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Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance
  1. John Olajide Olawepo1,2,
  2. Echezona Edozie Ezeanolue2,3,
  3. Adanma Ekenna2,4,
  4. Olabanjo O Ogunsola5,
  5. Ijeoma Uchenna Itanyi2,4,
  6. Elima Jedy-Agba6,
  7. Emmanuel Egbo2,
  8. Chukwudi Onwuchekwa7,
  9. Alexandra Ezeonu2,
  10. Abiola Ajibola8,
  11. Babayemi O Olakunde2,9,
  12. Omololuoye Majekodunmi10,
  13. Amaka G Ogidi2,
  14. JohnBosco Chukwuorji2,11,
  15. Nwamaka Lasebikan2,12,
  16. Patrick Dakum6,
  17. Prosper Okonkwo5,
  18. Bolanle Oyeledun8,
  19. John Oko7,
  20. Hadiza Khamofu10,
  21. Akudo Ikpeazu13,
  22. Uchechukwu Emmanuel Nwokwu14,
  23. Gambo Aliyu15,
  24. Oladapo Shittu16,
  25. Anne F Rositch17,
  26. Byron J Powell18,
  27. Donaldson F Conserve19,
  28. Gregory A Aarons20,
  29. Ayodotun Olutola21
  1. 1Department of Health Sciences, Northeastern University, Boston, Massachusetts, USA
  2. 2Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria
  3. 3Healthy Sunrise Foundation, Las Vegas, Nevada, USA
  4. 4Department of Community Medicine, University of Nigeria, Nsukka, Enugu, Nigeria
  5. 5APIN Public Health Initiatives, Abuja, FCT, Nigeria
  6. 6Institute of Human Virology Nigeria, Abuja, FCT, Nigeria
  7. 7Caritas Nigeria, Abuja, FCT, Nigeria
  8. 8Center for Integrated Health Programs (CIHP), Abuja, FCT, Nigeria
  9. 9Department of Community Prevention and Care Services, National Agency for Control of AIDS (NACA), Abuja, FCT, Nigeria
  10. 10FHI360, Abuja, FCT, Nigeria
  11. 11Department of Psychology, University of Nigeria, Nsukka, Enugu, Nigeria
  12. 12Oncology Center, University of Nigeria Teaching Hospital, Ituku Ozalla, Enugu, Nigeria
  13. 13National AIDS, Viral Hepatitis and Sexually Transmitted Infections Control Programme, Federal Ministry of Health, Abuja, FCT, Nigeria
  14. 14National Cancer Control Programme, Federal Ministry of Health, Abuja, FCT, Nigeria
  15. 15National Agency for the Control of AIDS (NACA), Abuja, FCT, Nigeria
  16. 16Federal University of Health Sciences Otukpo, Otukpo, Benue State, Nigeria
  17. 17Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA
  18. 18Center for Mental Health Services Research, Brown School at Washington University in St Louis, St Louis, Missouri, USA
  19. 19Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA
  20. 20Department of Psychiatry, University of California, San Diego, La Jolla, California, USA
  21. 21Center for Clinical Care and Clinical Research, Abuja, FCT, Nigeria
  1. Correspondence to Professor Echezona Edozie Ezeanolue; eezeanolue{at}gmail.com

Abstract

There is limited capacity and infrastructure in sub-Saharan Africa to conduct clinical trials for the identification of efficient and effective new prevention, diagnostic and treatment modalities to address the disproportionate burden of disease. This paper reports on the process to establish locally driven infrastructure for multicentre research and trials in Nigeria known as the Nigeria Implementation Science Alliance Model Innovation and Research Centres (NISA-MIRCs). We used a participatory approach to establish a research network of 21 high-volume health facilities selected from all 6 geopolitical zones in Nigeria capable of conducting clinical trials, implementation research using effectiveness-implementation hybrid designs and health system research. The NISA-MIRCs have a cumulative potential to recruit 60 000 women living with HIV and an age-matched cohort of HIV-uninfected women. We conducted a needs assessment, convened several stakeholder outreaches and engagement sessions, and established a governance structure. Additionally, we selected and trained a core research team, developed criteria for site selection, assessed site readiness for research and obtained ethical approval from a single national institutional review board. We used the Exploration, Preparation, Implementation, Sustainment framework to guide our reporting of the process in the development of this network. The NISA-MIRCs will provide a nationally representative infrastructure to initiate new studies, support collaborative research, inform policy decisions and thereby fill a significant research infrastructure gap in Africa’s most populous country.

  • Cohort study
  • Clinical trial
  • Maternal health
  • Public Health
  • HIV

Data availability statement

Data are available upon request.

http://creativecommons.org/licenses/by-nc/4.0/

This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.

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Data availability statement

Data are available upon request.

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Footnotes

  • Handling editor Seye Abimbola

  • Twitter @olawepo_john

  • Contributors All authors contributed substantially to the design of the work and/or the acquisition, analysis and interpretation of the data, contributed meaningfully to the drafting and/or revision of the manuscript and provided approval for the publication. EEE (on behalf of NISA) is the guarantor for this manuscript and accepts full responsibility for the work, had access to the data, and was responsible for the decision to publish.

  • Funding Nigeria Implementation Science Alliance (NISA),Centre for Translation and Implementation Research (CTAIR) at the University of Nigeria, Enugu and the Healthy Sunrise Foundation.

  • Map disclaimer The inclusion of any map (including the depiction of any boundaries therein), or of any geographic or locational reference, does not imply the expression of any opinion whatsoever on the part of BMJ concerning the legal status of any country, territory, jurisdiction or area or of its authorities. Any such expression remains solely that of the relevant source and is not endorsed by BMJ. Maps are provided without any warranty of any kind, either express or implied.

  • Competing interests None declared.

  • Provenance and peer review Not commissioned; externally peer reviewed.