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. 2021 Jul 9;16(7):e0252905. doi: 10.1371/journal.pone.0252905

Table 1. Overview of EVICT study implementation, host and visitor country considerations*.

Key Process of Clinical Research and Goals (Bulleted) Stakeholders involved/Steps Taken
Definition of the patient care question and approach
  • Identify the problem and impact (i.e. Ebola virus persistence in patients needing cataract surgery)

  • Outline the approach to patient care

  • Patients–Ebola survivors and close-contacts of Ebola survivors with potential exposure

  • Ministry of Health and Sanitation National Eye Program ophthalmologists, eye surgeons and mid-level providers

  • Emory Ophthalmology, Infectious Disease specialists

  • Partners in Health and multiple non-governmental organizations (NGOs)

  • World Health Organization and public health experts

  • Centers for Disease Control and Prevention

Ethics and Institutional Review Board approval
  • Independent review of benefit of study, safety, and informed consent process

  • Host in-country and external approvals

  • Annual review to ensure amendments, consents and protocol up-to-date

  • Sierra Leone Ministry of Health and Sanitation Ethics and Institutional Review Board Committee

Emory University Institutional Review Board
Partnership Alignment
  • Programmatic support

  • Identification of patient populations and need

  • Patient mobilization

  • Technical guidance and expertise

  • Public health awareness and guidanace

  • Guidance for patient sensitivity, study awareness, and sociocultural considerations

  • Ministry of Health and Sanitation National Eye Programme, Sierra Leone

  • Ministry of Health and Sanitation Chief Medical Officer, District Medical Officers, and medical leadership

  • Sierra Leone Association of Ebola Survivors/Survivor Health Advocates

  • Emory Ophthalmologists, Infectious Disease specialists

  • World Health Organization Global Outbreak Alert Response Network

  • Lead NGO–Partners in Health

  • Multiple NGOs involved in Ebola response–MSF, GOAL, Save the Children

Laboratory Alignment
  • Ensure accurate testing to answer clinical research questions related to patient care

  • Quality control for specimen handling (i.e. infectious pathogen transport, temperature regulation)

  • Kenema Government Hospital Lassa Fever laboratory

  • Centers for Disease Control and Prevention (Materials Transfer Agreement for Import/Export and laboratory guidance)

  • Kissy United Methodist Church in-hospital laboratory

  • China Centers for Disease Control and Prevention

  • United States Army Medical Research Institute of Infectious Diseases (US AMRIID)

Site Selection and Approval
  • Verification of adequate space for procedure, ocular fluid sample handling and storage

  • Verification of site for infection prevention and control precautions

  • Local hospital, medical board, and institutional approvals prior to study

  • Ministry of Health and Sanitation National Eye Programme Ophthalmologists

  • Lowell and Ruth Gess Eye Hospital leadership

  • Kissy United Methodist Church Medical Board

  • Non-government organization guidance and support (i.e. Central Global Vision Fund)

  • Emory University Infectious Disease and Ophthalmology service verification of site and study design

Patient Mobilization and Program Implementation
  • Ensure adequate patient recruitment

  • Address patient clinical service needs

  • Promote understanding of research protocol, clinical need, potential benefits and risks to Ebola survivors

  • Communicate program and support informed consent for patients with adequate interpretation

  • Ministry of Health and Sanitation, Sierra Leone–Comprehensive Program for Ebola Survivors

  • Sierra Leone Association of Ebola Survivors and Survivor Health Advocates

  • Partners in Health and NGOs involved in Ebola outbreak response

Preoperative Ophthalmic Examination, EVICT Study Procedures
  • Design workflows for high-volume EVICT patient screening in urban and rural settings

  • Conduct visual acuity, ophthalmic exam and diagnostic procedures

  • Perform ocular fluid sampling for EVD survivors

  • Perform cataract surgery using manual small incision cataract surgery

  • Provide opportunities for education for local mid-level providers, and ophthalmologists from Sierra Leone and Guinea

  • Ensure long-term follow-up for patients following cataract surgery

  • Ministry of Health and Sanitation Sierra Leone ophthalmologists and mid-level providers

  • Ophthalmologist based at Lowell and Ruth Gess Eye Hospital

  • Research administrative lead from Lowell Ruth Gess Eye Hospital

  • Ophthalmic technicians from Lowell and Ruth Gess Eye Hospital

  • Emory University ophthalmologists and partners

  • Emory University Infectious Disease physicians for IPC monitoring during study procedure

  • Kissy United Methodist Church Hospital anesthesia technician

  • Other study personnel: Hygienist, Phlebotomist

  • Visiting ophthalmologists from Guinea

*Key process steps of clinical research and their goals are shown. These steps involved stakeholders in-country and visitor country organizations and institutions involved in implementing the clinical research project. Steps included definition of key patient needs and approaches, ethical and regulatory approvals, partnership alignment, laboratory alignment, site selection, patient mobilization, patient protection, and sociocultural context for proper program implementation of the technical demands of the project (i.e. patient evaluation, procedures, surgery, and ensuring appropriate long-term follow-up).