Goals and Objectives
The Clinical Outcomes Core will serve the following functions:
- Provide the resources necessary to validate new, robust, and biologically valid outcome measures for epidemiological research and treatment trials in HIV-associated cognitive disorders.
- Develop new instruments that will integrate measurements of medication adherence and cognition.
- Provide validated test batteries critical for rapid development of clinical trials of novel therapeutic agents for the treatment of HIV dementia.
- Develop a logical data infrastructure across multicenter modalities to allow efficient querying of clinical and laboratory data.
- Develop and apply appropriate statistical and epidemiological methods to support studies involving the Center Grant resources.
- Provide a resource for and linkage with ongoing Neuro-AIDS trial consortia including the Neurological AIDS Research Consortium (NARC, PI-Dr David Clifford), and the AIDS Clinical Trials Group (ACTG, Neurology Subcommittee Chairman-Dr Bruce Cohen through 2005, Dr Ned Sacktor from 2006 through 2007).
The Clinical Outcomes Core plays a central role in the proposed center, and will interact with several of the Cores.
The Core is justified by the recognized need to develop new outcome measures for HIV-associated cognitive disorders in the era of highly active antiretroviral therapy (HAART) that are not only robust and well validated, but also sensitive to changes that are expected earlier in the development of HIV-associated cognitive impairment. Also, the statistical power of recent trials for HIV dementia has been limited by excessive variance in the scores of standard neuropsychological test batteries (1).
There is currently no funding venue for the kind of outcome measure development proposed in this Core.
The individual responsibilities of key personnel are detailed in the Budget Justification. In brief, Dr Ned Sacktor will direct this Core and oversee the collection of clinical data including neurological assessments. Dr Ola Selnes will oversee the collection of neuropsychological data and assist Dr Sacktor in subject characterization. Drs Scott Zeger, Kelly Gebo, and Richard Skolasky will collaborate with them on the design, data collection and management, statistical analyses, and interpretation of the performance characteristics of the instruments. Dr Richard Moore, a recognized expert in the development of touch-screen testing devices will supervise these aspects of the Core.