. Primary outcomes (HIV testing frequency, HIV status knowledge, linkage to confirmatory testing, and linkage to HIV care) and secondary outcomes (depression, condom use efficacy, consistent condom use, sexual relationship power, HIV stigma, and adolescent sexual and reproductive health stigma) will be evaluated. RESULTS: The study has been conducted in accordance with CONSORT (Consolidated Standards of Reporting Trials) guidelines. The study has received ethical approval from the University of Toronto (June 14, 2019), Mildmay Uganda (November 11, 2019), and the Uganda National Council for Science and Technology (August 3, 2020). The Tushirikiane trial launched in February 2020, recruiting a total of 452 participants. Data collection was paused for 8 months due to COVID-19. Data collection for wave 2 resumed in November 2020, and as of December 10, 2020, a total of 295 participants have been followed-up. The third, and final, wave of data collection will be conducted between February and March 2021. CONCLUSIONS: This study will contribute to the knowledge of differentiated HIV testing implementation strategies for urban refugee and displaced youth living in informal settlements. We will share the findings in peer-reviewed manuscripts and conference presentations. TRIAL REGISTRATION: ClinicalTrials.gov NCT04504097; https://clinicaltrials.gov/ct2/show/NCT04504097. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/26192.