Published in:
01-11-2013 | Original Paper
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, NIMH Collaborative HIV/STD Prevention Trial Group
Published in:
AIDS and Behavior
|
Issue 9/2013
Login to get access
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.