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PA-477 Building a national network for inpatient pediatric clinical research in Mozambique
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  1. Jahit Sacarlal1,
  2. W Chris Buck1,2,
  3. Alfeu Passanduca1,
  4. Eugénia Macassa1,3,
  5. Alarquia Saíde4,
  6. Kajal Chhaganlal5,
  7. Merunissa Gafur6,
  8. Amir Seni5,7,
  9. Sara Machava8,
  10. Luzidina Martins9,
  11. Faiaz Issa10,
  12. Eleutéria Macanze8,
  13. Nádia Manjate9,
  14. Sílvia Chaúque10,
  15. Stella Langa1,3,
  16. Muhammad Sidat1,
  17. Uneisse Cassia1,
  18. Atija Salimo4,
  19. Celda Mavume1,
  20. Cláudia Massitela1,
  21. Alice Maieca1,
  22. Winete Joaquim1,
  23. Sónia Martins1,
  24. Quim Adriano1,
  25. Mastalina Zandamela11,
  26. Justina Bramugy11,
  27. Quique Bassat11,12,
  28. Cinta Moraleda13,
  29. Alfredo Tagarro13,
  30. Mike Sharland14,
  31. Pablo Rojo13,15,16
  1. 1Universidade Eduardo Mondlane Faculdade de Medicina, Mozambique
  2. 2University of California Los Angeles David Geffen School of Medicine, USA
  3. 3Hospital Central de Maputo, Mozambique
  4. 4Universidade Lúrio Faculdade de Ciências de Saúde, Mozambique
  5. 5Universidade Católica de Moçambique Faculdade de Ciências de Saúde, Mozambique
  6. 6Hospital Central de Nampula, Mozambique
  7. 7Hospital Central de Beira, Mozambique
  8. 8Hospital Provincial da Matola, Mozambique
  9. 9Hospital Geral de Mavalane, Mozambique
  10. 10Hospital Geral José Macamo, Maputo, Mozambique
  11. 11Centro de Investigação em Saúde de Manhiça (CISM), Mozambique
  12. 12ISGlobal, Hospital Clínic – Universitat de Barcelona, Spain
  13. 13Paediatric Unit for Research and Clinical Trials (UPIC), Hospital 12 de Octubre Health Research Institute (i+12), Spain
  14. 14St George’s University of London, UK
  15. 15Universidad Complutense, Spain
  16. 16Servicio Madrileño de Salud (SERMAS), 12 de Octubre University Hospital-Paediatric Unit for Research and Clinical Trials (UPIC), Spain

Abstract

Background Universidade Eduardo Mondlane (UEM) and Hospital Central de Maputo (HCM) were invited to join a consortium of established pediatric research groups from 5 other sub-Saharan Africa countries in a proposal for the EMPIRICAL trial, which received EDCTP funding in 2019 (RIA2017MC-2013). At that time, HCM and UEM did not have an active pediatric research team, nor a history of collaboration on a pediatric clinical trial.

Methods A research office was established on the HCM pediatric wards. Procurement and laboratory cooperation was established with another Mozambique recruiting site, Centro de Investigação em Saúde de Manhiça. Dedicated and part-time staff were hired, including an HCM pediatrician and nurse. Comprehensive research training was conducted, and the first EMPIRICAL patient was recruited in May 2020. Due to slow recruitment across the consortium, UEM agreed to extend to an additional 3 hospitals in Maputo, again including Ministry of Health staff at each new site. Recruitment was similarly extended to the principal referral/academic hospitals in the other regions of Mozambique with inclusion of Hospital Central de Beira in 2020 and Hospital Central de Nampula in 2021, in partnership with Universidade Católica de Moçambique and Universidade Lúrio. This network has led recruitment in EMPIRICAL, is participating in four pharmacokinetic substudies and an autopsy substudy, and has 2 local ancillary studies, one with EDCTP Career Development Fellowship support (TMA2020CDF-3217).

Results The infrastructure and capacity established through EMPIRICAL has been leveraged for additional pediatric inpatient research opportunties, with UEM leading 4 hospitals participating in the EDCTP-funded PediCAP trial (RIA2017MC-2023), and 2 hospitals in the UNITED-meningitis diagnostic study.

Conclusion A successful pediatric inpatient research network was quickly established in Mozambique with donor support that facilitated capacity building, and a model that prioritized inclusion of Ministry of Health hospital staff in research teams with inter-institutional collaboration to achieve national coverage.

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