The Utility of a Composite Biological Endpoint in HIV/STI Prevention Trials |
| |
Authors: | Tyler D. Hartwell Willo Pequegnat Janet L. Moore Corette B. Parker Lisa C. Strader Annette M. Green Thomas C. Quinn Judith N. Wasserheit Jeffrey D. Klausner |
| |
Affiliation: | 1. Research Triangle Institute, Research Triangle Park, Durham, NC, USA 2. National Institute of Mental Health, 6001 Executive Boulevard, Room 6111, Bethesda, MD, 20892-9621, USA 3. Johns Hopkins University, Baltimore, MD, USA 4. University of Washington, Seattle, WA, USA 5. University of California, Los Angeles, Los Angeles, CA, USA
|
| |
Abstract: | A human immunodeficiency virus (HIV) as a biological endpoint in HIV prevention trials may not be feasible, so investigators have used surrogate biological outcomes. In a multisite trial, the epidemiology of STIs may be different across sites and preclude using one STI as the outcome. This study explored using a composite STI outcome to address that problem. The combined biological endpoint was the incidence of any of six new STIs (chlamydia, gonorrhea, trichomonas (women only), syphilis, herpes simplex virus type 2 infection and HIV) during a 24-month follow up period. We investigated how a composite STI outcome would perform compared to single and dual STI outcomes under various conditions. We simulated outcomes for four populations that represented a wide range of sex and age distributions, and STI prevalences. The simulations demonstrated that a combined biologic outcome was superior to single and dual STI outcomes in assessing intervention effects in 82 % of the cases. A composite biological outcome was effective in detecting intervention effects and might allow more investigations to incorporate multiple biological outcomes in the assessment of behavioral intervention trials for HIV prevention. |
| |
Keywords: | |
本文献已被 SpringerLink 等数据库收录! |
|