Division of AIDS Overview

The Division of AIDS (DAIDS) was formed in 1986 to develop and implement the national research agenda to address the HIV/AIDS epidemic. Toward that end, the division supports a global research portfolio to advance biological knowledge of HIV/AIDS, its related co-infections, and co-morbidities. With the ultimate goal of creating an “AIDS-Free Generation,” the division develops and supports the infrastructure and biomedical research needed to: 1) halt the spread of HIV through the development of an effective vaccine and biomedical prevention strategies that are safe and desirable; 2) develop novel approaches for the treatment and cure of HIV infection; 3) treat and/or prevent HIV co-infections and co-morbidities of greatest significance; and 4) partner with scientific and community stakeholders to efficiently implement effective interventions.

Organizationally, DAIDS is comprised of the Office of the Director (OD) and four scientific programs. Within the OD are the: 1) Workforce Operations, Communications, and Reporting Branch; 2) Science Planning and Operations Branch; 3) Office of Clinical Site Oversight, which includes the Pharmaceutical Affairs Branch, Monitoring and Operations Branch, Africa and the Domestic Partners Branch, and Asia and the Americas Branch; and 4) Office for Policy in Clinical Research Operations, which includes the Regulatory Affairs Branch, Clinical Research Resources Branch, and the Protection of Participants, Evaluation and Policy Branch.

The four scientific programs include the: 1) Basic Sciences Program, which includes the Pathogenesis and Basic Research Branch, Targeted Interventions Branch, and the Epidemiology Branch; 2) Therapeutics Research Program, which includes the HIV Research Branch, Drug Development and Clinical Sciences Branch, TB Clinical Research Branch, and the Complications and Co-infections Research Branch; 3) Vaccine Research Program, which includes the Preclinical Research and Development Branch, Vaccine Translational Research Branch, and the Vaccine Clinical Research Branch; and 4) Prevention Sciences Program, which includes the Preclinical Microbicide and Prevention Research Branch, Clinical Microbicide Research Branch, Clinical Prevention Research Branch, and the Maternal, Adolescent, and Pediatric Research Branch.

Supports a portfolio of basic, preclinical, and epidemiologic research designed to

  • Increase understanding of HIV transmission, virus-host interactions, and mechanisms of disease progression
  • Stimulate research towards a cure for HIV/AIDS
  • Enhance understanding of the basic biology of both latent and persistently replicating reservoirs leading to a cure for HIV/AIDS
  • Develop methods to simply and accurately measure the viral reservoir
  • Identify and clinically evaluate novel concepts or strategies that target and eliminate viral reservoirs resulting in a functional cure
  • Develop new therapeutic and vaccine targets
  • Focus on relevant bioethics research issues in HIV/AIDS research

Supports a portfolio of preclinical and clinical research designed to

  • Discover, develop, and evaluate novel interventions, monoclonal antibodies, sustained release formulations, and assays of select biomarkers to diagnose and treat HIV, leading to significant, durable improvements in therapy and treatment outcomes
  • Inform strategies towards a cure or sustained remission of HIV
  • Improve tuberculosis (TB) diagnostics, optimize treatment, and develop new drugs and vaccine strategies that prevent acquisition and/or reactivation of TB
  • Evaluate therapeutics for hepatitis C co-infection and develop improved diagnostics, noninvasive indicators of liver injury, and prognostic biomarkers for treatment outcomes
  • Enhance understanding of the mechanisms of chronic immune activation and associated co-morbidities such as cardiovascular disease, neurologic consequences, and end organ and metabolic diseases

Read more about HIV treatment.

Supports a portfolio of preclinical, translational, and clinical research designed to

  • Develop a safe and efficacious vaccine to prevent HIV infection
  • Confirm and extend the results of the RV144 “Thai” trial
  • Identify and characterize selected viral envelopes that stimulate broadly neutralizing antibodies (bNAbs)
  • Promote research programs to discover novel vaccine strategies
  • Establish and support the infrastructure for the manufacturing and testing of novel immunogens and bNAbs
  • Develop strategies to optimize the evaluation of B-cell responses
  • Rapidly assesses potential correlates of immunogenicity and of protection elicited by experimental vaccines

Read more about HIV vaccine development.

Supports a portfolio of preclinical and clinical research designed to

  • Deliver prevention tools that can reduce HIV incidence in populations at risk
  • Create and maintain a pipeline of non-vaccine HIV prevention products including sustained delivery methods and combination products
  • Advance HIV prevention and treatment candidates, such as topical microbicides, systemic pre-exposure prophylaxis, and immune-based products, to licensure
  • Improve treatment as prevention by optimizing the testing, linkage to care, and treatment cascade
  • Develop integrated HIV prevention strategies that will reduce incidence at a population level
  • Support development of optimized, low-cost, point-of-care incidence assays
  • Optimize HIV treatment and advance cure research for pregnant women, infants, children, and adolescents
  • Improve TB diagnostics, treatment, and prevention in maternal and pediatric populations

Read more about HIV prevention.

  • Manages and supports DAIDS clinical research and helps ensure: compliance with applicable regulations, standards, and good clinical practice guidelines; study participant safety and welfare; and study quality and integrity
  • Develops and maintains division-wide clinical research polices and standard procedures and performs quality assurance activities
  • Provides consultation and expertise to address complex human subjects protection regulatory issues
  • Manages a portfolio of contracts to provide regulatory compliance support and clinical research services
  • Implements the DAIDS safety monitoring and reporting system, related safety data and reporting standards, and pharmacovigilance capacity; provides safety-related expertise and training
  • Manages Investigational New Drug applications and other regulatory functions
  • Manages the protocol registration process, its policies, procedures, and related training activities
  • Develops clinical trial agreements and other agreements for division-sponsored clinical research

  • Coordinates division-wide operational activities, including those associated with human capital, workforce planning, and space management
  • Coordinates communications activities related to division-sponsored research highlights, clinical trial results, and ongoing scientific programs through the development and/or dissemination of written materials, correspondence, presentations, briefing documents, and scientific reports
  • Maintains relevant internal and public websites
  • Coordinates internal scientific reporting processes, congressional and media requests, and requests made under the Freedom of Information Act Provides leadership and oversight for division-wide contracts providing scientific and administrative support personnel and logistics support for division-sponsored scientific workshops and meetings of Data Safety and Monitoring Boards
  • Provides leadership and oversight for the operations of the Web-based Clinical Research Management System, including release activities, change requests, and new technology developments
  • Fosters engagement, learning, and development among staff, grantees, and collaborators

  • Facilitates and coordinates the scientific initiative planning and development process
  • Coordinates fiscal planning, allocation of resources, and budget tracking
  • Provides policy guidance and operational support to staff on administrative and/or policy issues for grants and contracts
  • Manages and coordinates the scientific, administrative, and operational activities associated with the AIDS Subcommittee of the NIAID Advisory Council and the AIDS Research Advisory Committee
  • Facilitates evaluation and portfolio analysis of DAIDS research programs

  • Manages a portfolio of cooperative agreements supporting domestic and international Clinical Trials Units and Clinical Research Sites associated with the HIV/AIDS Clinical Trials Networks
  • Coordinates a range of clinical site management activities for network and non-network studies, including site establishment/closure, administration, and performance
  • Serves as a resource on operational and regulatory issues and ensures that appropriate clinical research standards, policies, and procedures are used by clinical research sites
  • Provides oversight and management of a contract to ensure that clinical site monitoring is conducted in accordance with applicable regulatory requirements
  • Provides pharmaceutical expertise for protocol development and implementation as well as oversight of a study product storage and distribution contract
  • Verifies that optimal safeguards are employed for participant safety and ensures that high quality research practices are used
  • Monitors clinical site progress of enrolling underserved populations and ensuring community representation
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