The over 14 million African children who are HIV-exposed but uninfected (CHEU) are at risk for poor health outcomes, including neurodevelopmental conditions such as autism; however, no study to date has examined autism in CHEU in Africa, where the vast majority of these children live. Scalable diagnostic and neurobehavioural tools, including powerful, low-cost approaches such as eye-tracking, for detection and study of mechanistic neural processes are necessary to advance autism research in these settings. The objective of this study is to examine autism diagnostic outcomes and eye-tracking biomarkers in relation to CHEU while at the same time building capacity for neuro-health research in Kenya.

This study will leverage a longitudinally assessed cohort of CHEU and children who are HIV-unexposed and uninfected (CHUU) with well characterised HIV-related and contextual exposures. We will first determine and compare autism diagnostic outcomes between young CHEU and CHUU across a large cohort (n=850) of Kenyan children using research-grade autism assessment tools, and, second, determine whether neurobehavioural eye-tracking markers predict autism outcomes across this cohort.

Human subjects approvals have been obtained from Moi University Institutional Review and Ethics Committee (IREC; IREC/909/2024; Approval #0004835), Kenya’s National Commission for Science, Technology and Innovation (NACOSTI; Reference #NACOSTI/P/25/415028), the Institutional Review Board of the Indiana University School of Medicine (Protocol #23171), with reliance agreements executed with Purdue University and Boston University. Dissemination of findings will occur through multiple channels within the research and clinical community, including peer-reviewed journal publications and conference abstracts and presentations. As part of capacity building efforts, the research team will also communicate study results to policy makers, the lay public and other health systems involved in the care of young children with disabilities via study-hosted workshops and conferences.

The Circle of Security-Parenting (COS-P) group intervention has demonstrated efficacy in reducing maternal perinatal mental health difficulty (PMHD) symptoms in some contexts. The Circle of Security Intervention (COSI) study, a multisite, individually randomised, single-blind, parallel-arm controlled trial, was conducted in England to assess the clinical effectiveness of COS-P in reducing perinatal psychopathology, parenting and infant development, as well as its acceptability among the National Health Service (NHS) participants and staff. The main aim of this work is to estimate the cost-utility of COS-P plus treatment as usual (TAU) relative to TAU among mothers and birthing parents receiving NHS perinatal mental health services (PMHS) in England.

A within-trial economic evaluation was performed comparing COS-P plus TAU with TAU alone, using data from the COSI trial, which employed a 2:1 randomisation ratio. Analyses were conducted from both NHS and personal social services (PSS) and societal perspectives. A 12-month time horizon was used, consistent with the final trial follow-up.

Secondary care NHS perinatal health services across multiple centres in England.

A total of 371 mothers and birthing parents with PMHD were randomised and had complete economic outcome data; 248 received COS-P plus TAU and 123 received TAU alone. Participants were eligible if they were receiving NHS PMHS; exclusion criteria were defined in the trial protocol.

Participants in the intervention arm received the COS-P group programme in addition to TAU. The control group received TAU alone.

The primary economic outcome was quality-adjusted life years (QALYs) over 12 months, derived from the 5-level EuroQol five-dimensional (EQ-5D-5L) questionnaire - responses. Costs were estimated from NHS and PSS as well as societal perspectives, including healthcare utilisation and productivity losses due to work absence.

Compared with TAU, COS-P was associated with higher costs from both NHS and PSS (£180.58; 95% CI –£1075 to £1436) and societal (£72.94; 95% CI –£1473 to £1619) perspectives. COS-P was marginally less effective in terms of QALYs (–0.01; 95% CI –0.06 to 0.05). Probabilistic sensitivity analyses indicated substantial uncertainty around cost and effectiveness estimates.

On average, COS-P was associated with higher costs and did not demonstrate improvements in health-related quality of life compared with TAU alone. Given the uncertainty surrounding the estimates, further research is warranted to explore potential longer term economic and clinical impacts of COS-P in perinatal mental health settings.

SRCTN18308962.

To evaluate the efficacy of melatonin, a neurohormone regulating the sleep–wake cycle, in preventing delirium within 5 days of hospitalisation among older adult patients (≥65 years) admitted to general medical wards.

Single-centre, double-blinded, randomised, placebo-controlled trial.

General medical wards of a tertiary hospital in Oman.

Patients aged ≥65 years admitted within 24 hours to general medical wards were screened. Key exclusion criteria included prevalent delirium, use of vasopressors, non-invasive ventilation, intensive or high-dependency unit admission and aphasia.

Participants were randomly assigned to receive either 5 mg or 8 mg of melatonin or a placebo nightly for up to 5 days during hospitalisation or until discharge, whichever occurred first.

The primary outcome was the incidence of delirium within 5 days, assessed using the 3-Minute Diagnostic Confusion Assessment Method. Secondary outcomes included delirium treatment, average sleep duration or sleep maintained, 28-day mortality and 28-day readmission. Analyses followed the intention-to-treat (ITT) principle, with per-protocol (PP) analyses conducted for robustness.

The study was terminated early due to futility. At termination, a total of 115 participants were recruited, 109 of whom were included in the ITT analyses: 55 in the melatonin group (5 mg or 8 mg) and 54 in the placebo group. The overall incidence of delirium by day 5 was 2.75%, 3.64% in the melatonin group and 1.85% in the placebo group (p=1.000). No statistically significant differences were found in the average sleep duration (p=0.136), 28-day mortality (3.64% vs 1.85%, p=1.000) or 28-day readmission (21.82% vs 20.37%, p=0.853). PP analyses and subgroup sensitivity yielded similar findings.

In this trial, melatonin did not significantly reduce the incidence of delirium. The lower-than-expected numbers of outcome events and resultant early termination for futility limited the study’s power. As a result, the study findings should be interpreted with caution, and further research is necessary before definitive recommendations can be made.

NCT06509191.

To evaluate the incremental diagnostic value and sub-phenotyping capability of Cardiovascular Magnetic Resonance (CMR) compared with Transthoracic Echocardiography (TTE) in patients with elevated left ventricular filling pressure (LVFP).

Prospective registry study. [Results from ClinicalTrials.gov ID NCT05114785]

A single NHS hospital in the UK.

The primary outcome was the rate of diagnostic discordance between TTE and CMR. Secondary outcomes included the characterisation of specific pathologies identified by CMR where TTE was normal, non-diagnostic or provided a non-specific diagnosis.

CMR demonstrated diagnostic discordance with TTE in 74% (n=194) of cases. In patients with a normal TTE (n=54), CMR identified heart failure with preserved ejection fraction (HFpEF) in 46% (n=25) and ischaemic heart disease (IHD) in 19% (n=10). For non-diagnostic TTE cases (n=15), CMR detected HFpEF in 53.3% (n=8) and IHD in 26.7% (n=4). Among those with non-specific left ventricular hypertrophy on TTE (n=47), CMR revealed HFpEF in 45% (n=21) and hypertrophic cardiomyopathy in 34% (n=16).

CMR markedly improves diagnostic precision and sub-phenotyping in patients with elevated LVFP, identifying key conditions like HFpEF, IHD and specific cardiomyopathies that TTE frequently misses. These findings highlight CMR’s critical role as a complementary imaging tool for refining diagnoses and informing management strategies in cardiovascular conditions.

To provide the first national estimate of syphilis prevalence among people who inject drugs (PWID) in Georgia, alongside updated HIV prevalence and associated risk behaviours, and to identify factors associated with infection.

Cross-sectional Integrated Bio-Behavioural Surveillance Survey conducted in 2022. Respondent-driven sampling was used to recruit PWID. Data were collected through standardised face-to-face interviews using structured questionnaires, and venous blood samples were collected for laboratory testing. HIV was diagnosed by serology, and syphilis was assessed using a two-step algorithm (Rapid Plasma Reagin screening with Treponema pallidum haemagglutination assay confirmation). Logistic regression models were applied to identify correlates of infection.

The study was conducted in community settings across seven major cities of Georgia that represent the main urban centres with large PWID populations. Survey implementation was supported by local peer-led and community-based harm reduction organisations with established trust and access to PWID networks, facilitating participant recruitment and ensuring feasibility.

HIV prevalence was 0.9% and syphilis prevalence 2.1%. Coinfection with HIV and syphilis was observed in 0.2% of participants. HIV infection was significantly associated with longer duration of injection drug use (adjusted OR (aOR) 0.2; 95% CI 0.5 to 0.9) and lack of access to HIV prevention services (aOR 2.8; 95% CI 1.1 to 7.8). Syphilis prevalence was significantly lower among PWID who had not had casual or paid sex in the past year (OR 0.06; 95% CI 0.02 to 0.2). Unsafe sexual behaviours were common: 25.8% reported sex with a casual partner in the past year, 12.3% reported a paid partner, and only around half used condoms consistently with these partners.

Despite a relatively low HIV prevalence, syphilis prevalence among PWID in Georgia highlights ongoing sexual risk behaviours. Current harm reduction programmes primarily address injection-related risks, with limited sexually transmitted infection (STI) prevention efforts. Expanding sexual health interventions within harm reduction services, including STI screening, structured counselling and safe sex education, is essential to reduce STI transmission and improve health outcomes among PWID.

Social norms are often implicit informal rules that most people accept and abide by, and can influence how people behave, sometimes based on perceived rewards and/or sanctions. Social norms are propelled by some reference or population groups who exert a considerable amount of influence on behaviour because people value their approval or disapproval. Despite these observations, little research exists on the influence of social norms on diabetes risk-taking behaviours. We explored diet-related social norms and their influence on risk-taking behaviours for type 2 diabetes (T2D).

We conducted a multi-method qualitative study guided by the Social Norms Exploration Toolkit participatory tools. A total of 45 participants were interviewed for this study, including (10) T2D patients, (10) caregivers of T2D patients, (10) healthcare providers, (2) village health teams, (4) diabetes-free community members; (4) community influencers like cultural leaders and (5) family members. The study was conducted in eastern Uganda in the districts of Bugiri and Busia. Data were collected on health workers, caregivers, patients and community members using focus group discussions, in-depth interviews and non-participant observation. Data were manually analysed to identify emerging social norms and other information of interest following a thematic framework approach.

Most participants were aware that frequent consumption of fatty foods and sugary refined foods could increase one’s risk of getting T2D. The study highlights three themes: general awareness of T2D risk factors, common social norms influencing dietary behaviours and behavioural risk factors that are influenced by the social norms. The study highlights significant behavioural and social drivers of T2D, which include consumption of high-fat, high-sugar diets, limited exercise and stress. Gendered and cultural norms strongly influence dietary behaviours, with women preparing unhealthy foods to meet societal expectations, fearing sanctions like divorce or community stigma, while men’s dietary preferences were linked to respect and social status. Norms around staple food preferences and respect linked to weight further perpetuate T2D risk behaviours. Community influencers, family dynamics and cultural traditions reinforce these practices, underscoring the need for gender-transformative, culturally sensitive and community-centred interventions. However, healthcare providers and village health teams are critical for promoting healthier behaviours and reducing T2D prevalence.

Our deep-dive social norms diagnosis has revealed that even when people know the risk factors for T2D, they will still follow the social norm influence regarding lifestyles. Inclusive strategies that actively engage and reshape norms are therefore vital to reduce the prevalence of T2D.