Document Detail

Modifications of a large HIV prevention clinical trial to fit changing realities: a case study of the Breastfeeding, Antiretroviral, and Nutrition (BAN) protocol in Lilongwe, Malawi.
MedLine Citation:
PMID:  18805510     Owner:  NLM     Status:  MEDLINE    
In order to evaluate strategies to reduce HIV transmission through breast milk and optimize both maternal and infant health among HIV-infected women and their infants, we designed and implemented a large, randomized clinical trial in Lilongwe, Malawi. The development of protocols for large, randomized clinical trials is a complicated and lengthy process often requiring alterations to the original research design. Many factors lead to delays and changes, including study site-specific priorities, new scientific information becoming available, the involvement of national and international human subject committees and monitoring boards, and alterations in medical practice and guidance at local, national, and international levels. When planning and implementing a clinical study in a resource-limited setting, additional factors must be taken into account, including local customs and program needs, language and socio-cultural barriers, high background rates of malnutrition and endemic diseases, extreme poverty, lack of personnel, and limited infrastructure. Investigators must be prepared to modify the protocol as necessary in order to ensure participant safety and successful implementation of study procedures. This paper describes the process of designing, implementing, and subsequently modifying the Breastfeeding, Antiretrovirals, and Nutrition, (BAN) Study, a large, on-going, randomized breastfeeding intervention trial of HIV-infected women and their infants conducted at a single-site in Lilongwe, Malawi. We highlight some of the successes, challenges, and lessons learned at different stages during the conduct of the trial.
Charles van der Horst; Charles Chasela; Yusuf Ahmed; Irving Hoffman; Mina Hosseinipour; Rodney Knight; Susan Fiscus; Michael Hudgens; Peter Kazembe; Margaret Bentley; Linda Adair; Ellen Piwoz; Francis Martinson; Ann Duerr; Athena Kourtis; A Edde Loeliger; Beth Tohill; Sascha Ellington; Denise Jamieson;
Publication Detail:
Type:  Journal Article; Randomized Controlled Trial; Research Support, N.I.H., Extramural; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, P.H.S.     Date:  2008-09-07
Journal Detail:
Title:  Contemporary clinical trials     Volume:  30     ISSN:  1559-2030     ISO Abbreviation:  Contemp Clin Trials     Publication Date:  2009 Jan 
Date Detail:
Created Date:  2008-12-22     Completed Date:  2009-03-24     Revised Date:  2014-09-22    
Medline Journal Info:
Nlm Unique ID:  101242342     Medline TA:  Contemp Clin Trials     Country:  United States    
Other Details:
Languages:  eng     Pagination:  24-33     Citation Subset:  IM    
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MeSH Terms
Anti-Retroviral Agents / administration & dosage,  therapeutic use*
Breast Feeding*
Clinical Protocols
HIV Infections / diagnosis,  prevention & control*,  transmission*
Infant, Newborn
Infectious Disease Transmission, Vertical / prevention & control*
Malawi / epidemiology
Malnutrition / diet therapy
Nevirapine / therapeutic use
Nutritional Support / methods*
Patient Selection
Research Design
Grant Support
13-01 U48-CCU409660-09//PHS HHS; 2-D43 TW01039-06/TW/FIC NIH HHS; 26-04 U48-DP000059-01/DP/NCCDPHP CDC HHS; D43 TW001039/TW/FIC NIH HHS; D43 TW001039-10/TW/FIC NIH HHS; D43 TW001039-11/TW/FIC NIH HHS; P30 AI050410/AI/NIAID NIH HHS; P30 AI050410-08/AI/NIAID NIH HHS; P30 AI050410-09/AI/NIAID NIH HHS; P30 AI050410-10/AI/NIAID NIH HHS; P30 AI050410-11/AI/NIAID NIH HHS; P30 AI050410-12/AI/NIAID NIH HHS; P30-AI50410/AI/NIAID NIH HHS; R24 HD050924/HD/NICHD NIH HHS
Reg. No./Substance:
0/Anti-Retroviral Agents; 99DK7FVK1H/Nevirapine

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