UM1AI154468

ICAP Clinical Trials Unit - 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 out 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.

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 the development of new research concepts, participation in network protocols, scientific committees, and working groups, and robust accrual and retention of diverse participants.

The Trustees Of Columbia University In The City Of New York

TO ASSIST PUBLIC AND PRIVATE NONPROFIT INSTITUTIONS AND INDIVIDUALS TO ESTABLISH, EXPAND AND IMPROVE BIOMEDICAL RESEARCH AND RESEARCH TRAINING IN INFECTIOUS DISEASES AND RELATED AREAS, TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS. TO ASSIST PUBLIC, PRIVATE AND COMMERCIAL INSTITUTIONS TO CONDUCT DEVELOPMENTAL RESEARCH, TO PRODUCE AND TEST RESEARCH MATERIALS, TO PROVIDE RESEARCH SERVICES AS REQUIRED BY THE AGENCY FOR PROGRAMS IN INFECTIOUS DISEASES, AND CONTROLLING DISEASE CAUSED BY INFECTIOUS OR PARASITIC AGENTS, ALLERGIC AND IMMUNOLOGIC DISEASES AND RELATED AREAS. PROJECTS RANGE FROM STUDIES OF MICROBIAL PHYSIOLOGY AND ANTIGENIC STRUCTURE TO COLLABORATIVE TRIALS OF EXPERIMENTAL DRUGS AND VACCINES, MECHANISMS OF RESISTANCE TO ANTIBIOTICS AS WELL AS RESEARCH DEALING WITH EPIDEMIOLOGICAL OBSERVATIONS IN HOSPITALIZED PATIENTS OR COMMUNITY POPULATIONS AND PROGRESS IN ALLERGIC AND IMMUNOLOGIC DISEASES. BECAUSE OF THIS DUAL FOCUS, THE PROGRAM ENCOMPASSES BOTH BASIC RESEARCH AND CLINICAL RESEARCH. SMALL BUSINESS INNOVATION RESEARCH (SBIR) PROGRAM EXPANDS AND IMPROVES PRIVATE SECTOR PARTICIPATION IN BIOMEDICAL RESEARCH. THE SBIR PROGRAM INTENDS TO INCREASE AND FACILITATE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, TO INCREASE SMALL BUSINESS PARTICIPATION IN FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. THE SMALL BUSINESS TECHNOLOGY TRANSFER (STTR) PROGRAM STIMULATES AND FOSTERS SCIENTIFIC AND TECHNOLOGICAL INNOVATION THROUGH COOPERATIVE RESEARCH AND DEVELOPMENT CARRIED OUT BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO FOSTER TECHNOLOGY TRANSFER BETWEEN SMALL BUSINESS CONCERNS AND RESEARCH INSTITUTIONS, TO INCREASE PRIVATE SECTOR COMMERCIALIZATION OF INNOVATIONS DERIVED FROM FEDERAL RESEARCH AND DEVELOPMENT, AND TO FOSTER AND ENCOURAGE PARTICIPATION OF SOCIALLY AND ECONOMICALLY DISADVANTAGED SMALL BUSINESS CONCERNS AND WOMEN-OWNED SMALL BUSINESS CONCERNS IN TECHNOLOGICAL INNOVATION. RESEARCH CAREER DEVELOPMENT AWARDS SUPPORT THE DEVELOPMENT OF SCIENTISTS DURING THE FORMATIVE STAGES OF THEIR CAREERS. INDIVIDUAL NATIONAL RESEARCH SERVICE AWARDS (NRSAS) ARE MADE DIRECTLY TO APPROVE APPLICANTS FOR RESEARCH TRAINING IN SPECIFIED BIOMEDICAL SHORTAGE AREAS. IN ADDITION, INSTITUTIONAL NATIONAL RESEARCH SERVICE AWARDS ARE MADE TO ENABLE INSTITUTIONS TO SELECT AND MAKE AWARDS TO INDIVIDUALS TO RECEIVE TRAINING UNDER THE AEGIS OF THEIR INSTITUTIONAL PROGRAM.

93.279 - Drug Abuse and Addiction Research Programs

National Institute of Allergy and Infectious Diseases (NIAID) [HHS - NIH]

National Institute on Drug Abuse (NIDA) [HHS - NIH]

New York, New York 10032 United States

Single Zip Code

HIV/AIDS Clinical Trials Units (UM1 Clinical Trial Required) (RFA-AI-19-045)

Termination This cooperative agreement was reported as terminated by the Department of Government Efficiency (DOGE) in July 2025. See All
Amendment Since initial award the total obligations have increased 1713% from $577,676 to $10,475,165.