A brief iPad-based screening measure for HIV-associated neurocognitive disorders

Period of Performance: 01/25/2017 - 08/31/2017

$310K

Phase 2 STTR

Recipient Firm

Digital Artefacts, LLC
IOWA CITY, IA 52240
Principal Investigator
Principal Investigator

Abstract

Despite significance advances in anti-retroviral treatments, HIV-associated neurocognitive disorder (HAND) remains prevalent, and can affect a broad range of everyday activities. An effective brief cognitive screen that could be implemented in busy HIV clinics, where clinicians have limited time to provide care for patients with complex medical, psychiatric, and cognitive conditions, has the potential to significantly impact patient care, in terms of both identifying patients who may warrant additional treatment considerations as well as the potential to track changes in cognition over time. Unfortunately, current brief cognitive screens have lacked sensitivity to the generally mild and mild-to-moderate deficits associated with modern HAND. Phase I saw the development of a brief, iPad-based cognitive screening tool that could be self-administered, and exhibited good validity (relative to a gold-standard neuropsychological (NP) test battery) and test-retest reliability. The 4-test combination, taking only 6 minutes to complete, produced very good classification accuracy, with sensitivity, specificity, positive and negative predictive values all approximately 80%. The aims of Phase II are to 1) enhance the technical capabilities and usability of the iPad-based cognitive screen for both patients and clinicians, 2) improve the clinical relevance of the iPad-based cognitive screening tool, and 3) establish the clinical utility of the revised tool. To accomplish these aims, we will improve the existing interface by creating a revised dashboard based upon input from senior clinicians and adapt it to present results in a user-friendly and easily interpretable manner, and add additional brief questions address mood and problems with everyday functioning. In year 1 we will develop demographically-adjusted norms based upon 125 healthy adults, including norms for 6- and 12-month follow-up assessments in order to optimize the tool for use in monitoring patients over time. In year 2 we will implement this new, normed tool in HIV clinics in both San Diego and collaborating clinics in the United States. At least 150 HIV+ participants will complete the iPad measure in clinics, and at a 6-month (or clinic visit approximating that time) follow-up. A subset of these individuals (n = 100) will also provide more detailed neuropsychological data captured during a clinic or research-based evaluation. We will then assess the effectiveness of the tool in detecting HIV-related cognitive impairments based upon a gold-standard assessment. As a result of this project we will have a fully functional, validated and marketable brief screening measure for evaluating patient cognition, improving HIV patient care, facilitating future studies of HAND and its treatment, and which will position Digital Artefacts in a key leadership role in the development of user- and clinician-friendly screening measures for HAND, as well as potentially other neurologic conditions.