ICAP Clinical Trials Unit

Columbia University Health Sciences, New York NY

Investigators

Linked publications, trials & patents

Abstract

While much has been achieved in the HIV response over the past four decades, enormous challenges remain. Only 60% of people with HIV access treatment and 1.7M new HIV infections were reported in 2023. In the United States, annual new HIV infections have remained largely stable, without the desired decrease. The ICAP Clinical Trials Unit (ICAP CTU), based at ICAP at Mailman School of Public Health, oversees research affiliated clinical research sites (CRSs), all serving population at high risk for HIV. Led by Drs. Wafaa El-Sadr and Jessica Justman, the ICAP CTU will pursue an innovative and comprehensive approach to HIV prevention research that tailors tools and strategies to the population at risk. The specific aims of the ICAP CTU are (1) to advance the scientific agendas of the NIH HIV Prevention Trials Network (HPTN); (2) to build a strong CTU administrative structure that is outstanding in its capabilities and streamlined in its procedures, with efficiency, transparency, clear lines of authority, continuous quality improvement, full community engagement, and the highest performance standards; (3) to engage fully with the communities it serves through education, outreach and support of CRS community advisory boards; (4) to support core CRS technical functions, e.g., laboratory, pharmacy, regulatory, data management, quality assurance, training and staff development; and (5) to align the CRSs into a cohesive and synergistic Unit that is truly pluripotent through the development of new research concepts; participation in network protocols, scientific committees and working groups; and robust accrual and retention of research participants.