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Abstract Background In the U.S. there are significant racial and gender disparities in the uptake of pre-exposure prophylaxis (PrEP). Black Americans represented 14% of PrEP users in 2022, but accounted for 42% of new HIV diagnoses in 2021 and in the South, Black people represented 48% of new HIV diagnoses in 2021 but only 21% of PrEP users in 2022. Women who use drugs may be even less likely than women who do not use drugs have initiated PrEP. Moreover, women involved in community supervision programs (CSP) are less likely to initiate or use PrEP, More PrEP interventions that focus on Black women with recent history of drug use in CSPs are needed to reduce inequities in PrEP uptake. Methods We conducted a secondary analysis from a randomized clinical trial with a sub-sample (n = 336) of the total (N = 352) participants from the parent study (E-WORTH), who tested HIV negative at baseline were considered PrEP-eligible. Black women were recruited from CSPs in New York City (NYC), with recent substance use. Participants were randomized to either E-WORTH (n = 172) an HIV testing plus, receive a 5-session, culturally-tailored, group-based HIV prevention intervention, versus an HIV testing control group (n = 180). The 5 sessions included an introduction to PrEP and access. This paper reports outcomes on improved awareness of PrEP, willingness to use PrEP, and PrEP uptake over the 12-month follow-up period. HIV outcomes are reported in a previous paper. Results Compared to control participants, participants in this study assigned to E-WORTH had significantly greater odds of being aware of PrEP as a biomedical HIV prevention strategy (OR = 3.25, 95% CI = 1.64–6.46, p = 0.001), and indicated a greater willingness to use PrEP as an HIV prevention method (b = 0.19, 95% CI = 0.06–0.32, p = 0.004) over the entire 12-month follow-up period. Conclusions These findings underscore the effectiveness of a culturally-tailored intervention for Black women in CSP settings in increasing awareness, and intention to initiate PrEP. Low uptake of PrEP in both arms highlight the need for providing more robust PrEP-on-demand strategies that are integrated into other services such as substance abuse treatment. Trial Registration ClinicalTrials.gov Identifier: NCT02391233 .

Abstract Background Islamic leaders, staff, and Muslim parents in the UK are supportive of healthy lifestyle intervention delivery through Islamic Religious Settings. Such interventions are necessary given high obesity rates in British South Asian (40%) compared to White British (32%) children of equivalent age. Co-production can facilitate the development of culturally appropriate health interventions, however it can be theoretically and practically challenging, and evaluation of co-production within an Islamic Religious Setting context is lacking. The aim of this study was to examine the feasibility and acceptability of taking a co-production approach to develop an obesity-prevention toolkit for Islamic Religious Settings. Methods An obesity-prevention toolkit for use in Islamic Religious Settings, incorporating physical activity, healthy diet, and organisational change, has been co-produced to be evidence-informed and contextually relevant. A qualitative process evaluation was employed to examine experiences of co-production. Semi-structured interviews (n = 15) and a focus group (n = 5) were conducted with toolkit co-production stakeholders, e.g., subject experts, an Islamic scholar, and Islamic Religious Setting staff. Transcripts were analysed inductively using reflexive thematic analysis. Results The analysis revealed four major themes regarding stakeholders' experiences of co-producing a childhood obesity-prevention toolkit for Islamic Religious Settings. These themes are: (1) attitudes towards obesity-prevention through Islamic Religious Settings, (2) benefits of co-production including capacity building and ownership (3) negotiating involvement, power, and perspectives within the co-production process, and (4) the complexities of effective communication in co-production. Conclusion This study adds to the evidence-base in support of delivering health promotion through faith settings. Taking a co-production approach to develop an obesity-prevention toolkit for Islamic Religious Settings provided benefit to the toolkit product and local stakeholders. The toolkit is currently being implemented across Bradford, UK and there is potential to adapt the toolkit to other geographical contexts, and for evaluating effectiveness for preventing obesity in British Muslim families.

Plain language summary Family planning programmes have traditionally focused on increasing access to modern contraceptive methods. There is growing evidence that merely increasing access will not reach every woman. More focus on improving the quality of the family planning programmes and developing targeted interventions for women and men not currently reached with the current models is necessary. Despite the high prevalence of depression in women of reproductive age living in LMICs, its impact on women’s access and use of contraception has been largely neglected. Our study using data from a cohort of pregnant women recruited in rural Malawi aimed to investigate if depression in the year before pregnancy impacted on women’s risk of having an unintended pregnancy and on contraceptive use at time of pregnancy and in the postpartum period. Our results show that women who reported depression in the year before pregnancy had increased risk of inconsistent contraceptive use and having an unplanned pregnancy. They were also more likely to not use contraception in the early postpartum period and choose less effective methods, with important consequences for risk of subsequent unplanned pregnancies. Our results highlight a need for health services to develop holistic models of care for women where both their mental and reproductive health needs are met.

Abstract Background Gastric cancer (GC), gastroesophageal junction cancer (GEJC), and esophageal adenocarcinoma (EAC), together, are leading causes of cancer deaths worldwide. Patient health-related quality of life (HRQoL) and well-being has become increasingly important alongside traditional oncologic outcomes for both patients and clinicians and may aid treatment decisions. We conducted a survey to examine the clinical characteristics, humanistic burden, and the effects of first-line (1L) treatment in patients with GC/GEJC/EAC, across different geographic regions, to address the paucity of real-world data. Methods Clinicians treating patients with unresectable advanced or metastatic GC/GEJC/EAC in China, France, Germany, Japan, the United Kingdom, and the United States, during April–October 2019, were invited to provide data on their patients’ demographics, clinical characteristics, treatment, and HRQoL via medical chart reviews, clinician surveys, and patient questionnaires. Data were analyzed using descriptive statistics, regression analyses comparing active treatment and best supportive care. Patients were also stratified into subgroups that were identified either as human epidermal growth factor receptor 2 (HER2) positive, HER2 negative (which has a higher prevalence but for whom there are limited treatment options), or unknown HER2 status. Results Survey data were analyzed for 995 patients, 87% of whom were on active treatment, most commonly dual or triple chemotherapy. Demographics and clinical characteristics were similar across countries with most patients having GC and the lowest incidence of GEJC and EAC in China. Overall, most patients had de novo disease with good response to 1L treatment, while their HRQoL and well-being was significantly worse than the general population. In 682 patients on active treatment with HER2 negative or unknown status, HRQoL also appeared to be worse in those with recurrent disease. Regression analysis identified several drivers of treatment decisions and factors impacting patients’ HRQoL, including stage of disease and comorbidities. Conclusions In patients with advanced GC/GEJC/EAC, screening and assessment of HER2 status as well as patient-reported HRQoL outcomes are invaluable in aiding treatment decisions. The introduction of appropriate therapy soon after diagnosis has the prospect of achieving improved HRQoL and survival in these patients.

Abstract Background Systems approaches are currently being advocated and implemented to address complex challenges in Public Health. These approaches work by bringing multi-sectoral stakeholders together to develop a collective understanding of the system, and then to identify places where they can leverage change across the system. Systems approaches are unpredictable, where cause-and-effect cannot always be disentangled, and unintended consequences – positive and negative – frequently arise. Evaluating such approaches is difficult and new methods are warranted. Methods Ripple Effects Mapping (REM) is a qualitative method which can capture the wider impacts, and adaptive nature, of a systems approach. Using a case study example from the evaluation of a physical activity-orientated systems approach in Gloucestershire, we: a) introduce the adapted REM method; b) describe how REM was applied in the example; c) explain how REM outputs were analysed; d) provide examples of how REM outputs were used; and e) describe the strengths, limitations, and future uses of REM based on our reflections. Results Ripple Effects Mapping is a participatory method that requires the active input of programme stakeholders in data gathering workshops. It produces visual outputs (i.e., maps) of the programme activities and impacts, which are mapped along a timeline to understand the temporal dimension of systems change efforts. The REM outputs from our example were created over several iterations, with data collected every 3–4 months, to build a picture of activities and impacts that have continued or ceased. Workshops took place both in person and online. An inductive content analysis was undertaken to describe and quantify the patterns within the REM outputs. Detailed guidance related to the preparation, delivery, and analysis of REM are included in this paper. Conclusion REM may help to advance our understanding and evaluation of complex systems approaches, especially within the field of Public Health. We therefore invite other researchers, practitioners and policymakers to use REM and continuously evolve the method to enhance its application and practical utility.

Plain English summary Women who have difficulty getting pregnant may choose to use fertility treatment to help. Fertility treatment known as ‘in vitro fertilisation’, or IVF, was developed around 40 years ago and has been increasingly used ever since. Over 8 million babies have been born this way around the world. There are many different reasons why women can have problems getting pregnant and in a quarter of cases the cause is never found. We know that some women, who have babies using IVF, get pregnant again afterwards without fertility treatment. Getting pregnant again quickly, or when a woman isn’t ready, can be worse for the health of the mother and child. Therefore, this study aims to understand what contraception women need after IVF to plan and space their future pregnancies. We spoke to 21 women who became pregnant without fertility treatment after having their first babies using IVF. Although most of these women had not been using contraception after their first baby, they were shocked to get pregnant again as they firmly believed they could not get pregnant without fertility treatment. Most of these pregnancies had happened quickly and not all the women were happy to be pregnant again. These women were not given the information they needed about their chances of getting pregnant after IVF without fertility treatment. Fertility and maternity services must close this gap. Health professionals also need to explore women’s beliefs about their own fertility after IVF before they can start to have helpful conversations about contraception.

Abstract Background Engaging in regular physical activity requires continued complex decision-making in varied and dynamic individual, social and structural contexts. Widespread shortfalls of physical activity interventions suggests the complex underlying mechanisms of change are not yet fully understood. More insightful process evaluations are needed to design and implement more effective approaches. This paper describes the protocol for a process evaluation of the JU:MP programme, a whole systems approach to increasing physical activity in children and young people aged 5–14 years in North Bradford, UK. Methods This process evaluation, underpinned by realist philosophy, aims to understand the development and implementation of the JU:MP programme and the mechanisms by which JU:MP influences physical activity in children and young people. It also aims to explore behaviour change across wider policy, strategy and neighbourhood systems. A mixed method data collection approach will include semi-structured interview, observation, documentary analysis, surveys, and participatory evaluation methods including reflections and ripple effect mapping. Discussion This protocol offers an innovative approach on the use of process evaluation feeding into an iterative programme intended to generate evidence-based practice and deliver practice-based evidence. This paper advances knowledge regarding the development of process evaluations for evaluating systems interventions, and emphasises the importance of process evaluation.

Abstract Effective physical activity messaging plays an important role in the pathway towards changing physical activity behaviour at a population level. The Physical Activity Messaging Framework (PAMF) and Checklist (PAMC) are outputs from a recent modified Delphi study. This sought consensus from an international expert panel on how to aid the creation and evaluation of physical activity messages. In this paper, we (1) present an overview of the various concepts within the PAMF and PAMC, (2) discuss in detail how the PAMF and PAMC can be used to create physical activity messages, plan evaluation of messages, and aid understanding and categorisation of existing messages, and (3) highlight areas for future development and research. If adopted, we propose that the PAMF and PAMC could improve physical activity messaging practice by encouraging evidence-based and target population-focused messages with clearly stated aims and consideration of potential working pathways. They could also enhance the physical activity messaging research base by harmonising key messaging terminologies, improving quality of reporting, and aiding collation and synthesis of the evidence.

Abstract Background Valid and reliable measures such as London Measure of Unplanned Pregnancy (LMUP) are imperative for understanding fertility-related behaviors and estimating unintended pregnancy. The aim of this study was to validate the LMUP in the Hindi language for a wider reach in India. Methods An interviewer administered version of the LMUP was translated and pretested in Hindi. The LMUP was field tested with married women in the reproductive age group across forty informal settlements in Mumbai in the post intervention census of a cluster randomized control trial to improve the health of women and children. Analyses involved the full sample and sub-groups according to time-from-conception. Reliability (internal consistency) was assessed using Cronbach’s alpha, inter-item correlations, and item-rest correlations. Construct validity was assessed by hypothesis testing and confirmatory factor analysis. Results 4991 women were included in the study (1180 were pregnant, 2126 in their first- and 1685 in their second postnatal year). LMUP item completion rates were 100 % and the full range of LMUP scores was captured. Reliability: the scale was internally consistent (Cronbach’s α = 0.84), inter-item correlations were positive, and item-rest correlations were above 0.2 for all items except item six (0.07). Construct validity: hypotheses were met, and confirmatory factor analysis showed that a one-factor model was a good fit for the data, confirming unidimensional measurement. The sub-group analysis (by pregnant, first-, and second postnatal year) showed that the psychometric properties of the LMUP were similar across the groups. In terms of LMUP scores, the women in the postnatal groups were very slightly, but significantly, more likely to have an LMUP score of 10 + compared to pregnant women; the difference between the first and second postnatal year was not significant. Conclusions The Hindi LMUP is valid and reliable measure of pregnancy intention that may be used in India. Trial Registration This study is registered with ISRCTN, number ISRCTN56183183, and Clinical Trials Registry of India, number CTRI/2012/09/003004.

Abstract Background In England, the onset of COVID-19 and a rapidly increasing infection rate resulted in a lockdown (March-June 2020) which placed strict restrictions on movement of the public, including children. Using data collected from children living in a multi-ethnic city with high levels of deprivation, this study aimed to: (1) report children’s self-reported physical activity (PA) during the first COVID-19 UK lockdown and identify associated factors; (2) examine changes of children’s self-reported PA prior to and during the first UK lockdown. Methods This study is part of the Born in Bradford (BiB) COVID-19 Research Study. PA (amended Youth Activity Profile), sleep, sedentary behaviours, daily frequency/time/destination/activity when leaving the home, were self-reported by 949 children (9–13 years). A sub-sample (n = 634) also self-reported PA (Physical Activity Questionnaire for Children) pre-pandemic (2017-February 2020). Univariate analysis assessed differences in PA between sex and ethnicity groups; multivariable logistic regression identified factors associated with children’s PA. Differences in children's levels of being sufficiently active prior to and during the lockdown were examined using the McNemar test; and multivariable logistic regression was used to identify factors explaining change. Results During the pandemic, White British (WB) children were more sufficiently active (34.1%) compared to Pakistani Heritage children (PH) (22.8%) or ‘Other’ ethnicity children (O) (22.8%). WB children reported leaving the home more frequently and for longer periods than PH and O children. Modifiable variables related to being sufficiently active were frequency, duration, type of activity, and destination away from the home environment. There was a large reduction in children being sufficiently active during the first COVID-19 lockdown (28.9%) compared to pre-pandemic (69.4%). Conclusions Promoting safe extended periods of PA everyday outdoors is important for all children, in particular for children from ethnic minority groups. Children’s PA during the first COVID-19 UK lockdown has drastically reduced from before. Policy and decision makers, and practitioners should consider the findings in order to begin to understand the impact and consequences that COVID-19 has had upon children’s PA which is a key and vital behaviour for health and development.

Abstract Background Stroke survivors are highly sedentary; thus, breaking up long uninterrupted bouts of sedentary behaviour could have substantial health benefit. However, there are no intervention strategies specifically aimed at reducing sedentary behaviour tailored for stroke survivors. The purpose of this study was to use co-production approaches to develop an intervention to reduce sedentary behaviour after stroke. Methods A series of five co-production workshops with stroke survivors, their caregivers, stroke service staff, exercise professionals, and researchers were conducted in parallel in two-stroke services (England and Scotland). Workshop format was informed by the behaviour change wheel (BCW) framework for developing interventions and incorporated systematic review and empirical evidence. Taking an iterative approach, data from activities and audio recordings were analysed following each workshop and findings used to inform subsequent workshops, to inform both the activities of the next workshop and ongoing intervention development. Findings Co-production workshop participants (n = 43) included 17 staff, 14 stroke survivors, six caregivers and six researchers. The target behaviour for stroke survivors is to increase standing and moving, and the target behaviour for caregivers and staff is to support and encourage stroke survivors to increase standing and moving. The developed intervention is primarily based on co-produced solutions to barriers to achieving the target behaviour. The developed intervention includes 34 behaviour change techniques. The intervention is to be delivered through stroke services, commencing in the inpatient setting and following through discharge into the community. Participants reported that taking part in intervention development was a positive experience. Conclusions To our knowledge, this is the first study that has combined the use of co-production and the BCW to develop an intervention for use in stroke care. In-depth reporting of how a co-production approach was combined with the BCW framework, including the design of bespoke materials for workshop activities, should prove useful to other researchers and practitioners involved in intervention development in stroke.

Abstract Background Stroke survivors are more sedentary than healthy, age-matched controls, independent of functional capacity. Interventions are needed to encourage a reduction in overall sedentary time, and regular breaks in prolonged periods of sedentary behaviour. This study captured the views and experiences of stroke survivors and their caregivers related to sedentary behaviour after stroke, to inform the development of an intervention to reduce sedentary behaviour. Methods Mixed-methods qualitative study. Non-participant observations were completed in two stroke services, inclusive of inpatient and community settings in the United Kingdom. Semi-structured interviews were conducted with stroke survivors and their caregivers (if available) at six- or nine-months post-stroke. Underpinned by the capability, opportunity and motivation (COM-B) model of behaviour change, observational data (132 h) were analysed thematically and interview data (n = 31 stroke survivors, n = 12 caregivers) were analysed using the Framework approach. Results Observation participants differed in functional ability whereas stroke survivor interviewees were all ambulant. Six themes related to sedentary behaviour after stroke were generated: (1) sedentary behaviour levels and patterns after stroke; (2) the physical and social environment in the stroke service and in the home; (3) standing and movement capability after stroke; (4) emotion and motivation after stroke; (5) caregivers’ influence on, and role in influencing stroke survivors’ sedentary behaviour; and (6) intervening to reduce sedentary behaviour after stroke. Capability, opportunity and motivation were influenced by the impact of the stroke and caregivers’ inclination to support sedentary behaviour reduction. Stroke survivors reported being more sedentary than they were pre-stroke due to impaired balance and co-ordination, increased fatigue, and reduced confidence in mobilising. Caregivers inclination to support stroke survivors to reduce sedentary behaviour depended on factors including their willingness to withdraw from the caregiver role, and their perception of whether the stroke survivor would act on their encouragement. Conclusions Many stroke survivors indicate being open to reducing sedentary behaviour, with appropriate support from stroke service staff and caregivers. The findings from this study have contributed to an intervention development process using the Behaviour Change Wheel (BCW) approach to develop strategies to reduce sedentary behaviour after stroke.

Abstract Background Health prior to conception can significantly impact offspring health, however, a clear definition of the attributes of the preconception population is currently lacking. We aimed to use existing literature to explore the concept and attributes of a preconception population by: [1] identifying characteristics and research recruitment methods; and [2] generating an attribute-based working definition of a preconception population. Methods A rapid review of current literature using CINAHL and the subject heading ‘pre-pregnancy care’ was conducted (Stage 1). Data extracted included definitions of preconception, participant inclusion/exclusion criteria, participant characteristics, and recruitment methods. Stage 2 involved a wider search of relevant publications beyond peer-reviewed literature followed by a concept analysis of the phrase “preconception population” applying Walker and Avant’s framework (Stage 2). Results Twenty-three papers (19 studies) were included in Stage 1. “Preconception” was explicitly defined in one study. Twelve studies specified participants must be planning a pregnancy. Stage 2 included 33 publications. Four key perspectives for the concept of the preconception population were derived: [1] intentional; [2] potential; [3] public health; and [4] life course. Conclusions Adopting these perspectives may allow researchers to accurately define, identify and recruit preconception populations and to develop interventions that are appropriately broad or tailored depending on population needs. We hope the definitions will facilitate research with this population and will subsequently improve the wellbeing of preconception men and women, which is essential to ensuring the health of future generations.

Abstract Background Sit-stand desk interventions have the potential to reduce workplace sedentary behaviour and improve employee health. However, the extent of sit-stand desk use varies between employees and in different organisational contexts. Framed by organisational cultural theory and product design theory, this study examined employees’ lived experience of taking part in a workplace sit-stand desk intervention, to understand the processes influencing feasibility and acceptability. Methods Participant observations and qualitative interviews were conducted with 15 employees from two office-based workplaces in the UK, as part of a process evaluation that ran alongside a pilot RCT of a workplace sit-stand desk intervention. Observational field notes and transcripts were analysed using thematic analysis. Results Three themes related to the experience of using a sit-stand desk at work were generated: employees’ relationship with their sit-stand desk; aspirations and outcomes related to employee health and productivity; and cultural norms and interpersonal relationships. The perceived usability of the desk varied depending on how employees interacted with the desk within their personal and organisational context. Employees reported that the perceived influence of the desk on their productivity levels shaped use of the desk; those who perceived that standing increased energy and alertness tended to stand more often. Sit-stand desks were voiced as being more acceptable than intervention strategies that involve leaving the desk, as productivity was conflated with being at the desk. Conclusions The findings indicate a range of organisational, social-cultural and individual-level factors that shape the feasibility and acceptability of sit-stand desk use, and suggest strategies for improving employees’ experiences of using a sit-stand desk at work, which might positively influence sedentary behaviour reduction and health. Trial registration Clinicaltrials.gov identifier NCT02172599, 22nd June 2014 (prospectively registered).

Abstract Background Office workers typically sit for most of the workday, which has been linked to physical and mental ill-health and premature death. This mixed-methods study sought to identify barriers and facilitators to reducing sitting and increasing standing among office workers who received an intervention prototype (the ‘ReSiT [Reducing Sitting Time] Study’). The intervention comprised a sit-stand workstation and tailored advice to enhance motivation, capability and opportunity to displace sitting with standing. Methods Twenty-nine UK university office workers (aged ≥18y, working ≥3 days per week, most time spent at a seated desk) participated in a 13-week uncontrolled study. They were initially monitored for one-week. In a subsequent face-to-face consultation, participants received sitting time feedback from a prior one-week monitoring period, and selected from a set of tailored sitting-reduction techniques. Quantitative data comprising sitting, standing and stepping time, which were objectively monitored for 7 consecutive days across three post-intervention timepoints, were descriptively analysed. Qualitative data, from semi-structured interviews conducted at 1, 6 and 12-weeks post-intervention, were thematically analysed. Results Compared to baseline, mean sitting time decreased at weeks 1, 6 and 12 by 49.7mins, 118.2mins, and 109.7mins respectively. Despite prior concerns about colleagues’ reactions to standing, many reported encouragement from others, and standing could be equally conducive to social interaction or creating private, personal space. Some perceived less cognitively-demanding tasks to be more conducive to standing, though some found standing offered a valued break from challenging tasks. Participants prioritised workload over sitting reduction and were more likely to stand after rather than during work task completion. Temporary context changes, such as holidays, threatened to derail newfound routines. Conclusions Our findings emphasise the importance of understanding workers’ mental representations of their work, and the social functions of sitting and standing in the workplace. Workplace intervention developers should incorporate a pre-intervention sitting time monitoring period, encourage workers to identify personally meaningful tasks and cues for standing, and build organisational support for sitting-reduction. We will use these insights to refine our intervention for self-administered delivery. Trial registration ISRCTN29395780 (registered 21 November 2016).

Abstract Background Unintended pregnancies are associated with negative consequences to both mother and baby. Female Sex Workers (FSWs) are at high risk of unintended/unplanned pregnancies. However, prevalence of pregnancy planning and its predictors among FSWs has not been comprehensively investigated. This study was designed to determine contraceptive use, the prevalence, and predictors of pregnancy planning among FSWs in Uganda. Methods In this cross-sectional study, 819 FSWs attending most at risk populations initiative (MARPI) clinics were recruited using systematic sampling and interviewed with a pretested questionnaire that included collection of data on pregnancy intention using the London Measure of Unplanned Pregnancy (LMUP). Data were analysed using STATA version 14.0. Multinomial logistic regression model was used to identify predictors of pregnancy planning, Results Of the 819 study participants, only 90 (11.0%) had planned pregnancies. Overall, 462 (56.4%) were hazardous alcohol users and 335 (40.9%) abused drugs; 172 (21.0%) had been raped in the last 2 years and 70 (40.7%) of these accessed emergency contraception post-rape. Dual contraception use (condom and other modern method) was 58.0%. Having a non-emotional partner as a man who impregnated the FSW compared to emotional partner was significantly associated with less planned relative to unplanned pregnancy, (aRR = 0.15 95%Cl =0.08, 0.30), so was lack of reported social support compared to support from friends, (aRR = 0.44; 95% CI = 0.22–0.87), keeping all factors constant in the model. Being raped (aRR = 0.51; 95% CI = 0.31–0.84) or abuse of substances (aRR = 0.65; 95% CI = 0.45–0.93) were significantly associated with lower ambivalence relative to unplanned pregnancy but not with planned relative to unplanned pregnancy. Conclusion Compared to women in the general population, pregnancy planning was low among FSWs amidst modest use of dual contraceptive. There is an urgent need to promote dual contraception among FSWs to prevent unplanned pregnancies especially with non-emotional partners, drug users, and post-rape.

Abstract Background Children with health insurance have increased access to healthcare and receive higher quality care. However, despite recent initiatives expanding children’s coverage, many remain uninsured. New technologies present opportunities for helping clinics provide enrollment support for patients. We developed and tested electronic health record (EHR)-based tools to help clinics provide children’s insurance assistance. Methods We used mixed methods to understand tool adoption, and to assess impact of tool use on insurance coverage, healthcare utilization, and receipt of recommended care. We conducted intent-to-treat (ITT) analyses comparing pediatric patients in 4 intervention clinics (n = 15,024) to those at 4 matched control clinics (n = 12,227). We conducted effect-of-treatment-on-the-treated (ETOT) analyses comparing intervention clinic patients with tool use (n = 2240) to intervention clinic patients without tool use (n = 12,784). Results Tools were used for only 15% of eligible patients. Qualitative data indicated that tool adoption was limited by: (1) concurrent initiatives that duplicated the work associated with the tools, and (2) inability to obtain accurate insurance coverage data and end dates. The ITT analyses showed that intervention clinic patients had higher odds of gaining insurance coverage (adjusted odds ratio [aOR] = 1.32, 95% confidence interval [95%CI] 1.14–1.51) and lower odds of losing coverage (aOR = 0.77, 95%CI 0.68–0.88), compared to control clinic patients. Similarly, ETOT findings showed that intervention clinic patients with tool use had higher odds of gaining insurance (aOR = 1.83, 95%CI 1.64–2.04) and lower odds of losing coverage (aOR = 0.70, 95%CI 0.53–0.91), compared to patients without tool use. The ETOT analyses also showed higher rates of receipt of return visits, well-child visits, and several immunizations among patients for whom the tools were used. Conclusions This pragmatic trial, the first to evaluate EHR-based insurance assistance tools, suggests that it is feasible to create and implement tools that help clinics provide insurance enrollment support to pediatric patients. While ITT findings were limited by low rates of tool use, ITT and ETOT findings suggest tool use was associated with better odds of gaining and keeping coverage. Further, ETOT findings suggest that use of such tools may positively impact healthcare utilization and quality of pediatric care. Trial registration ClinicalTrials.gov, NCT02298361; retrospectively registered on November 5, 2014.

Abstract Background This study examined the feasibility and acceptability of the low-intensity mental health support via telehealth-enabled network (LISTEN) intervention, for adults with diabetes, facilitated by diabetes health professionals (HPs). Methods LISTEN training. Three HPs participated in three half-day online workshops and applied their learnings during training cases (maximum four). Competency was assessed with a validated tool and achieved ‘satisfactory’ ratings for three consecutive sessions. LISTEN pilot. A single-group, pre-post study (up to four LISTEN sessions) with online assessments at baseline, post-intervention, and 4-week follow-up. Eligible participants were adults with type 1 or type 2 diabetes, with diabetes distress, but excluded if they had moderate/severe depressive and/or anxiety symptoms. Feasibility was assessed via recruitment and session completion rates. Acceptability was assessed with post-intervention self-report data. Changes in diabetes distress and general emotional well-being from baseline (T1) were explored at post-intervention (T2) and at 4-week follow-up (T3). Results Two HPs achieved competency (median training case sessions required: 7) and progressed to deliver LISTEN in the pilot study. In the pilot, N = 16 adults (Med [IQR] age: 60 [37–73] years; 13 women) with diabetes participated (median sessions per participant: 2). Twelve participants (75%) completed the post-intervention assessment (T2): 92% endorsed the number of sessions offered as ‘just right’, 75% felt comfortable talking with the HP, and 67% were satisfied with LISTEN. Perceived limitations were the structured format and narrow scope of problems addressed. Diabetes distress scores were lower post-intervention. Conclusions This pilot demonstrates the feasibility of training HPs to deliver LISTEN, and the acceptability and potential benefits of LISTEN for adults with diabetes. The findings highlight adaptations that may enhance the delivery of, and satisfaction with, LISTEN that will be tested in a hybrid type 1 effectiveness-implementation trial.

Abstract Background Mental health problems are common among people with diabetes. However, evidence-based strategies for the prevention and early intervention of emotional problems in people with diabetes are lacking. Our aim is to assess the real-world effectiveness, cost-effectiveness, and implementation of a Low-Intensity mental health Support via a Telehealth Enabled Network (LISTEN), facilitated by diabetes health professionals (HPs). Methods A hybrid type I effectiveness-implementation trial, including a two-arm parallel randomised controlled trial, alongside mixed methods process evaluation. Recruited primarily via the National Diabetes Services Scheme, Australian adults with diabetes (N = 454) will be eligible if they are experiencing elevated diabetes distress. Participants are randomised (1:1 ratio) to LISTEN—a brief, low-intensity mental health support program based on a problem-solving therapy framework and delivered via telehealth (intervention) or usual care (web-based resources about diabetes and emotional health). Data are collected via online assessments at baseline (T0), 8 weeks (T1) and 6 months (T2, primary endpoint) follow-up. The primary outcome is between-group differences in diabetes distress at T2. Secondary outcomes include the immediate (T1) and longer-term (T2) effect of the intervention on psychological distress, general emotional well-being, and coping self-efficacy. A within-trial economic evaluation will be conducted. Implementation outcomes will be assessed using mixed methods, according to the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework. Data collection will include qualitative interviews and field notes. Discussion It is anticipated that LISTEN will reduce diabetes distress among adults with diabetes. The pragmatic trial results will determine whether LISTEN is effective, cost-effective, and should be implemented at scale. Qualitative findings will be used to refine the intervention and implementation strategies as required. Trial registration This trial has been registered with the Australian New Zealand Clinical Trials Registry (ACTRN: ACTRN12622000168752) on 1 February, 2022.

Abstract Background Coronavirus disease 2019 (COVID-19) has been associated with late-onset cardiovascular complications primarily due to a hypercoagulable state. Its association with Wellens’ syndrome, which reflects a stenosis in the proximal left anterior descending coronary artery, is not well established. We present two cases diagnosed with this syndrome following their COVID-19 acute phase despite taking adequate anticoagulation. Case presentation We present two patients with incidental electrocardiography (ECG) showing the typical Wellens’-related changes, with an underlying severe triple-vessel coronary artery disease a few weeks following a severe COVID-19 infection associated with high inflammatory markers. The stenotic lesions were diagnosed by cardiac catheterization, and both patients underwent Coronary Artery Bypass Grafting successfully. Notably, patients’ baseline ECGs were normal, and they were maintained on Rivaroxaban 10 mg following their viral illness. Conclusion Despite advances in the preventive measures for COVID-19 complications, its pathophysiologic impact on vasculature and atherosclerosis is still incompletely understood. Further clinical trials must be conducted to study this association between Wellens’ syndrome and this virus to prevent life-threatening complications.

Abstract Background The aim of this work was to develop a National Evaluation Framework to facilitate the standardization of delivery, quality, reporting, and evaluation of diabetes education and support programs delivered throughout Australia through the National Diabetes Services Scheme (NDSS). The NDSS is funded by the Australian Government, and provides access to diabetes information, education, support, and subsidized product across diverse settings in each state and territory of Australia through seven independent service-providers. This article reports the approach undertaken to develop the Framework. Methods A participatory approach was undertaken, focused on adopting nationally consistent outcomes and indicators, nominating objectives and measurement tools, specifying evaluation processes, and developing quality standards. Existing programs were classified based on related, overarching indicators enabling the adoption of a tiered system of evaluation. Results Two outcomes (i.e., improved clinical, reduced cost) and four indicators (i.e., improved knowledge and understanding, self-management, self-determination, psychosocial adjustment) were adopted from the Eigenmann and Colagiuri national consensus position statement for diabetes education. This allowed for the identification of objectives (i.e., improved empowerment, reduced distress, autonomy supportive program delivery, consumer satisfaction) and related measurement instruments. Programs were categorized as comprehensive, topic-specific, or basic education, with comprehensive programs allocated to receive the highest-level of evaluation. Eight quality standards were developed, with existing programs tested against those standards. Based on the results of testing, two comprehensive (OzDAFNE for people with type 1 diabetes, DESMOND for people with type 2 diabetes), and eight topic-specific (CarbSmart, ShopSmart, MonitorSmart, FootSmart, MedSmart, Living with Insulin, Insulin Pump Workshop, Ready Set Go – Let’s Move) structured diabetes self-management education and support programs were nominated for national delivery. Conclusions The National Evaluation Framework has facilitated consistency of program quality, delivery, and evaluation of programs delivered by multiple service providers across diverse contexts. The Framework could be applied by other service providers who facilitate multiple diabetes education and support programs and could be adapted for use in other chronic disease populations where education and support are indicated.

Abstract Background This study objective was to evaluate the prevalence of alcohol use disorder (AUD) and related factors (smoking, internet addiction, social anxiety, child abuse, and bullying) among a representative sample of Lebanese adolescents, and to validate and confirm psychometric properties of the Alcohol Use Disorders Identification Test (AUDIT). Methods A cross-sectional study, conducted between January and May 2019, enrolled 1810 adolescents aged between 14 and 17 from schools of all Lebanese districts. From the total number of schools, a proportionate number was selected in each district. AUD was defined as a high AUDIT score (≥8; score range 0–40). A principal component analysis technique to confirm the validity of the construct of the AUDIT scale score was done and a confirmatory analysis to assess the structure of the instrument was conducted. Spearman correlation was used for linear correlation between continuous variables. The Mann-Whitney test was used to compare the means of two groups, while the Kruskal-Wallis test was used to compare three groups or more. A stepwise linear regression was conducted, taking the AUDIT total score as the dependent variable and taking child abuse (psychological, sexual, physical and verbal), cigarette and waterpipe smoking dependence, bullying, social phobia, and internet addiction as independent variables. Results The mean AUDIT score was 6.46 ± 8.44 and high risk of AUD was found in 507 (28.0%) adolescents [95% CI 0.259–0.301]. One factor solution of the AUDIT scale was found after running the factor analysis (αCronbach = 0.978). Higher AUDIT scores were significantly associated with higher cigarette (Beta = 0.527; p

Abstract For nearly 3 years now, Lebanon has been assailed by compounded crises. With the economic instability, the coronavirus pandemic, and the explosion of the Beirut Port on August 4, 2020; the fragile Lebanese healthcare system has found itself at massive risk of a catastrophic public health crisis secondary to cardiovascular drug shortages. The time has come for public health authorities to find urgent solutions for this national trajedy that is projected to last for years.