Chagas disease affects millions of individuals across Latin America and imposes a substantial economic burden on healthcare systems, particularly in rural and underserved regions. Chronic Chagasic cardiomyopathy remains one of the leading causes of heart failure-related mortality in endemic countries. Tissue inhibitor of metalloproteinases-1 (TIMP-1) has emerged as a potential biomarker of myocardial fibrosis in cardiomyopathies. This study was designed to investigate the association between TIMP-1 and myocardial fibrosis in chronic Chagas disease and to assess its potential as an early biomarker of fibrotic remodelling.

Bottom of form: The PTICH trial is a single-centre, prospective observational cohort study conducted at a government reference clinic in Pernambuco, Brazil. The study aims to enrol 210 adults with Chagas heart disease: 140 without ventricular dysfunction (left ventricular ejection fraction (LVEF) ≥52% in women and ≥54% in men) and 70 with ventricular dysfunction (LVEF

The Research Ethics Committee (REC) of Chagas disease and heart failure outpatient clinic—PROCAPE approved the PTICH trial (CAAE number: 65746322.8.1001.5192). Written informed consent has been obtained from all participants enrolled to date, and data handling is in compliance with applicable privacy and data protection regulations. Study findings will be disseminated through targeted outreach to civil society, the scientific community, healthcare professionals and Brazilian Unified Health System (SUS) policymakers; school-based science communication activities conducted in collaboration with state education departments (potentially including oral health educational materials); policy briefs and targeted reports for public health managers; technical meetings and institutional presentations; a plain-language summary published on the institutional website; and submissions to peer-reviewed journals and presentations at academic and health policy conferences.

RBR-3dcrj98.

The visibility and acceptance of transgender identities have increased, leading to more young individuals questioning their gender or identifying as transgender.1 This shift is reflected in the rise in referrals to specialist gender services, presenting challenges for healthcare systems.1 Gender dysphoria, defined as the psychological...

Due to the multisystemic nature of sickle cell disease (SCD), complications can occur together and thus discerning costs associated with individual complications requires a methodology that can estimate the costs of a given complication while accounting for the presence of other complications. In this study, we aimed to estimate period-based incremental costs associated with specific chronic complications in patients with SCD in England while accounting for multimorbidity.

All-cause primary and secondary care healthcare resource utilisation (HCRU) was obtained for a retrospective cohort of patients with SCD using Clinical Practice Research Datalink (CPRD) Aurum linked to Hospital Episode Statistics (HES) datasets. Annualised HCRU and costs were calculated, dividing patient-level events by patient-level time (in years) to obtain per person per year estimates. A series of generalised linear models were used with adjustment for demographic factors and proportion of follow-up time with each complication to estimate the costs associated with 10 chronic SCD-related complications of interest. For these costs, annual equivalent costs can be obtained by dividing by the median follow-up time of 4.74 years.

Patients with a diagnosis of SCD, with or without complications, in CPRD or HES with at least 12 months follow-up.

Period-based all-cause direct healthcare costs.

Of the 1271 patients with SCD included in the study, 49.9% (n=634) had at least one complication and of these 41.3% (n=262) had two or more complications either at baseline or during follow-up. Patients with complications had higher all-cause healthcare costs compared with patients without complications (mean (SD) annualised cost £16 058 (£21 488) vs £4399 (£6635)). Patients with complications had four times the number of annualised inpatient admissions (6.1 vs 1.5 admissions) and more than double the number of annualised bed days in hospital (8.3 vs 3.8 days) over a median 4.74 years of follow-up. Of the complications evaluated, end-stage renal disease had the highest estimated incremental cost of £252 083 (95% CI £214 478 to £283 745) over 4.74 years; this is in addition to the £18 547 period-based cost among patients with SCD without complications. Osteonecrosis was the most common complication with an estimated incremental cost of £27 399 (95% CI £6417 to £43 319) over the same period.

Estimating the cost of complications, while accounting for multimorbidity, is essential to determine the true direct cost of SCD. The modelling method presented in our study provides period-based estimates of cost and hospital admissions for individual complications in patients with SCD, accounting for multimorbidity. This approach can be used and extended to other diseases with multisystemic complications to estimate the direct HCRU and costs of individual complications.

The real-world evidence on the association between vitamin D supplementation and cognitive outcomes has been scant and controversial. We aimed to investigate the longitudinal association between vitamin D supplement use and subsequent cognitive functioning among US older adults.

Prospective cohort study.

A nationally representative ageing cohort in USA: the Health and Retirement Study (HRS).

Participants were drawn from the HRS wave 12 and included respondents who had complete data on dietary supplement use and cognitive assessment. A total of 5065 participants (mean age: 67.5±10.2 years, 61.6% female, 76.6% White ethnicity) were included, of whom 2004 (39.6%) participants were vitamin D supplement users.

Change in cognitive function scores over 6 years of follow-up (from HRS waves 12–15), estimated by linear mixed model adjusted for multiple covariates.

Compared with non-users, vitamin D users had an accelerated decline in global cognitive function (difference in the rate of change: –0.052 points/year; 95% CI –0.092 to –0.013, p=0.010) and in executive function score (difference: –0.021 points/year; 95% CI –0.037 to –0.005, p=0.010). Sensitivity analysis suggested that accelerated cognitive decline was only observed among supplement users with normal baseline serum 25(OH)D level (p=0.004), but not the group with insufficient/deficient levels (p=0.826).

Our findings do not support vitamin D supplementation as a means of preventing or slowing cognitive decline in older people with adequate vitamin D status. While healthcare providers should encourage adequate vitamin D intake from dietary sources and moderate sun exposure, caution should be taken when recommending such supplements to older adults without a clear indication for it.

To investigate the efficacy of two volumes of acute isometric wall squat exercise on pain sensitivity (primary outcome: pressure pain threshold (PPT)) and intensity (secondary outcome) in adults with knee osteoarthritis.

A parallel-group randomised controlled trial.

Outpatient physiotherapy clinics at hospitals in Saudi Arabia.

Participants (n = 90; mean (SD) age 49.0 (13.0) years) with chronic knee osteoarthritis, diagnosed by a specialist orthopaedic physician using radiographic evidence and clinical judgement, were recruited via two tertiary hospitals in Saudi Arabia.

Participants were stratified by sex and randomly allocated to one of three groups: isometric single-repetition wall-squat (ISO-SR; one repetition of a 3-min wall squat or to volitional fatigue at a 100° knee joint angle), isometric multiple-repetition wall-squat (ISO-MR; three repetitions of the same intervention) and control (quiet sitting for 7 min).

PPT was measured at the calf (primary site of interest), lumbar spine and forearm using a pressure algometer. Pain intensity was assessed using a visual analogue scale. Primary analyses compared changes between intervention and control groups. All participants were included in the ITT analysis.

The ISO-MR group had higher mean PPT ratings immediately postintervention in the calf (mean difference=9.4 (95% CI 5.6 to 13.2), p

Both the ISO-SR and ISO-MR exercises to volitional fatigue reduced pain sensitivity in patients with knee osteoarthritis. Neither exercise volume changed clinical pain intensity.

ClinicalTrials.gov registry (ID: NCT05605444).

To develop prediction models for short-term outcomes following a first acute myocardial infarction (AMI) event (index) or for past AMI events (prevalent) in a national primary care cohort.

Retrospective cohort study using logistic regression models to estimate 1-year and 5-year risks of all-cause mortality and composite cardiovascular outcomes.

Primary care practices in England contributing data to the Clinical Practice Research Datalink (CPRD) Aurum and CPRD GOLD databases between 2006 and 2019.

Patients with an incident (index) or prevalent AMI event. Models were trained on a random 80% sample of CPRD Aurum (n=1018 practices), internally validated on the remaining 20% (n=255) and externally validated using CPRD GOLD (n=248).

Discrimination assessed using sensitivity, specificity and area under the receiver operating characteristic curve (AUC). Calibration assessed using calibration plots.

In the index (prevalent) cohorts, 94 241 (64 789) patients were included in the training and internal validation sets, and 16 832 (7479) in the external validation set. For the index cohort, AUCs for 1-year [5-year] all-cause mortality were 0.802 (95% CI 0.793 to 0.812) [0.847 (0.841 to 0.853)] internally and 0.800 (0.790 to 0.810) [0.841 (0.835 to 0.847)] externally. For the primary composite outcome (stroke, heart failure and all-cause death), AUCs were 0.763 (0.756 to 0.771) [0.824 (0.818 to 0.830)] internally and 0.748 (0.739 to 0.756) [0.808 (0.801 to 0.815)] externally. Discrimination was higher in the prevalent cohort, particularly for 1-year mortality (AUC: 0.896, 95% CI 0.887 to 0.904). Models excluding treatment variables showed slightly lower but comparable performance. Calibration was acceptable across models.

These models can support clinicians in identifying patients at increased risk of short-term adverse outcomes following AMI, whether newly diagnosed or with a prior history. This can inform monitoring strategies and secondary prevention and guide patient counselling on modifiable risk factors.

Neurogranin (Ng) has a role in synaptic plasticity and is considered a biomarker of synaptic dysfunction, a process hypothesised to be important in delirium. Few studies examining Ng in delirium exist, with mixed findings. This study aimed to investigate associations between cerebrospinal fluid (CSF) Ng concentrations and delirium in acutely admitted hip fracture patients.

Cross-sectional study.

Acutely admitted orthopaedic patients with hip fracture recruited from four participating hospitals in eastern Norway, representing secondary and tertiary care settings.

This study included 392 hip fracture patients. All admitted hip fracture patients operated in spinal anaesthesia were, regardless of age, considered for inclusion.

An in-house ELISA was used to measure CSF Ng concentration in patients acutely admitted with a hip fracture (n=392). Delirium status was evaluated daily according to The Diagnostic and Statistical Manual of Mental Disorders, Fifth Editions criteria independently by two experienced geriatricians. A value > 3.44 on The Informant Questionnaire on Cognitive Decline in the Elderly was used as a surrogate marker of probable dementia.

180 patients (46 %) developed delirium and 70% of these had dementia. CSF Ng concentration did not differ significantly between those with and without delirium (176 pg/mL vs 164 pg/mL), with an estimated difference in medians of 12 (95% CI –5.8 to 29.8), p=0.185. Analyses adjusted for age, gender and dementia status did not show a statistically significant difference in Ng concentrations between the patients.

We did not find an association between delirium and CSF concentrations of Ng. This could imply that synaptic dysfunction and degeneration, involving Ng, are not key processes in the development of delirium. Further studies on other synaptic proteins are warranted to better explore synaptic dysfunction’s potential role in the pathophysiology of delirium.

Transitions of care (TOC) between hospital, ambulatory and home settings for high-risk adults with chronic diseases are complex, costly and often result in poor health outcomes. Suboptimal care transitions lead to medication errors, non-adherence, decreased self-management skills and inadequate follow-up, all of which contribute to readmissions or emergency department visits. The Transitional Care Model aims to address these challenges through patient-centred, in-home interventions. We propose to implement and evaluate TELE-TOC: Telehealth Education Leveraging Electronic Transitions Of Care for Chronic Obstructive Pulmonary Disease (COPD) patients. This study will evaluate the added value of a virtual, pharmacy-based intervention integrated into an existing COPD TOC program within a single healthcare system.

Informed by the Proctor Framework implementation, service and health outcome domains, we will conduct a randomised controlled trial comparing the addition of at-home pharmacy team-based virtual visits to the standard of care (ie, our existing COPD TOC programme). Adult patients hospitalised for a COPD exacerbation will be randomised to receive the standard COPD TOC programme alone or the standard programme plus TELE-TOC virtual at-home pharmacy visits. We will use a pragmatic type II hybrid effectiveness-implementation trial. The primary effectiveness outcome is inhaler technique at 30 days postdischarge, and the primary implementation outcome is the proportion of patients receiving the intervention. Intention-to-treat analysis will be applied to all outcomes with ² and logistic regression models adjusting for demographic factors. Treatment effects through 30 days will be assessed with generalised estimating equations and generalised linear mixed models.

This study, the waiver of consent and the opt-out flyer were approved by the University of Chicago Institutional Review Board (23–0934). Dissemination of the findings is planned for up to 4 years of completion of the study to local, regional and national conferences and peer-reviewed journals.

NCT05897125.

Real-world data and patient-reported outcomes in diabetes in Emilia–Romagna is a multi-centric observational cohort study aimed at improving diabetes care in the Emilia–Romagna region, by exploring trends and predictors of clinical and psychological parameters in a large population of people with diabetes, during and after the COVID-19 pandemic.

The study has a mixed retrospective/prospective design. The retrospective component involves computerised data linkage of administrative and clinical data from the local health authorities of Romagna and Reggio Emilia, and the University Hospital of Parma, covering a population of approximately 100 000 prevalent cases with diabetes, followed throughout the years 2019–2024. The selection of data items collected in the reference time frame is based on the International Consortium for Health Outcomes Measurement (ICHOM) standard set for diabetes, including clinical, lifestyle, social and healthcare service measurements. The prospective component includes primary data collection of indicators of psychological well-being through the WHO-5 Well-Being Index, diabetes distress using the Problem Areas In Diabetes-Short Form and depression through the Patient Health Questionnaire-9, measured at 0–6 months in an overall sample of 455 people with type 2 diabetes. Statistical analysis will include descriptive analysis and multivariate logistic regression using a two-step federated approach.

The study has obtained ethics approval from the Ethics Committee of Romagna and the Ethics Committee of Area Vasta Emilia Nord. The results of the study will be published in scientific journals to evaluate quality and outcomes of diabetes care across the region.

NCT06639100.

Brucellosis ranks fourth among the top seven priority zoonotic diseases for control in Uganda. The effect of individual actions on controlling the spread of infectious diseases in humans and the choices people make regarding symptoms and suspicions must be given a critical role in the management of zoonotic diseases. Understanding the experiences that shape response to brucellosis is crucial if we are to effectively control the spread of brucellosis in the human population. This study aimed to explore people’s experiences and health-seeking behaviour for human brucellosis and elucidate any challenges as perceived by the affected population. This study involved exploring the facilitating factors for seeking healthcare from the perspectives of the affected population and the potential barriers in accessing health services in Nakasongola.

Descriptive qualitative study.

The study was conducted in the cattle corridor of Nakasongola District within three sub-counties of Nabiswera, Wabinyonyi and Nakitoma, which were purposively selected because of the large herd number (150 cattle per square km and 30–50 cattle per household), high prevalence of brucellosis in humans, thus extensive human–animal interaction, and the community’s susceptibility to brucellosis. Data were collected from November 2023 to January 2024.

Semi-structured, face-to-face interviews were conducted by the first author with 15 participants for in-depth interviews, who included the people who were recovering/had recovered and their caretakers, and 20 key informants including medical personnel, village health team members and social leaders who were purposively selected.

Thematic analysis was conducted to group themes originating in the data into higher-order themes using inductive and deductive approaches.

Key themes were identified in line with literature and the healthcare systems model. The findings highlighted a series of factors that influence and inhibit health-seeking behaviour for human brucellosis. Participants identified the role of sex and religion as some of the social factors, barriers to health information and perceptions of healthcare quality, accessibility and availability of treatment. These insights show the importance of understanding broader social norms and health system constraints to improve timely diagnosis, treatment adherence and overall disease control.

Addressing the factors identified requires a diverse approach that includes improving the quality of health services, promoting health education, challenging societal norms around gender and illness and leveraging the role of religious communities in health promotion. Such efforts could ultimately improve health outcomes in the affected community.

This review aims to map oral health plans, programmes and policies worldwide in countries with universal health coverage.

This protocol describes a scoping review that will follow the Joanna Briggs Institute methodology and the Preferred Reporting Items for Systematic Reviews and Meta-Analyses-Scoping Review checklist, guided by the PCC framework: Population—countries with universal health coverage (78 globally recognised); Concept—oral health plans, programmes and policies; Context—integration into health systems. Searches will be conducted in MEDLINE (PubMed), Scopus, Web of Science, Embase, Health System Evidence and Epistemonikos, with no restrictions on date, language or study type. Grey literature will be accessed through Google Scholar, OpenThesis and the Brazilian Digital Library of Theses and Dissertations. Official documents from ministries of health and international bodies, including the WHO and the International Monetary Fund, will also be reviewed. Two independent reviewers will screen titles and abstracts; a third will resolve disagreements. Eligible records will undergo full-text review. Data will be extracted into predefined categories reflecting health system components: population, structure, services, governance and oral health indicators. Results will be presented using tables, charts and figures to illustrate strategies and innovations.

This review does not involve primary data collection and does not require ethical approval. Results will be disseminated through a peer-reviewed publication and presentations at academic conferences and scientific events.

Open Science Framework (DOI 10.17605/OSF.IO/RCP8N).

To compare the presenting demographic and clinical characteristics of rhegmatogenous retinal detachment (RRD) with other RD types, investigate risk factors of blinding RD and the outcome of surgical intervention.

Prospective, cross-sectional and multicentre.

Four ophthalmic centres in three geographic locations of Nigeria.

264 eyes from 237 patients diagnosed with RRD, tractional retinal detachment (TRD) and exudative retinal detachment (ERD) seen between April 2019 and March 2020.

264 eyes of 237 patients were diagnosed out of 35 641 patients screened. RRD was the most common RD (n=167 (70.5%), TRD 61 (25.7%) and ERD 9 (3.8%) patients). The hospital-based prevalence of all RD is 6.6 per 1000 patients (0.66%), and for RRD alone, 4.7 per 1000 patients (0.47%). The most common symptom was a sudden decline in vision, 100 patients (42.2%); floaters and flashes were uncommon, 5 (2.1%). RRD presented earliest, with a median symptom duration of 2 months, and TRD and ERD at 7.5 months each.

The 46–65-year age group had the highest representation, RRD (n=70, 41.9%), TRD (n=41, 67.3%), ERD (n=4, 44.4%). The mean age was highest in TRD (52.3±12.7 years) and lowest in RRD (44.0±17.5 years) and ERD (45.2±20.4 years). Males dominated (RRD 70.1%, TRD 62.3%, and ERD 66.7%). Ocular trauma was highest in RRD 29.3%, TRD 7.5% and ERD 10%; fellow eye RD was highest in TRD 47.5%, ERD 20%, RRD 8% and myopia was highest in RRD 27.6%.

Two-thirds of eyes were blind (Snellen best-corrected visual acuity

Shorter symptom duration is associated with better preoperative and postoperative vision. In contrast, longer durations are connected to poorer outcomes. Eyes with symptoms lasting less than a week had a 17% rate of postoperative blindness, compared with 30% in cases lasting 1–3 months, and 51% in cases exceeding 6 months.

Delays in diagnosing and treating RD result in high rates of preoperative blindness, which can be reversed with surgery even after several weeks of symptoms. Understanding the associations between RD and the risk of blinding RD in developing countries will benefit early diagnosis, treatment and improve treatment outcomes.

Little research has been done on post-COVID symptoms at 24 months postinfection and on the association these may have on health-related quality of life (HRQOL).

We assessed the prevalence and severity of post-COVID symptoms and quantified EuroQol 5 Dimension 5 Level (EQ-5D-5L), self-perceived health question (EuroQol Visual Analogue Scale (EQ-VAS)) and health utility scores (HUS) up to 24 months follow-up.

The longitudinal multiple cohort CORona Follow-Up (CORFU) study combines seven COVID-19 patient cohorts and a survey among the general public. The participants received questionnaires on several time points. Participants were stratified by: without a known SARS-CoV-2 infection (control group), proven SARS-CoV-2 infection but non-hospitalised, proven SARS-CoV-2 infection hospitalised to the ward, and proven SARS-CoV-2 infection hospitalised to the intensive care unit (ICU).

In this study, data of seven COVID-19 patient cohorts and a survey among the general public are included.

Former COVID-19 patients and controls participated in this cohort study.

Former COVID-19 patients and non-COVID-19 controls were sent questionnaires on symptoms associated with post-COVID condition. The CORFU questionnaire included 14 symptom questions on post-COVID condition using a five-level Likert-scale format. Furthermore, HRQOL was quantified using the EuroQol EQ-5D-5L questionnaire: EQ-VAS and the EQ-5D-5L utility score. The EQ-5D-5L questionnaire includes five domains that are scored on a five-point Likert scale: mobility, self-care, usual activities, pain/discomfort and anxiety/depression.

A total of 901 participants (and 434 controls) responded at 24 months follow-up. In all former COVID-19 patients, the presence of post-COVID condition at 24 months was observed in 62 (42.5%, 95% CI 34.3% to 50.9%) of the non-hospitalised patients, 333 (65.0%, 95% CI 60.7% to 69.2%) of the hospitalised ward patients and 156 (63.2%, 95% CI 56.8% to 69.2%) of the ICU patients, respectively (p

Many former COVID-19 patients experience post-COVID symptoms at 24 months follow-up, with the highest prevalence in hospitalised participants. Also, former patients reported a lower HRQOL.

The CORFU study was registered at clinicaltrials.gov (registration number NCT05240742).

Progressive supranuclear palsy (PSP) is a devastating neurodegenerative disease characterised by cognitive, behavioural and motor problems. Motor symptoms are highly disabling, while cognitive and behavioural changes have a major impact on carer burden, quality of life and prognosis. Apathy and impulsivity are very common, often coexistent in PSP, and negatively predict survival. In preclinical models and other diseases, apathy and impulsivity are associated with noradrenergic deficits, which can be severe in PSP.

Noradrenaline for Progressive Supranuclear Palsy Syndromes trial is a randomised, double-blind, placebo-controlled, crossover design, Phase IIb clinical trial to evaluate the efficacy and safety of oral atomoxetine for the treatment of cognitive and behavioural changes in PSP. Participants receive atomoxetine 40 mg (10 mg/mL oral solution) once daily or a matched placebo solution, in random order, each for 8 weeks. An ‘informant’, who knows the patient with PSP well, is co-recruited to complete some of the trial outcome measures. Participants remain in the trial for 22 weeks after randomisation. The primary objectives are to assess (1) safety and tolerability and (2) efficacy versus placebo on challenging behaviours as reported in a subscale of the Cambridge Behavioural Inventory. Secondary and exploratory measures relate to cognition, the PSP Rating Scale, mood and potential baseline predictors of individual response to atomoxetine computed from imaging, genetic and cognitive measures at baseline.

The trial was approved by the South Central-Oxford B Research Ethics Committee (REC) and the Medicines and Healthcare products Regulatory Agency (REC reference: 20/SC/0416). Dissemination will include publication in peer-reviewed journals, presentations at academic and public conferences and engagement with patients, the public, policymakers and practitioners.

ISRCTN99462035; DOI: https://doi.org/10.1186/ISRCTN99462035; EudraCT (European Union Drug Regulating Authorities Clinical Trials Database)/CTIS (Clinical Trial Information System) number: 2019-004472-19; IRAS (Integrated Research Application System) number: 272063; Secondary identifying numbers: CPMS (Central Portfolio Management System) 44441.

Procedure-related pain should be minimised to prevent psychological trauma and the potential negative consequences on body physiology. Dressing changes in paediatric patients with burn injuries are frequently performed with analgesics alone where sedation is not indicated, especially in minor and superficial burns. It is hypothesised that distraction methods can be used in addition to pain alleviating medication to reduce the experience of pain in these patients.

With this research project, we aim to assess the effectiveness of a simple, inexpensive, non-electronic distraction method, a kaleidoscope, to reduce acute pain experienced in paediatric patients undergoing dressing changes in the outpatient clinic.

A randomised controlled trial will be performed at the Ngwelezana Tertiary Hospital, Empangeni, South Africa. Paediatric patients between the ages of 5 years and 12 years with minor and superficial partial thickness burn injuries who require dressing changes in the outpatient clinic, without sedation, will be randomised into two groups with a 1:1 allocation ratio. Fixed randomisation will be performed by a computer random number generator. The control group will receive standard practice of care which concerns a dressing change without any distraction methods, and the intervention group will receive distraction by use of a kaleidoscope as an additional method for potential pain alleviation. Patients in both groups will receive paracetamol or non-steroidal anti-inflammatory drugs when indicated according to hospital protocol. The primary outcome will be the change in pain score from pre-procedural to pain score during the dressing change and will be analysed with a linear regression analysis. Additionally, subanalyses will be performed to evaluate potentially modifying factors on the treatment effect. This will also be evaluated with a linear regression analysis and correlated with caregiver and healthcare worker observational pain scores. Participants and assessors are not blinded to group assignment due to the nature of the intervention. To achieve a power of 80% and a level of significance of 5% for detecting at least a 1-point difference in change in pain scores between the intervention and control group, a sample size of 50 patients in each group is required.

This study evaluates a non-invasive adjunct to reduce pain in children who undergo a painful procedure. Ethical approval has been granted from the University of Kwazulu-Natal’s biomedical research and ethics committee and the ethics and research committee of Ngwelezana Tertiary Hospital prior to recruitment (ref no. BREC/00005194/2023). Written informed consent will be acquired from all study participants’ caregivers. Study findings will be presented orally to staff at the paediatric burn unit of Ngwelezana Tertiary Hospital (study location). The research methodology and results will be presented at scientific conferences and will be submitted for publication in a peer-reviewed journal.

NCT06591195.

Persons living with HIV (PLWH) have an augmented risk of cardiovascular disease, including atherosclerosis and myocardial dysfunction, despite effective viral suppression with antiretroviral therapy. Despite the majority of PLWH residing in sub-Saharan Africa, there are limited reports from the region on structural cardiovascular changes due to this residual risk.

The Early Structural Cardiovascular Disease, HIV, and Tuberculosis in East Africa (ASANTE) cross-sectional study will be conducted in a public hospital in Nairobi, Kenya. It will enrol 400 participants (50% women, 50% PLWH) to undergo cardiovascular phenotyping using multimodal imaging (coronary CT angiography (CCTA) and echocardiography) and banking of biological samples (whole blood, peripheral blood mononuclear cells, plasma and urine). We will define the prevalence of subclinical coronary atherosclerosis by CCTA and subclinical myocardial dysfunction by transthoracic echocardiography and evaluate both traditional and non-traditional risk factors, including endemic infections such as latent tuberculosis. This study will contribute important data on phenotypes of and risk factors for HIV-associated cardiovascular disease in this understudied region.

Ethical approval for the ASANTE study was granted by the University of Nairobi-Kenyatta National Hospital Ethical Review Committee, Nairobi, Kenya, and the University of Washington Institutional Review Board, USA. Results will be submitted for publication in peer-reviewed journals.