Phase I SBIR proposals will be accepted. Fast-Track proposals will not be accepted. Phase I clinical trials will not be accepted. Number of anticipated awards: 1 Budget (total costs): Phase I: up to $243,500 for up to 6 months; Phase II of up to $1,000,000 and a Phase II duration of up to 2 years PROPOSALS THAT EXCEED THE BUDGET OR PROJECT DURATION LISTED ABOVE MAY NOT BE FUNDED. Background Electronic health record (EHR) technologies are increasingly promoted as innovative platforms to streamline preventive health programs and improve compliance with clinical guidelines. EHR alerts have been created to streamline hepatitis C virus (HCV) and HIV screening processes in primary care settings and to develop predictive models that identify patients at a high risk of HIV acquisition who may benefit from pre-exposure prophylaxis (PrEP). To our knowledge, there is a lack of such functionality to identify patients with HIV who are not in care; only at one medical center in New York has such a homegrown electronic medical record algorithm been developed to identify persons lost to HIV care. This SBIR project seeks to utilize EHR data that are typically available in EHR systems to develop a core algorithm that can be used in multiple healthcare systems to identify patients newly and previously diagnosed with HIV and categorize their linkage to care, antiretroviral (ART) prescriptions, retention in care, and viral suppression status. Interoperability of different EHR systems regarding this functionality will also be explored to improve generalizability and functionality throughout the country. Persons living with HIV may not be engaged in HIV care but may continue to access the health care system in other settings, such as other primary care or specialty clinics, emergency rooms, urgent care, and inpatient admissions. Such access can provide opportunities to re-engage them to HIV care. The data derived from the algorithm could be displayed on an EHR dashboard which would be accessible in any clinical setting affiliated with a healthcare system. Healthcare providers could utilize the information displayed to immediately identify a patient as not-in-care, and initiate care coordination and re-engagement efforts. Alternatively, a health care system could query its EHR data at regular intervals, to identify patients who may have fallen out of care. Project Goals This SBIR project seeks to develop a novel EHR-based algorithm to create a dashboard that identifies all patients with HIV and display their current linkage to care, antiretroviral therapy and viral load status. Specific groups highlighted by the algorithm may include patients with a new HIV diagnosis, patients that never linked to HIV care, patients that have disengaged from care (last visit with an HIV provider >6 months prior) and patients with an unsuppressed viral load (VL) on last measurement. Additional Page 129 information, such as age appropriate cancer screening, immunizations (e.g., COVID-19, pneumonia) could also be displayed. Phase I Activities and Expected Deliverables Create an algorithm that uses different data parameters to identify persons with HIV, and their current linkage to care, ART prescription and viral suppression status. Examples of data parameters that can be used include ICD 10 codes, laboratory results, appointment data, pharmacy refill data or similar data sources. Information from the algorithm would be displayed on a new dashboard (utilizing visualization software) within the EHR. The dashboard could use a color system (e.g., red, yellow, green) to easily identify if a patient has diagnosed HIV (new versus known infection), linkage to care status (last visit with HIV clinic provider), on ART (last ART refill date), and/or viral suppression status (last HIV RNA VL result). The goal of Phase I is to determine the feasibility of designing an algorithm based on EHR information that will correctly and accurately identify persons with HIV who may not be engaged in HIV care or have not achieved viral suppression. The expected deliverable will be the algorithm to identify persons with HIV who are not engaged in care or are not virally suppressed using data available in EHR systems and create a dashboard to flag this information. Interoperability of different EHR systems regarding this functionality may also be explored. ImpactPersons with HIV who are retained in care and are virally suppressed are 94% less likely to transmit HIV than persons with undiagnosed HIV. Accordingly, re-engaging people who are not in care confers important individual-level health and population-level prevention benefits, with retention in care and viral suppression as critical components of the HIV care continuum. The national goal of Ending the HIV Epidemic (EHE) is to reduce the number of incident HIV transmissions in the U.S. by at least 90% by 2030. The Treat Pillar of the EHE initiative seeks to treat HIV rapidly and effectively to reach sustained viral suppression. We hypothesize that development of this EHR-based algorithm could be an innovative and effective model to identify out-of-care persons with HIV, including priority groups and hardly reached populations, with the goal of re-engaging them in HIV care. Commercialization Potential There are an estimated 250,000 individuals in the U.S. who are aware of their HIV infection, but not receiving HIV care and treatment. The U.S. government spends $20 billion in annual direct health expenditures for HIV prevention and care. The Ending the HIV Epidemic (EHE) plan will focus on areas where HIV transmission occurs most frequently, providing 57 geographic focus areas (Phase 1 jurisdictions) with an infusion of resources, expertise, and technology. This innovative algorithm should be of interest to EHE Phase 1 jurisdictions, large healthcare systems, hospitals, clinics, and urgent care systems. This algorithm could help identify and re-engage persons with HIV who are not in care, not receiving antiretroviral treatment and/or not virally suppressed. CDC estimates the overall viral suppression rate in the United States is 53 percent. This SBIR project would be a novel and innovative intervention sought after by multiple healthcare systems and models as a necessary component to help jurisdictions achieve the important EHE goals to increase viral suppression to 90 percent nationally by 2030. In addition, technology developed through this project could be applied to other chronic health conditions (such as diabetes, hypertension, or others), for which lifelong or long-term treatment and engagement in care are necessary, potentially leading to a much wider commercialization potential.
