Stopping the control arm in response to the DSMB: Mother's choice of HIV prophylaxis during breastfeeding in the BAN Study

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; Breastfeeding, Antiretrovirals and Nutrition (BAN) Study Team

doi:10.1016/j.cct.2011.10.006

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Stopping the control arm in response to the DSMB: Mother's choice of HIV prophylaxis during breastfeeding in the BAN Study

Journal article

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Stopping the control arm in response to the DSMB: Mother's choice of HIV prophylaxis during breastfeeding in the BAN Study

Charity Chavula, Dustin Long, Enalla Mzembe, Dumbani Kayira, Charles Chasela, Michael G. Hudgens, Mina Hosseinipour, Caroline C. King, Sascha Ellington, Margret Chigwenembe, …

Contemporary clinical trials, Vol.33(1), pp.55-59

01/01/2012

DOI: 10.1016/j.cct.2011.10.006

PMCID: PMC3253884

PMID: 22041453

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https://www.ncbi.nlm.nih.gov/pmc/articles/3253884View

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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.

Antiretorival prophylaxis

Breastfeeding

Postnatal HIV transmission

Details

Title: Subtitle: Stopping the control arm in response to the DSMB: Mother's choice of HIV prophylaxis during breastfeeding in the BAN Study
Creators: Charity Chavula - UNC Project, Lilongwe, Malawi
Dustin Long - University of North Carolina at Chapel Hill
Enalla Mzembe - UNC Project, Lilongwe, Malawi
Dumbani Kayira - UNC Project, Lilongwe, Malawi
Charles Chasela - UNC Project, Lilongwe, Malawi
Michael G. Hudgens - University of North Carolina at Chapel Hill
Mina Hosseinipour - University of North Carolina at Chapel Hill
Caroline C. King - Centers for Disease Control and Prevention
Sascha Ellington - Centers for Disease Control and Prevention
Margret Chigwenembe - UNC Project, Lilongwe, Malawi
Denise J. Jamieson - National Center for Chronic Disease Prevention and Health Promotion
Charles van der Horst - University of North Carolina at Chapel Hill
Breastfeeding, Antiretrovirals and Nutrition (BAN) Study Team
Resource Type: Journal article
Publication Details: Contemporary clinical trials, Vol.33(1), pp.55-59
DOI: 10.1016/j.cct.2011.10.006
PMID: 22041453
PMCID: PMC3253884
NLM abbreviation: Contemp Clin Trials
ISSN: 1551-7144
eISSN: 1559-2030
Publisher: Elsevier Inc
Language: English
Date published: 01/01/2012
Academic Unit: Obstetrics and Gynecology; VPMA - Administration
Record Identifier: 9984446456102771

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