Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis, may provide cross-protection against the closely related bacterium N. gonorrhoeae. This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+).

This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm³), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies.

Ethical approval was obtained from the St Vincent’s Hospital Human Research Ethics Committee, St Vincent’s Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences.

NCT04415424.

To examine the effectiveness of shared medical appointments (SMAs) compared with one-to-one appointments in primary care for improving health outcomes and reducing demand on healthcare services by people with one or more long-term conditions (LTCs).

A systematic review of the published literature.

Six databases, including MEDLINE and Web of Science, were searched 2013–2023. Relevant pre-2013 trials identified by forward and backward citation searches of the included trials were included.

Randomised controlled trials of SMAs delivered in a primary care setting involving adults over 18 years with one or more LTCs. Studies were excluded if the SMA did not include one-to-one patient-clinician time. All countries were eligible for inclusion.

Data were extracted and outcomes narratively synthesised, meta-analysis was undertaken where possible.

Twenty-nine unique trials were included. SMA models varied in terms of components, mode of delivery and target population. Most trials recruited patients with a single LTC, most commonly diabetes (n=16). There was substantial heterogeneity in outcome measures. Meta-analysis showed that participants in SMA groups had lower diastolic blood pressure than those in usual care (d=–0.086, 95% CI=–0.16 to –0.02, n=10) (p=0.014). No statistically significant differences were found across other outcomes. Compared with usual care, SMAs had no significant effect on healthcare service use. For example, no difference between SMAs and usual care was found for admissions to emergency departments at follow-up (d=–0.094, 95% CI=–0.27 to 0.08, n=6, p=0.289).

There was a little difference in the effectiveness of SMAs compared with usual care in terms of health outcomes or healthcare service use in the short-term (range 12 weeks to 24 months). To strengthen the evidence base, future studies should include a wider array of LTCs, standardised outcome measures and more details on SMA components to help inform economic evaluation.

CRD42020173084.

Sarcopenia is characterised by age-related loss of skeletal muscle and function and is associated with risks of adverse outcomes. The prevalence of sarcopenia increases due to ageing population and effective interventions is in need. Previous studies showed that β-hydroxy β-methylbutyrate (HMB) supplement and vibration treatment (VT) enhanced muscle quality, while the coapplication of the two interventions had further improved muscle mass and function in sarcopenic mice model. This study aims to investigate the efficacy of this combination treatment in combating sarcopenia in older people. The findings of this study will demonstrate the effect of combination treatment as an alternative for managing sarcopenia.

In this single-blinded randomised controlled trial, subjects will be screened based on the Asian Working Group for Sarcopenia (AWGS) 2019 definition. 200 subjects who are aged 65 or above and identified sarcopenic according to the AWGS algorithm will be recruited. They will be randomised to one of the following four groups: (1) Control+ONS; (2) HMB+ONS; (3) VT+ONS and (4) HMB+VT + ONS, where ONS stands for oral nutritional supplement. ONS will be taken in the form of protein formular once/day; HMB supplements will be 3 g/day; VT (35 Hz, 0.3 g, where g=gravitational acceleration) will be received for 20 mins/day and at least 3 days/week. The primary outcome assessments are muscle strength and function. Subjects will be assessed at baseline, 3-month and 6-month post treatment.

This study was approved by Joint CUHK-NTEC (The Chinese University of Hong Kong and New Territories East Cluster) Clinical Research Management Office (Ref: CRE-2022.223-T) and conformed to the Declaration of Helsinki. Trial results will be published in peer-reviewed journals and disseminated at academic conferences.

NCT05525039.

Faith-based organisations (FBOs) and religious actors increase vaccine confidence and uptake among ethnoracially minoritised communities in low-income and middle-income countries. During the COVID-19 pandemic and the subsequent vaccine rollout, global organisations such as the WHO and UNICEF called for faith-based collaborations with public health agencies (PHAs). As PHA-FBO partnerships emerge to support vaccine uptake, the scoping review aims to: (1) outline intervention typologies and implementation frameworks guiding interventions; (2) describe the roles of PHAs and FBOs in the design, implementation and evaluation of strategies and (3) synthesise outcomes and evaluations of PHA-FBO vaccine uptake initiatives for ethnoracially minoritised communities.

We will perform six library database searches in PROQUEST-Public Health, OVID MEDLINE, Cochrane Library, CINAHL, SCOPUS- all, PROQUEST - Policy File index; three theses repositories, four website searches, five niche journals and 11 document repositories for public health. These databases will be searched for literature that describe partnerships for vaccine confidence and uptake for ethnoracially minoritised populations, involving at least one PHA and one FBO, published in English from January 2011 to October 2023. Two reviewers will pilot-test 20 articles to refine and finalise the inclusion/exclusion criteria and data extraction template. Four reviewers will independently screen and extract the included full-text articles. An implementation science process framework outlining the design, implementation and evaluation of the interventions will be used to capture the array of partnerships and effectiveness of PHA-FBO vaccine uptake initiatives.

This multiphase Canadian Institutes of Health Research (CIHR) project received ethics approval from the University of Toronto. Findings will be translated into a series of written materials for dissemination to CIHR, and collaborating knowledge users (ie, regional and provincial PHAs), and panel presentations at conferences to inform the development of a best-practices framework for increasing vaccine confidence and uptake.

Work-related stress is a social determinant of global health that represents a huge cost to workers’ health and reduces work performance. In Australia, mental well-being is a pressing national issue—with one in five Australians experiencing mental disorders. Antidepressants are a first-line medication commonly used to treat mental disorders. Recently, Australia has seen a dramatic increase in the use of prescribed antidepressant medications to treat mental health related illnesses. Australia has also seen a dramatic increase in the use of prescribed opioid analgesics for non-cancer pain including opioid use for psychological distress and social stressors. It is plausible a rise in mental health problems and antidepressant and opioid medication use is partly attributable to the corporate climate for worker mental health (ie, the psychosocial safety climate, PSC). This research aims to identify how PSC and workplace conditions contribute to employee well-being and distress that culminate in antidepressant and opioid medication use.

Data will be collected through creative data linkage from the Australian Workplace Barometer (AWB), to medication data (via the Pharmaceutical Benefits Scheme, PBS). The participant sample will include 1372 working Australians from the AWB project from 2009 to 2021. Four waves of longitudinal data from 2009 to 2021 will be used to investigate the plausible link between Australia’s high levels of antidepressant and opioid use and distress at work. The project advances theory by probing the role corporate climate plays in work design, distress, mental health problems and antidepressant and opioid use. It will determine if antidepressant and opioid use has led to an underestimation of work stress effects. Proposed theoretical models will be analysed through linked data, using continuous time structural equation modelling, hierarchical linear modelling, logistic regression and cost estimation.

The study has been approved by the Human Research Ethics Committee of the University of South Australia (Ethics Protocol: 203003). Further, approval from the Australian Institute of Health and Welfare Ethics Committee was also granted for linkage of AWB data and PBS data (EthOS Application EO2022/1/1190).

Results of the study will be disseminated through worldwide keynotes, key international settings, high-impact peer-reviewed journals, industry conference presentations and media outlets to reach managers, workers, and industry partners. Further, UniSA requires publications from public projects to be held in an institutional repository which fulfils the Australian Research Council’s Open Access Policy.

Certain criteria for ventilator-associated events (VAE) definition might influence the type of an event, its detection rate and consequently the resource expenditure in intensive care unit. The Impact of Infections by Antimicrobial-Resistant Microorganisms - Ventilator-Associated Pneumonia (IMPACTO MR-PAV) aims to evaluate the incidence and diagnostic accuracy of ventilator-associated pneumonia (VAP) using the current criteria for VAP surveillance in Brazil versus the VAE criteria defined by the US National Healthcare Safety Network-Center for Diseases Control and Prevention (CDC) criteria.

The study will be conducted in around 15 centres across Brazil from October 2022 to December 2023. Trained healthcare professionals will collect data and compare the incidence of VAP using both the current criteria for VAP surveillance in Brazil and the VAE criteria defined by the CDC. The accuracy of the two criteria for identifying VAP will also be analysed. It will also characterise other events associated with mechanical ventilation (ventilator-associated condition, infection-related ventilator-associated complication) and adjudicate VAP reported to the Brazilian Health Regulatory Agency (ANVISA) using current epidemiological diagnostic criteria.

This study was approved by the Institutional Review Board under the number 52354721.0.1001.0070. The study’s primary outcome measure will be the incidence of VAP using the two different surveillance criteria, and the secondary outcome measures will be the accuracy of the two criteria for identifying VAP and the adjudication of VAP reported to ANVISA. The results will contribute to the improvement of VAP surveillance in Brazil and may have implications for other countries that use similar criteria.

NCT05589727; Clinicaltrials.gov.

The dynamics of self-harm vary substantially around the world, yet it is severely under-researched outside of a small number of high-income ‘Western’ countries. South Asia is disproportionately impacted by suicide, yet we know less about non-suicidal self-injury (NSSI) in the region.

To review and summarise evidence on the prevalence, correlates and common methods of NSSI in South Asia.

We searched Medline, Embase and PsycINFO for the period 1 January 2000 to 31 August 2023, for peer-reviewed observational studies. A total of 11 studies from eight South Asian countries that reported prevalence and/or correlates of NSSI were included in this review. We assessed the quality of the studies using the Study Quality Assessment Tools for Observational Cohort and Cross-Sectional Studies. We used meta-regression to describe the sources of heterogeneity. Abstracted data were summarised using thematic synthesis.

For non-clinical populations, the 12-month prevalence of NSSI ranged from 3.2% to 44.8%, and the lifetime prevalence ranged from 21% to 33%. For clinical populations, the 12-month prevalence of NSSI ranged from 5% to 16.4%, while the lifetime prevalence ranged from 2% to 27%. Male sex, unemployment, financial stress, history of suicidal behaviour and depression were associated with a higher risk of NSSI. Better access to counselling services, higher self-esteem and self-knowledge were associated with a lower risk of NSSI.

The burden of NSSI in South Asia appears to be high in both clinical and non-clinical populations. Further research, especially with general population samples, is needed to build evidence on the epidemiology, context and meaning of NSSI in South Asia to inform the design of context-specific interventions.

CRD42022342536.