Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance

John Olajide Olawepo, Department of Health Sciences, Northeastern University, Boston, Massachusetts, USA.
Echezona Edozie Ezeanolue, Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria eezeanolue@gmail.com.
Adanma Ekenna, Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria.
Olabanjo O. Ogunsola, APIN Public Health Initiatives, Abuja, FCT, Nigeria.
Ijeoma Uchenna Itanyi, Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria.
Elima Jedy-Agba, Institute of Human Virology Nigeria, Abuja, FCT, Nigeria.
Emmanuel Egbo, Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria.
Chukwudi Onwuchekwa, Caritas Nigeria, Abuja, FCT, Nigeria.
Alexandra Ezeonu, Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria.
Abiola Ajibola, Center for Integrated Health Programs (CIHP), Abuja, FCT, Nigeria.
Babayemi O. Olakunde, Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria.
Omololuoye Majekodunmi, FHI360, Abuja, FCT, Nigeria.
Amaka G. Ogidi, Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria.
JohnBosco Chukwuorji, Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria.
Nwamaka Lasebikan, Center for Translation and Implementation Research (CTAIR), University of Nigeria, Nsukka, Enugu, Nigeria.
Patrick Dakum, Institute of Human Virology Nigeria, Abuja, FCT, Nigeria.
Prosper Okonkwo, APIN Public Health Initiatives, Abuja, FCT, Nigeria.
Bolanle Oyeledun, Center for Integrated Health Programs (CIHP), Abuja, FCT, Nigeria.
John Oko, Caritas Nigeria, Abuja, FCT, Nigeria.
Hadiza Khamofu, FHI360, Abuja, FCT, Nigeria.
Akudo Ikpeazu, National AIDS, Viral Hepatitis and Sexually Transmitted Infections Control Programme, Federal Ministry of Health, Abuja, FCT, Nigeria.
Uchechukwu Emmanuel Nwokwu, National Cancer Control Programme, Federal Ministry of Health, Abuja, FCT, Nigeria.
Gambo Aliyu, National Agency for the Control of AIDS (NACA), Abuja, FCT, Nigeria.
Oladapo Shittu, Federal University of Health Sciences Otukpo, Otukpo, Benue State, Nigeria.
Anne F. Rositch, Department of Epidemiology, Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
Byron J. Powell, Center for Mental Health Services Research, Brown School at Washington University in St Louis, St Louis, Missouri, USA.
Donaldson F. Conserve, Department of Prevention and Community Health, Milken Institute School of Public Health, The George Washington University, Washington, DC, USA.
Gregory A. Aarons, Department of Psychiatry, University of California, San Diego, La Jolla, California, USA.
Ayodotun Olutola, Center for Clinical Care and Clinical Research, Abuja, FCT, Nigeria.

Document Type

Journal Article

Publication Date

4-1-2022

Journal

BMJ global health

Volume

7

Issue

4

DOI

10.1136/bmjgh-2021-008241

Keywords

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

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.

Department

Prevention and Community Health

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