The goal of the current project is to elaborate upon, reconstruct and advance to pivotal trial readiness a recently validated Plasticity-based Adaptive Cognitive Remediation program (PACR) for the treatment of HIV-Associated Neurocognitive Disorders (HAND). In the first specific aim, we will organize a series of small focus groups composed of people with HAND to discuss and play various computer games and cognitive training programs. Based on questionnaires from and discussions with these focus groups, we will define a set of enhancements to PACR designed to make the user experience and the gameplay sufficient to motivate the thirty hours of program. We will then employ established methods of software design and development and iteratively refine the implemented design to complete the development of the enhanced program for a feasibility trial conducted locally, in collaboration with the San Francisco Aids Foundation. At the completion of this project we will have data sufficient to propose a multi-site, randomized, controlled medical-device trial designed to establish medical claims defining the efficacy of this cognitive training program. At the completion of Phase II, we expect to be able to complete the FDA regulatory pathway, and clear the program as the first software based medical device intended for the treatment of HAND, and have the opportunity to improve the lives of millions of people suffering from this condition.
The goal of this project is to elaborate upon, reconstruct and advance to pivotal trial readiness a recently validated Plasticity-based Adaptive Cognitive Remediation program (PACR) for the treatment of HIV-Associated Neurocognitive Disorders (HAND). This is important because this large HIV+ population suffers from lack of viable treatment options.
