Mixed methods implementation research of oral antiviral treatment for COVID-19 in low- and middle-income countries: a study protocol.
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2025-09
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Abstract
Introduction
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.Methods and analysis
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.Ethics and dissemination
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.Trial registration number
NCT06360783.Type
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Narayanasamy, Shanti, Fiona Gambanga, Caroline E Boeke, Krishna Udayakumar, Leo Brothers, Cameron R Wolfe, Chukwuemeka Agwuocha, Maame Nkansaa Asamoa-Amoakohene, et al. (2025). Mixed methods implementation research of oral antiviral treatment for COVID-19 in low- and middle-income countries: a study protocol. BMJ open, 15(9). p. e088465. 10.1136/bmjopen-2024-088465 Retrieved from https://hdl.handle.net/10161/33904.
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Scholars@Duke
Shanti Narayanasamy
Krishnakumar Udayakumar
Dr. Krishna Udayakumar is the founding Director of the Duke Global Health Innovation Center, focused on generating deeper evidence and support for the study, scaling, and adaptation of health innovations and policy reforms globally. He is also Executive Director of Innovations in Healthcare, a non-profit co-founded by Duke, McKinsey & Company, and the World Economic Forum to curate and scale the impact of transformative health solutions globally.
At Duke University, Dr. Udayakumar holds the rank of Professor of Global Health along with a secondary faculty appointment in Medicine. He is a core faculty member of the Duke-Margolis Institute for Health Policy. His work has been published in leading academic journals such as the New England Journal of Medicine, Health Affairs, and Academic Medicine.
Born in Bangalore, India, Dr. Udayakumar spent his childhood in Virginia, and is a Phi Beta Kappa graduate of the University of Virginia, with a bachelor’s degree in interdisciplinary studies with distinction. He received both an MD and an MBA (with a concentration in Health Sector Management) from Duke University, where he was a Fuqua Scholar. Dr. Udayakumar completed his residency training in internal medicine at Duke and served as Assistant Chief Resident at the Durham VA Medical Center before joining the faculty of Duke University.
Cameron Robert Wolfe
HIV infection, Transplant-related infectious diseases, general infectious diseases, Biological and Emergency Preparedness for hospital systems, influenza and respiratory viral pathogens
Hayden Barry Bosworth
Dr. Bosworth is a health services researcher and Deputy Director of the Center of Innovation to Accelerate Discovery and Practice Transformation (ADAPT) at the Durham VA Medical Center. He is also Vice Chair of Education and Professor of Population Health Sciences. He is also a Professor of Medicine, Psychiatry, and Nursing at Duke University Medical Center and Adjunct Professor in Health Policy and Administration at the School of Public Health at the University of North Carolina at Chapel Hill. His research interests comprise three overarching areas of research: 1) clinical research that provides knowledge for improving patients’ treatment adherence and self-management in chronic care; 2) translation research to improve access to quality of care; and 3) eliminate health care disparities.
Dr. Bosworth is the recipient of an American Heart Association established investigator award, the 2013 VA Undersecretary Award for Outstanding Achievement in Health Services Research (The annual award is the highest honor for VA health services researchers), and a VA Senior Career Scientist Award. In terms of self-management, Dr. Bosworth has expertise developing interventions to improve health behaviors related to hypertension, coronary artery disease, and depression, and has been developing and implementing tailored patient interventions to reduce the burden of other chronic diseases. These trials focus on motivating individuals to initiate health behaviors and sustaining them long term and use members of the healthcare team, particularly pharmacists and nurses. He has been the Principal Investigator of over 30 trials resulting in over 400 peer reviewed publications and four books. This work has been or is being implemented in multiple arenas including Medicaid of North Carolina, private payers, The United Kingdom National Health System Direct, Kaiser Health care system, and the Veterans Affairs.
Areas of Expertise: Health Behavior, Health Services Research, Implementation Science, Health Measurement, and Health Policy
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