Growing recognition of the unprecedented nature and momentum of this human catastrophe, coupled with the increased understanding and growing availability of technical tools needed to halt its devastating progress, has mobilized political will and financial resources worldwide to bring treatment options to those most in need. Three initiatives highlight recent financial and operational steps being taken to accelerate access to ART and other HIV/AIDS care and prevention programs in resource-constrained settings. On December 1, 2003, also World AIDS Day, the World Health Organization (WHO) and Joint United Nations Programme on HIV/ AIDS (UNAIDS) launched the “3-by-5” campaign, with a global target of providing ART to 3 million people with HIV/AIDS in developing countries by the end of 2005 (WHO, 2003b). In November 2003, the government of South Africa approved its landmark Operational Plan for Comprehensive HIV and AIDS Care, Management and Treatment for South Africa (South Africa Department of Health, 2003). One of the goals of the plan is to administer ARVs to more than 1 million people with HIV infection by 2008–2009; this goal is to be accomplished by negotiating with multiple competing drug suppliers and eventually producing the drugs locally. Finally, in January 2003, during his State of the Union address, U.S. President George W. Bush promised $15 billion to international AIDS activities over the course of the next 5 years as part of the President’s Emergency Plan for AIDS Relief (U.S. Department of State, 2003). One of the goals of the plan is to provide ART to 2 million HIV-infected people in the poorest, most afflicted countries in Africa, the Caribbean, and Vietnam.

The clinical, financial, and epidemiological effects of implementing such widespread treatment and prevention programs must be considered, and rational methods for informing such efforts developed. One major concern is that of fostering the premature emergence of widespread resistance to ARVs, thereby reducing the long-term viability of ART regimens in developing countries.

In this context, the Institute of Medicine was asked to provide an independent review and assessment of ART scale-up programs currently under way and in development. The Committee on Examining the Probable Consequences of Alternative Patterns of Widespread Antiretroviral Drug Use in Resource-Constrained Settings was formed to conduct this study. The committee was charged to provide (1) an examination and evaluation of current ART implementation programs, efficacy studies, infrastructure costing models, existing guidelines for program implementation, and models that demonstrate successful scale-up of ART programs; (2) a study of the role of ongoing well-developed operations research in the field and in parallel with treatment implementation to establish sustainability outcome measures; (3) a determination of the components necessary for a system-

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