EPIDEMIOLOGY AND SOCIAL SCIENCE A Public Health Approach to Rapid Scale-Up of Antiretroviral Treatment in Malawi During 2004–2006 David W. Lowrance, MD, MPH,* Simon Makombe, Dip Clin Med,† Anthony D. Harries, MD,†‡§ Ray W. Shiraishi, PhD, k Mindy Hochgesang, MPH,¶ John Aberle-Grasse, MPH,¶ Edwin Libamba, MBBS,† Erik Schouten, MD,†# Tedd Ellerbrock, MD,* and Kelita Kamoto, MBBS† Background: Approximately 1 million people are infected with HIV in Malawi, where AIDS is the leading cause of death in adults. By December 31, 2007, more than 141,000 patients were initiated on antiretroviral treatment (ART) by use of a public health approach to scale up HIV services. Methods: We analyzed national quarterly and longitudinal cohort data from October 2004 to December 2006 to examine trends in characteristics of patients initiating ART, end-of-quarter clinical outcomes, and 6- and 12-month survival probability. Findings: During a 27-month period, 72,666 patients were initiated on ART, of whom about two-thirds werewomen. The percentage of patients initiated on ART who were children and farmers increased from 5.5% to 9.0% and 23% to 32%, respectively (P , 0.001 for trends). Estimated survival probability ranged from 85% to 88% at 6 months and 81% to 84% at 12 months on ART. Interpretation: In Malawi, a public health approach to ART increased treatment access and maintained high 6- and 12-month survival. Resource-limited countries scaling up ART programs may benefit from this approach of simplified clinical decision making, standardized ART regimens, nonphysician care, limited laboratory support, and centralized monitoring and evaluation. Key Words: public health approach, antiretroviral treatment, outcomes, national, sub-Saharan Africa, survival (J Acquir Immune Defic Syndr 2008;49:287–293) INTRODUCTION In 2003, Malawi, a resource-limited country in sub- Saharan Africa with a population of 13.6 million, had an adult HIV seroprevalence of 14% with approximately 1 million persons living with HIV/AIDS. 1 In 2004, an estimated 170,000 persons were in need of antiretroviral treatment (ART). National scale-up of free ART, funded primarily by the Global Fund to Fight AIDS, Tuberculosis, and Malaria, began in June 2004. 2 Influenced by the success of the tuberculosis (TB) directly observed therapy—short-course program, which is based on case finding, standardized treatment regimens, and simplified monitoring and evaluation of patient outcomes, and spurred by a dire shortage of human resources in the health sector, Malawi adopted a public health approach to rapidly scale up HIV treatment services. 2–7 This approach, which is characterized by simplified clinical decision making, standardized ART regimens, non- physician care, limited laboratory support, and centralized monitoring and evaluation, resulted in more than 141,000 persons being initiated on ART in the public sector by December 31, 2007. 8 Those initiated on ART represent about two thirds of patients estimated to be eligible for ART (A. D. Harries, MD, written personal communication 2008). Although a few facilities in Malawi receive external technical and financial support from international organizations, such as Me ´decins Sans Frontieres, 9 government health care workers are the sole providers in most ART clinics. As of December 31, 2007, 45 private sector sites had initiated ART, based on the national clinical guidelines and monitoring and evaluation tools, for more than 5400 patients. The World Health Organization (WHO) has recom- mended a public health approach to scale up ART services in resource-limited countries. However, trends in national ART program outcomes have not been previously reported from sub-Saharan Africa. We examined trends in 4 measures of program quality, including treatment access, key early clinical outcomes, such as mortality, program retention, and 6- and 12-month survival probability during a 27-month period of the ART program in Malawi to determine whether the public health approach to rapid scale-up of ART has been successful. METHODS The National ART Guidelines In Malawi, the first-line ART regimen is a fixed-dose combination tablet of stavudine, lamivudine, and nevirapine that is taken twice daily. 10 Adults and children older than Received for publication February 20, 2008; accepted August 5, 2008. From the *HIV/AIDS Care and Treatment Branch, Global AIDS Program, US Centers for Disease Control and Prevention, Atlanta, GA; †Clinical HIV Unit, Ministry of Health, Lilongwe, Malawi; ‡Family Health International, Arlington, VA; §London School of Hygiene and Tropical Medicine, London, United Kingdom; k Epidemiology and Strategic Information Branch, Global AIDS Program, Centers for Disease Control and Prevention, Atlanta, GA; {Global AIDS Program, Centers for Disease Control and Prevention, Lilongwe, Malawi; and #Management Sciences for Health, Cambridge, MA. The findings and conclusions in this article are those of the authors and do not necessarily represent the views of the Centers for Disease Control and Prevention. We declare that we have no conflicts of interest in regard to the findings contained in this article. Correspondence to: David W. Lowrance, MD, MPH, Global AIDS Program, Centers for Disease Control and Prevention–Rwanda; 2657 Avenue Gendermarie, P.O. Box 28, Kigali, Rwanda (e-mail: lowranced@rw.cdc.gov). Copyright Ó 2008 by Lippincott Williams & Wilkins J Acquir Immune Defic Syndr  Volume 49, Number 3, November 1, 2008 287 Copyright © 2008 Lippincott Williams & Wilkins. Unauthorized reproduction of this article is prohibited.