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Abstracts of Poster and e-Poster Presentations
PA-675 Navigating the COVID-19 pandemic for participant recruitment and follow-up: experiences from the PediCAP clinical trial consortium
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  1. Andrew Kiggwe1,2,
  2. Damalie Nalwanga1,3,
  3. Abner Tagoola4,
  4. Shabir Madhi5,
  5. David Moore5,
  6. Moherndran Archary Archary6,
  7. Veronica Mulenga7,8,
  8. Hilda Angela Mujuru9,10,
  9. Jahit Sacarlal11,
  10. Chris Buck11,12,
  11. Muhammad Sidat11,
  12. Hanh Nguyen13,
  13. Farjana Haque13,
  14. Emily Dennis13,
  15. Michelle Clements13,
  16. Brendan Murphy13,
  17. Ben Spittle13,
  18. Francesca Viero14,
  19. Julia Bielick15,
  20. Victor Musiime1,3,
  21. Mike Sharland15
  1. 1Makerere University Lung Institute, Uganda
  2. 2China Uganda Friendship Hospital – Naguru, Uganda
  3. 3Makerere University, College of Health Sciences, Department of Paediatrics and Child Health, Uganda
  4. 4Jinja Regional Referral Hospital, Uganda
  5. 5Chris Hani Baragwanath Academic Hospital, South Africa
  6. 6Africa Health Research Institute, King Edward VIII Hospital, South Africa
  7. 7University Teaching Hospital, Zambia
  8. 8Chawama Level 1 Hospital, Zambia
  9. 9University of Zimbabwe Clinical Research Centre, Zimbabwe
  10. 10Chitungwiza Hospital, Zimbabwe
  11. 11Universidade Eduardo Mondlane Faculdade de Medicina, Mozambique
  12. 12University of California Los Angeles David Geffen School of Medicine, USA
  13. 13Medical Research Council Clinical Trials Unit at University College London, UK
  14. 14Fondazione PENTA ONLUS, Italy
  15. 15St George’s University of London, UK

Abstract

Background COVID-19, first reported in Wuhan, China in December 2019, was declared a pandemic in March 2020, causing restrictions of movement of people and goods worldwide. This affected every aspect of life, including the conduct of clinical trials. We highlight the challenges faced by the PediCAP consortium and how we navigated them.

Methods The PediCAP consortium is composed of 14 partners (https://projectpedicap.org/the-consortium/) in Africa and Europe. The EDCTP-funded clinical trial (ISRCTN63115131) is enrolling children aged 2months to 6years with pneumonia in Mozambique, Uganda, South Africa, Zambia and Zimbabwe. Participant recruitment started in December 2020, during the COVID-19 pandemic; and by end of April 2023, 987 of the targeted 1100 participants (89.7%) had been enrolled. The challenges faced by the clinical sites, and measures taken to mitigate them, were obtained from minutes of monthly teleconferences and interviews with site staff, and summarized in themes.

Results The following were reported as challenges and their mitigating measures:

  • Delays in obtaining ethical and regulatory approvals: Ethical and regulatory bodies adopted paperless submissions, virtual review meetings, and used online tools to interact with applicants.

  • Slow recruitment of participants resulting from reduction in numbers of patients attending hospitals, due to fear of contracting COVID-19, and lockdowns restricting movement. This was solved by adding a partner and satellite sites. Additionally, a no-cost extension of the project was made to allow for extension of the recruitment period.

  • Site initiation, protocol training, procurement of trial drugs, and clinical trial monitoring were delayed/problematic. The sponsor adopted virtual platforms and local monitors to mitigate this.

  • A need to protect site staff and participants from contracting COVID-19. Country specific COVID-19 risk management plans were developed and implemented.

Conclusion COVID-19 impeded smooth progress of PediCAP trial activities. However, a joint and collaborative effort was key in navigating the challenges.

https://doi.org/10.1136/bmjgh-2023-EDC.264

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