Pre-positioned Outbreak Research: The Joint Medical Emerging Diseases Intervention Clinical Capability Experience in Uganda

Karen A Martins¹, Rodgers R Ayebare¹, Nahid Bhadelia¹, Francis Kiweewa¹, Peter Waitt¹, Derrick Mimbe¹, Stephen Okello¹, Prossy Naluyima¹, David M Brett-Major¹, James V Lawler¹, Monica Millard¹, Richard Walwema¹, Anthony P Cardile¹, Chi Ritchie¹, Antonia Kwiecien¹, Helen Badu¹, Benjamin J Espinosa¹, Charmagne Beckett¹, Sina Bavari¹, Saima Zaman¹, George Christopher¹, Danielle V Clark¹, Mohammed Lamorde¹, Hannah Kibuuka¹

Affiliations

Affiliation

¹ Karen A. Martins, PhD, is Research Health Science Program Manager, Medical Division; Chi Ritchie, MT, M(ASCP), is a Microbiologist; and Sina Bavari, PhD, is Science Director; all at the US Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD. Rodgers R. Ayebare, MB ChB, CIC, is Site Coordinator; and Peter Waitt, MD, is Clinical Lead, Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC), Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda. Nahid Bhadelia, MD, MA, is Associate Professor and Medical Director, Special Pathogens Unit, Section of Infectious Diseases, Boston University School of Medicine, Boston, MA. Francis Kiweewa, MD, is Head of Research and Scientific Affairs, Makerere University Walter Reed Project, and Strengthening Institutional Capacity for Research Administration (SICRA), Kampala, Uganda. Derrick Mimbe, MSC, and Stephen Okello, MD, are Program Managers, JMEDICC; Prossy Naluyima, PhD, is Laboratory Director; and Hannah Kibuuka, MD, is Executive Director, all in the Makerere University Walter Reed Project, Kampala, Uganda. David M. Brett-Major, MD, MPH, is a Professor, College of Public Health, and James V. Lawler, MD, MPH, is Executive Director, International Programs and Innovation, Global Center for Health Security and Division of Infectious Diseases; both at the University of Nebraska Medical Center, Omaha, NE. Monica Millard, MPH, is Country Program Director, US Army Medical Research Directorate-Africa/Uganda (MRD-A/U), Walter Reed Army Institute of Research (WRAIR), Kampala, Uganda. Richard Walwema is a Laboratorian, and Mohammed Lamorde, PhD, is Head of Global Health Security, Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda. Anthony P. Cardile, DO, is at the Richard Barquist US Army Health Clinic, Ft. Detrick, MD. Antonia Kwiecien and Helen Badu are International Program Managers-Uganda, and Danielle V. Clark, PhD, is Director; all at Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO), Henry M. Jackson Foundation, Bethesda, MD. Benjamin J. Espinosa, PhD, is Deputy Director, Biological Defense Research Directorate, Naval Medical Research Center, Frederick, MD. Charmagne Beckett, MD MPH, is with the Infectious Diseases Directorate, Naval Medical Research Center, Silver Spring, MD. Saima Zaman, MPH, is International Project Manager, Biological Threat Reduction Program, Defense Threat Reduction Agency, Fort Belvoir, VA. George Christopher, MD, is Joint Project Manager, Chemical, Biological, Radiological, and Nuclear Medical, Joint Program Executive Office for CBRN Defense, US Department of Defense, Fort Detrick, MD.

PMID: 32324070
DOI: 10.1089/hs.2019.0112

Pre-positioned Outbreak Research: The Joint Medical Emerging Diseases Intervention Clinical Capability Experience in Uganda

Karen A Martins et al. Health Secur. 2020 Mar/Apr.

. 2020 Mar/Apr;18(2):114-124.

doi: 10.1089/hs.2019.0112.

Authors

Affiliation

¹ Karen A. Martins, PhD, is Research Health Science Program Manager, Medical Division; Chi Ritchie, MT, M(ASCP), is a Microbiologist; and Sina Bavari, PhD, is Science Director; all at the US Army Medical Research Institute of Infectious Diseases (USAMRIID), Fort Detrick, MD. Rodgers R. Ayebare, MB ChB, CIC, is Site Coordinator; and Peter Waitt, MD, is Clinical Lead, Joint Mobile Emerging Disease Intervention Clinical Capability (JMEDICC), Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda. Nahid Bhadelia, MD, MA, is Associate Professor and Medical Director, Special Pathogens Unit, Section of Infectious Diseases, Boston University School of Medicine, Boston, MA. Francis Kiweewa, MD, is Head of Research and Scientific Affairs, Makerere University Walter Reed Project, and Strengthening Institutional Capacity for Research Administration (SICRA), Kampala, Uganda. Derrick Mimbe, MSC, and Stephen Okello, MD, are Program Managers, JMEDICC; Prossy Naluyima, PhD, is Laboratory Director; and Hannah Kibuuka, MD, is Executive Director, all in the Makerere University Walter Reed Project, Kampala, Uganda. David M. Brett-Major, MD, MPH, is a Professor, College of Public Health, and James V. Lawler, MD, MPH, is Executive Director, International Programs and Innovation, Global Center for Health Security and Division of Infectious Diseases; both at the University of Nebraska Medical Center, Omaha, NE. Monica Millard, MPH, is Country Program Director, US Army Medical Research Directorate-Africa/Uganda (MRD-A/U), Walter Reed Army Institute of Research (WRAIR), Kampala, Uganda. Richard Walwema is a Laboratorian, and Mohammed Lamorde, PhD, is Head of Global Health Security, Infectious Diseases Institute, College of Health Sciences, Makerere University, Kampala, Uganda. Anthony P. Cardile, DO, is at the Richard Barquist US Army Health Clinic, Ft. Detrick, MD. Antonia Kwiecien and Helen Badu are International Program Managers-Uganda, and Danielle V. Clark, PhD, is Director; all at Austere environments Consortium for Enhanced Sepsis Outcomes (ACESO), Henry M. Jackson Foundation, Bethesda, MD. Benjamin J. Espinosa, PhD, is Deputy Director, Biological Defense Research Directorate, Naval Medical Research Center, Frederick, MD. Charmagne Beckett, MD MPH, is with the Infectious Diseases Directorate, Naval Medical Research Center, Silver Spring, MD. Saima Zaman, MPH, is International Project Manager, Biological Threat Reduction Program, Defense Threat Reduction Agency, Fort Belvoir, VA. George Christopher, MD, is Joint Project Manager, Chemical, Biological, Radiological, and Nuclear Medical, Joint Program Executive Office for CBRN Defense, US Department of Defense, Fort Detrick, MD.

PMID: 32324070
DOI: 10.1089/hs.2019.0112

Abstract

The West Africa Ebola virus disease outbreak of 2014-2016 demonstrated that responses to viral hemorrhagic fever epidemics must go beyond emergency stopgap measures and should incorporate high-quality medical care and clinical research. Optimal patient management is essential to improving outcomes, and it must be implemented regardless of geographical location or patient socioeconomic status. Coupling clinical research with improved care has a significant added benefit: Improved data quality and management can guide the development of more effective supportive care algorithms and can support regulatory approvals of investigational medical countermeasures (MCMs), which can alter the cycle of emergency response to reemerging pathogens. However, executing clinical research during outbreaks of high-consequence pathogens is complicated and comes with ethical and research regulatory challenges. Aggressive care and excellent quality control must be balanced by the requirements of an appropriate infection prevention and control posture for healthcare workers and by overcoming the resource limitations inherent in many outbreak settings. The Joint Mobile Emerging Disease Intervention Clinical Capability was established in 2015 to develop a high-quality clinical trial capability in Uganda to support rigorous evaluation of MCMs targeting high-consequence pathogens like Ebola virus. This capability assembles clinicians, laboratorians, clinical researchers, logisticians, and regulatory professionals trained in infection prevention and control and in good clinical and good clinical laboratory practices. The resulting team is prepared to provide high-quality medical care and clinical research during high-consequence outbreaks.

Keywords: Infectious diseases; Medical countermeasures; Outbreak response; Uganda; Viral hemorrhagic fevers.

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Pre-positioned Outbreak Research: The Joint Medical Emerging Diseases Intervention Clinical Capability Experience in Uganda

Affiliation

Pre-positioned Outbreak Research: The Joint Medical Emerging Diseases Intervention Clinical Capability Experience in Uganda

Authors

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Abstract

MeSH terms

LinkOut - more resources

Full Text Sources

Medical