Initial validation of a novel pre-screening tool for HIV-associated CNS impairment: The Virtual Driving and CNS Assessment System (VDCA)

针对 HIV 相关中枢神经系统损伤的新型预筛查工具的初步验证：虚拟驾驶和中枢神经系统评估系统 (VDCA)

• 批准号: 10080545
• 负责人: Venkatesh Kandadai
• 金额: $ 25.52万
• 依托单位: DIAGNOSTIC DRIVING, INC.
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-08-04 至 2022-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10080545
• 关键词: Acquired Immunodeficiency Syndrome; Activities of Daily Living; Algorithms; Area; Automobile Driving; Clinic; Clinical; Clinical Treatment; Code; Comprehensive Health Care; Data; Delaware; Detection; Development; Diagnosis; Diagnostic tests; Disease; Early Diagnosis; Ensure; Evaluation; Face; Federally Qualified Health Center; Focus Groups; Future; Goals; Group Interviews; HIV; HIV diagnosis; Human Resources; Human immunodeficiency virus test; Impaired cognition; Impairment; Individual; Licensing; Link; Longitudinal cohort; Magnetoencephalography; Measures; Medical; Medical Care Team; Memory; Monitor; Motor; National Institute of Mental Health; Neurocognitive Deficit; Neuropathogenesis; Ohio; Online Systems; Outpatients; Participant; Patients; Performance; Phase; Pilot Projects; Production; Protocols documentation; Quality of life; Research; Research Priority; Resources; Risk; Safety; Screening procedure; Self-Direction; Sensitivity and Specificity; Short-Term Memory; Small Business Innovation Research Grant; Structure; System; Testing; Training; Universities; Validation; Work; base; clinical care; clinical decision support; cognitive control; cognitive task; cohort; cost; design; disability; driving safety; early screening; executive function; experience; functional disability; health care service; impaired driving performance; improved; innovation; insight; interest; member; neuroAIDS; neuroimaging; novel; phase 2 study; programs; recruit; screening; support tools; tool; usability; virtual

Project Summary and Abstract The standard paradigm for the detection of HIV-associated CNS impairment (HIVCI) involves protocols that require trained personnel, often impractical and unavailable in typical outpatient clinical settings. As a result, HIVCI is often undetected or detected late, leading to a lower quality of life and decreased survival. With the need for earlier detection and the availability of new medical billing codes, a recent push to change the paradigm towards earlier screening of cognitive impairment as a precursor to diagnostic testing is currently underway; however, severely limited in its capability and scope. Therefore, there is an urgent need to enable this new paradigm to detect HIVCI earlier in the disease course (a topic area of interest to NIMH’s Division of AIDS Research and HIV Neuropathogenesis Program): universal screening (not requiring trained staff) to reliably refer HIV+ patients to neuropsychometric (NP) diagnostic testing (by trained staff). This SBIR proposes a novel value proposition: A universal screening tool based on a known functional impairment - driving. Thus, the long-term goal of this SBIR is a new Virtual Driving and CNS Assessment System (VDCA) as a valid, low cost, easy-to-administer, universal screening system for HIV+ patients. To achieve these objectives and develop the VDCA, we will leverage (1) our commercially-successful virtual driving test (VDT) as a platform on which to develop the VDCA; (2) our team’s scientific know-how in utilizing driving to task cognitive, sensorimotor and memory systems (including those implicated in HIVCI); and (3) our exclusive access to an established longitudinal cohort of HIV+ participants. Our preliminary work using magnetoencephalography (MEG) supports the development of the VDCA as a meaningful probe of cognitive control and functional capacity that will become a universal screen for HIVCI. We propose three Phase 1 aims before pursuing a larger Phase II project: Aim 1: Develop a research production-grade version of VDCA incorporating new driving scenarios to task cognitive, sensorimotor and memory systems with associated metrics as guided by our complementary work with MEG; Aim 2: Conduct an observational pilot study by recruiting HIV+ patients from Drexel University’s established and NIMH-supported longitudinal cohort to test the hypothesis that VDCA performance can differentiate participants with and without HIVCI - thereby providing initial evidence to support the VDCA as a HIVCI screening solution; Aim 3: Assess the usability, feasibility and barriers of implementing the VDCA in a clinical setting by leveraging insights from the Aim 2 implementation team and from a comprehensive healthcare team providing HIV healthcare services in a limited-resource clinical setting. These insights will provide support for utility and feasibility of the VDCA as a universal screen and set the direction for future refinement, testing and evaluation in Phase II.

项目摘要及摘要