To assess the feasibility of conducting a cluster randomised controlled trial comparing the effects of Advanced Trauma Life Support (ATLS) and Primary Trauma Care (PTC) with standard care on patient outcomes.

This was a pilot pragmatic three-armed parallel, cluster randomised, controlled trial conducted between April 2022 and February 2023. Patients were followed up for 30 days.

Tertiary care hospitals across metropolitan areas in India.

Adult trauma patients and residents managing these patients were included.

ATLS or PTC training was provided for residents in the intervention arms.

The outcomes were the consent rate, loss to follow-up rate, missing data rates, differences in the distribution between observed data and data extracted from medical records, and the resident pass rate.

Two hospitals were randomised to the ATLS arm, two to the PTC arm and three to the standard care arm. We included 376 patients and 22 residents. The percentage of patients who consented to follow-up was 77% and the percentage of residents who consented to receive training was 100%. The loss to follow-up rate was 14%. The pass rate was 100%. Overall, the amount of missing data for key variables was low. The data collected through observations were similar to data extracted from medical records, but there were more missing values in the extracted data.

Conducting a full-scale cluster randomised controlled trial comparing the effects of ATLS, PTC and standard care on patient outcomes appears feasible, especially if such a trial would use data and outcomes available in medical records.

NCT05417243.

A ‘7-1-7’ timeliness metric, developed for hastening the response to infectious disease outbreaks/pandemics, was adapted to improve screening and managing household contacts (HHCs) of pulmonary tuberculosis (TB) patients. The feasibility, enablers, challenges and utility of implementing this modified metric through TB Champions (TB survivors) for HHC management were assessed.

This was an explanatory mixed-methods study with a cohort design (quantitative) followed by a descriptive design with focus group discussions (qualitative).

The study was conducted within routine programmatic settings in public health facilities in six districts from three states of India.

In total, 595 drug-susceptible index pulmonary TB patients registered for treatment in the selected health facilities, and their listed 2108 HHCs were included in the study between December 2022 and August 2023. All 17 TB Champions involved in implementation participated in the focus group discussions.

The primary outcome measures were the percentage of eligible participants receiving the desired service within the ‘7-1-7’ timeliness metric and challenges in achieving the timeliness metrics.

In 89% of 595 index patients, their HHCs were line-listed within 7 days of initiating anti-TB treatment (‘First-7’). In 90% of 2108 HHCs, screening outcomes were ascertained within 1 day of line-listing (‘Next-1’). In 42% of 2073 HHCs eligible for further evaluation, anti-TB treatment, TB preventive treatment (TPT) or a decision to not receive medication were made within 7 days of screening (‘Second-7’). Barriers to TPT uptake included lack of money and daily wage losses for travelling to clinics, reluctance of asymptomatic contacts to take medication and fear of adverse events. TB Champions felt timeliness metrics improved performance in the systematic and timely management of HHCs.

TB Champions found ‘7-1-7’ timeliness metrics were feasible and useful, and national TB programmes should consider their operationalisation.

Community participatory modelling merges participatory research approaches with mathematical modelling. Participatory approaches are grounded in the engagement of people with lived experience (eg, who are affected by the health condition under study) throughout the research process. Mathematical modelling of infectious disease (ID) dynamic transmissions is increasingly used as a tool for public health decision-making, generating predictions, inferring mechanisms and estimating the impact of potential interventions—all of which guide policies, strategies and resource allocation as part of the preparation and response to ID epidemics. However, little is known about the engagement of people with lived experience and affected communities in the ID modelling process. We will map the literature to explore participatory approaches undertaken in ID modelling (practical aspects of formalising participatory modelling), levels of participation and the potential influence from the perspective of communities engaged.

The scoping review will follow the Joanna Briggs Institute Manual for Evidence Synthesis. The search strategy includes three electronic bibliographic databases (MEDLINE, Scopus and Embase), no language restrictions and sources published from 2000 to present. We will implement the search with and without the participatory keyword, as we recognise that some studies do not explicitly term community engagement as participatory modelling. After deduplication, two authors will independently screen the titles, abstracts and full texts, with discrepancies resolved with a third team member. We will extract the relevant information from the main text, parameter tables, supplemental files, bibliography, acknowledgment and author affiliation sections. The data extraction will follow a deductive content analysis where we draw from community-based participatory research approaches and established mathematical modelling steps. We will also extract data to assess whether there was equitable engagement of knowledge users by checking for indicators of three equitable engagement domains as outlined by the Ward framework (equity within partnership (eg, whether knowledge user influenced modelling decisions or remuneration), capacity to engage in future partnerships and shift in power/influence (eg, coauthorship). We will supplement our narrative analyses with summaries in tabular format and using appropriate data visualisations.

No ethics approval will be required for this scoping review because we will map evidence from publicly available literature sources. We will develop multilingual abstracts or one-page lay summaries of the findings (English, French and Swahili), a policy brief and will coauthor an open-access journal article. A summary of the findings will be shared via knowledge user-led presentations at the Maisha HIV and AIDS Conference and with other community-based organisations at the quarterly peer-to-peer support meetings.

The protocol has been registered in Open Science Framework, DOI: https://doi.org/10.17605/OSF.IO/XQ2WP (December 2024).

Mitochondrial dysfunction and disrupted cerebral energy metabolism have been increasingly linked to the pathophysiology of schizophrenia. Preclinical studies suggest that certain atypical antipsychotics may exacerbate mitochondrial dysfunction by inhibiting respiratory complex I, contributing to adverse effects. Risperidone, a dopamine D2/serotonin 5-HT2 antagonist, and aripiprazole, a partial dopamine D2 agonist, were selected because of their contrasting pharmacological profiles and reported differential effects on mitochondrial complex I activity. Despite these findings, the clinical implications remain poorly understood. This randomised controlled trial aims to evaluate and compare the biochemical and clinical effects of risperidone and aripiprazole on mitochondrial dysfunction in patients with schizophrenia.

In this randomised, open-label, parallel-arm clinical trial, 60 patients with schizophrenia who were drug-naïve or had not taken any antipsychotic drugs for at least 4 weeks before recruitment were randomly assigned to risperidone or aripiprazole treatment for 12 weeks, with inclusion of an additional group of 30 healthy individuals for baseline comparisons. The primary outcome is the change in mitochondrial respiratory chain complex I concentration in platelets, and secondary outcomes include serum lactate, pyruvate, creatine kinase levels and Newcastle Mitochondrial Disease Adult Scale (NMDAS) scores. Clinical efficacy and safety are evaluated using the Positive and Negative Syndrome Scale (PANSS) and monitoring treatment-emergent adverse events. Intention-to-treat analysis will be done for all parameters using suitable statistical tools.

Ethical approval was obtained from the Institutional Ethics Committee and the study conformed to the provisions of the Declaration of Helsinki and ICMR’s national ethical guidelines for biomedical and health research involving human participants (2017). Written informed consent will be obtained from the legally authorised representative of the patients. Results will be disseminated through peer-reviewed publications and conferences to inform safer treatment strategies for schizophrenia.

NCT06236451.

In Africa, 75% of households are exposed to household air pollution (HAP), a key contributor to cardiovascular disease (CVD). In Nigeria, 90 million households rely on solid fuels for cooking, and 40% of adults have hypertension. Though clean fuel and clean stove (CF-CS) technologies can reduce HAP and CVD risk, their adoption in Africa remains limited.

Using the Exploration, Preparation, Implementation and Sustainment framework, this cluster-randomised controlled trial evaluates the implementation and effectiveness of a community mobilisation (CM) strategy versus a self-directed condition (i.e., receipt of information on CF-CS use without CM) on adoption of CF-CS technologies and systolic blood pressure (SBP) reduction among 1248 adults from 624 households across 32 peri-urban communities in Lagos, Nigeria. The primary outcome is CF-CS adoption at 12 months; secondary outcomes are SBP reduction at 12 months and sustainability of CF-CS use at 24 months. Adoption is assessed via objective monitoring of stove usage with temperature-triggered iButton sensors. SBP is assessed in 2 adults per household using validated automated blood pressure monitor. Generalised linear mixed-effects regression models will be used to assess study outcomes, accounting for clustering at the level of the peri-urban communities (unit of randomisation) and households. To date, randomisation is completed, and a total of 1248 households have enrolled in the study. The final completion of the study is expected in June 2026.

The study was approved by the Institutional Review Boards (IRB) of NYU Grossman School of Medicine (primary IRB of record; protocol ID: i21-00586; Version 6.0 approved on 4 June 2024), and Lagos State University Teaching Hospital (protocol ID: LREC 06/10/1621). Written consent was obtained from all participants. Findings will inform scalable and culturally appropriate strategies for reducing HAP and CVD risk in low-resource settings. Results will be disseminated through peer-reviewed publications, conference presentations and stakeholder engagements.

NCT05048147