Systemic sclerosis (SSc) is an autoimmune disorder causing progressive fibrosis of internal organs and skin, leading to increased thickness and rigidity. It frequently results in malnutrition, which can decrease survival rates and physical performance, while also imposing financial burdens on healthcare systems and society. Multimodal nutritional interventions may encompass various approaches, including nutritional counselling, consumption of oral nutritional supplements and disease-specific dietary regimens based on nutritional needs. The present clinical trial is designed to examine the effectiveness of multimodal nutritional intervention on nutritional status, quality of life, food intake, body composition and fatigue in patients with SSc.

This is a parallel, randomised, placebo-controlled clinical trial that will investigate the impacts of multimodal nutritional interventions in SSc patients. 46 qualified SSc participants will be chosen at random and given multimodal nutritional intervention or dietary recommendations for a period of 8 weeks. The primary outcomes of this study are changes in nutritional status and quality of life. The secondary outcomes include changes in body composition, fatigue, body weight, body mass index and calf circumference. Statistical analysis will be conducted using the SPSS software (Version 24).

The current trial received approval from the Medical Ethics Committee of Tehran University of Medical Sciences, Tehran, Iran (IR.TUMS.MEDICINE.REC.1403.345). The findings will be submitted to international, peer-reviewed publications and presented at national and international conferences.

IRCT20220208053971N4.

There is an absence of real-world evidence, especially from low- and middle-income countries (LMICs), on the implementation successes and challenges of COVID-19 Test and Treat (T&T) programmes. In 2022, nirmatrelvir/ritonavir was provided as standard of care for mild to moderate COVID-19 treatment in eight LMICs (Ghana, Kenya, Laos, Malawi, Nigeria, Rwanda, Uganda and Zambia). This manuscript describes a research protocol to study novel drug introduction during the COVID-19 health emergency, with implications and learnings for future pandemic preparedness. The goal of the study is to provide simultaneous programme learnings and improvements with programme rollout, to fill a gap in real-world implementation data on T&T programmes of oral antiviral treatment for COVID-19 and inform programme implementation and scale-up in other LMICs.

This multiple methods implementation research study is divided into three components to address key operational research objectives: (1) programme learnings, monitoring and evaluation; (2) patient-level programme impact; and (3) key stakeholder perspectives. Data collection will occur for a minimum of 6 months in each country up to the end of grant. Quantitative data will be analysed using descriptive statistics for each country and then aggregated across the programme countries. Stakeholder perspectives will be examined using the Consolidated Framework for Implementation Research implementation science framework and semistructured interviews.

This study was approved by the Duke University Institutional Review Board (Pro00111388). The study was also approved by the local institutional review boards in each country participating in individual-level data collection (objectives 2 and 3): Ghana, Malawi, Rwanda, Nigeria and Zambia. The study’s findings will be published in peer-reviewed journals and disseminated through dialogue events, national and international conferences and through social media.

NCT06360783.