After resuscitation from out of hospital cardiac arrest (OHCA), mechanical ventilation (MV) and respiratory management are fundamental to support patients in the intensive care unit (ICU) and to minimise secondary brain injury. Best practices for MV and association with clinical outcomes in patients with OHCA remain unclear.

This protocol describes a pre-planned respiratory-focused series of sub-analyses within the Sedation, Temperature and Pressure after Cardiac Arrest and Resuscitation (STEPCARE) trial, an ongoing interventional study evaluating 6-month mortality after randomisation in patients admitted to ICUs following OHCA. The primary aim is to describe real-world ventilator settings and gas-exchange targets during the first 72 hours after ICU admission in patients receiving invasive mechanical ventilation after OHCA. Secondary aims include to estimate the incidence of respiratory complications during ICU stay (eg, ventilator-associated pneumonia, acute respiratory distress syndrome, barotrauma); and to explore the association between early ventilator settings/gas-exchange parameters and 6-month outcomes (mortality and neurological status). Exploratory aim is to characterise weaning and extubation practices, including timing and failure rates.

Eligible patients will include adult STEPCARE participants receiving invasive MV after return of spontaneous circulation with available respiratory data recorded within the STEPCARE database.

Data collected in the STEPCARE trial that will be analysed include patients’ prehospital characteristics; clinical examination at hospital admission and at ICU admission; ventilator settings and arterial blood gases recorded at predefined time points during ICU stay. In particular: MV setting (mode, tidal volume, positive end-expiratory pressure, fraction of inspired oxygen, tidal volume, mechanical power, plateau/driving pressures), gas-exchange values (arterial partial pressure of oxygen and carbon dioxide, pH, arterial saturation of oxygen), timing of measurements and the occurrence/timing of respiratory complications and weaning outcomes.

The STEPCARE study has been approved by the regional ethics committee at Lund University (Dnr 2022-02425-01, Approved IRB on 2022-06-18) and by all ethics boards in the participating countries. No additional ethical approval is required for this predefined secondary analysis, as no further data collection or interventions will be performed. Findings will be disseminated through publication in peer-reviewed journals and, where appropriate, conference abstracts and presentations. Patients and the public were not involved.

NCT05564754.

Emerging evidence supports a role for interleukin 6 (IL-6), a pro-inflammatory cytokine, in the pathogenesis of treatment-resistant major depressive disorder (TRD). However, interventional studies targeting IL-6 in this population remain scarce. Tocilizumab is a humanised monoclonal antibody that inhibits IL-6 signalling and is approved for the treatment of autoimmune conditions such as rheumatoid arthritis. The primary objective of this study is to examine whether IL-6 inhibition via tocilizumab can impact depressive symptoms, inflammation-related biomarkers and cognition in patients with TRD. A secondary objective is to compare the biological profiles of patients with TRD with elevated inflammation to those of healthy controls.

This is a proof-of-concept, randomised, parallel-group, triple-blind, placebo-controlled clinical trial. 22 adult outpatients diagnosed with TRD and evidence of low-grade inflammation (serum C reactive protein≥3 mg/L) will be randomised (1:1) to receive either one intravenous infusion of tocilizumab (8 mg/kg; maximum 800 mg) or normal saline, administered as an add-on to their ongoing treatment. Psychiatric, cognitive and biomarker assessments will be performed at baseline and at follow-up visits on days 7, 14 and 28 post-infusion. Additionally, 10 healthy controls with no psychiatric history will undergo the same baseline assessments for biomarker comparison.

The study has been approved by the Research Ethics Committee of the Hospital de Clínicas de Porto Alegre (Project number: 2025-0245, CAAE: 88904825.7.0000.5327). Findings will be disseminated through peer-reviewed publications, scientific meetings and, on request, lay summaries for participants.

NCT07052058.

An affordable heart-healthy dietary approach is essential for the management of familial hypercholesterolaemia (FH); however, the optimal dietary pattern and the role of adjunctive nutrient supplementation remain uncertain. This study aims to evaluate the effects of the Brazilian Cardioprotective Diet (DICA Br), adapted from the Portfolio Diet, with or without phytosterol and/or krill oil supplementation in individuals with probable or definite FH according to the Dutch Lipid Clinic Network (Dutch MEDPED) criteria.

The DICA-FH study is a national, multicentre, randomised, factorial, parallel-group, superiority, placebo-controlled clinical trial with a 1:1:1:1 allocation ratio. Participants aged ≥16 years receiving age-appropriate lipid-lowering therapy will be randomised into four groups: (1) adapted cardioprotective diet (DICA-FH) plus phytosterol placebo and krill oil placebo; (2) DICA-FH plus phytosterol 2 g/day and krill oil placebo; (3) DICA-FH plus phytosterol placebo and krill oil 2 g/day or (4) DICA-FH plus phytosterol 2 g/day and krill oil 2 g/day. All participants will undergo whole-genome sequencing and receive appropriate genetic counselling. Primary outcomes will be means of low-density lipoprotein cholesterol and lipoprotein(a) levels after 120 days. Secondary outcomes will include additional lipid biomarkers, adherence to protocol and adverse events. The planned sample size is 300 participants. Follow-up is expected to conclude in July 2026.

This study was registered under CAAE 65549622.2.1001.0060 and received ethical approval from the Hcor Research Ethics Committee (approval number 5.805.072) and the Brazilian National Research Ethics Commission (CONEP; approval number 6.864.951). Written informed consent will be obtained from all participants prior to enrolment. The study findings will be disseminated through peer-reviewed publications, scientific conferences and channels aimed at the general public.

NCT06331195.

To assess the relationship between the structural position of individuals within their village network and symptoms of depression and postpartum depression, among men and women.

Community-based, observational, cross-sectional study.

176 villages in the Copan region of Honduras.

Village residents, comprising 25 605 adults surveyed in a census-based study; using data collected between October 2015 and December 2019.

Symptoms of depression and postpartum depression, among men and women.

Across all participants, 34.99% reported depression symptoms (40.50% for women and 27.62% for men). Among recent parents with a new child in the last 6 months, 28.89% reported postpartum depression symptoms (31.29% for women and 24.31% for men). Women with higher social intransitivity (ie, a greater proportion of friend-pairs among their friends that were not themselves connected) had higher odds of depression symptoms (OR=1.27, 95% CI 1.14 to 1.41), an association not found for men nor in postpartum parents. Because this coefficient is estimated on a 0–1 scale, it corresponds to approximately 2.4% higher odds of depression per 10 percentage-point increase in social intransitivity. In a signed-network decomposition that also included adversarial ties, only the proportion of incomplete/no-tie friend-pairs was associated with depression in women (OR=1.03, 95% CI 1.01 to 1.04), corresponding to approximately 3% higher odds of depression per 10 percentage-point increase.

We report that structural social network position and connectedness beyond dyadic ties, including the friendships and adversarial ties of a person’s friends, are associated with depression. These findings highlight the importance of linking psychological health to broader social connections in the context of face-to-face relationships.

Digital health interventions (DHIs) show considerable promise in supporting hypertension self-management by promoting preventative care and self-monitoring. While their efficacy is increasingly evident, the long-term uptake, acceptance and sustained engagement with these tools are frequently challenged by issues such as usability, trust and varying user experiences. This review aims to synthesise qualitative evidence to identify barriers and facilitators and the key factors that impact the adoption, acceptance and engagement with DHIs for hypertension self-management.

Systematic review of qualitative literature using thematic analysis following Cochrane’s qualitative and implementation methods guidance.

PubMed, PsycInfo, Web of Science and the Cochrane Library were searched in February 2025.

The searches included relevant qualitative and mixed-methods studies on the use of digital devices for hypertension management, which described the barriers and facilitators associated with these tools. We included studies published from 2015 to 2025 to capture relevant evidence. Only studies published in English with a qualitative approach were included.

From an initial 10 943 identified publications, 15 met our inclusion criteria, primarily originating from Europe and the USA, exploring diverse racial and ethnic group experiences. Our thematic synthesis revealed 7 analytical and 22 descriptive themes detailing barriers and facilitators encountered by patients with hypertension, healthcare providers (HCPs) and caregivers. These themes covered technology utilisation, design components, linguistic and cultural relevance, healthcare factors, trust and credibility and interpersonal interactions.

Our analysis underscores that factors such as the usability, design and relevance of social support profoundly influence the uptake and acceptance of DHIs in hypertension self-management among patients, caregivers and HCPs.

CRD42023480389.

Total knee arthroplasty (TKA) is a common and effective procedure for end-stage knee osteoarthritis, yet patients frequently encounter a complex and dynamic symptom experience during the initial period that can significantly impact their rehabilitation and quality of life. This study aimed to explore the symptom experience of patients within 6 weeks after TKA.

A longitudinal qualitative study using semi-structured interviews.

This study was conducted in an orthopaedics department of a tertiary general hospital in China.

Interviews were conducted with 16 patients at 3–5 days postoperatively, 14 patients at 2 weeks postoperatively and 10 patients at 6 weeks postoperatively.

Data were collected between July 2024 and November 2024. A purposive sampling method was used to recruit patients. Data were analysed using directed content analysis, with data collection and analysis performed concurrently.

Three themes and nine subthemes were identified: (1) symptom perception, including perceived complexity of symptoms, self-identity conflict due to functional limitations, activation of negative emotions and psychological adaptation and interaction and amplification effects among symptoms; (2) symptom evaluation, characterised by the dynamic cognitive reframing of symptom meaning, self-blame tendency and internalisation of responsibility and interference from social and medical information; (3) symptom coping, involving dynamic evolution of active coping strategies and self-efficacy reinforcement, temporal characteristics of passive coping patterns and rehabilitation barriers.

The symptom experience of patients who had TKA is complex and dynamic. Healthcare providers should implement tailored interventions based on patients’ symptom experiences at different stages to facilitate symptom management, alleviate distress and negative emotions and improve quality of life.

The DREAMSPHEN study (Dose REduction of Antipsychotics vs. Maintenance treatment in schizophrenia after Stratification based on psychotic PHENotype) aims to compare the benefits and risks of a hyperbolic tapering method for antipsychotics to the maintenance of antipsychotics in a sample of clinically stabilised patients with schizophrenia spectrum disorder.

A sample of 288 patients will be recruited from 12 centres in France. Inclusion criteria are: diagnosis of schizophrenia spectrum disorder (according to the 5th version of the Diagnostic and Statistical Manual of mental disorders, DSM-5), minimum of 3 months remission of psychotic symptoms and in treatment with antipsychotic medication (except clozapine and long-acting antipsychotic injection). First, the psychotic phenotype of the patients (cycloid psychosis vs other psychotic phenotype) will be assessed. Then, patients will be randomised either to the maintenance of treatment (MT) or to the antipsychotics dose reduction (DR) arm. DR will follow a hyperbolic schema according to Horowitz protocol. Patients will be assessed at baseline, and every 2 months until 24 months follow-up regarding social functioning, psychotic and negative symptoms, side effects of antipsychotic medication, cognitive functioning, patient satisfaction, substance and alcohol use, and quality of life. The primary outcome will be a good social functioning after 24 months defined as a score at the Personal and Social Performance Scale >70. Secondary outcome measures will include: psychotic and negative symptoms, hospitalisation for psychotic episode, antipsychotic dose, antipsychotic side effects, withdrawal symptoms, cognitive functioning, patient’s well-being and quality of life. Safety measures will include death, admissions to psychiatric hospital, psychotic relapses and severe self-harm.

The DREAMSPHEN trial aims to better identify patients with psychotic disorders who are most likely to benefit from antipsychotic tapering with an aim to inform future clinical treatment guidelines for antipsychotic treatment. DREAMSPHEN V2.0 of the 14 May 2025 has received ethical approval from Comité de protection des personnes Ile de France IV (N° 2023-509558-80-00) on 17 July 2025.

EU Clinical Trials Register – EudraCT no. 2023-509558-80-00. Clinical trials: NCT07152184. Registered on 9 August 2025.

Sexually transmitted infections (STIs) have emerged as significant public health concerns, imposing a substantial burden on both individuals and the healthcare system of the country. Additionally, STIs may also result in major extensive psychological consequences that profoundly affect individuals with STIs. Despite the government’s implementation of different initiatives aimed at addressing STI-related challenges, these conditions are associated with shame and stigma which act as barriers to the effective utilisation of healthcare services. The purpose of the present study is to generate evidence on barriers and facilitators to service utilisation and management of STIs in India.

Indian Council of Medical Research, New Delhi, is conducting a multi-centre study employing a mixed-method approach. The study involves different levels of healthcare systems, including both government and private healthcare facilities across seven sites in several states of India, including Maharashtra, Rajasthan, Punjab, Bihar, Uttar Pradesh and New Delhi. For the quantitative data, individuals seeking healthcare services related to STIs will be enrolled and assessed using a semi-structured pilot-tested questionnaire. In-depth interviews and focus group discussions will also be conducted with different stakeholders as per the standard guidelines of the qualitative method by the designated trained project staff. Descriptive and inferential statistics will be applied to the quantitative data, while the qualitative data will be analysed using a deductive approach with thematic content analysis.

The study protocol has been approved by the ethics review committees of all the participating sites individually. The findings from this study will be published in peer-reviewed journals and disseminated through scientific conferences and meetings among policy-makers and government agencies. AIIMS/IEC/2024/609; AIIMS/Pat/IEC/2024/1205; F. 7/BIOETHICS/AIIMS-RBL/APPROEM/2021/1; KIMSDU/IEC/11/2022; LHMC/IEC/2024/11; IEC/02/EX/2024; PGI/IEC/2024EIC000373.

Patients on low-dose prednisolone may develop adrenal insufficiency causing reduced health-related quality of life (HRQoL) and increased risk of adrenal crisis. This study examines whether supplemental hydrocortisone during mild to moderate stress improves HRQoL in patients with polymyalgia rheumatica/giant cell arteritis (PMR/GCA) with adrenal insufficiency on low-dose prednisolone.

A multicentre, randomised, double-blinded, placebo-controlled, clinical trial including patients with PMR/GCA receiving ongoing prednisolone ≤5 mg/day. Eligible patients undergo an adrenocorticotropic hormone (ACTH) test, and 250 patients with a stimulated cortisol

The study is approved by the Ethics Committee of the Capital Region of Denmark and the Danish Medicines Agency. Recruitment began June 2022. The last patient’s last visit is expected in 2026. Results will be disseminated via peer-reviewed publication and conference presentations.

EudraCT:2021-002528-18, CTIS:2024-518272-30-00, NCT05435781.

To identify subgroups with similar social determinants of health (SDOH) characteristics using latent class analysis (LCA) and examine their associations with physical and mental health, cognitive function and missed workdays at 3 and 6 months post-SARS-CoV-2 infection. We hypothesised that intersecting SDOH factors would differentially influence COVID-19-related health outcomes across subgroups.

Prospective cohort study from the Innovative Support for Patients with SARS-CoV-2 Infections Registry (INSPIRE), with longitudinal data collection and cross-sectional analyses at baseline, 3-month and 6-month follow-ups.

Multicentre registry across eight US academic medical centres (Chicago, Dallas, Houston, Los Angeles, New Haven, Philadelphia, San Francisco and Seattle).

Adults aged ≥18 years, fluent in English or Spanish, with self-reported acute COVID-19 symptoms and a confirmed positive SARS-CoV-2 test within 42 days before enrolment (9 December 2020 to 12 August 2022), and access to an internet-connected device. Exclusions included incarceration, inability to provide informed consent, lack of confirmed SARS-CoV-2 infection or no internet access. Of 3791 eligible participants with complete baseline data, 2897 (76.4%) completed the 3-month follow-up and 2666 (70.3%) completed the 6-month follow-up; most were aged 18–49 years (74–75%), female (66–67%), white (86.6–87.5%) and non-Hispanic (86.6–87.5%).

Prespecified primary outcomes were physical and mental health (Patient-Reported Outcomes Measurement Information System (PROMIS)-29 V.2.1 T-scores for depression, anxiety, fatigue, sleep disturbance, pain interference, physical function and social participation), cognitive function (PROMIS Cognitive Function Short Form 8 T-scores) and missed workdays due to illness (binary: >1 week vs ≤1 week, from a single-item survey). All measures were self-reported and collected at baseline, 3 months and 6 months; no changes from protocol.

LCA identified a 4-class model as optimal (lowest Bayesian Information Criterion (BIC) after evaluating 1–7 class models; significant demographic differences (² p

In this US prospective cohort, SDOH-based subgroups showed persistent disparities in health outcomes post-SARS-CoV-2 infection. Findings highlight the urgent need for intersectional approaches to address systemic inequities in post-COVID-19 recovery.

NCT04610515.

In current practice, fluid volumes administered to children following kidney transplant vary widely. Up to 52% of children experience fluid overload-related complications. Current fluid guidelines are not evidence-based and the optimal amount of fluid for children after transplant is not known. The aim of Randomised multiple centre trial of conservative versus LIberal fluid adMInisTration for children receiving a kidney tranSplant (LIMITS) is to determine whether relative limitation of fluid volume administered to children receiving kidney transplants is superior to liberal fluid volume administration.

LIMITS is a pragmatic, open-label, UK-based, multicentre randomised controlled trial, with an internal pilot phase and integrated economic evaluation. A total of 140 children receiving kidney transplants will be randomised to receive either conservative postoperative fluid administration (maximum of 150 mL/m²/hour for no longer than 18 hours, followed by a fixed daily target of maximum 1.5 L/m²/day thereafter) versus the comparator of liberal postoperative fluid administration (fluid volume administered to replace urine output and insensible losses for at least 48 hours with target urine output >2 mL/kg/hour). The primary outcome is mean days at home in the first 30 days after kidney transplant. The primary outcome will be analysed using a mixed linear regression model adjusted for donor type (living vs deceased donor) and participant weight (

The trial received Health Research Authority approval on 20 August 2025 (REC reference: 25/EE/0161, IRAS project ID: 354370). Findings will be presented to academic groups via national and international conferences and peer-reviewed journals. The patient and public involvement group will play an important part in disseminating the study findings to the public domain.

ISRCTN21516608.

Adult-onset type 1 diabetes (T1D) is often misclassified as type 2 diabetes (T2D), resulting in delayed treatment, missed opportunities for referrals to specialists and increased risk of complications including diabetic ketoacidosis. An electronic medical record (EMR)-based algorithm—originally trained on a large national EMR dataset to identify likely misclassified adult-onset T1D cases—was tested and retrained on a health information exchange (HIE) dataset from HealthShare Exchange (HSX). Promising results were achieved on historical data, particularly when using the retrained algorithm. However, its prospective validation is essential to more reliably assess its clinical utility and real-world precision in flagging high-risk patients for clinician review.

This is a prospective, multicentre, non-interventional cohort study in two HSX-member healthcare organisations (HCOs) in southeastern Pennsylvania. At the onset of the study, all adult T2D patients are scored by the algorithm analysing HIE data on relevant predictors found in the 24-month lookback period. Patients meeting a prespecified score threshold estimated in retrospective testing to yield 10% recall will be presented to designated endocrinology or primary care providers for structured chart review, attribution confirmation and guideline-concordant follow-up (including autoantibody testing where appropriate). The primary endpoint is positive predictive value for confirmed adult-onset T1D among flagged patients. Secondary endpoints characterise operational cascade metrics (attribution, provider recommendation, test ordering/results and diagnosis updates) along with 95% CIs. Exploratory endpoints will assess provider adoption, interpretability and workflow integration via structured provider interviews.

This study was reviewed and approved by Advarra Institutional Review Board (protocol Pro00075945). The Institutional Review Board waived patient informed consent and granted a full waiver of HIPAA authorisation for patient records, while providers were required to provide written informed consent. HSX data were accessed and shared under its member-defined use cases. Findings will be disseminated via peer-reviewed publications and conference presentations. Reporting will follow Strengthening the Reporting of Observational Studies in Epidemiology guidance for cohort studies.

Major depressive disorder (MDD) is a prevalent mental illness characterised by persistent sadness, loss of interest in activities and cognitive impairment. While pharmacological and psychotherapeutic treatments remain the standard for MDD management, non-pharmacological interventions, such as aerobic exercise, have gained attention for their potential benefits in reducing depressive symptoms and improving quality of life. Although several studies have explored the effectiveness of aerobic exercise in managing MDD, there is still no comprehensive synthesis of the existing evidence. This study aims to synthesise existing evidence on the effects of aerobic exercise interventions in the management of individuals diagnosed with MDD.

The systematic review will be conducted in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses Protocol (PRISMA-P) guidelines. A comprehensive search will be conducted across Cochrane, Medline, PEDro, CINAHL, Scopus, Web of Science and BioMed Central databases. Search terms will be developed using the Population, Intervention, Comparison, Outcome and Study design (PICOS) framework, incorporating keywords and Medical Subject Headings related to ‘Major Depressive Disorder’, ‘Aerobic Exercise’, ‘Depression’, and ‘Quality of Life’. Only intervention studies, including randomised controlled trials, quasi-experimental and pre–post intervention studies, will be included involving adults aged 18 years or older diagnosed with MDD according to standardised criteria (eg, Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition and International Statistical Classification of Diseases and Related Health Problems -10 (ICD-10)). For included intervention studies, the comparator will be standard care, placebo or no-exercise control groups. The primary outcome is change in depressive symptoms, and secondary outcomes include quality of life, anxiety and stress-related biomarkers. Three independent reviewers will screen studies, extract data using Covidence software (Veritas Health Innovation in partnership with Cochrane) and assess study quality using the updated Cochrane Risk of Bias 2.0 (Rob-2) tool alongside the Grading of Recommendations Assessment, Development and Evaluation (GRADE) approach. If feasible, a meta-analysis will be conducted using RevMan V.5.4 (Cochrane's Review Manager), with effect sizes determined by mean differences, standardised mean differences or ORs, depending on the outcome type. This study is currently at the proposal stage, with article searches expected to begin in November 2025 and data extraction anticipated to be completed by January 2026.

No ethical approval is required as this review uses existing published data. Findings will be disseminated through a peer-reviewed journal and presented at academic conferences.

CRD420251151897.

Information anxiety (IA) describes the distress caused by the gap between the information individuals have and what they feel they should possess. In the current digital environment—marked by volatility, uncertainty, complexity and ambiguity—IA has expanded beyond traditional academic and workplace contexts to become a pervasive concern across populations. Mapping the empirical evidence on IA is critical to understanding its prevalence, determinants, impacts and coping strategies.

This protocol outlines a scoping review guided by the Joanna Briggs Institute methodology and reported in accordance with Preferred Reporting Items for Systematic Reviews and Meta-Analyses Extension for Scoping Reviews (PRISMA-ScR). We will systematically search EBSCOhost, Scopus and Web of Science for peer-reviewed empirical studies published from 1 January 2000 to the planned end date of 5 November 2025. Two reviewers will independently screen records, with a third resolving discrepancies. Data extraction will be conducted using a customised tool, and results will be synthesised narratively and visually, structured around bibliometric characteristics, the Population, Concept, Context framework and a Stimulus-Organism-Response model. Subgroup analyses will be conducted across populations, disciplines and regions.

As this study is based on secondary analysis of published data, ethical approval is not required. Findings will be disseminated through peer-reviewed journals and academic conferences.

This study aimed to evaluate the prevalence and metabolic, hormonal and clinical characteristics of metabolic syndrome among women with polycystic ovary syndrome (PCOS) in the Oran region (western Algeria).

Cross-sectional study.

Outpatient endocrinology and gynaecology services in the Oran region, western Algeria.

A total of 313 women aged 16–45 years diagnosed with PCOS according to the Rotterdam 2004 criteria.

Prevalence of metabolic syndrome and differences in anthropometric (body mass index (BMI)), metabolic (fasting glucose and lipid profile), hormonal (gonadotropins, androgens, anti-Müllerian hormone (AMH), progesterone, vitamin D) and clinical features (hyperandrogenism, menstrual irregularity, infertility) between women with and without metabolic syndrome.

Of the 313 participants, 181 (57.9%) met the criteria for metabolic syndrome. These women had significantly higher BMI (26.70±5.93 vs 25.06±6.47 kg/m²; p=0.004), elevated fasting glucose (133.43±28.52 vs 105.41±28.54 mg/dL; p

More than half of women with PCOS exhibited metabolic syndrome, characterised by obesity, dyslipidaemia, insulin resistance and vitamin D deficiency. These findings highlight the need for early metabolic screening and holistic management in women with PCOS to reduce long-term cardiovascular and reproductive risks.

South African women are vulnerable to HIV acquisition during the postpartum period which can result in perinatal transmission via breastfeeding; many male partners do not know their HIV status. Biomedical approaches to preventing HIV for postpartum women include pre-exposure prophylaxis (PrEP) and antiretroviral treatment for male partners with HIV. Gaps in implementation include low uptake of PrEP among postpartum women and infrequent testing of men who may be motivated to test for HIV to protect the health of their infant.

We will conduct a randomised pilot trial in KwaZulu-Natal (KZN) Province, South Africa among postpartum women and their male partners. The study will pilot a combination intervention consisting of cognitive behavioural strategies (including communication skills training, motivational interviewing and problem-solving) to promote HIV self-testing (HIVST) for Partners and PrEP uptake for HIV-uninfected Postpartum Women, the ‘H4P’ intervention. The study aims to determine the feasibility, acceptability and preliminary effectiveness of the H4P intervention. We will enrol 60 HIV-uninfected women, aged 18 years and older, in their third trimester of pregnancy and reporting a partner whose HIV-serostatus is unknown. Sixty male partners will also be eligible to enrol. Enrolled women will receive three oral HIVST kits to distribute to their male partners and standard of care information on HIVST and PrEP. Women randomised to the intervention arm will receive additional counselling and reproductive health-centred HIVST information for the male partner, including information about why HIV testing is important during their partners’ postpartum period. To evaluate feasibility, we will calculate screening-to-enrolment ratios for women and men, the number of women who distribute HIVST kits to their male partners and the number of men who test. Acceptability will be evaluated using the Client Satisfaction Questionnaire and qualitative interviews. Effectiveness will be assessed at 3 months by measuring the proportion of women initiating PrEP via self-report and urine tenofovir measurements or receipt of injectable PrEP and the proportion of men who test positive who link to HIV care. Qualitative interviews will explore perceptions of the intervention.

Ethics approval for this study was obtained from the Human Research Ethics Committee at The University of the Witwatersrand, Johannesburg, South Africa (Reference number: 250612) and the Institutional Review Boards at Massachusetts General Brigham (2025P002271, Boston, Massachusetts, USA) and the University of Alabama at Birmingham (300015167, Birmingham, Alabama, USA) in the USA. Site support and approvals were obtained from the health facility and the KwaZulu-Natal Provincial Department of Health. Results will be disseminated through peer-reviewed manuscripts, reports and both local and international presentations.

NCT07194902.

The study aims to estimate the prevalence of anxiety, depression and post-traumatic stress disorder (PTSD) in the Greater Kasai region of the Democratic Republic of the Congo (DRC) and to examine how demographic and socio-economic factors, such as displacement status and livelihood conditions, are associated with these mental health outcomes.

A cross-sectional two-stage multi-cluster sampling survey.

In 2016–2019, a violent conflict in the Greater Kasai region of the DRC led to widespread atrocities and massive displacement. The population not only has to cope with the aftermath of interpersonal violence, loss of loved ones and displacement but also faces severe food shortages and livelihood crises.

Data were collected in 2022 from 4069 randomly selected heads of households (displaced and non-displaced) within 126 randomly selected localities in 27 health zones in the Greater Kasai. The study collected data from households with different displacement experiences: internally displaced people (IDPs), returned IDPs, repatriated refugees and members of the host community (those without a displacement history).

The primary outcomes are mental health disorders. Anxiety, depression and PTSD were measured with the Generalised Anxiety Disorder-7, the Patient Health Questionnaire-9 and the Primary Care PTSD Screen for the Diagnostic and Statistical Manual of Mental Disorders, 5th edition.

The prevalence of anxiety, depression and PTSD was 8.3%, 18.3% and 37.8%, respectively. Anxiety affected 10% of non-displaced respondents, with a similar prevalence among IDPs (9%) and returned IDPs (8%), compared with a substantially lower prevalence among repatriated refugees (4%). About 17% of non-displaced respondents have symptoms of depression; this number is considerably higher for IDPs (22%) and returned IDPs (22%) but lower for repatriated refugees (11%). Around 40% of the non-displaced individuals, IDPs and repatriated refugees are characterised by PTSD, while this share is lower for returned IDPs (31%). Overall, a one unit increase in food insecurity (on a 0–7 scale) is associated with higher levels of anxiety (0.33 on a 0–21 scale, p

Food insecurity is associated with poor mental health in Greater Kasai. Further research needs to explore how to develop synergistic interventions to improve both mental health and livelihoods in conflict-affected populations.

Referrals to speech and language pathology are infrequent for people with Parkinson’s disease (PD), despite speech and communication being often affected and greatly impacting their quality of life. This study investigated the knowledge, self-competence and challenges faced by speech and language pathologists (SLPs) in Malaysia when managing PD cases.

Participants self-administered an online-survey in a cross-sectional study design. The survey consisted of 14 questions on current practices of SLPs with their patients with PD, self-perceived competence when assessing and managing PD and perceived barriers for catering to patients with PD. Inferential statistics were run on self-perceived competence across domains and their relationship with demographic/current practice factors. Descriptive statistics were used to analyse perceived barriers.

The survey was administered in English through Google Forms.

54 Malaysian SLPs with at least one active case of PD in their caseload were invited via email and WhatsApp Messenger. These contacts were obtained from the Speech-Language Therapists Association of Malaysia (SPEAK), and snowball sampling was encouraged to recruit additional SLPs through other social networks.

To quantify Malaysian SLPs’ self-perceived competence levels (assessed on 5-point Likert scales) in assessing and managing five key domains in patients with PD: speech, language, oro-motor skills, cognition and swallowing; and to identify the frequency and types of barriers encountered in clinical practice with patients with PD through structured multiple-choice questions. Secondary outcomes included quantifying current service delivery patterns (frequency of PD referrals, stage at referral, caseload size), multidisciplinary consultation patterns and confidence levels in managing rehabilitation risks associated with PD, all measured through structured survey items with categorical or ordinal response options.

Most participants had 1–5 patients with PD in their active caseload, referred at a middle or advanced stage of the disease. The majority of participants felt competent in assessing and managing motor speech and language in patients with PD. Conversely, most of them did not feel competent in assessing and managing cognition in these patients, regardless of demographic factors or current practices. This difference was significant. Most participants also reported facing barriers such as health conditions or comorbidities, family expectations on the therapy outcome and the unavailability of a multidisciplinary approach.

The study reveals that SLPs working in Malaysia feel competent in working with motor speech and language in individuals with PD. However, it highlights a need for additional training to address cognitive assessment and management as a crucial tool to boost functional communication in people with PD. The study also reveals a need for promoting a multidisciplinary approach.

To compare use of electronic nicotine delivery systems (ENDS) with nicotine replacement therapies (NRTs) on risk of cigarette smoking relapse by people who had already quit cigarettes.

Prospective cohort study.

The American Cancer Society Cancer Prevention Study-3, a nationwide US cohort with follow-up every 3 years beginning in 2015.

Adults who in 2015 had already quit smoking (n=3112) or were smoking (n=1018) and who in 2018 reported past or current exclusive use of ENDS or NRT and provided smoking status.

Relapse to cigarette smoking in 2018 among people who were already quit in 2015, and abstinence from cigarettes in 2018 among people who were smoking in 2015.

Among respondents who had already quit in 2015, the unadjusted risk of relapse in 2018 was approximately three times greater for those who reported past exclusive ENDS versus past exclusive NRT use (11.2% vs 3.9%; relative risk (RR)=2.90, 95% CI 2.12 to 3.98). This association remained significant in a multivariable-adjusted model (RR=2.09, 95% CI 1.49 to 2.92). Among those smoking in 2015, the unadjusted likelihood of abstinence in 2018 was higher for those who reported current ENDS versus NRT use (RR=1.35, 95% CI 1.01 to 1.80), but the multivariable model adjusted for smoking frequency indicated no difference in abstinence (RR=1.38; 95% CI 0.93 to 2.05).

ENDS use was associated with greater relapse risk than NRT among people who had already quit. Although ENDS may support shorter-term cessation, further long-term observational research is needed to clarify relapse risks associated with ENDS relative to NRT.

Hypertension is the leading global risk factor for mortality, causing over 10 million deaths annually. In sub-Saharan Africa, hypertension prevalence is high, particularly in rural areas, where it is less likely to be diagnosed, treated or controlled effectively. This results in a high burden of complications, including heart failure, stroke and kidney disease. Community-centred approaches using community health workers (CHWs), risk-based approaches and simplified treatment regimens have shown promise in improving hypertension management. However, there is limited evidence on the effectiveness of such approaches in rural sub-Saharan Africa.

The primary aim of this study is to assess the feasibility of a community-centred intervention for hypertension management in rural Kenya and The Gambia. The objectives are to evaluate the intervention’s adoption, fidelity, reach and dose; understand the mechanisms of action and contextual factors affecting its implementation; assess acceptability from the perspectives of patients, healthcare providers and policymakers; estimate the costs associated with the intervention; and evaluate study procedures to inform the design of a future full-scale trial.

We will conduct a mixed-methods, non-randomised, single-arm feasibility study, designed in accordance with the Consolidated Standards of Reporting Trials (CONSORT) framework and checklist for feasibility and pilot studies, including best practice guidance for non-randomised feasibility studies. The study will be conducted in two rural sites: Kilifi, Kenya and Kiang West, The Gambia. The intervention was codesigned with stakeholders and includes community-based hypertension screening by CHWs, risk stratification and hypertension-mediated organ damage assessment at primary healthcare facilities, followed by treatment initiation using single-pill combination (SPC) antihypertensive therapy for eligible individuals. Training will be provided to all healthcare providers involved in the study. We will screen 500 participants aged 30–80 years at their residence (250 from each country), and we expect that about 45% will be referred for additional assessments and of these 25% (or 10% of the total sample) will be prescribed treatment with SPC. Data collection to evaluate the intervention and its implementation will involve quantitative measures of feasibility and clinical outcomes; observations to assess fidelity and costing measures; and qualitative interviews and focus group discussions with patients, healthcare providers and policymakers to understand the acceptability and contextual influences on intervention implementation.

Ethics approval was obtained from the Kenyan National Committee for Science, Technology and Innovation (ref: 415561), the Gambia Government/Medical Research Council Joint Ethics Committee (ref: 31372) and the London School of Hygiene and Tropical Medicine Ethics Committee (ref: 31372). Study findings will be disseminated through peer-reviewed publications, conferences, policy briefs, community engagement forums and accessible summaries shared via the Improving Hypertension Control in Rural sub-Saharan Africa and partner newsletters.

This study is registered with the ISRCTN- The UK’s Clinical Study Registry (ISRCTN81228019), and Pan African Clinical Trials Registry (PACTR202504839027548).