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

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.

Comparative effectiveness of implementation strategies for Accelerating Cervical Cancer Elimination through the integration of Screen-and-treat Services (ACCESS study): protocol for a cluster randomized hybrid type III trial in Nigeria

“…The study will leverage the 21 comprehensive HIV treatment sites across the six geopolitical zones of Nigeria that have been designated as Nigeria Implementation Science Alliance (NISA) Model Innovation and Research Centers (NISA-MIRC) [ 65 ]. The NISA-MIRC sites are part of the ICON-3 Practice-based Research Network which is made up of the 21 NISA-MIRCs and the 6 Regional Centers of Excellence.…”

“…The NISA-MIRC sites are part of the ICON-3 Practice-based Research Network which is made up of the 21 NISA-MIRCs and the 6 Regional Centers of Excellence. The NISA-MIRCs have over 60,000 WLHIV in care who are eligible for enrollment into clinical trials and other implementation research studies [ 65 ]. Our proposed study will be anchored at 12 sites (see Figure 2 and Additional file 1 ) from the 21 NISA-MIRCs.…”

Rapid implementation mapping to identify implementation determinants and strategies for cervical cancer control in Nigeria

“…In 2021, the Nigeria Implementation Science Alliance established 21 Model Innovation and Research Centers for multi-center clinical trials and implementation research. The process of establishment of these model centers has been reported elsewhere ( 17 ). The HIV prevention leads from the six implementing partners collaborated with the research team to conduct a needs assessment for integrating cervical cancer screening and treatment into the existing comprehensive HIV program in Nigeria.…”

AVIVA: a telehealth tool to improve cervical cancer screening in resource-constrained settings

“…NISA is a research collaboration of local PEPFAR-supported implementing partners, government health agencies and universities. NISA has established and maintained research infrastructure for implementation science in high volume health facilities and their surrounding communities across Nigeria’s six geopolitical regions 31. NISA’s research base is anchored at the Center for Translation and Implementation research at the University of Nigeria.…”