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Trajectories of metabolic risk clusters and adverse outcomes in patients with chronic kidney disease: a prospective cohort study in Taiwan

Por: Lo · W.-C. · Wu · M.-Y. · Chen · Y.-H. R. · Wu · M. S. · Wong · C.-S.
Objectives

To investigate the association between longitudinal trajectories of metabolic risk clusters and the risk of progression to end-stage kidney disease (ESKD) and major adverse kidney events (MAKEs) in patients with chronic kidney disease (CKD).

Design

Prospective registry-based cohort study.

Setting

Secondary and tertiary care settings in Taiwan, using data from a multidisciplinary pre-ESKD care programme.

Participants

A total of 1494 adult patients with CKD stages 3b–5 enrolled in a structured pre-ESKD care programme.

Primary and secondary outcome measures

Time to initiation of dialysis (primary outcome) and time to MAKE, defined as a composite of dialysis initiation or all-cause mortality (secondary outcome). Group-based multitrajectory modelling was used to categorise longitudinal trajectories of metabolic risk clusters, including systolic blood pressure, fasting blood glucose and low-density lipoprotein (LDL) cholesterol.

Results

Four trajectory groups were identified: Group I had controlled blood pressure and glucose but elevated LDL (dialysis incidence: 19.5 per 1000 person-years); Group II had borderline-high blood pressure and elevated glucose (33.6 per 1000 person-years); Group III had controlled glucose and low LDL but borderline-high blood pressure (38.8 per 1000 person-years) and Group IV had controlled glucose but elevated blood pressure and LDL (46.7 per 1000 person-years). Compared with the other groups, Group I exhibited significantly longer dialysis-free and MAKE-free survival (log-rank test, p

Conclusion

Longitudinal trajectories of metabolic risk cluster are associated with differential risks of CKD progression to ESKD and death. Our findings provide valuable insights into the monitoring of metabolic risk profiles over time in patients with CKD.

Multicentre, retrospective observational study on risk factors of major cardiovascular adverse events in patients with chronic kidney disease in Taiwan

Por: Wong · C.-S. · Wu · M.-Y. · Chen · Y.-H. R. · Lo · W.-C. · Wu · M. S.
Objectives

To assess the incidence and risk of major adverse cardiovascular events (MACE) in patients with different stages of chronic kidney disease (CKD) and end-stage kidney disease (ESKD) in Taiwan.

Design

Retrospective cohort study.

Setting

Secondary and tertiary care; data were collected from three affiliated hospitals in northern Taiwan.

Participants

A total of 7038 adult patients with clinically confirmed CKD stages 3–5 were included, of whom 14.09% had progressed to ESKD. Patients were identified from a multicentre database in northern Taiwan. Key exclusion criteria included age under 20 years, prior MACE, cancer or renal transplantation.

Primary and secondary outcome measures

The primary outcome was the incidence of MACE during follow-up. Secondary analyses included time to MACE and subgroup comparisons by CKD stage and comorbid conditions (eg, diabetes, cardiovascular disease).

Results

MACE occurred in 49.8% of patients with CKD and 64.1% of those with ESKD. After adjustment for covariates, the ESKD group had a significantly higher risk of MACE (HR=1.52; 95% CI 1.08 to 2.16) compared with the non-ESKD group. Relative to stage 3a, the adjusted HRs for MACE were 1.13 (95% CI 0.74 to 1.73) for stage 3b, 1.13 (95% CI 0.74 to 1.70) for stage 4, 1.82 (95% CI 1.18 to 2.81) for stage 5 (non-ESKD) and 2.32 (95% CI 1.51 to 3.57) for stage 5D (ESKD). Diabetes and cardiovascular comorbidities were associated with increased MACE incidence and shorter time to MACE, but their associations became non-significant after adjustment.

Conclusions

Based on a multicentre cohort from Taiwan, our findings provide insights into the prognosis of patients with CKD across disease stages and highlight the importance of targeted interventions and integrated care to improve cardiovascular outcomes.

Stroke Investigation Group in North and Central London (SIGNAL): cohort profile of a prospective large-scale comprehensive stroke registry

Por: Ozkan · H. · Ambler · G. · Nash · P. S. · Browning · S. · Mussa · R. · Leff · A. · Jäger · H. R. · Nachev · P. · Perry · R. · Chan · E. · Simister · R. · Werring · D. J.
Purpose

Large-scale stroke registries can provide critical insights into disease mechanisms, progression and healthcare needs, informing prevention and care. However, few collect detailed demographic, brain imaging, and comprehensive long-term follow-up data. To address this, we established the prospective Stroke Investigation Group in North And central London (SIGNAL) registry in 2017.

Participants

The SIGNAL registry included 3931 adults aged ≥18 years with confirmed acute stroke (cerebral ischaemia or intracerebral haemorrhage (ICH)) admitted to the University College London Hospital hyperacute stroke unit between January 2017 and 2020, drawn from an ethnically diverse North and Central London population (~1.6 million). Baseline data included demographic, clinical, brain imaging and next-of-kin information. Six month follow-up included measures of functional status and non-motor outcomes (anxiety, depression, fatigue, sleep, pain, language, continence, social participation, cognition) via face-to-face, telephone or postal follow-up methods.

Findings to date

The mean age of individuals included in the SIGNAL registry was 72.1 years, and 1806 (45.9%) were female. The ethnic distribution comprised 2365 (60%) white, 649 (16.5%) black and 511 (13%) Asian. Stroke diagnoses included 3371 (85.8%) with cerebral ischaemia and 560 (14.2%) with ICH. On admission, 2240 individuals (57.0%) had a National Institutes of Health Stroke Scale score >4, indicating moderate stroke severity. At hospital discharge, the median functional outcome, measured by the modified Rankin Scale, was 3 (IQR 1–4), indicating moderate disability. At 6 months, functional outcomes measured with mRS were available for 3755 individuals (95.6%) with a median score of 1 (IQR=0–3) and non-motor outcomes were available for 3080 individuals (92.3%). The most prevalent adverse non-motor outcomes were fatigue 1756 (57%), reduced social participation 1694 (55%) and sleep disturbance 1663 (54%).

Future plans

Further analyses of SIGNAL registry data will investigating associations between stroke mechanisms, subtypes and neuroimaging features and 6-month functional status, non-motor outcomes and cognitive impairment. Longer term follow-up of survivors for ~10 years is also planned.

Epidemiology and disease burden of connective tissue disease-associated interstitial lung disease (CTD-ILD) in Asia: a systematic review and meta-analysis protocol

Por: Chua · F. · Subramaniam · S. · Lai · W. H. · Tan · S. H. · Yean · H. R. A. · Kho · S. S. · Yew · J. S. Y. · Hong · H. C. · Ng · C. C. M. · Sirol Aflah · S. S. · Mohd Zaidi · N. A. · Ong · V. H. · Chai · G. T. · Ang · S. H. · Maamor · H. · Muhamad · N. A.
Introduction

Interstitial lung diseases (ILD) associated with an underlying connective tissue disease (CTD), also known as a systemic autoimmune rheumatic disease or SARD, are chronic conditions with a tendency to progress. CTD-ILDs are increasingly diagnosed and pose an important global health challenge. This systematic review aims to provide an overarching evaluation of their epidemiology and disease burden in Asia. In this review, the term CTD-ILD will be used to denote all major forms of ILD arising in the context of a SARD.

Methods and analysis

This systematic review will adhere to the standards of the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines, including a flow diagram to depict the process by four independent reviewers that will assess titles and abstracts against the following predetermined criteria. A systematic review of the literature search published from 2000 to 2024 will be conducted using five electronic databases including PubMed/MEDLINE, Scopus, EMBASE, Cochrane Library and Web of Science. Publications that meet the inclusion criteria of this review will be subjected to a full-text review to extract relevant data. Collated data will be analysed and organised into categories based on the expected outcome and objectives. The quality of published evidence, including heterogeneity across studies, will be checked against PRISMA checklists and assessed by Newcastle-Ottawa Scale.

Ethics and dissemination

Ethics approval is not applicable for this study since no original data will be collected. The findings of this review will be disseminated through a peer-reviewed publication in a scientific journal and conference communications, with the aim of contributing insights to the field by identifying research gaps and informing clinical practice.

PROSPERO registration number

The protocol of this systematic review is registered with the National Medical & Research Register (ID-24–03600-GUB) and International Prospective Register of Systematic Reviews PROSPERO (CRD420251037095).

Effectiveness of digital physiotherapy interventions in patients with knee osteoarthritis: a systematic review and meta-analysis of randomised controlled trials

Por: Cheung · T. H. R. · Elliott · M. T. · Stephens · G. · Mansfield · M.
Objectives

This systematic review and meta-analysis aims to provide an overview of the effectiveness of digital physiotherapy interventions on pain, physical functions and quality of life for patients with knee osteoarthritis.

Design

Systematic review and meta-analysis using the Grading of Recommendation, Assessment, Development and Evaluation (GRADE) approach.

Data sources

A systematic search of electronic databases, including MEDLINE, EMBASE, Web of Science, PsycInfo, CINAHL, Scopus and Cochrane Library, was conducted on 19 February 2025.

Eligibility criteria for selecting studies

We included randomised controlled trials which compared digital physiotherapy interventions to standard physiotherapy care for patients with knee osteoarthritis. Main outcomes included pain, physical functions and quality of life.

Data extraction and synthesis

25 studies met the inclusion criteria, and 18 studies were eligible for meta-analysis. The primary author conducted the initial search, selected articles and extracted data from eligible studies, which were independently checked by a second reviewer. Risk of bias (ROB) was assessed by Cochrane ROB-2 tool. Quality of evidence was evaluated by the GRADE approach.

Results

Overall, digital physiotherapy was associated with a small but statistically significant improvement in physical function (SMD=0.24, 95% CI 0.13 to 0.35); an overall meta-analysis was not performed for pain and quality of life due to considerable heterogeneity. Subgroup analyses revealed both video-conferencing and app- or web-based physiotherapy significantly reduced pain (SMD=–0.53, 95% CI –1.06 to –0.01 and SMD=–0.47, 95% CI –0.70 to –0.25, respectively) and physical function (SMD=0.32, 95% CI 0.10 to 0.54 and SMD=0.30, 95% CI 0.09 to 0.50 respectively). Digital physiotherapy interventions with individualised exercise components also reduced pain (SMD=–0.43, 95% CI –0.66 to –0.21) and improved physical function (SMD=0.30, 95% CI 0.17 to 0.43), when compared with non-exercise interventions.

Conclusion

There was moderate-quality evidence to support the use of digital physiotherapy interventions in improving pain and function in patients with knee osteoarthritis. Subgroup analyses revealed low-to-moderate quality evidence in using video-conferencing and app-/web-based physiotherapy and interventions with exercise components to treat patients with knee osteoarthritis. Overall, there were limited high-quality trials in drawing a robust conclusion. High ROB and huge heterogeneity were observed across studies. Further research should minimise the ROB and investigate the effect of different digital modalities, intervention components and length of follow-up.

Impact assessment of neonatal care interventions on regional neonatal care capacity: a simulation study based on clinical data in the Netherlands

Por: Wagenaar · J. H. L. · Dietz · A. · Huang · Y. · Reiss · I. K. M. · Been · J. V. · Spaan · J. · Kornelisse · R. F. · Taal · H. R. · Hinrichs-Krapels · S.
Objective

To analyse the impact of selected neonatal care interventions on regional care capacity.

Design

Discrete event simulation modelling based on clinical data.

Setting

Neonatal care in the southwest of the Netherlands, consisting of one tertiary-level neonatal intensive care unit (NICU), four hospitals with high-care neonatal (HCN) wards and six with medium-care neonatal (MCN) wards.

Participants

44 461 neonates admitted to at least one hospital within the specified region or admitted outside of the region but with a residential address inside the region between 2016 and 2021.

Interventions

The impact of three interventions was simulated: (1) home-based phototherapy for hyperbilirubinaemia, (2) oral antibiotic switch for culture-negative early onset infection and (3) changing tertiary-level NICU admission guidelines.

Main outcome measure

Regional neonatal capacity defined as: (1) occupancy per ward level, (2) required operational beds per ward level to provide care to all inside region patients at maximum 85% occupancy, (3) proportion rejected, defined as outside region transfers due to no capacity to provide local care and (4) the weekly rejections in relation to occupancy to provide a combined analysis.

Results

In the current situation, with many operational beds closed due to nurse shortages, occupancy was extremely high at the NICU and HCNs (respectively 91.7% (95% CI 91.4 to 92.0) and 98.1% (95% CI 98.0 to 98.2)). The number of required beds exceeded available beds, resulting in >20% rejections for both NICU and HCN patients. Although the three interventions individually demonstrated effect on capacity, clinical impact was marginal. In combination, NICU occupancy was reduced below the 85% government recommendation at the cost of an increased burden for HCNs, highlighting the need for redistribution to MCNs.

Conclusion

Our model confirmed the severity of current neonatal capacity strain and demonstrated the potential impact of three interventions on regional capacity. The model showed to be a low-cost and easy-to-use method for regional capacity impact assessment and could provide the basis for making informed decisions for other interventions and future scenarios, supporting data-driven neonatal capacity planning and policy development.

Association of blood pressure control, lifestyle and socioeconomic status with self-rated health in patients with hypertension: a national cross-sectional study

Por: Behgam · N. · Karimi Ghahfarokhi · M. · Azizpour · Y. · Naderyan Feli · S. · Mozafari · S. · Lotfaliany · M. · Tohidinik · H. R. · Kompani · F. · Rezaei · N. · Djalalinia · S.
Objectives

To examine demographic, behavioural and clinical determinants of self-rated health (SRH) among Iranian adults with hypertension (HTN), with a particular focus on the association between blood pressure (BP) control and perceived health.

Design

National cross-sectional analysis of 15 predictors spanning demographic, lifestyle and clinical domains.

Setting

2021 Iranian STEPwise Approach to Non-communicable Disease Risk Factor Surveillance, a nationally representative survey.

Participants

A total of 8812 adults with HTN (mean age 56.97 years; 57% female). Controlled HTN was defined as systolic blood pressure

Primary and secondary outcome measures

The primary outcome was SRH, measured on a standard EuroQol-Visual Analogue Scale (0–100).

Results

Controlled HTN was independently associated with higher SRH scores (β=1.31, 95% CI 0.07 to 2.54). Positive predictors of SRH included male gender (β=4.34, 95% CI 3.38 to 5.31), higher wealth (richest vs poorest: β=5.52, 95% CI 4.06 to 6.97), sufficient physical activity (β=4.38, 95% CI 3.48 to 5.28), healthier diet (β=3.06, 95% CI 1.99 to 4.14) and complementary insurance coverage (β=2.50, 95% CI 0.63 to 4.37). Significant negative predictors included diabetes mellitus (β=–4.23, 95% CI –5.59 to –3.26), dyslipidaemia (β=–3.61, 95% CI –4.62 to –2.59), people who smoke (β=–4.21, 95% CI –5.64 to –2.78) and older age. Notably, antihypertensive medication use showed one of the strongest negative associations with SRH (monotherapy: β=–4.83; combination therapy: β=–5.28), likely reflecting underlying disease severity and treatment burden.

Conclusions

Better SRH among hypertensive adults was associated with controlled BP, healthier lifestyle patterns and higher socioeconomic status. Conversely, comorbidities, smoking, older age and antihypertensive treatment were linked to poorer perceived health. Integrating SRH screening into HTN management may help identify vulnerable individuals and inform targeted interventions addressing behavioural and socioeconomic determinants of health.

Patients experiences of ward rounds in a Swedish context: a qualitative study

Por: Larsson · E. · Hordiienko · Y. · Fagerström · C. · Almerud-Österberg · S. · Finnbogadottir · H. R. · Persson · C.
Objective

The aim was to explore patients’ experiences of ward rounds in inpatient care.

Design

An exploratory qualitative design was chosen, collecting data with one-to-one semistructured interviews, conducted from March to May 2023. An interview guide was used as a basis for the interviews. Data were analysed using reflexive thematic analysis.

Setting

A medical and a surgical ward at a medium-sized hospital in southern Sweden.

Participants

Purposeful sampling was used to recruit patients aged 18 years or older. 16 patients were recruited with an age range of 38–72 years.

Results

The findings showed that patients’ experiences of ward rounds have a wide range of variation. The main theme was: ‘The ward round as a bridge between patients’ experiences and knowledge and healthcare professionals’. The main theme consisted of two subthemes, reflecting the variation in patients’ experiences: ‘Feeling of togetherness versus loneliness’ and ‘Getting answers or being left in limbo’. The subthemes also highlighted patients’ experiences of factors that enabled satisfactory interactions between patients and healthcare professionals during ward rounds, such as comprehensible detailed information and supportive atmosphere, as well as experiences of factors that obstructed such interactions and caused patients to feel uncertainty.

Conclusions

Ward rounds in inpatient care play an important role for patient care and health, functioning as a bridge between patients and healthcare professionals. It is important for healthcare practitioners and policy-makers to create a model for ward rounds that can contribute to an open and supportive atmosphere as well as sharing comprehensible and detailed information.

Use and reporting of intervention mapping for adaptation: a systematic review protocol

Por: Kang · E. · Sanchez-Blas · H. R. · Obekpa · E. O. · Fernandez · M. E.
Introduction

Intervention adaptation is likely to occur to some extent when implementing interventions in new implementation contexts. Using systematic frameworks can guide intentional and effective adaptation processes. Intervention Mapping for Adaptation (IM-ADAPT) is a framework that offers step-by-step guidance for systematic, theory-based intervention adaptation. Despite the increasing use of IM-ADAPT, there is limited understanding of the contexts in which it has been applied and how effectively it is used and reported. Addressing this knowledge gap can improve current adaptation practices and inform future enhancements of the IM-ADAPT framework and the broader science of intervention adaptation. This review aims to (1) determine the context in which IM-ADAPT is used, (2) assess how studies apply IM-ADAPT tasks and (3) evaluate how these studies report their IM-ADAPT findings.

Methods and analysis

This protocol followed the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols guidelines. The eligibility criteria include original peer-reviewed English articles that used Intervention Mapping or IM-ADAPT to adapt interventions. We searched PubMed/Medline, Web of Science, Embase and the Intervention Mapping literature library, and conducted forward citation searches using two landmark articles from inception to 19 July 2024. At least two independent coders will screen the records to determine eligibility and extract data from the included articles. Any discrepancies will be resolved through regular co-author meetings or in consultation with a senior author. The study protocol was registered on the Open Science Framework (https://doi.org/10.17605/OSF.IO/D5TCP).

Ethics and dissemination

As this systematic review only used published data, no ethics approval was required. We will disseminate the findings of this review through open-access channels and journals.

Prehabilitation of frail elderly PAtients undergoing majoR surgEry at HOME (PREPARE-HOME): a superiority parallel-group randomised controlled trial protocol evaluating smart wearable enhanced prehabilitation versus usual care

Por: Leong · Y. H. · Tay · V. Y. J. · Yang · X. · Tan · C. J. · Au-Yong · P.-S. · Sim · J. L. X. · Ng · R. R. G. · Ong · M. E. H. · Tan · B. P. Y. · Abdullah · H. R. · Ke · Y.
Introduction

Frailty is a key predictor of adverse surgical outcomes in older adults, contributing to increased postoperative complications, prolonged hospitalisation and delayed recovery. Prehabilitation—targeting improvements in physical function before surgery—can mitigate these risks. However, traditional programmes often face low adherence due to logistical barriers. Integrating smart wearable devices into tele-supervised, home-based prehabilitation may enhance adherence, engagement and clinical outcomes.

This trial protocol describes the PREhabilitation of frail elderly PAtients undergoing majoR surgEry at HOME study with the objective to evaluate the effectiveness of a wearable-enhanced, tele-supervised prehabilitation programme (swSEP) versus standard care (unsupervised prehabilitation, uSEP) on improving preoperative functional capacity and postoperative outcomes in frail older adults undergoing major elective surgery.

Methods and analysis

This single-centre, prospective, randomised controlled trial will enrol 190 patients aged ≥65 years scheduled for major elective, non-cardiac surgery at Singapore General Hospital. Participants with frailty (Edmonton Frail Scale ≥6) will be randomised 1:1 to either the swSEP group (tele-supervised exercise with Fitbit Inspire 3 monitoring) or the uSEP group (standard physiotherapy education, exercise booklet and inspiratory muscle training if maximal inspiratory pressure 2O). The primary outcome is change in 6 min walk test distance from baseline to 1–3 days presurgery. Secondary outcomes include 30 s sit-to-stand test, handgrip strength, postoperative complications (per American College of Surgeons National Surgical Quality Improvement Program), hospital length of stay, readmissions, five-level version of the EuroQol five-dimensional questionnaire (EQ-5D-5L) and adherence. Data will be analysed using t-tests, analysis of covariance, logistic regression and Cox models, with stratification by baseline nutritional status.

Ethics and dissemination

Approved by the SingHealth Institutional Review Board (CIRB Ref: 2024/2242). Trial registered on ClinicalTrials.gov (NCT06633614). Results will be disseminated via peer-reviewed publications and academic conferences. Contact: irb@singhealth.com.sg

Trial registration number

ClinicalTrials.gov Identifier: NCT06633614

Prevalence and predictors of depression and other mental health disorders in Brazilian adults with intellectual disabilities: a population-based secondary analysis

Por: Wagner · G. A. · Gerum · P. C. L. · Martins · L. F. · Silva · H. R. S. · Lima · M. · Duraes · F. R. · Covolan · L.
Objectives

To investigate the occurrence of depression and mental health disorders other than depression among Brazilian people with intellectual disabilities, analysing data from a national household survey.

Design

Cross-sectional epidemiological study using data from the 2019 National Health Survey (PNS).

Setting

Brazil, nationwide data collection in urban and rural private households.

Participants

272 499 individuals, among whom 1.2% (n=3198) reported intellectual disabilities.

Primary outcome measures

Self-reported depression and mental health disorders other than depression (anxiety, panic, schizophrenia, bipolar disorder, psychosis or obsessive–compulsive disorder (OCD)), either isolated or comorbid.

Results

Among people with intellectual disabilities, 43.2% reported at least one mental health disorder versus 13.7% without disabilities. In adults aged 0–59 years, intellectual disability was associated with higher odds of depression (adjusted OR (aOR) 3.25, 95% CI 1.76 to 6.00), mental health disorders other than depression (aOR 12.23, 95% CI 7.52 to 19.90) and depression associated with other mental health disorders (aOR 14.34, 95% CI 7.92 to 25.96). In older adults (≥60 years), risks also remained elevated: depression (aOR 1.71, 95% CI 1.04 to 2.79), mental health disorders other than depression (aOR 4.33, 95% CI 2.09 to 8.94) and depression associated with other mental health disorders (aOR 2.98, 95% CI 1.49 to 5.95). Women with intellectual disabilities were more likely to report depression and multimorbidity, while men more often reported non-depressive disorders. Poorer self-perceived health was consistently linked to worse outcomes across age groups.

Conclusions

Mental health disorders and their comorbidities are significantly more prevalent among people with intellectual disabilities in Brazil. These findings highlight the urgent need for inclusive, equitable and specialised mental healthcare policies.

Azithromycin as adjunctive treatment for uncomplicated severe acute malnutrition (AMOUR): study protocol for a double-masked randomised controlled trial

Por: Bountogo · M. · Zakane · A. · Ouedraogo · T. A. · Ouermi · L. · Compaore · G. · Compaore · A. · Coulibaly · B. · Koueta · F. · Burroughs · H. R. · Fetterman · I. · La Mons · J. L. · Lebas · E. · Doan · T. · Hsiang · M. · OBrien · K. S. · Arnold · B. · Sie · A. · Oldenburg · C. E.
Introduction

Amoxicillin is recommended for children with uncomplicated severe acute malnutrition (SAM). However, some trials have shown no difference in amoxicillin for nutritional recovery in children with SAM compared with placebo. In addition, amoxicillin treatment requires two times per day dosing for 7 days, which may influence adherence. Azithromycin is a broad-spectrum antibiotic that can be provided as a single dose and has reduced mortality in children aged 1–59 months when provided by mass drug administration. The AMOUR trial is designed to assess amoxicillin, azithromycin and placebo as part of outpatient treatment of uncomplicated SAM.

Methods and analysis

This double-masked randomised controlled trial will enrol 3000 children over 3 years in an individually randomised 1:1:1 allocation to azithromycin, amoxicillin or placebo arms and follow them for 12 months. Children eligible to enrol in the study will be aged 6–59 months and have uncomplicated non-oedematous SAM as defined by weight-for-height Z-score

Ethics and dissemination

Ethical approval was obtained from the Institutional Review Board at the University of California, San Francisco (Protocol 23–39411) and the Comité d’Ethique pour la Recherche en Santé in Ouagadougou, Burkina Faso (Protocol 2024-01-08). The results of this study will be disseminated to the Ministry of Health, community stakeholders and via peer-reviewed publications and academic conferences.

Trial registration number

NCT06010719.

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