{
  "abstract": "Background Preparedness for emerging pathogens can be strengthened by leveraging lessons from COVID-19 therapeutic trials. The COVERAGE Africa trial ( NCT04920838, ANRS033, 2021–22), one of the few COVID-19 therapeutics trials conducted in resource-limited settings, sought to identify early treatment strategies for ambulatory patients at-risk for severe disease in Guinea and Burkina Faso. This implementation research, based on secondary data from the Burkina Faso sites, aimed to document the trial’s implementation and to identify the factors that influence it.Methods The PEARLES framework was applied to identify and classify indicators related to political, economic, administrative, regulatory, logistical, ethical and societal factors influencing trial’s implementation. Data drawn from regulatory documents, weekly internal reports, financial documents, programmatic data, equipment receipt slips, contracts and logistical documents, as well as the dynamic of recruitment in the trial were analysed to describe these indicators as either facilitators—supporting the trial’s execution as planned—or barriers—causing delays, hindering progress or leading to deviations.Results Barriers to trial implementation included: (1) the trial’s adaptive design, needing iterative protocol amendments leading to regulatory delays that were aggravated by the misalignment between national and international care guidelines, (2) funding disbursement lags, (3) challenges in participants’ enrolment due to inadequate screening sites organisation that compromised patient confidentiality and (4) significant increase in the refusal rate during the trial, rising from 3% in 2021 to 38% in 2022. Despite these constraints, mitigation strategies such as prefinancing, mobile team deployment and site renovations enabled effective trial delivery. Strong governmental support, rapid mobilisation of funders and flexibility in staff deployment facilitated trial’s implementation.Conclusion To enhance trial readiness in emergency situations, countries need political commitment, preapproved protocols, dedicated research infrastructure and rapid funding mechanisms. Stakeholder engagement and preparedness exercises are essential to strengthen clinical trial capacity in low-resource settings particularly across sub-Saharan Africa.",
  "authors": [
    {
      "affiliations": [
        "National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Talence, Nouvelle-Aquitaine, France",
        "Department of Infectious Diseases, Centre MURAZ, Bobo-Dioulasso, Burkina Faso"
      ],
      "name": "Mwinmalo Inès Evelyne Da"
    },
    {
      "affiliations": [
        "National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Talence, Nouvelle-Aquitaine, France"
      ],
      "name": "Mélanie Plazy"
    },
    {
      "affiliations": [
        "National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Talence, Nouvelle-Aquitaine, France"
      ],
      "name": "Anthony L’hostellier"
    },
    {
      "affiliations": [
        "National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Talence, Nouvelle-Aquitaine, France",
        "Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, CHU Bordeaux GH Pellegrin, Bordeaux, Nouvelle-Aquitaine, France"
      ],
      "name": "Denis Malvy"
    },
    {
      "affiliations": [
        "National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Talence, Nouvelle-Aquitaine, France"
      ],
      "name": "Olivier Marcy"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, Centre MURAZ, Bobo-Dioulasso, Burkina Faso",
        "University of Daniel Ouezzin Coulibaly (UDOC), Dedougou, Burkina Faso"
      ],
      "name": "Abdramane Berthe"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, Centre MURAZ, Bobo-Dioulasso, Burkina Faso"
      ],
      "name": "Anselme Sanon"
    },
    {
      "affiliations": [
        "National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Talence, Nouvelle-Aquitaine, France"
      ],
      "name": "Camille Fritzell"
    },
    {
      "affiliations": [
        "Bacteriology–Virology Laboratory, University Hospital Sanou Souro, Bobo-Dioulasso, Hauts-Bassins Region, Burkina Faso"
      ],
      "name": "Abdoul-Salam Ouedraogo"
    },
    {
      "affiliations": [
        "Department of Infectious Diseases, Centre MURAZ, Bobo-Dioulasso, Burkina Faso",
        "Department of Infectious and Tropical Diseases, Sourou Sanou University Hospital Center, Bobo-Dioulasso, Hauts-Bassins Region, Burkina Faso"
      ],
      "name": "Armel Poda"
    },
    {
      "affiliations": [
        "National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Talence, Nouvelle-Aquitaine, France",
        "Department of Infectious Diseases and Tropical Medicine, Division of Tropical Medicine and Clinical International Health, CHU Bordeaux GH Pellegrin, Bordeaux, Nouvelle-Aquitaine, France"
      ],
      "name": "Alexandre Duvignaud"
    },
    {
      "affiliations": [
        "National Institute for Health and Medical Research (INSERM) UMR 1219, Research Institute for Sustainable Development (IRD) EMR 271, Bordeaux Population Health Centre, University of Bordeaux, Talence, Nouvelle-Aquitaine, France"
      ],
      "name": "Joanna Orne-Gliemann"
    }
  ],
  "title": "Investigation of barriers and facilitators to implementing a randomised controlled trial during health emergency using the PEARLES framework: insights from the coverage Africa trial on COVID-19 treatments in Burkina Faso",
  "uid": "c030a71e-38b5-5199-a5bb-ba29fe7060b5"
}