key: cord-0030806-ld2ljw1h
authors: Olawepo, John Olajide; Ezeanolue, Echezona Edozie; Ekenna, Adanma; Ogunsola, Olabanjo O; Itanyi, Ijeoma Uchenna; Jedy-Agba, Elima; Egbo, Emmanuel; Onwuchekwa, Chukwudi; Ezeonu, Alexandra; Ajibola, Abiola; Olakunde, Babayemi O; Majekodunmi, Omololuoye; Ogidi, Amaka G; Chukwuorji, JohnBosco; Lasebikan, Nwamaka; Dakum, Patrick; Okonkwo, Prosper; Oyeledun, Bolanle; Oko, John; Khamofu, Hadiza; Ikpeazu, Akudo; Nwokwu, Uchechukwu Emmanuel; Aliyu, Gambo; Shittu, Oladapo; Rositch, Anne F; Powell, Byron J; Conserve, Donaldson F; Aarons, Gregory A; Olutola, Ayodotun
title: Building a national framework for multicentre research and clinical trials: experience from the Nigeria Implementation Science Alliance
date: 2022-04-21
journal: BMJ Glob Health
DOI: 10.1136/bmjgh-2021-008241
sha: 3f0aa16b4b1a174ed20abc8bd717f902769d8e77
doc_id: 30806
cord_uid: ld2ljw1h

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.

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.

BACKGROUND Individuals living in low-income and middleincome countries (LMICs) bear a large proportion of the global disease burden for communicable and non-communicable diseases. 1 In order to decrease this burden, implementation science, the study of methods to promote the adoption and integration of evidence-based practices (EBP), interventions and policies into routine healthcare and public health settings, is critical. 2 Clinical trials for identification of efficient and effective new prevention, diagnostic and treatment modalities are also needed to address the disproportionately high burden of communicable (e.g., HIV, tuberculosis and malaria) and non-communicable diseases (e.g., cancer,

⇒ Lack of research infrastructure has limited the participation of many low-income and middle-income countries (LMICs) in clinical and implementation research and the generation of scientific knowledge on diseases that primarily affect their population. ⇒ The Nigeria Implementation Science Alliance (NISA) developed the research infrastructure at 21 highvolume health facilities across all six geopolitical regions in Nigeria to create the Model Innovation and Research Centres (NISA-MIRCs) with the capacity to conduct clinical and implementation research. ⇒ Our study documents the process including implementation strategies applied in the development of the NISA-MIRCs and shares lessons learnt that could inform planning and strategy decisions in other LMICs. ⇒ The NISA-MIRCs provide an important foundation and research infrastructure that can support the growing number of professionals interested in clinical and implementation research in Nigeria.

hypertension and diabetes) in LMICs. However, in many LMICs, especially in sub-Saharan Africa (SSA), there are limited infrastructures to conduct clinical trials and implementation research that drive scientific discovery and answer questions on local and regional health challenges, including multimorbidities such as HIV and cancer. 3 4 The process of building research collaborations that develop local research infrastructure is poorly described in the literature. Nigeria has the largest population in Africa and the third largest HIV burden in the world with an estimated 1.7 million people living with HIV (PLWH). 5 Fifty-six per cent (estimated at 960 000) of PLWH are females aged 15 years and older, while 7.6% (130 000) are children 14 years old or younger. 5 With funding from the US President's Emergency Plan for AIDS Relief (PEPFAR) and the Global Fund, plus advances in drug development, there has been significant progress in HIV treatment over the last two decades with expansion of testing and treatment access and reduction of new infections. [6] [7] [8] [9] Since 2004 when the HIV program commenced in Nigeria, over $6 billion has been invested by global partners. 10 11 Overall, 90% of PLWH have been diagnosed, 86% of those diagnosed placed on antiretroviral therapy (ART), and 72% of those on treatment achieved viral suppression in 2020. 5 An estimated 9 62 578 women are currently receiving care through PEPFAR-supported facilities in Nigeria. Although the country has made significant progress by reducing the number of new annual HIV infections among children from 58 000 in 2014 12 to 21 000 in 2020, 5 13 significant gaps remain along the prevention of mother-to-child transmission of HIV (PMTCT) continuum of care. 14 Nigeria still has a final MTCT of HIV rate of 25% and this contributes about 14% of the global burden of children infected through MTCT. 13 15 Nigeria remains as only one of the four countries in the world where annual new HIV infections among children are 10 000 or more. 13 16 Several barriers to progress in eliminating mother-to-child HIV transmission in Nigeria have been identified including low uptake of PMTCT and ART services, stigma and poor attitudes towards PMTCT, poor understanding of the impact of community-based services, and poor health financing. 17 With about 2277 health facilities 18 providing comprehensive HIV treatment services across the 6 geopolitical regions of Nigeria, a total of 1.5 million people have been placed on ART. 18 More recently, there have been efforts to build on the HIV service infrastructure by integrating testing for other diseases (e.g., hepatitis B, sickle cell disease, hypertension, perinatal depression) [19] [20] [21] [22] [23] and integrating other health services (e.g., cancer prevention). 24 There have been calls to also leverage these comprehensive HIV treatment sites to develop infrastructure to test new innovations, drugs and programs. Several gaps and challenges have been identified in the effort to build capacity for clinical trials and implementation research in resource-limited settings. These include insufficient funding for research, inadequate infrastructure for research, research-policy misalignment and poor mentorship. 3 25-28 Several efforts are being made to improve recruitment and participation in clinical trials around the world. 3 4 28 29 While some success has been recorded in building the capacity and infrastructure for research, sustainability remains a challenge. 3 4 30 For example, Teklu et al developed a clinical longitudinal cohort of PLWH in Ethiopia to study the impact of ART on women living with HIV (WLWH), but the cohort collapsed after funding ended. 28 Imam et al also documented challenges with recruiting sufficient in-country specialists in The Gambia. 4 A recent systematic review identified specific challenges with funding and complex regulatory and prolonged administrative processes. 3 Some of these challenges remain even in high-income countries. The USA still struggles to recruit minorities into clinical trials to achieve the diversity needed to understand the effect of drugs on its diverse population. [31] [32] [33] The National Institutes of Health (NIH) in the USA developed a framework to create a large national consortium of cohorts with one million Americans, and identified several challenges that include feasibility, coordination and ongoing funding. 29 Researchers and stakeholders in Nigeria have therefore sought to address similar challenges by forming strategic alliances and multicentre collaborative research projects to study our diverse participant population.

The Nigeria Implementation Science Alliance Formed in 2015 in collaboration with the NIH Fogarty International Centre, the Nigeria Implementation Science Alliance (NISA) is a consortium of 20 organisations that include academic institutions, local PEPFARsupported implementing partners (IPs), and policymakers (e.g., Ministry of Health). The core vision of NISA is to (1) create a dissemination platform to share experiences on what has worked and what is not working, (2) enhance the capacity of a well-educated workforce for research focused on implementation science and clinical trials, and (3) build research infrastructure and develop the capacity of the comprehensive HIV treatment centres to conduct clinical and implementation research. 34 NISA has been used as a case study for sustainability of research networks in LMICs with similar infrastructure being funded by Adolescent HIV Prevention and Treatment Implementation Science Alliance (AHISA) and Central and West Africa Implementation Science Alliance (CAWISA). 35 36 Model Innovation and Research Centres NISA had a goal to build a cohort of the existing health facilities into Model Innovation and Research Centres (MIRCs) in order to advance the implementation of evidence-based interventions to improve public health and clinical outcomes for diseases of public health importance in Nigeria. 25 37 To establish these MIRCs, NISA has leveraged the PEPFAR-supported infrastructure and the expertise among its members in cohort design, research BMJ Global Health methodologies and participant recruitment and management. NISA also relied on the leadership of the Centre for Translation and Implementation Research (CTAIR) at the University of Nigeria which acts as the NISA research coordinating unit. Following the identification and establishment of these MIRCs, NISA has embarked on its first project, a two-step approach to build a multicentre longitudinal clinical and epidemiological cohort of HIV-infected and age-matched HIV-uninfected women of reproductive age (15-49 years) . This paper reports on the process NISA used to establish the NISA-MIRCs, providing a model that could catalyse implementation science and clinical trials at the national level and across SSA. A companion paper will report on the baseline description and characteristics of participants being recruited at these centres and their health outcomes.

We used the Exploration, Preparation, Implementation, Sustainment (EPIS) framework to organise the reporting of the development of the NISA-MIRCs. 38 39 EPIS is a process and determinant framework that was developed to facilitate the implementation and sustainment of EBP in public sectors. 38 39 We selected this framework because of its importance in guiding the implementation process in different settings, including low-income countries. 39 EPIS comprises four key phases (EPIS), enumerates potential influencing factors (i.e., determinants and mechanisms) in each phase across levels of outer and inner contexts, and considers the 'bridging factors' that represent unidirectional or bidirectional influences between the outer system and inner organisational contexts, and characteristics of the innovation(s) being implemented. 38 39 The outer context (system) represents larger, often external, factors such as federal, state or local policies, funding, leadership and interorganisational environment and networks that can either facilitate or hinder implementation. 38 39 The inner context (organisation/clinic) represents the factors within the organisations that are implementing EBPs, such as organisational characteristics (e.g., culture/climate), leadership, organisational staffing processes, workflows, and individual characteristics of service providers that can influence implementation. 38 39 During the development of the NISA-MIRCs, we used 19 of the 73 implementation strategies from the Expert Recommendations for Implementing Change (ERIC) compilation (see table 1 ). These 19 strategies are from 5 of the 9 clusters including-use evaluative and iterative strategies (3 strategies), provide interactive assistance (3 strategies), adapt and tailor to context (3 strategies), develop stakeholder interrelationships (8 strategies), and train and educate stakeholders (2 strategies). 40 41 These strategies were deployed as needed all through the establishment and development of the NISA-MIRCs.

During the annual NISA conferences in 2016 and 2017, we used the Nominal Group Technique 42 43 to identify barriers and challenges to conducting research and clinical trials in LMICs. 25 26 During this process, we identified several additional barriers to those noted from our literature review [44] [45] [46] and also identified potential strategies to overcome these challenges. The identified barriers include funding gaps, poor research focus, inadequate training for early-stage investigators, inadequate research infrastructure, poor collaboration and partnership among local IPs and academic institutions, research-policy dissonance, poor leadership buy-in, limited research opportunities, and poorly defined roles on potential research projects. 25 26 These sessions demonstrated the need for building a robust research infrastructure in Nigeria that will attempt to address these gaps and barriers. 3

We conducted several stakeholder meetings to identify why children are still being infected with HIV in Nigeria and potential strategies to overcome these barriers. 17 The identified barriers included poor coordination among government, implementers and researchers, poor health-seeking behaviours among women, low uptake of antenatal, delivery and postnatal care services, inadequate community-based interventions to support women through pregnancy and postpartum periods, challenges with transitioning mothers from PMTCT to ART services and back, inadequate skilled health workers in the rural areas, among others. Some of the proposed strategies were for NISA to develop a continuous training program for health workers in the HIV space, support a learning health system, and strengthen tracking services for mother-baby pairs. 17 PREPARATION Establish governance structure NISA established four broad levels of governance for the NISA-MIRCs (see figure 1 ). ► Health facilities: This level of governance is made up of the health facility personnel including the data clerk, the site research coordinator, site investigators and the hospital administration. Each participating NISA-MIRC will be represented at this level of governance that will be responsible for the facility implementation of all research studies. ► Scientific committee: Members of this committee were chosen from university researchers, investigators from IPs and investigators from collaborating 

The NISA CEOs made a formal commitment to support and sustain this cohort.

We conducted local consensus discussion during the annual NISA conference and the NISA board meetings to determine the need for the cohort.

We have a scientific committee and program committee that provide advice to the Stakeholder Committee 6. Use an implementation advisor The program committee includes very experienced implementation experts and advisors that have in-depth experience in research and program implementation. 

We assembled a core team of researchers with capacity and experience in clinical trial designs, HIV research and program implementation, epidemiology, health policy and systems strengthening, implementation science, mixed methods and health economic evaluation. All members of our core research team have completed the CITI training on the ethics of human subject research.

We conducted several engagement visits and meetings with our stakeholders. ► Engagement with IP CEOs: Several focused meetings and discussions were held by the NISA board for the establishment of the cohort during the annual NISA conferences from 2015 to 2017 that revealed the need for establishing the NISA-MIRCs. The concept was further developed at subsequent board meetings and the need for regional representation was finalised and agreed on. ► Outreach to Government Agencies: Following the go-decision by the NISA board, the CTAIR team reached out to the government agencies (NASCP and NACA). NASCP became the lead government agency involved in this infrastructure development. ► Outreach to IPs: The CTAIR team subsequently held several meetings and discussions with program leads from the IPs. These meetings provided a better understanding of the current HIV program implementation and reporting systems, and a review of routinely reported aggregate data from the health facilities. The team also discussed and agreed on the variables to be obtained from the health facilities. ► Outreach to sites: The program team working with the CTAIR team had several meetings and discussions with the site focal persons for PMTCT and SI. These meetings helped to explain the NISA-MIRCs to the health facilities, answer questions, clarify the terms of engagement and plan for future research projects.

The scientific and program teams led the development of the criteria to select the NISA-MIRCs. The criteria for the selection of these health facilities are that they: (1) offer comprehensive HIV care and treatment services to women, men, and children;

(2) have functional Electronic Medical Record (EMR) systems; (3) have dedicated management and clinical teams on-site; (4) have at least 1000 women on ART; (5) are easily accessible by road and (6) are in a community devoid of any significant communal unrest or security problems. These criteria were applied to the list of sites submitted by the IPs and all the sites were ranked. After the ranking, a list BMJ Global Health of the top five sites from each state where the IPs work was generated.

The scientific and program team worked together to select sites to be included in NISA-MIRCs following the criteria defined above. The NISA-MIRCs are made up of both secondary and tertiary health facilities. The core IPs that contributed sites to the NISA-MIRCs are APIN Public Health Initiatives (APIN), Caritas Nigeria, Centre for Integrated Health Programmes (CIHP), Nigeria, Family Health International 360, and Institute of Human Virology Nigeria (IHVN). Collectively, these 5 IPs support 1300 health facilities that provide HIV care and treatment services across Nigeria. The site selection was in two phases. The first phase included an initial 12 health facilities that were selected based on the number of women on ART (>1000), the number of women attending antenatal care and the representativeness of all 6 geopolitical regions in Nigeria and the 5 IPs. The second phase included an additional 9 high-volume health facilities with >2000 women on ART. These nine health facilities were selected independent of the geopolitical region and IPs. This process gave a total of 21 sites with a potential 60 000 women on ART who may be eligible for enrolment into research and clinical trials. The selection of the NISA-MIRCs was guided by the need for representativeness across all zones in the country. The first round of selection was for equality where each geopolitical region has two sites, while the second round was to achieve equity when looking at the burden of disease. In the future, other sites will continue to be evaluated and added to the NISA-MIRCs as needed. The list of the selected health facilities can be found in table 2 and the geographical distribution is shown in figure 2 .

The team considered technology framework to be a critical part of this research infrastructure development. The team evaluated the technology needs and established that a robust routine clinical data collection system was already in place in the 21 In addition, we will strengthen the already existing system to support research data collection, transmission, storage, and analyses. The team built a research data collection and management system using the Research Electronic Data Capture (REDCap) and Microsoft Azure cloud-based information technology infrastructure as-aservice. REDCap is a secure, web-based software platform designed to support data capture for research studies, providing (1) an intuitive interface for validated data capture; (2) audit trails for tracking data manipulation and export procedures; (3) automated export procedures for seamless data downloads to common statistical packages and (4) procedures for data integration and interoperability with external sources. 50 51 Identify and train key site personnel and data clerks At the level of the health facility, the team identified two focal persons-the PMTCT focal person and a data clerk. In August 2021, we conducted a virtual training on Informed Consent and Research Ethics for a total of 84 participants involved with the NISA-MIRCs. The participants included health facility staff (57), IP staff (11) and CTAIR staff (16) . This training was to ensure the highest ethical standards among the research staff. Additionally, we have created a group communication platform using WhatsApp. The WhatsApp group includes members of the CTAIR team and the health facility focal persons, and provides opportunities for easy flow of communication, ongoing group learning and progress updates. 52 

The selection and training of regional research coordinators who are embedded with the IPs' HIV service programs are part of our sustainability plan. They remain as champions within the programs and are ready to lead scale-up when new strategies, products, and programs are found to be effective thereby contributing to the learning health system. Our plan for sustainment is to continue to identify, recruit, and train clinical research coordinators both at the health facility level and regional levels as NISA-MIRCs participation in implementation research and clinical trials evolve. These trained personnel will have continuing education to increase their skill set and help job retention over time and will be able to support the epidemiological cohort needs for participant recruitment, follow-up and project implementation for multiple clinical trials.

Our team is actively seeking opportunities to expand and maintain the NISA-MIRCs. We are open to collaborations BMJ Global Health 

that build equitable partnerships with both local and international researchers, institutions and organisations. Having developed these centres, we will embark on cohort development. We are actively applying for multiple research grants from NIH and other funders of biomedical research.

Our team faced significant challenges in establishing the NISA-MIRCs. The greatest challenge that faced our team was inadequate financial and human capacity. Highly qualified and trained personnel are needed to propose, initiate and implement clinical trials and other types of studies. 3 4 Such human resource development requires relatively stable, well-resourced research institutions and well-established science governance systems, which have not been the case in Nigeria and other LMICs. 30 We have summarised the challenges and strategies used to address them in table 3.

The establishment of NISA-MIRCs will enable Nigeria to answer globally relevant research questions that it had previously been ill equipped to address with efficiency and rigor. As designed, NISA-MIRCs will systematically gather and create evidence using effectivenessimplementation hybrid designs, 53 while applying the most promising evidence to improve care. This will be a gradual process and will expand over time thereby contributing to a learning health system. 54 The process of selecting at least two MIRCs from each of the six geopolitical zones in Nigeria provides the opportunity to understand how the different contexts and cultures impact the health systems and health outcomes. While clinical trials are important to scientific understanding and discovery, LMICs, especially those in Africa have often been sidelined. For example, as of November 2021, only 3.3% (13,034 of 395,555) of clinical trials globally were in Africa. 55 This inequity poses significant challenges to the achievement of global goals like the UNAIDS 95-55-95, WHO cervical cancer elimination 90-70-90 goals, and the health-related Sustainable Development Goals (SDGs). [56] [57] [58] It is also important to note that clinical trials need to be established on strong pre-existing institutional infrastructures, so as to achieve smooth operationalisation and sustained outcomes 

which both builds on and further strengthens the preexisting infrastructure, making it available for other substudies, clinical trials or implementation research. 59 In this instance, collaborations are critical; Africa cannot afford to continue with research infrastructure that fails and collapses when the external funding ends. 3 4 28 59 Our approach to developing the 21 NISA-MIRCs has several strengths, the first of which is the representativeness of all 6 geopolitical regions of Nigeria and the potential size of the corresponding clinical and epidemiological cohort (NISA-WICS). The collaboration of health facilities, government agencies, academic institutions and IPs, facilitated by NISA, which was established in 2015, is also an important strength that will support the sustainability of this research infrastructure. Additionally, since the foundation of NISA-MIRCs is locally funded, there is limited fear of the collapse of this collaboration, as has been seen with other cohorts in SSA. 28 Finally, the availability of EMR systems in the selected health facilities also provides the opportunity to obtain consistent clinical records of enrolled participants, averting recall bias that may arise from self-report. The main limitation to the NISA-MIRCs is security challenges in parts of Nigeria that could potentially limit technical assistance and support to the site. However, as part of our selection criteria, we have attempted to address this by selecting health facilities located in areas with no significant security challenges, while at the same time achieving a national representation.

Our team set out to build a research infrastructure that could support clinical and implementation research and thus could also carry out hybrid-type study designs, 53 which are increasingly important in LMIC contexts. This paper is the first of a two-paper series-(1) the first is to describe the establishment of the research infrastructure that can host clinical, implementation and health system research, and (2) the second will focus on using this infrastructure to educate and recruit women into research studies and trials. Although we are building on existing HIV infrastructure, it is not limited to HIV research. This infrastructure will also be used to conduct health system and policy research or research on other BMJ Global Health diseases. It will provide the infrastructure to design and test aspects of the six pillars of the health system. 60 For example, the NISA-MIRCs can be used to test the effectiveness of task-shifting strategies (health workforce); the comparative effectiveness of mental health services delivered via telepsychiatry compared with trained lay mental health providers (service delivery and health information); and strategies to implement the national cancer treatment guidelines (policy). The development of this cohort of sites will have far-reaching implications for research and practice in Nigeria and SSA. The NISA-MIRCs will be a valuable resource for research evidence in maternal and child health, epidemiology, implementation science, health services, and chronic diseases like cancer, hepatitis, diabetes and cardiovascular diseases. 61 This cohort of sites and the corresponding clinical and epidemiological cohort (NISA-WICS) will provide crucial information on disease-specific maternal and child health outcomes, and their associated factors, similar to cohorts in other settings. [62] [63] [64] [65] [66] [67] Additionally, the NISA-MIRCs will provide a nationally representative infrastructure to initiate new studies, support scientific collaborative research projects, and provide preliminary data to support research grant applications and graduate-level student research projects in a region where such infrastructure is limited and data is often unavailable, thereby filling a significant research gap in Africa's most populous country. 68 69 Finally, the process described here can be a model for others looking to catalyse implementation science and clinical trials at a national level or across SSA. While the NISA-MIRCs may not be generalisable to other LMICs facing similar challenges, we hope that our approach could inform the strategies they choose to develop sustainable research infrastructure in their respective countries.

Our participatory approach and the systematic process of developing the NISA-MIRCs have been critical to the progress to date. This process highlights the significance of engaging relevant stakeholders and using implementation strategies in establishing large cohorts in lowresource settings. NISA provides a collaborative platform to effectively engage with relevant stakeholders, which is not only important for smooth operational processes, but also for the dissemination of research findings and best practices. This process will also serve as an example for other researchers in Nigeria and other LMICs on how to build effective collaborations and develop local research infrastructure for clinical and implementation research, thereby taking these countries a step closer to achieving their biomedical and health-related goals.

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.

Ethics approval Ethical clearance for the development of the epidemiological cohort (called the NISA Women and Infant Cohort Study (NISA-WICS)) was obtained from the National Health Research Ethics Committee of Nigeria (NHREC, Approval number: NHREC/01/01/2007-25/03/2021). This single national Institutional Review Board (IRB) approval was critical because it covered all the 21 NISA-MIRCs, thereby avoiding the need for multiple ethical approvals from each hospital. This approval covered the team to approach patients and consent them for the longitudinal clinical cohort (the first project embarked on by NISA-MIRCs). Ethical approval will be obtained for any additional clinical trials or implementation research.

Provenance and peer review Not commissioned; externally peer reviewed.

Data availability statement Data are available upon request.

Open access This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which

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