Multifaceted Intervention to Improve Graft Outcome Disparities in African American Kidney Transplants (MITIGAAT)

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PROJECT SUMMARY Compared to Caucasians, African American (AA) kidney transplant recipients have twice the risk of graft loss. Despite recent studies demonstrating marginal improvements in access to transplant, a kidney transplanted today functions about half as long in AA recipients as compared to Caucasians. Our formative research demonstrates that in contemporary kidney recipients, several late (≥2 years) post-transplant clinical markers, including acute rejection, high tacrolimus trough variability and sub-optimal control of hypertension and diabetes can explain disparities in AAs. We completed a 60 patient prospective interventional pilot study demonstrating significant improvements in the control of hypertension and diabetes through a technology-enabled intervention. This study demonstrated that clinical improvements in hypertension control were more substantial in AAs. We also completed two randomized controlled trials demonstrating that real-time medication adherence monitoring is feasible and highly accepted within kidney recipients. This demonstrates a technology-based automated medication monitoring system is a promising intervention to identify and prevent late medication non-adherence, thus reducing high tacrolimus variability and the risk of late rejection. Based on this formative research, we propose to conduct the Multifaceted Intervention to Improve Graft outcome disparities in African American Kidney Transplants (MITIGAAT) study. The overarching hypothesis for MITIGAAT is that the increased burden of late clinical events and comorbidity burden within AA kidney transplant recipients are the primary contributor to disparities in graft survival and a multimodal intervention that achieves improved identification and management of these issues will address this disparity. We will test this hypothesis through a rigorously conducted large-scale, long-term, prospective, randomized, controlled clinical trial in kidney transplant recipients aiming to demonstrate improved tacrolimus trough variability and control of hypertension and diabetes in those randomized to the intervention arm, as compared to the control arm while reducing disparities in AAs. Our secondary aim is to conduct a cost benefit analysis to demonstrate that the intervention reduces healthcare utilization and associated costs; our exploratory aim is to measure the incidence of acute rejection and graft loss in AA kidney recipients, comparing this between the intervention and a control cohort. The enduring goal of this proposal is to demonstrate an effective, efficient, and feasibly deployable method to improve long-term outcomes in AA kidney recipients while reducing health disparities.