Antiretroviral therapy (ART) decreases morbidity and mortality in patients with HIV/AIDS, both in industrialized and less developed settings. Important questions about the use of ART remain: key among them is the optimal time to initiate ART in resource-poor settings. Current World Health Organization (WHO) guidelines recommend treatment initiation later in the course of the disease than the US Department of Health and Human Services and the International AIDS Society guidelines. There is currently no consensus on the issue. Policy decisions regarding the timing of ART initiation must incorporate complex trade-offs among clinical benefits, risks of medication-related toxicity, human resource requirements, financial cost, treatment efficacy, adherence, and drug resistance. The candidate proposes to address this issue by conducting a cost-effectiveness analysis of early versus delayed ART in a study that is separate but complementary to the CIPRA HT 001 randomized clinical trial that is underway at the GHESKIO Center (Haitian Study Group on Kaposi's Sarcoma and Opportunistic Infections) in Haiti. The ongoing clinical trial randomizes patients with pre-AIDS disease (WHO stage I, II, or III) and CD4 cells counts between 200 and 350 to early (within 2 weeks) versus delayed (CD4 <200 or clinical AIDS) ART. The primary outcome for the CIPRA trial is survival. The candidate's proposed research will add critical information regarding the impact of adherence and the cost-effectiveness of early versus delayed ART. The research plan of the proposed decision model is composed of two specific aims: 1. To compare adherence to ART and adherence barriers between patients in the early and delayed treatment groups in the CIPRA trial. Adherence will be measured by pharmacy pill counts and by patient self-report. 2. To conduct a cost-effectiveness analysis comparing early versus delayed ART in Haiti in the presence or absence of tuberculosis from a societal perspective. Outcome measures will include life expectancy, lifetime total direct medical costs, and cost-effectiveness in dollars per life-year gained. Sensitivity analyses will examine the impact of adherence rates, hospitalization rates, and cost of ART. This research is relevant to public health, as this will be the first cost-effectiveness analysis of the timing of ART initiation that is based on randomized clinical trial data, and will impact the treatment of HIV globally.

National Institute of Health (NIH)
Fogarty International Center (FIC)
Research Scientist Development Award - Research &amp; Training (K01)
Project #
Application #
Study Section
Special Emphasis Panel (ZRG1-BDA-K (50))
Program Officer
Jessup, Christine
Project Start
Project End
Budget Start
Budget End
Support Year
Fiscal Year
Total Cost
Indirect Cost
Brigham and Women's Hospital
United States
Zip Code
Noel, Edva; Esperance, Morgan; McLaughlin, Megan et al. (2013) Attrition from HIV testing to antiretroviral therapy initiation among patients newly diagnosed with HIV in Haiti. J Acquir Immune Defic Syndr 62:e61-9
Koenig, Serena P; Rodriguez, Luis A; Bartholomew, Courtenay et al. (2012) Long-term antiretroviral treatment outcomes in seven countries in the Caribbean. J Acquir Immune Defic Syndr 59:e60-71
Koenig, Serena P; Bang, Heejung; Severe, Patrice et al. (2011) Cost-effectiveness of early versus standard antiretroviral therapy in HIV-infected adults in Haiti. PLoS Med 8:e1001095
Koenig, S; Ivers, Lc; Pace, S et al. (2010) Successes and challenges of HIV treatment programs in Haiti: aftermath of the earthquake. HIV Ther 4:145-160
Koenig, Serena P; Schackman, Bruce R; Riviere, Cynthia et al. (2010) Clinical impact and cost of monitoring for asymptomatic laboratory abnormalities among patients receiving antiretroviral therapy in a resource-poor setting. Clin Infect Dis 51:600-8
Koenig, Serena P; Riviere, Cynthia; Leger, Paul et al. (2009) High mortality among patients with AIDS who received a diagnosis of tuberculosis in the first 3 months of antiretroviral therapy. Clin Infect Dis 48:829-31
Koenig, Serena P; Kuritzkes, Daniel R; Hirsch, Martin S et al. (2006) Monitoring HIV treatment in developing countries. BMJ 332:602-4