We propose a regional clinical trials program in southern New England as a new CPCRA site. The New England Program for AIDS Clinical Trials (ProACT) is the product of a collaboration among existing clinical trials sites at Yale University School of Medicine in New Haven, Connecticut, Brown University and Memorial Hospital in Providence, Rhode Island and Community Research Initiative in Boston, Massachusetts. ProACT will contribute to the scientific agenda of the CPCRA by: 1) adding to the CPCRA expert and committed clinical investigators at the three sites who will actively participate at the local and national levels; 2) providing a large and diverse population of people with HIV disease for recruitment, enrollment and retention in CPCRA long- term strategy trials; 3) contributing expertise in a number of areas relevant to the CPCRA scientific agenda, including adherence, pharmacology, immune based therapies, cost effectiveness analysis. ProACT will consist of three principal sites, each with tightly linked sub-sites or affiliates. Procedures and structures to ensure effective governance, standardization of research practice, quality assurance and close communication within ProACT have been developed to create a strong and scientifically and clinically sound CPCRA clinical trials program. Among the three ProACT sites we will enroll and follow 200 patients on study protocols at any given time over the course of this grant.
