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Open Access
Peer-reviewed
Research Article
Implementation of good clinical practice in clinical research in the context of limited resources settings: Lessons learnt from the freeBILy trial using an embedded mixed methods approach
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Leonard Gunga ,
Contributed equally to this work with: Leonard Gunga, Pia Rausche
Roles Conceptualization, Data curation, Formal analysis, Investigation, Project administration, Writing – original draft
Affiliations RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany, German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany
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Pia Rausche ,
Contributed equally to this work with: Leonard Gunga, Pia Rausche
Roles Conceptualization, Data curation, Formal analysis, Visualization, Writing – original draft
Affiliations RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany, German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany
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Rivo Andry Rakotoarivelo,
Roles Funding acquisition, Investigation, Writing – review & editing
Affiliation Infectious diseases service, University Hospital Tambohobe, Fianarantsoa, Madagascar
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Mandranto Rasamoelina,
Roles Funding acquisition, Investigation, Writing – review & editing
Affiliation Centre Infectiolologie Charles Mérieux (CICM), Antananarivo, Madagascar
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Jeannine Solonirina,
Roles Investigation, Writing – review & editing
Affiliation University Antananarivo, Antananarivo, Madagascar
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Elveric Fesia,
Roles Investigation, Writing – review & editing
Affiliation Infectious diseases service, University Hospital Tambohobe, Fianarantsoa, Madagascar
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Ravo Razafindrakoto,
Roles Investigation, Writing – review & editing
Affiliation Centre Infectiolologie Charles Mérieux (CICM), Antananarivo, Madagascar
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Njary Rakotozandrindrainy,
Roles Investigation, Writing – review & editing
Affiliation University Antananarivo, Antananarivo, Madagascar
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Mickael Radomanana,
Roles Investigation, Writing – review & editing
Affiliation Infectious diseases service, University Hospital Tambohobe, Fianarantsoa, Madagascar
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Valentina Marchese,
Roles Investigation, Writing – review & editing
Affiliations RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany, German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany
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Nagham Issa,
Roles Data curation, Formal analysis, Writing – review & editing
Affiliation RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany
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Jean-Marc Kutz,
Roles Investigation, Writing – review & editing
Affiliation RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany
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Aaron Remkes,
Roles Investigation, Writing – review & editing
Affiliations RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany, German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany
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Anna Jager,
Roles Investigation, Writing – review & editing
Affiliations German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany, Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany
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Dewi Ismajani Puraduredja,
Affiliation Interdisciplinary Academy of Competence and Education for Global Health (iACE), Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany
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Govert van Dam,
Roles Funding acquisition, Writing – review & editing
Affiliation Department of Parasitology, Leiden University Medical Center, Leiden, the Netherlands
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Norbert Schwarz,
Roles Funding acquisition, Writing – review & editing
Affiliation Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany
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Jürgen May,
Roles Funding acquisition, Writing – review & editing
Affiliations German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany, Department of Infectious Diseases Epidemiology, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany
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Raphaël Rakotozandrindrainy,
Roles Funding acquisition, Investigation, Project administration, Writing – review & editing
Affiliation University Antananarivo, Antananarivo, Madagascar
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Natalie Fischer ,
Roles Conceptualization, Formal analysis, Investigation, Project administration, Validation, Writing – original draft
¶‡ NF and DF also contributed equally to this work.
Affiliation RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany
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Daniela Fusco ,
Roles Conceptualization, Funding acquisition, Investigation, Methodology, Project administration, Validation, Writing – original draft
* E-mail: fusco@bnitm.de
¶‡ NF and DF also contributed equally to this work.
Affiliations RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany, German Center for Infection Research (DZIF), Hamburg-Borstel-Lübeck-Riems, Hamburg, Germany
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on behalf of the freeBILy consortium
¶Membership of freeBILy consortium is provided in the Acknowledgements.
Affiliation RG Implementation Research, Bernhard Nocht Institute for Tropical Medicine (BNITM), Hamburg, Germany
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Implementation of good clinical practice in clinical research in the context of limited resources settings: Lessons learnt from the freeBILy trial using an embedded mixed methods approach
- Leonard Gunga,
- Pia Rausche,
- Rivo Andry Rakotoarivelo,
- Mandranto Rasamoelina,
- Jeannine Solonirina,
- Elveric Fesia,
- Ravo Razafindrakoto,
- Njary Rakotozandrindrainy,
- Mickael Radomanana,
- Valentina Marchese
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- Published: February 9, 2026
- https://doi.org/10.1371/journal.pntd.0013899