PEDIATRIC AIDS CLINICAL TRIALS UNIT

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The Duke Pediatric AIDS Clinical Trials Unit is a multicenter program which provides ACTG protocol care to HIV infected and exposed children throughout North Carolina, southern Virginia, and northern South Carolina. To provide these services in a cost-effective, regional approach, the North Carolina Children's AIDS Network (NC-CAN) was created. The core of the network is at Duke, where the largest number of patients are seen, data entry and quality assurance activities are based, and interface occurs with several large basic science programs. There is a full sub-unit at the University of North Carolina at Chapel Hill, which began with a focus on adolescents (because of a large hemophilia center), but has evolved to emphasize perinatal prophylaxis and primary therapy trials. The NC-CAN has two Outreach Clinics, at the Carolinas Medical Center in Charlotte, NC, and the Brenner Children's Hospital at Bowman Gray School of Medicine in Winston-Salem, NC. To serve these clinics, a physician-nurse team from Duke travels to Charlotte and Winston-Salem on a regularly scheduled basis (every 2 to 4 weeks for each site). In the Outreach Clinics, patients are seen by their local pediatric infectious diseases specialist for care, and by the Duke Travel Team for ACTG protocol related issues. Thus, patients can participate in ACTG protocols closer to their local community, making access to cutting edge medical care more easily available for this generally poor and disadvantaged population. The Travel Team also participates in Screening Clinics in Greenville, NC (East Carolina University School of Medicine) and Roanoke, VA (Community Hospital of the Roanoke Valley) where patients are seen and evaluated regarding their suitability for ACTG protocols, again in coordination with their local pediatric infectious diseases specialists. In addition to providing medical care closer to the patients' homes, the NC-CAN model as a whole allows the Duke PACTU to maintain tight quality assurance, since the forms are completed by Duke staff, and to provide Optimum laboratory specimen delivery, since clinical specimens from the Outreach and Screening Clinics are hand delivered to ACTG certified retrovirology and cytometry labs at UNC and Duke (respectively).