It is the intent of Howard University to develop the capacity for establishing an AIDS Clinical Trial Unit (ACTU) with a research focus on minority populations, and at the same time nurture the development of minority investigators conducting AIDS clinical research. The approach to the project has been designed to facilitate efficient management of the project tasks as they relate to performance time frames and the grouping of those tasks into four functional categories: (1) administration, (2) clinical activities, (3) program support, and (4) health services. The approach has also been divided into the following four organizationally discrete, but interrelated phases. In each phase and through the performance of each task, careful attention will be paid to the development of a partnership between the Howard University project staff and NIAID, as well as the AIDS Clinical Trials Group (ACTG) as a whole. The first phase of the approach will focus on organization of the project and assessment of resources which exist as Howard, while concurrently assessing other needs that must be met in developing the necessary clinical trials infrastructure. Assessment will include a review of revellent literature, as well as visits to NIAID and select institutions involved in AIDS clinical trials research. Major activities during the assessment visits will involve a review of facility layout, computer hardware and software, the clinical trials process in action, and the types of personnel conducting these trials. The second phase will involve developing plans for various aspects of the research infrastructure and the production of some of the elements specified in those plans. Each plan will be related to one of the four functional categories. In the third phase, implementation of the developed plans will proceed as the necessary infrastructure takes shape. A major activity in this phase will be the physical preparation of the facilities for an HIV Clinic, where patient assessment, counseling, treatment, and research will occur. Patients who will have been recruited early during this phase and determined eligible to participate in AIDS clinical research, will take part in a pilot-test effort involving Phase I and Phase II clinical protocols. These protocols will have been approved by NIAID, the appropriate ACTG committees, and the University Institutional Revision Board (IRB) at Howard University. Outreach to community physicians and other health professionals, as well as community awareness activities will also occur during this phase. The culminating fourth phase will involve the preparation of an ACTG application, as specified in the RFA, and the preparation of a Project Final Report. This Report will cover the accomplishments and steps taken during the three year period of performance to develop the necessary infrastructure at Howard University for operating an AIDS Clinical Trials Unit.
