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Introduction: Chlamydia is a very common bacterial sexual transmitted infection (STI) among young adults. High numbers of asymptomatic cases hamper a timely treatment start, whereas the treatment itself is efficient and cheap. Proactive screening can decrease this mismatch. There are many models which are able to evaluate and simulate different screening options.Most of them though are based on old or insufficient data, are not accessible for everybody, or are not designed in a user-friendly way. Aim: We want to determine the feasibility of developing an easy-to-use chlamydia infection model, which can be easily updated to reflect changes in medical knowledge.Methods: Starting with a literature review, we have set up a chlamydia infection model. This model was refined with the help of STI experts. The model was implemented by using the programming language Java (version 1.6). We validated the model using internal and external validation methods. Results: The implementation of the model allows users to edit all parameters. The model consists of two separate sub-models. One sub-model simulates health effects of chlamydia for individuals, including the different outcomes in males and females. The other sub-model tracks the spreading of chlamydia within the computed cohort and regards heterosexual as well as homosexual partnerships. Both sub-models are independent of each other and therefore easily exchangeable. The overall model can be kept up to date by either updating single parameters of the model or exchanging a sub-model. The model can be operated by graphical user interfaces to enable non-health economists and non-modelling experts to work with this disease model. Discussion: We showed the feasibility of implementing an easy-to-use chlamydia model. This study can be regarded as a step towards more user-friendly decision support tools in health economics to assist decision makers in medicine.

BackgroundMost people living with dementia want to remain living in their own homes and are supported to do so by family carers. No interventions have consistently demonstrated improvements to people with dementia's life quality, functioning, or other indices of living as well as possible with dementia. We have co-produced, with health and social care professionals and family carers of people with dementia, a new intervention (NIDUS-family). To our knowledge, NIDUS-family is the first manualised intervention that can be tailored to personal goals of people living with dementia and their families and is delivered by facilitators without clinical training. The intervention utilizes components of behavioural management, carer support, psychoeducation, communication and coping skills training, enablement, and environmental adaptations, with modules selected to address dyads' selected goals. We will evaluate the effect of NIDUS-family and usual care on goal attainment, as measured by Goal Attainment Scaling (GAS) rated by family carers, compared to usual care alone at 12-month follow-up. We will also determine whether NIDUS-family and usual care is more cost-effective than usual care alone over 12 months.MethodsA randomised, two-arm, single-masked, multi-site clinical trial involving 297 people living with dementia-family carer dyads. Dyads will be randomised 2:1 to receive the NIDUS-family intervention with usual care (n = 199) or usual care alone (n = 98). The intervention group will be offered, over 1 year, via 6-8 video call or telephone sessions (or face to face if COVID-19 restrictions allow in the recruitment period) in the initial 6 months, followed by telephone follow-ups every 1-2 months to support implementation, with a trained facilitator.DiscussionIncreasing the time lived at home by people living with dementia is likely to benefit lives now and in the future. Our intervention, which we adapted to include remote delivery prior to trial commencement due to the COVID-19 pandemic, aims to address barriers to living as well and as independently as possible that distress people living with dementia, exacerbate family carer(s) stress, negatively affect relationships, lead to safety risks, and frequently precipitate avoidable moves to a care home.Trial registrationInternational Standard Randomised Controlled Trials Number ISRCTN11425138 . Registered on 7 October 2019.

Background: The aim was to pilot an adapted manualised weight management programme for persons with mild-moderate intellectual disabilities affected by overweight or obesity ("Shape Up-LD"). Method: Adults with intellectual disabilities were enrolled in a 6-month trial (3-month active intervention and 3-month follow-up) and were individually randomised to "Shape Up-LD" or a usual care control. Feasibility outcomes included recruitment, retention, initial effectiveness and cost. Results: Fifty people were enrolled. Follow-up rates were 78% at 3 months and 74% at 6 months. At 3 and 6 months, controlling for baseline weight, no difference was observed between groups (3 months: [beta]: -0.34, 95% confidence interval [CI]: -2.38, 1.69, 6 months: [beta]: -0.55, 95%CI -4.34, 3.24). Conclusion: It may be possible to carry out a trial of "Shape Up-LD," although barriers to recruitment, carer engagement and questionnaire completion need to be addressed, alongside refinements to the intervention.

Background The need to engage boys in gender-transformative relationships and sexuality education (RSE) to reduce adolescent pregnancy is endorsed by the World Health Organization and the United Nations Educational, Scientific and Cultural Organization. Objectives To evaluate the effects of If I Were Jack on the avoidance of unprotected sex and other sexual health outcomes. Design A cluster randomised trial, incorporating health economics and process evaluations. Setting Sixty-six schools across the four nations of the UK. Participants Students aged 13–14 years. Intervention A school-based, teacher-delivered, gender-transformative RSE intervention (If I Were Jack) versus standard RSE. Main outcome measures Self-reported avoidance of unprotected sex (sexual abstinence or reliable contraceptive use at last sex) after 12–14 months. Secondary outcomes included knowledge, attitudes, skills, intentions and sexual behaviours. Results The analysis population comprised 6556 students: 86.6% of students in the intervention group avoided unprotected sex, compared with 86.4% in the control group {adjusted odds ratio 0.85 [95% confidence interval (CI) 0.58 to 1.26], p = 0.42}. An exploratory post hoc analysis showed no difference for sexual abstinence [78.30% intervention group vs. 78.25% control group; adjusted odds ratio 0.85 (95% CI 0.58 to 1.24), p = 0.39], but more intervention group students than control group students used reliable contraception at last sex [39.62% vs. 26.36%; adjusted odds ratio 0.52 (95% CI 0.29 to 0.920), p = 0.025]. Students in schools allocated to receive the intervention had significantly higher scores on knowledge [adjusted mean difference 0.18 (95% CI 0.024 to 0.34), p = 0.02], gender-equitable attitudes and intentions to avoid unintended pregnancy [adjusted mean difference 0.61 (95% CI 0.16 to 1.07), p = 0.01] than students in schools allocated to receive the control. There were positive but non-significant differences in sexual self-efficacy and communication skills. The total mean incremental cost of the intervention compared with standard RSE was £2.83 (95% CI –£2.64 to £8.29) per student. Over a 20-year time horizon, the intervention is likely to be cost-effective owing to its impact on unprotected sex because it would result in 379 (95% CI 231 to 477) fewer unintended pregnancies, 680 (95% CI 189 to 1467) fewer sexually transmitted infections and a gain of 10 (95% CI 5 to 16) quality-adjusted life-years per 100,000 students for a cost saving of £9.89 (95% CI –£15.60 to –£3.83). Limitations The trial is underpowered to detect some effects because four schools withdrew and the intraclass correlation coefficient (0.12) was larger than that in sample size calculation (0.01). Conclusions We present, to our knowledge, the first evidence from a randomised trial that a school-based, male engagement gender-transformative RSE intervention, although not effective in increasing avoidance of unprotected sex (defined as sexual abstinence or use of reliable contraception at last sex) among all students, did increase the use of reliable contraception at last sex among students who were, or became, sexually active by 12–14 months after the intervention. The trial demonstrated that engaging all adolescents early through RSE is important so that, as they become sexually active, rates of unprotected sex are reduced, and that doing so is likely to be cost-effective. Future work Future studies should consider the longer-term effects of gender-transformative RSE as students become sexually active. Gender-transformative RSE could be adapted to address broader sexual health and other settings. Trial registration This trial is registered as ISRCTN10751359. Funding This project was funded by the National Institute for Health and Care Research (NIHR) Public Health Research programme (PHR 15/181/01) and will be published in full in Public Health Research; Vol. 11, No. 8. See the NIHR Journals Library website for further project information. Plain language summary Adolescent pregnancy is often thought to be an issue for young women alone, but it is important to engage young men to tackle the problem and find solutions. The If I Were Jack intervention was especially designed to engage with boys as well as girls aged 14 years and to promote positive masculinity and gender equality to prevent adolescent pregnancy and promote positive sexual health. It uses tailored interactive films and resources, made with the help of students and teachers, to make it relevant to each of the four UK nations. This relationship and sexuality education intervention encourages adolescents to avoid unprotected sex by delaying sexual activity until they feel ready and to use reliable contraception once sexually active. It also promotes knowledge, attitudes (such as beliefs about gender and masculinities), skills and intentions for safe and pleasurable relationships. In this trial, we compared students in 33 schools randomly allocated to deliver the intervention with students in 33 schools that continued with their usual relationship and sexuality education practices. Four schools withdrew, two because of COVID-19 school closures. This left a total of 6556 students who completed questionnaires at the start of the study and 12–14 months later. Responses from all these students showed that If I Were Jack had a positive impact on knowledge, attitudes and intentions required for safe and pleasurable relationships, but did not have a significant effect on overall avoidance of unprotected sex. This was because the intervention had no effect on delaying sexual activity. However, we found that the intervention was effective in increasing the use of reliable contraception as students became sexually active, as well as for those who already were sexually active prior to receiving the intervention. We also found that If I Were Jack was likely to provide value for money by reducing unintended pregnancies and improving sexual health. Scientific summary Background The need for relationship and sexuality education (RSE) to especially engage with young men and boys to promote positive sexual health for all, and to be gender transformative to challenge the gender inequalities that underlie young women’s generally poorer sexual health outcomes (especially in relation to sexual violence, adolescent pregnancy and sexually transmitted infections), is widely endorsed by the World Health Organization and the United Nations Educational, Scientific and Cultural Organization, among others. Objectives The JACK trial evaluated the effectiveness and cost-effectiveness of the If I Were Jack intervention, a schools-based RSE intervention, which is designed to especially engage young men as well as young women and promote joint responsibility in preventing adolescent pregnancy by avoiding unprotected sex and in promoting positive sexual health and relationships. We assessed whether there would be higher rates of self-reported avoidance of unprotected sex (either by remaining sexually abstinent or by using a reliable form of contraception) among students in schools allocated to use If I Were Jack than among those in schools that continued with their usual RSE. Design We undertook a multicentre, parallel-group cluster randomised trial of the If I Were Jack intervention with schools as the unit of randomisation. We incorporated a health economic cost–consequences analysis and process evaluation. Setting The trial was conducted in secondary-level schools across the four nations of the UK. Recruitment We sampled schools from Department of Education-listed secondary schools in each nation of the UK (Northern Ireland, Wales, Scotland and England), with consideration of the socioeconomic status of schools [based on the proportion of students eligible for free school meals (FSM) as indicated by the School Meal Census]. In each nation, eligible schools were stratified into two levels according to FSM eligibility rates (schools above and below the median national percentage of FSM for all eligible schools). Independent private, special, and Irish/Welsh-medium and Scottish Gaelic schools and schools with

Background: Stepping Stones Triple P (SSTP) is a complex parent‐mediated intervention aimed to reduce behaviours that challenge in children with moderate to severe intellectual disabilities, aged 30–59 months. Methods: To formulate a comprehensive understanding of SSTP implementation in the UK, we conducted a process evaluation collecting stakeholder views and considering intervention fidelity, dose, reach, delivery adaptations, and acceptability. Results: Fidelity and quality of delivery ratings were high. Parents perceived SSTP as valuable, reporting increased parental confidence and understanding of the child's behaviours. However, only 30% of families received an adequate dose of the intervention. Parents who only received treatment as usual described feeling abandoned by current services. Service managers emphasised the importance of availability of resources and therapist training for successful intervention delivery. Conclusions: SSTP supports effective management of early‐onset behaviours that challenge. Further work is needed to ensure equitable access to the intervention across health and social care services. Trial Registration: NCT03086876 – https://www.clinicaltrials.gov/ct2/show/NCT03086876?term=Hassiotis+Angela&draw=1&rank=1. [ABSTRACT FROM AUTHOR]

Objectives: There is limited evidence on the effectiveness of parenting interventions to improve disruptive behaviour in children with intellectual developmental disabilities. This clinical trial evaluated whether an adapted group parenting intervention for preschool children with intellectual developmental disabilities who display challenging behaviour is superior to treatment as usual in England. Study design: 261 children aged 30–59 months with moderate to severe intellectual developmental disabilities and challenging behaviour were randomised to either the intervention (Stepping Stones Triple P) and treatment as usual or treatment as usual alone. The primary outcome was the parent-rated Child Behaviour Checklist at 52 weeks after randomisation. A health economic evaluation was also completed. Results: We found no significant difference between arms on the primary outcome (mean difference -4.23; 95% CI: -9.99 to 1.53; p = 0.147). However, a subgroup analysis suggests the intervention was effective for participants randomised before the COVID-19 pandemic (mean difference -7.12; 95% CI: -13.44 to -0.81; p = 0.046). Furthermore, a complier average causal effects analysis (mean difference -11.53; 95% CI: -26.97 to 3.91; p = 0.143) suggests the intervention requires participants to receive a sufficient intervention dose. The intervention generated statistically significant cost savings (-£1,057.88; 95% CI -£3,218.6 to -£46.67) but the mean point estimate in Quality Adjusted Life Years was similar in both groups. Conclusion: This study did not find an effect of the intervention on reducing challenging behaviour, but this may have been influenced by problems with engagement. The intervention could be considered by services as an early intervention if families are supported to attend, especially given its low cost. [ABSTRACT FROM AUTHOR]

BACKGROUND: PlGF (placental growth factor)-based testing reduces severe maternal adverse outcomes. Repeat PlGF-based testing is not associated with improved perinatal or maternal outcomes. This planned secondary analysis aimed to determine whether there is a subgroup of women who benefit from repeat testing. METHODS: Pregnant individuals with suspected preterm preeclampsia were randomized to repeat revealed PlGF-based testing, compared with usual care where testing was concealed. Perinatal and maternal outcomes were stratified by trial group, by initial PlGF-based test result, and by PlGF-based test type (PlGF or sFlt-1 [soluble fms-like tyrosine kinase-1]/PlGF ratio). RESULTS: A total of 1252 pregnant individuals were included. Abnormal initial PlGF-based test identified a more severe phenotype of preeclampsia, at increased risk of adverse maternal and perinatal outcomes. Repeat testing was not significantly associated with clinical benefit in women with abnormal initial results. Of women with a normal initial result, 20% developed preeclampsia, with the majority at least 3 to 4 weeks after initial presentation. Repeat test results were more likely to change from normal to abnormal in symptomatic women (112/415; 27%) compared with asymptomatic women (163/890; 18%). A higher proportion of symptomatic women who changed from normal to abnormal were diagnosed with preeclampsia, compared with asymptomatic women. CONCLUSIONS: Our results do not demonstrate evidence of the clinical benefit of repeating PlGF-based testing if the initial result is abnormal. Judicious use of repeat PlGF-based testing to stratify risk may be considered at least 2 weeks after a normal initial test result, particularly in women who have symptoms or signs of preeclampsia. [ABSTRACT FROM AUTHOR]