The COVID-19 pandemic led to major disruptions in society across many spheres, including healthcare, the economy and social behaviours. While early predictions warned of an increased risk of suicide during and after the COVID-19 pandemic, rates of suicide deaths remained stable or decreased over that period for most countries. In contrast, the prevalence of suicidal ideation doubled and suicide attempts slightly increased during the COVID-19 pandemic in the adult general population worldwide, accompanied by a higher prevalence of major depressive disorder and anxiety disorders. While these data can tell us what happened, they cannot tell us why. Qualitative suicide research seeks to understand experiences of individuals with suicide-related thoughts and behaviours, provides an in-depth exploration of their lives and interactions with others and centres their views and unique context. There is little qualitative research focusing on suicidality during the pandemic. This study will use a qualitative approach to explore the extent and impact of the COVID-19 pandemic on Canadians who experienced suicidality and review their experiences of accessing mental healthcare to identify key components in supporting safety and recovery.

This study will involve approximately 100 semistructured interviews with participants across four Canadian provinces and will explore experiences with suicide-related thoughts and behaviours during the COVID-19 pandemic. Transcripts will be analysed through qualitative analysis informed by constructivist grounded theory.

The study was approved by the Research Ethics Board of the Centre for Addiction and Mental Health, Toronto Academic Health Sciences Network (for JZ: CAMH REB No 104-2022). In addition to traditional peer-reviewed presentations and publications, a report will make study findings accessible to policy makers, media and the public.

Persistent epithelial defect (PED) management can be challenging. First line of treatment includes lubrication, bandage contact lenses and punctal plugs. The second line of treatment includes autologous serum (AS). Topical insulin has been shown to be safe for topical use and improve corneal epithelial healing. Therefore, a controlled clinical trial (control group with current standard treatment, ie, AS) multicentre, randomised and with a blind third observer will be conducted to evaluate the efficacy and safety of the use of insulin eye-drops in the treatment of PED.

A preselection of patients with epithelial defect after 1 week of treatment will be made and blood tests will be obtained in order to dispense AS if necessary. After 2 weeks of standard treatment, if the PED persists and the patient meets criteria, patients will be enrolled after signing an informed consent form. Patients will be randomly allocated to receive either insulin (1 UI/mL, 4 times a day) or AS (20%, 5–6 times a day) eye-drops for 3 months. 234 patients will be included, 117 in each treatment group. The main variable (PED size) will be obtained from slit-lamp photographs, an objective and easily quantifiable variable which will be evaluated by a blinded investigator (third observer). Patients will be examined every 3–5 days until week 4 of study treatment and once a week until 6 weeks, to continue with a visit every 2 weeks until reaching 3 months of follow-up. Primary endpoints are: complete epithelialisation, epithelialisation rate (initial defect area/days until epithelialisation) and time until complete closure.

Ethical approval has been obtained from Hospital Clinico San Carlos in Madrid and Agencia Española del Medicamento y Productos Sanitarios (AEMPS). The findings will be disseminated in peer-reviewed publications and presentations at meetings.

EudraCT 2022-003589-19.

People identified as higher risk by a machine learning algorithm (Future Innovations in Novel Detection of Atrial Fibrillation [FIND-AF]) are at increased risk of cardio-renal-metabolic-pulmonary disease and cardiovascular death. The OPTIMISE-1 randomised controlled trial aims to test the effect of community-based specialist-led identification and management of cardio-renal-metabolic-pulmonary (CRMP) disease and risk factors compared with usual care on the use of therapeutic interventions over a follow-up of 6 months among high FIND-AF risk community-dwelling individuals.

OPTIMISE-1 is a multicentre, pragmatic, prospective, randomised, open-label, blinded-endpoint strategy trial that will recruit 138 participants aged 30 years or older, with a high FIND-AF risk score and previously enrolled in the FIND-AF pilot study (NCT05898165), to be randomised 1:1 to a specialist-led care intervention or usual care. The primary endpoint is a composite of initiation or increase of guideline-directed CRMP therapies. The secondary endpoints are the components of the primary endpoint, time to primary endpoint, diagnosis of new CRMP diseases or risk factors, time to diagnosis of new CRMP diseases or risk factors, initiation or increase of guideline-directed CRMP therapies for participants with recorded CRMP disease, initiation or increase of guideline-directed CRMP therapies for participants with newly diagnosed CRMP disease and change in participant-reported quality of life.

The study has ethical approval (the North East & North Tyneside 2 Research Ethics Committee reference 24/NE/0188). Findings will be announced at relevant conferences and published in peer-reviewed journals in line with the Funder’s open access policy.

Clinicaltrials.gov NCT06444711.

To assess atrial fibrillation (AF) burden, symptoms and quality of life (QoL) in endurance athletes with paroxysmal AF.

Prospective cohort study.

Otherwise healthy endurance athletes with paroxysmal AF in Norway, Australia and Belgium. The current study presents baseline measurements collected before the intervention of a randomised controlled trial on effects of individually tailored training adaptation.

AF burden (percentage time in AF) was measured by insertable cardiac monitors (Confirm Rx, Abbott). AF-related symptoms and QoL were assessed using the Atrial Fibrillation Effect on QualiTy-of-Life Questionnaire (AFEQT) with any score

43 athletes (age 57±10 (mean±SD), range 33–75 years, 3 women) were included. The athletes were monitored for 50±18 days. Median AF burden was 0.18% (IQR 0%–2.6%). Out of 29 athletes with at least one AF episode, 21 (72%) had AF episodes >60 min. 13 athletes (30%) had AFEQT overall score 60 min were associated with reduced QoL (mean AFEQT score 78 vs 90, p=0.001 and 78 vs 90, p=0.001, respectively). There were large individual variations between the athletes concerning AF burden, symptoms and QoL.

Although most athletes were still competing, more than half had troublesome symptoms. One-third had reduced QoL, which was associated with higher AF burden and longer duration of AF episodes. Variations between the athletes highlight the need for individually tailored AF management in athletes with paroxysmal AF.

NCT04991337.

To gain insight into patients’ views, perceptions, experiences and expectations postlumbar discectomy.

A qualitative study using interpretative phenomenological analysis (IPA) purposively recruited patients undergoing lumbar discectomy at one UK spinal centre. Purposive criteria included age, sex, ethnicity, symptom duration, work/sick leave, education level and co-existing psychological issues. Semi-structured interviews were conducted using a patient co-constructed topic guide. Interview transcriptions were analysed in accordance with IPA. Strategies enhancing trustworthiness included suspension of judgements and presuppositions, reflexivity, iterative coding process and critique from co-investigators.

Data from 14 participants (eight elective, 6 emergency surgery) informed four themes. The theme ready to move forwards was characterised by high satisfaction with post-operative improvement, positivity and optimism, with readiness to work towards personal goals. The theme post-operative fear and uncertainty was characterised by reflections on pre-operative difficulties fuelling fear about potential recurrence and long-term impacts. The theme of advice and guidance considered important was characterised by the expectation and value of support provided (verbal, written); instances of negative influences from healthcare interactions and access to unregulated patient information sources suggest scope for future improvement. The final theme, heterogeneity in peri-operative needs, was characterised by variation in depth/access to patient information, perceived post-operative support and wide-ranging preoperative activity/fitness.

Surgery offers physical and psychosocial changes which could be better harnessed to positively influence recovery through high quality verbal/written communication. Peri-operative advice and guidance was valued; while this was sufficient for some, personalised rehabilitation should be available owing to the identified heterogeneity.

To identify the patterns of tuberculosis (TB) notification rates and examine their relationship with social and economic determinants in Nepal between 2020 and 2023.

Cross-sectional study.

Nepal.

All TB cases across all ages.

Prevalence of TB cases.

This cross-sectional spatial analysis used the data set of the National Tuberculosis Control Centre, Nepal, covering the Fiscal Year (FY) 2020–2021 to 2022–2023. Moran’s I and Local Indicators of Spatial Association were employed to detect the spatial autocorrelation between the prevalence of TB and associated social and demographic factors.

The overall prevalence rate for TB in FY 2020–2021 was 98.08 per 100 000 population. This increased to 129.82 per 100 000 population in FY 2021–2022, followed by a slight decrease to 128.39 per 100 000 population in FY 2022–2023. The highest TB prevalence was observed in Kathmandu, with 146 cases per 100 000 population in 2020–2021, and in Dang district, the rate decreased from 215–191 per 100 000 population. We investigated the spatial patterns of TB prevalence and highlighted the geographic areas in each district in Nepal from 2021 to 2023 with Moran’s I of 0.558, 0.614 and 0.596, respectively. The consistent identification of High-High clusters in specific districts like Banke, Kapilbastu and Parsa across all 3 years periods highlighted persistent high-risk areas for TB transmission in Nepal.

This study emphasised the strong spatial associations and the complex, diverse aspects of TB transmission shaped by demographic and socioeconomic factors. Our results highlighted the need for tailored public health approaches that account for specific social determinants to address TB effectively.

Body contouring surgery (BCS) can be applied to reduce the physical and mental burden of excess skin after massive weight loss. Self-reported outcomes of patients are used to assess this burden and to evaluate the effectiveness of BCS. The aim of this study is to clarify what is reflected in self-reports of excess skin after bariatric surgery. We hypothesise that the self-reported burden of excess skin is associated with both objectively assessed excess skin and the disposition to experience negative emotions.

This cross-sectional study will include 68 outpatients presenting at a plastic surgery clinic with a request for BCS. Patients fill out two questionnaires (the BODY-Q and the Sahlgrenska Excess Skin Questionnaire (SESQ)) to measure the size and burden of excess skin as well as the Big Five Inventory (BFI) to measure the disposition towards negative emotionality. Anonymised photographs of excess skin will be rated independently by four plastic surgeons using the Pittsburgh Rating Scale (PRS) Rainbow Classification to establish the objective amount of excess skin. Multiple linear regression analyses will be performed to identify the association of BODY-Q and SESQ scores with objective appraisals of excess skin by plastic surgeons, negative emotionality and demographics. Interobserver agreement for PRS Rainbow Classification will be established by Fleiss’ kappa.

Ethical approval was obtained from the regional medical ethics committee (METC; W20.258) and the institutional review board (Lokale Toetsing, St. Antonius Hospital in Nieuwegein, no. Z23.035). Informed consent of participants will be obtained. The results of this study will be submitted for publication in a peer-reviewed journal.

The prevalence of women with primary dysmenorrhoea is high and negatively impacts physical and mental health. The intense cyclic episodes of pain generate central nervous system dysfunctional processing. In this sense, strategies focused on the central nervous system are important to re-establish normal functioning. Home-based self-administered transcranial direct current stimulation (tDCS) emerges as a strategy to modulate dysfunctional brain areas and improve the symptoms. This protocol aims to evaluate the effects of home-based self-administered tDCS for pain, premenstrual symptoms, physical performance, quality of life, electroencephalography and patient global impression in women affected by primary dysmenorrhoea.

This is a single-centre, parallel, randomised, double-blinded clinical trial protocol. 40 women affected by primary dysmenorrhoea will be randomised into two groups (active-tDCS or sham-tDCS). Then, 20 consecutive sessions of home-based self-administered tDCS will be performed. The assessments will occur at five time points: baseline, after the 20th sessions, at the first, second and third cycles after tDCS interventions (follow-ups). Primary outcome will be pain according to visual analogue scale. Quality of life, premenstrual symptoms screening, depression, anxiety, physical performance, electroencephalography and participants’ satisfaction will be the secondary outcomes. A mixed analysis of variance will calculate the effect of stimulation.

The study was approved by the ethics committee of the Federal University of Rio Grande do Norte (No. 6.037.756) and registered in the Brazilian Clinical Trials Registry (n° RBR-747k8vb). Participants may withdraw at any time without penalty. Free support will be available from the lead researcher if needed. All procedures will follow Good Clinical Practice and international ethical standards.

https://ensaiosclinicos.gov.br/rg/RBR-747k8vb

This study aimed to assess treatment outcome, medication adherence and predictors among epilepsy patients at three low-resource setting hospitals in Mekelle City, Northern Ethiopia.

A multicentre hospital-based observational cross-sectional study was conducted.

The study was conducted in three resource-limited tertiary care hospitals in Mekelle City, Northern Ethiopia: Ayder Comprehensive Specialized Hospital, Mekelle General Hospital and Quiha General Hospital.

A total of 351 patients with epilepsy receiving regular follow-up care at adult neurology outpatient clinics in three low-resource setting hospitals were included in the study.

The study assessed adherence to antiepileptic drugs (AEDs), treatment outcomes and identified independent predictors of these outcomes.

A total of 351 study participants were included in the final analysis, with a mean (±SD) age of 37.98±14.27 years. More than one-third (39%) had poorly controlled seizures. Living in urban areas (adjusted odds ratio (AOR)= 3.36, 95% CI 1.1 to 10.4, p=0.037), being government-employed (AOR = 4.0, 95% CI 1.1 to 14.5, p=0.035) and being a student (AOR = 4.0, 95% CI 1.1 to 14.5, p=0.035) were associated with good seizure control. Half of the participants (177, 50.6 %) were non-adherent to their medications. Being a farmer (AOR = 4.2, 95% CI 1.5 to 11.3, p=0.005), a housewife (AOR = 4.9, 95% CI 1.4 to 17.2, p=0.012), absence of seizure-triggering factors (AOR = 3.7, 95% CI 2.34 to 6.06, p

More than two-thirds of patients with epilepsy experienced poor seizure control. Place of residence, employment status and the number of seizure episodes prior to treatment initiation were identified as significant predictors of treatment outcomes. Approximately half of the study participants were adherent to their medications, with employment status, the presence of seizure-triggering factors, comorbidities and seizure control serving as predictors of medication adherence.

The nursing profession has undergone significant evolution over the past century, shifting from a role traditionally viewed as an auxiliary to physicians to one of autonomous healthcare professionals equipped with specialised skills and expertise. This shift is driven by the increasing recognition of the importance of evidence-based practice in enhancing patient outcomes and advancing the field of nursing. Consequently, nursing research has emerged as a critical priority in the profession. This study seeks to explore the nursing research landscape in Malaysia, where data remain limited, by examining trends before, during and after the COVID-19 pandemic.

This scoping review will be conducted following the Arksey and O'Malley framework, using four electronic databases: PubMed, Scopus and CINAHL for journal articles published between 2015 and 2024, and Web of Science for conference proceedings from the same period.

The findings from this scoping review will provide an overview of the nursing research landscape in the Malaysian context, offering insights that could guide the future advancement of nursing research in the country. The results will be disseminated through submission to a peer-reviewed scientific journal for publication. Ethical approval is not required for this scoping review, as it involves the synthesis of data from available published literature.

While chronic kidney disease (CKD) is well characterised in adults, less is known about the prevalence of CKD in children and adolescents, where it is rare and associated with unique characteristics and implications for long-term health outcomes. This study protocol outlines a systematic review to assess the global prevalence of CKD in children and adolescents along with causes and associated risk factors. This is warranted to better characterise prevalence and to identify at-risk groups that would benefit from screening efforts. We will explore the risk and burden of CKD and its variations by sociodemographic characteristics (age group, race, sex/gender) and geographical regions (country, International Society of Nephrology region and income groups based on World Bank country classifications).

We will conduct a systematic review of studies reporting on the prevalence of CKD in children and adolescents following the Preferred Reporting Items for Systematic Review and Meta-Analysis Protocols 2015 (PRISMA-P-2015) and the PRISMA 2020 methodological guidelines (PRISMA 2020). Searches will be undertaken in the following databases with the date range from 2000 to date: Ovid MEDLINE, Ovid Embase, CINAHL, Cochrane Library, ProQuest Dissertations & Theses Citation Index (via Clarivate), Web of Science Core Collection, Google Scholar and grey literature sites (registries, government reports) to identify studies that report on the prevalence of CKD in children and adolescents from ages 0 to 18. The primary outcome will be the global prevalence of CKD in children and adolescents. Secondary outcomes will include the causes of and risk factors for CKD, and examining differences and temporal trends in CKD prevalence across countries, geographical regions, income levels and sociodemographic characteristics.

No direct involvement with patient data will be used in this systematic review, as data will be obtained from previously published reports. Ethical approval is therefore not required. Our findings will be published in an open-access peer-reviewed journal and presented at scientific conferences.

CRD42024547467.

Rapid urbanisation and the dense population of Bangladesh foster the growth of slum settlements, where poverty and food insecurity are magnified by economic instability and inflationary pressures, adversely affecting psychological health.

This study aimed to assess household food security and its influence on psychological well-being among adults living in urban slums of Bangladesh.

A cross-sectional study using convenient sampling was conducted among 300 adults in slums in Dhaka, Bangladesh, using a semistructured questionnaire to collect data on sociodemographics, food security and mental health status. Multivariable logistic regression analyses were conducted to observe the influence of food insecurity on mental health status, controlling for other covariates.

The majority of the participants experienced food insecurity, with 38.0% expressing severe food insecurity. High levels of psychological distress were observed, including stress (54.7%), anxiety (63.3%) and depression (73.3%). Older adults (aOR 4.5, 95% CI 1.3 to 15.5) and females (aOR 4.1, 95% CI 2.0 to 8.4) had higher odds of experiencing anxiety. Single individuals were more prone to experience depression, while homemakers exhibited elevated levels of both depression and anxiety. Furthermore, moderate to severe food insecurity was significantly associated with higher odds of depression (aOR 2.8, 95% CI 1.2 to 6.7) and anxiety (aOR 8.2, 95% CI 3.3 to 20.3) compared with no or mild food insecurity.

This study highlights the pervasive influence of household food insecurity on urban slum dwellers’ psychological well-being. Addressing vulnerabilities tied to age, marital status and occupation is crucial for alleviating mental health burdens.

Evidence that smoking cessation benefits physical and mental health has led to recommendations to support quitting. Unsuccessful quit attempts are common and associated with guilt and frustration; however, their impact on mental health is unclear. This review investigated the association between the success/failure of smoking cessation attempts and changes in symptoms of depression and anxiety.

Systematic review and meta-analysis, following Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) and Meta-analysis of Observational Studies in Epidemiology (MOOSE) guidelines.

Inclusion and exclusion lists of two previous reviews, plus update searches of Embase, Medline and PsycINFO (January 2020–January 2025).

Trials and longitudinal observational studies measuring symptoms of anxiety or depression before and after a smoking cessation attempt, beyond the withdrawal period (6 weeks), in adults who successfully quit and made an unsuccessful attempt.

Standardised methods were used for screening and data extraction. Two independent reviewers screened a minimum of 25% and extracted data for 100% of studies. Meta-analyses were conducted using random effects models, and narrative synthesis was used when necessary. Study quality, heterogeneity and publication bias were assessed using the adapted Newcastle-Ottawa Scale, I² and funnel plots, respectively.

62 studies were included, representing 36 150 participants. Most featured behavioural smoking cessation interventions and defined successful cessation attempts by self-reported or biologically verified abstinence. Follow-up ranged from 6 weeks to 4 years. Overall, successfully quitting smoking was associated with reduced symptoms of depression (standardised mean difference (SMD)=–0.21, 95% CI –0.27 to –0.16) and anxiety (SMD=–0.22, 95% CI –0.33 to –0.12) compared with unsuccessful quit attempts. Heterogeneity was substantial (I²=50-69%).

Most studies indicated a positive trend in alleviating symptoms of anxiety and depression during a quit attempt. Successful quitters experienced more substantial reductions in these symptoms compared with those who were unsuccessful. Importantly, those who made an unsuccessful quit attempt did not experience worse mental health.

CRD42022314728.

The majority of studies in our review indicated a positive trend in alleviating symptoms of anxiety and depression when individuals attempt to quit smoking. Successful quitters experienced more substantial reductions in these symptoms compared with those who were unsuccessful. Importantly, those who attempted to quit but failed did not experience worse mental health. These findings are relevant to people who smoke tobacco and the health professionals who support them as they may hold some apprehensions about quitting smoking or the anticipated emotional consequences of failing to quit. The current review contributes to clinical practice by adding to the information on which risk-benefit decisions are made regarding smoking cessation.

A ‘cluster’ is an area with a higher occurrence of tuberculosis (TB) than would be expected in an average random distribution of that area. Tuberculosis clustering is commonly reported in Ethiopia, but most studies rely on registered data, which may miss patients who do not visit health facilities or those who attend but are not identified as having TB. This makes the detection of actual clusters challenging. This study analysed the clustering of pulmonary TB and associated risk factors using symptom-based population screening in Dale, Ethiopia.

A prospective population-based cohort study.

All households in 383 enumeration areas were visited three times over a 1-year period, at 4-month intervals.

Individuals with pulmonary TB aged ≥15 years with demographic, socioeconomic, clinical and geographical data residing in 383 enumeration areas (ie, the lowest unit/village in the kebele, each with approximately 600 residents).

Pulmonary TB (ie, bacteriologically confirmed by sputum microscopy, GeneXpert or culture plus clinically diagnosed pulmonary TB) and pulmonary TB clustering.

We identified pulmonary TB clustering in 45 out of the 383 enumeration areas. During the first round of screening, 39 enumeration areas showed pulmonary TB clustering, compared with only 3 enumeration areas in the second and third rounds. Our multilevel analysis found that enumeration areas with clusters were located farther from the health centres than other enumeration areas. No other determinants examined were associated with clustering.

The distribution of pulmonary TB was clustered in enumeration areas distant from the health centres. Routine systematic community screening may be costly, but using existing health infrastructure with health extension workers through targeted screening, they can identify and refer persons with TB symptoms more quickly for diagnosis and treatment, thereby decreasing the duration of disease transmission and contributing to the reduction of TB burden.

To assess the feasibility of conducting a pragmatic, multicentre randomised controlled trial (RCT) to test the clinical and cost-effectiveness of a pain management training intervention to support people with persistent musculoskeletal pain and their informal carers.

Two-arm, multicentre, pragmatic, open, feasibility RCT with embedded qualitative study.

National Health Service (NHS) providers in four English hospitals.

Adults receiving NHS care for persistent musculoskeletal pain and their informal carers.

Control: usual NHS care. Experimental: usual NHS care plus a carer-patient pain management training intervention (JOINT SUPPORT), comprising five, 1-hour, group-based sessions for patients and carers, delivered by trained physiotherapists or occupational therapists. Content included understanding pain, pacing, graded activity, fear avoidance, goal-setting, understanding the benefits of physical activity and medication management. This was re-enforced with a workbook. After the group-based sessions, patients and carers were supported through three telephone sessions.

Central randomisation was computer-generated (2:1 Experimental:Control), stratified by hospital and patient-participant age (≤65 years). There was no blinding.

Data collected at baseline and 3 months post-randomisation included screening logs, intervention logs, fidelity checklists and clinical outcomes on quality of life, physical and emotional outcomes, adverse events and resource use. Interviews with 14 patient-carer participants and six health professionals who delivered the intervention.

A total of 76 participants (38 patients; 38 carers) were enrolled. Sixty per cent (312/480) of patients screened were eligible with 12% consenting to be randomised (38/312). Fifty-four per cent (13/24) of the experimental group reached minimal compliance with the JOINT SUPPORT intervention. There was no evidence of treatment contamination. For patient-participant outcomes, within-group differences from baseline to 3 months favoured the control group when assessed by EQ-5D and Generalised Self-Efficacy total score, but favoured the intervention group when assessed by numerical rating scale pain, fatigue and Centre for Epidemiologic Studies Depression Scaletotal score. Qualitative data demonstrated the acceptability of the trial design and JOINT SUPPORT intervention with modifications to improve trial processes.

The JOINT SUPPORT intervention was acceptable to patient-carer dyads and health professionals. Modifications to trial design, particularly enhanced recruitment strategies, are required.

ISRCTN78169443.

The data that support the findings of this study are available from the corresponding author (TS) on reasonable request. This includes access to the full protocol, anonymised participant-level dataset and statistical code.

The HOLA study is a 12-month randomised, hybrid implementation-effectiveness, phase IV, double-arm, open-label, multicentric study including virologically suppressed people living with HIV (PWH). HOLA, which started in September 2023, evaluates acceptability, appropriateness, feasibility and satisfaction of out-of-hospital administration of cabotegravir and rilpivirine long-acting (CAB+RPV LA).

A total of 110 PWH who are already under treatment with CAB+RPV LA or switch their antiretroviral therapy to CAB+RPV LA will be recruited from two main hospitals in Barcelona (Germans Trias I Pujol and Vall d’Hebrón) and Costa del Sol Hospital, in Marbella. The patients will be randomised 1:1 into a hospital group (administration of CAB+RPV LA in the hospital) and the outpatient group (out-of-hospital administration), including community or primary care centres. The main objectives of the study are to compare the acceptability at month 12 of the administration of CAB+RPV LA in and out-of-hospital centres from the perspective of patients, and assess and compare the safety and tolerability of CAB+RPV LA. The study takes place at nine clinical units in Catalonia and Andalusia (three tertiary hospitals (recruiting centres), one community centre, one sexually transmitted infection clinic and four primary care centres).

The current publication refers to V.3.0 of the protocol, with issue date 14 April 2024, as approved by the Comité de Ética de la Investigación con medicamentos del Hospital Universitari Germans Trias i Pujol (approval number AC-23-042-HGT-CEIM). The clinical trial will be conducted according to the principles of the Declaration of Helsinki, Fortaleza, Brazil, October 2013. This study will be conducted according to Spanish regulations regarding clinical trials (Royal Decree 1090/2015) and biomedical investigations (Organic Law 14/2007 of biomedical investigation and the Royal Decree 1716/2011), and the Clinical Trial Regulation (Regulation EU No 536/2014). Confidentiality requirements will follow the required Data Protection legislation. Enrolment completion in the study is expected by the end of May 2024, with an end of study expected in May 2025. Results emerging from this study will be reported in HIV national and international meetings as well as published in international journals with a high impact factor. If the outcome is deemed positive, we will also develop and propose policy guidelines for the integration of the administration of CAB+RPV LA in alternative outpatient facilities into the standard of care in the HIV care pathway.

NCT06185452/EUCT number: 2023-503963-41-00.

To qualitatively explore Bangladeshi adult males’ perceptions of existing bidi (tobacco-leaf cigarettes hand-rolled in tendu leaf) packs, which are currently sold in various shapes and sizes, often without the required graphic health warning label (HWL) covering 50% of the top of the pack, versus a proposed standard bidi pack, which was designed by advocates and is a cardboard, rectangular box shape with the required 50% HWL coverage.

Focus group study

Male participants were recruited from predetermined low-income urban and rural areas in three geographic divisions (Dhaka, Khulna, Sylhet) of Bangladesh.

98 males participated in 14 focus group discussions (FGDs). An equal number of groups were conducted with males who currently used bidis (n=7 groups) and males who never used tobacco (n=7 groups). Each group had 6–8 participants. For FGDs with males who used bidis, participants were eligible if they were at least 18 years old and reported smoking bidis on at least one of the past 30 days. For FGDs with males who never used tobacco, participants were eligible if they were between 18 and 35 years old to capture those at most risk of initiating tobacco and reported never using any tobacco.

Participants were shown four existing bidi packs sold in Bangladesh and one standard bidi pack. The groups were asked to first rank and discuss the existing bidi packs in terms of perceived attractiveness, HWL noticeability and perceived harmfulness. Next, the groups discussed how the standard bidi pack compared with the existing bidi packs in terms of the same three outcomes.

All groups, regardless of bidi use status, discussed the limited noticeability of HWLs on existing bidi packs, which reduced perceived product harm. In contrast, most groups discussed how the standard pack HWL was clearly printed, easy to see and increased perceived harm. Overall, most groups across bidi use status found that the standard pack was as attractive or more attractive than the existing bidi packs, particularly noting that the standard pack shape, colour and cardboard material were attractive.

Standardising the size and shape of bidi packs has the potential to improve HWL compliance and increase harm perceptions. Complementing a standard bidi pack policy with a plain packaging policy (eg, packs only sold in a single drab olive colour), as well as efforts to enhance HWL compliance at the point of manufacturer, could further reduce product appeal and enhance harm perceptions.