Trichomonas vaginalis is estimated to be the most common non-viral sexually transmitted infection (STI) worldwide with 156 million new cases each year. In 2021, the United States Centres for Disease Control and Prevention (CDC) updated their STI Treatment Guidelines to recommend multi-dose oral metronidazole (MTZ) for all T. vaginalis-infected women. Although multi-dose oral MTZ 500 mg twice daily was found to be superior to single-dose 2 g oral MTZ in multiple trials in women, multi-dose oral MTZ still had unacceptably high rates of breakthrough infection (9%–11%) at test-of-cure. With approximately 156 million cases of T. vaginalis worldwide per year, over 17 million persons per year are estimated to be insufficiently treated with multi-dose oral MTZ. Moreover, past trials only included women, and single-dose 2 g oral MTZ remains the recommended treatment for men. Thus, there is a critical need to further refine T. vaginalis treatment in women and men. A single dose of 2 g of oral secnidazole (SEC), a next generation 5-nitroimidazole with a longer half-life than oral MTZ and improved tolerability, may be a good option. This study will examine the effectiveness of multi-dose oral MTZ versus single-dose oral SEC in both men and women infected with T. vaginalis.

This is a multi-centred open-label effectiveness trial comparing oral multi-dose MTZ (500 mg twice daily for 7 days) to 2 g of single-dose oral SEC. This trial aims to enrol 1200 T. vaginalis-infected women and men aged 18 years and older at four clinical sites: the University of Alabama at Birmingham (UAB) Sexual Health Clinic and the UAB Gynaecology Clinics in Birmingham, AL, LSU-CrescentCare Sexual Health Centre (LSUHSC-NO) in New Orleans, LA, and HealthCare Clinical Data, Inc. in Miami, FL. Those who are pregnant/lactating, have been treated with a 5-nitroimidazole within the last 28 days, used intra-vaginal boric acid or any other intra-vaginal treatment for T. vaginalis within the last 14 days, have a history of a type 1 hypersensitivity reaction to 5-nitroimidazoles, are taking phenytoin and/or warfarin, use any medications which may alter the metabolism of oral MTZ, or have previously been enrolled will be excluded from the study. Participants will be randomised in a 1:1 fashion to either multi-dose oral MTZ or single-dose oral SEC. A test-of-cure (TOC) visit will be performed 4 weeks after completion of treatment (window 1 week before and 2 weeks after scheduled TOC visit).

This protocol is approved through a single Institutional Review Board (IRB) mechanism by the Tulane Human Research Protection Programme (Protocol # 2024–101 SPHTM). External relying sites are the UAB IRB (including both the UAB Sexual Health Research Clinic and Gynaecology Clinics; Protocol ID IRB-300012617), the LSUHSC-NO IRB (LSU-CrescentCare Sexual Health Centre; Protocol ID 6979) and the Advarra IRB (Healthcare Clinical Data Inc; Protocol ID Pro00085531). This study is also approved for referral purposes only by the Research Review Committee at the Jefferson County Department of Health (JCDH) Sexual Health Clinic in Birmingham, AL (JCDH Research Number 2024–03). Study findings will be presented in scientific conferences and peer-reviewed journals, shared with treatment advisory boards, as well as disseminated to providers and patients in communities of interest. The study Data Safety and Monitoring Board (DSMB) will meet twice a year to review patient safety data and study progress and provide recommendations on the study’s continuation or modification.

NCT06261840.

Leprosy remains a significant public health challenge in many low and middle-income countries, including India. People affected by leprosy face multifaceted challenges: physical, psychological, social and economic. In response, donors support self-help groups (SHGs) to improve health, social integration and economic circumstances for marginalised people, including those with leprosy. This study aims to assess the sustainability of SHGs in India after the withdrawal of donor support by examining whether they remain functional and exploring the key factors, barriers and facilitators that influence their long-term social and economic viability.

To examine the functionality of SHGs after withdrawal of donor support, and to explore the factors, barriers and facilitators influencing their long-term social and economic sustainability.

Using qualitative methods, we conducted semistructured interviews with 40 key informants associated with five SHGs formed under the Self-Help Community Development Project implemented in an endemic state of India and funded by The Leprosy Mission Trust India.

It was an exploratory qualitative study using interviews with SHG members and key informants, situated within the self-help community-based project.

While some SHGs demonstrated resilience and adaptability, others faced challenges such as internal discord, loss of members to migration and lack of access to government schemes. Thematic analysis revealed key drivers and barriers to sustainability and realising the benefits of SHGs, highlighting variations in leadership, governance, economic performance and social engagement across groups.

SHGs are often sustained after the funding and managerial donor support have been withdrawn. The findings emphasise the importance of strong leadership, community support and external facilitation in sustaining SHGs and enhancing their impact on marginalised populations. This study contributes to understanding the role of SHGs in addressing the socioeconomic challenges faced by individuals affected by leprosy and offers insights for improving their long-term viability.

Monitoring physical rehabilitation is an essential component of patient recovery after knee arthroplasty. Monitoring can be remote, or clinic based. In India, unsupervised home-based physical rehabilitation is a common practice, but there is a lack of evidence to demonstrate the effectiveness of remote monitoring. Therefore, we developed and piloted a mobile application (TeleREhabilitation after knee ArThroplasty app) based on behaviour design thinking to support the recovery period. This trial aims to compare the effectiveness, acceptability, cost and safety of this app-supported home-based intervention against usual care using an open label, 1:1 individual randomised superiority trial at two tertiary care hospitals in India.

Consecutive adults undergoing partial or total, unilateral or bilateral knee arthroplasty who can use a smart phone will be invited to participate in this trial. Consenting individuals will be randomised to either an app-supported intervention or a usual home-based rehabilitation which typically consists of provision of oral or written instructions at discharge and follow-up check-up with the surgeon or physiotherapist at their discretion or as per individual need. We aim to recruit 300 individuals over a period of eighteen months. The primary objective is to compare patient-reported knee function between the two groups at 3 and 6 months postsurgery. Secondary objectives are to compare patient-reported outcomes (pain and activity), performance-based outcomes (lower limb strength and knee function), resource utilisation and quality of life. Fidelity of implementation, end-user experiences and challenges in implementing this intervention will be measured using both quantitative and qualitative methods. Quantitative data will be analysed in Stata, and group comparisons will be done using mixed effect linear regression. A mixed-methods approach will be used to analyse and interpret the process evaluation data. A modified intention-to-treat approach will be taken, which includes all those who were randomised irrespective of their adherence to trial protocol if they had at least one follow-up visit after enrolment.

The protocol has been approved by the ethics committees of the sponsor institute (The George Institute for Global Health) and the two clinical sites (All India Institute for Medical Sciences, Delhi & Indraprastha Apollo Hospitals, Delhi). The results will be disseminated via peer-reviewed publications, conference presentations and via plain language newsletters to the trial participants.

CTRI/2024/06/068838.

Patients with fragility fractures are two times as likely to suffer future fractures as their peers who have not suffered a fracture. In addition, 40% of those who suffer fragility fractures do not recover their level of functioning in terms of activities of daily living after 1 year. The present study aims to verify the hypothesis that a semipersonalised home-based exercise intervention may improve patients’ independence and reduce the number of hospital admissions compared with usual care for a population that suffers fragility fractures.

This parallel-arm single-blinded randomised-controlled trial will take place at the University of Cordoba (Spain) between September 2022 and September 2024. Patients aged >50 years old who have undergone surgery for a fragility hip fracture and who were prefracture independent (Barthel index (BI)>60) will be invited to participate. Patients will be excluded if they present a different type of fracture, mild or greater cognitive impairment or contraindication to exercise training. Patients will then be randomised into exercise or usual care group. The former will receive a daily walking appointment (number of steps to be completed inside home, interspersed with sit-to-stand movements) with the total volume increasing weekly. The latter will receive the usual care. The outcomes, collected at baseline, at the end of training (3 months) and at follow-up (6 months) by blinded operators will include the BI and number of readmissions (primary outcomes) and quality of life, exercise capacity, strength, cognitive status, bone mineral density and laboratory biomarkers (secondary outcomes). Variables related to quality of life, cognitive status, laboratory markers and densitometry will also be analysed.

The research ethics committee of the province of Cordoba approved the project (number 326; date 28 July 2021). Patients who meet the eligibility criteria will receive a patient information document and the consent form and will be encouraged to ask any questions. The proposed research respects the fundamental principles of the Declaration of Helsinki, the Council of Europe Declaration on Human Rights and Biomedicine, the UNESCO Universal Declaration on the Human Genome and Human Rights, and the Oviedo Council on Human Rights and Biomedicine. The data obtained in this study will be confidential. They will be treated by the Organic Law 3/2018, of 5 December, on the Protection of Personal Data and Guarantee of Digital Rights, keeping it strictly confidential and not accessible to unauthorised third parties, and the Regulation (EU) 2016/679 of the European Parliament and of the Council of 27 April 2016 on Data Protection (RGPD). Written informed consent will be obtained from all the participants. The study’s results will be published in peer-reviewed journals and presented at scientific congresses worldwide. The results will also be disseminated through patient advocacy group newsletters and social media platforms. Patient partners will help select the appropriate channels and develop plain-language summaries tailored to their communities’ needs.

ClinicalTrials.gov ID: NCT04934358 (registration date: 14 June 2021).

Despite the known haemostatic action of emicizumab (Hemlibra) in haemophilia A patients, its role in the prevention and control of bleeding in high-demand haemostatic situations, such as major surgery, remains to be determined. Patients receiving regular emicizumab prophylaxis often require concomitant factor VIII (FVIII) therapy during major surgery to prevent uncontrolled bleeding and to promote postoperative healing. However, there are limited prospective surgical data relating to concomitant FVIII and emicizumab use. Simoctocog alfa (Nuwiq) is a B-domain deleted recombinant FVIII produced in a human cell line without chemical modification or protein fusion with proven efficacy as surgical prophylaxis in adult and paediatric patients. The Nuwiq for Perioperative management Of patients With haemophilia A on Emicizumab Regular prophylaxis (NuPOWER) study aims to examine perioperative efficacy and safety of simoctocog alfa in haemophilia A patients on emicizumab prophylaxis undergoing major surgery.

NuPOWER is a prospective, open-label, single-arm, multicentre study that will be conducted at approximately 15 centres worldwide. Up to 28 male patients ≥12 years with severe haemophilia A and no FVIII inhibitors will be recruited. All patients must be receiving regular emicizumab prophylaxis and scheduled to undergo a major surgical procedure during which concomitant simoctocog alfa will be administered. The primary endpoint is the overall haemostatic efficacy of simoctocog alfa, adjudicated by an independent data monitoring committee using a pre-defined algorithm, and will consider intraoperative and postoperative efficacy assessments by the surgeon and investigator, respectively. Secondary endpoints include intraoperative haemostatic efficacy, postoperative haemostatic efficacy, number of allogeneic blood products transfused, perioperative FVIII plasma levels (as measured by FVIII activity) and thrombin generation, and safety parameters. In the era of non-factor therapy, NuPOWER will generate valuable prospective data on concomitant use of simoctocog alfa and emicizumab prophylaxis in patients with severe haemophilia A undergoing major surgery.

Ethical approval has been received from institutional review boards/independent ethics committees, and the study will be conducted in compliance with the Declaration of Helsinki. This work will be disseminated by publication of peer-reviewed manuscripts and presentations at scientific meetings.

CT EU 2022-502060-21-00; NCT05935358.

To evaluate the cost-effectiveness of anti-vascular endothelial growth factor (VEGF) treatments for neovascular age-related macular degeneration (nAMD) using a value-based model that considers drug durability, dosing regimens and real-world administration strategies, including safe vial fractionation.

Model-based pharmacoeconomic analysis using data from randomised clinical trials and network meta-analyses. Analysis conducted from the payer perspective using cost data from the Spanish National Health System.

A model-based analysis compared five anti-VEGF agents—innovator and biosimilar ranibizumab, aflibercept 2 mg, brolucizumab and faricimab—across three dosing regimens: fixed, Pro Re Nata and Treat-and-Extend (TAE). Administration formats included single-use vials, prefilled syringes and vial fractionation (VF), with or without dead-space-free (DSF) syringes to minimise waste. The primary outcome was cost per optimal responder, defined as a patient gaining ≥15 Early Treatment Diabetic Retinopathy Study (ETDRS) letters, with and without adverse events. Cost-effectiveness was evaluated using Number Needed to Treat (NNT), Net Efficacy Adjusted for Risk-NNT (adjusted for safety) and incremental cost-effectiveness ratios. Secondary outcomes included the number of treated patients and optimal responders achievable within a fixed 1 000 000 budget.

The most cost-effective strategy was aflibercept 2 mg under a TAE regimen using DSF VF, with a total cost of 6214 per patient and a cost per optimal responder of 27 155. Under a fixed budget of 1 000 000, this approach allowed treatment of 160 patients, yielding 36 optimal responders. Faricimab with DSF VF ranked second, with a total cost of 5847 and a cost per optimal responder of 28 652, treating 171 patients and achieving 34 responders. In contrast, single-use vials without VF led to substantially higher total costs (eg, 11 305 for aflibercept TAE) and lower treatment capacity (eg, 88 patients treated).

This model demonstrates that combining durable agents, extended dosing intervals and optimised delivery strategies (eg, prefilled syringes and DSF VF) can substantially improve the cost-effectiveness and sustainability of anti-VEGF therapy in public health systems.

To estimate the frequency of antidiabetic prescriptions in type 2 diabetes mellitus (T2DM) in Spain and describe changes in prescription patterns between 2018–2022 and 2023-2024.

Observational study.

Patients from primary care centres newly diagnosed with T2DM in 2018–2022 and 2023–2024.

In each period, the prescription frequency of an antidiabetic medication at the diagnosis of T2DM was calculated and subsequently subdivided into monotherapy and combination therapy. The prescription frequency of the most common antidiabetic drugs was also calculated. Calculations were made for the entire group of subjects and stratified by sex and age (under 60 years and 60 years or older). Comparison of the frequencies between the two periods was performed using the chi-square test.

In 2018–2022 and 2023–2024, 78.4% and 88.9% of patients, respectively, were prescribed an antidiabetic medication. The prescription frequencies for monotherapy and combination therapy were 66.1% and 33.9% in the first period and 57.4% and 42.6% in the second. The prescription frequencies for metformin as monotherapy and combination therapy were 57.4% and 27.8% in the first period and 46.6% and 39.8% in the second. Prescribing metformin with sodium-glucose cotransporter-2 inhibitors (SGLT2i) and/or glucagon-like peptide receptor 1 agonists (GLP1a) was the most frequent combination therapy: 12.8% in 2018–2022 and 29.5% in 2023–2024. With a few exceptions, the prescribing pattern was similar by sex and age. The difference between the prescribing distributions in the two periods is significant.

Antidiabetic medication prescribing at the diagnosis of T2DM was high. Most prescriptions contained metformin. Monotherapy decreased in 2023–2024 compared with 2018–2022, while combination therapy increased due to increased prescriptions of metformin with SGLT2i and/or GLP1a.

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.

Misinformation about cardiovascular health has the potential to negatively impact public health outcomes. Understanding the nature and spread of such misinformation is crucial for developing effective interventions to mitigate this potential risk. However, despite the critical importance of this issue, there is a gap in comprehensive reviews mapping the existing literature on cardiovascular health misinformation. This scoping review aims to map the existing literature on cardiovascular health misinformation, identifying its spread, prevalence, impact and strategies for correction across diverse populations and settings.

This review will follow the Joanna Briggs Institute guidelines for conducting a scoping review. A comprehensive search will be conducted across multiple databases, including MEDLINE, EMBASE, SCOPUS and Web of Science, along with grey literature sources. The last date of search was January 2025. The review will include studies without date that involve individuals affected by cardiovascular disease (CVD) misinformation, examine the spread, prevalence, impact or correction of misinformation related to cardiovascular health, and capture various cultural, geographic or setting-specific factors. The exclusion criteria include studies that do not directly address misinformation related to CVD. All identified records will be imported into Covidence systematic review software. Two reviewers will independently screen titles and abstracts, followed by full-text reviews of potentially relevant studies. Discrepancies will be resolved through discussion or by consulting a third reviewer. Data extraction will be conducted by two reviewers using a pre-piloted tool, and a descriptive presentation of the findings will be done. Both inductive and deductive content analysis methods will be employed for objectives related to the impact and strategies to combat misinformation.

Given that the study involves synthesising data from existing published literature, ethical approval is not required. The findings will be disseminated through international conference presentations, published in a peer-reviewed journal and shared with public health organisations and policymakers.