PEDIATRIC AIDS CLINICAL TRIALS UNIT

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The state of North Carolina currently has two pediatric AIDS Clinical Trials Units. A complete pediatric ACTU has been at Duke since January 1987, with funding provided as part of a mixed adult/pediatric AIDS Treatment Evaluation Unit until 1989. The University of North Carolina at Chapel Hill has been seeing children at a pediatric component of an Adult ACTU since 1990. Affiliated with the UNC subunit is a small perinatal program at the Carolinas Medical Center in Charlotte, NC. We propose to merge these three sites and two other units, at Brenner Children's Hospital in Winston-Salem and East Carolina University Medical School in Greenville, into a single unified program, the North Carolina Children's AIDS Network (NC-CAN). All five sites will be capable of enrolling children into ACTG pediatric protocols, and 4 of the 5 will enroll children onto perinatal studies (ECU will not). The unification of these programs will serve several purposes: 1) Access to ACTG protocols will be improved. North Carolina is the tenth largest state in population, but its citizens and its HIV infected children are evenly divided between urban and rural settings. The 5 sites are geographically distributed and are near the highest HIV seroprevalence regions of the state. 2) All of the state's medical schools will be working together in a unified manner, decreasing competition and allowing for more efficient utilization of resources. In addition, medical students and residents from across the state will be exposed to the growing problem of pediatric HIV and trained to provide care for these difficult patients. 3) The research skills of the 5 institutions can be pooled and applied to the critical mass of patients who will enroll in the NC-CAN system. 4) The NC-CAN will provide a model for the provision of research based care in a rural setting. The Southeast has the largest number of heterosexually transmitted AIDS cases in the United States, and in North Carolina the HIV seroprevalence among women is rapidly escalating. The NC-CAN will demonstrate methods to perform clinical research in this type of population which will then be applicable as the epidemic spreads to other non-urban sectors of the country. As an example of the current success of the programs, despite the fact that patients travel a median of more than 90 minutes each way to get to Duke and UNC, the clinic show rate is 88% for protocol patients. This is primarily attributable to social workers and volunteers focusing on the issue of transportation, to the respect given the patients and families, and to the families' involvement in the clinical care and research program.