ICAP Clinical Trials Unit

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PROJECT SUMMARY/ABSTRACT While much has been achieved in the global HIV response, enormous challenges remain. Only 60% of people living with HIV (PLWH) access treatment and 1.7M new HIV infections were reported in 2018. In sub- Saharan Africa, elimination of mother to child transmission has stalled, men and youth lag behind in knowledge of HIV status, four of five new infections among adolescents occur among girls, and young women are twice as likely as men to have HIV. In the United States, annual new HIV infections have remained stable since 2013, with Black and Latino men who have sex with men (MSM) and women of color disproportionately affected. The ICAP Clinical Trials Unit (ICAP CTU), based at ICAP at Columbia University, will oversee research at five clinical research sites (CRSs): three in New York City (NYC), one in Eswatini, and one in Western Kenya. The NYC sites serve priority populations of great relevance to the current HIV epidemic, both living with and at risk for HIV, including Black and Latino MSM, women of color, young people, and people who inject drugs (PWID). The Eswatini and Kenya sites, in communities with some of the highest rates of new HIV infections in the world, have the capacity to engage children, adolescents, women at risk, men and key populations. Led by Drs. Wafaa El-Sadr and Jessica Justman, the ICAP CTU will pursue an innovative and comprehensive approach to HIV prevention and therapeutic research that tailors tools and strategies to the demographic characteristics, behavioral risks, co-morbidities and life circumstances of persons living with or at risk of acquiring HIV. Research undertaken by the CTU will be multi-faceted, accommodating the complexities of individual-level responses to interventions across numerous populations, and focused on advances that will support population-level reductions in HIV infection and improvements in quality of life and survival of PLWH. The specific aims of the ICAP CTU are (1) to advance the scientific agendas of all four NIH HIV networks by contributing to the development of effective HIV prevention, treatment and care interventions, with the goal of enhancing the lives of PLWH and stemming HIV transmission; (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 constituent CRSs into a cohesive and synergistic Unit that is truly pluripotent and that effectively advances the research agendas of the networks through development of new research concepts; participation in network protocols, scientific committees and working groups; and robust accrual and retention of diverse participants.