Article ID | Journal | Published Year | Pages | File Type |
---|---|---|---|---|
3462858 | Contemporary Clinical Trials | 2012 | 5 Pages |
Abstract
The Data and Safety Monitoring Board (DSMB) for the Breastfeeding, Antiretrovirals, and Nutrition study, a clinical trial aimed to prevent postnatal HIV transmission, recommended halting randomization to the enhanced standard-of-care (control) arm. The 67 mother–infant pairs on the control arm and less than 21 weeks postpartum at the time of the DSMB recommendation were read a script informing them of the DSMB decision and offering them the maternal or infant antiretroviral interventions for the remainder of the 28-week breastfeeding period. This paper describes the BAN study response to the DSMB decision and what the women on the control arm chose, when given a choice to start the maternal or infant antiretroviral interventions.
Keywords
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Authors
Charity Chavula, Dustin Long, Enalla Mzembe, Dumbani Kayira, Charles Chasela, Michael G. Hudgens, Mina Hosseinipour, Caroline C. King, Sascha Ellington, Margret Chigwenembe, Denise J. Jamieson, Charles van der Horst,