Charles van der Horst|Charles Chasela|Yusuf Ahmed|Irving Hoffman|Mina C. Hosseinipour|R. J. Knight|Susan A. Fiscus|Michael G. Hudgens|Peter N. Kazembe|Margaret E. Bentley|Linda S. Adair|Ellen Piwoz|Francis Martinson|Ann Duerr|Athena P. Kourtis|A Loeliger|Beth Carlton Tohill|Sascha Ellington|Denise J. Jamieson
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
University of North Carolina at Chapel Hill|Centers for Disease Control and Prevention|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|Principia College|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|Kamuzu Central Hospital|University of North Carolina at Chapel Hill|University of North Carolina at Chapel Hill|Academy for Educational Development|University of North Carolina at Chapel Hill|University of Washington|Centers for Disease Control and Prevention|GlaxoSmithKline (United Kingdom)|Centers for Disease Control and Prevention|Centers for Disease Control and Prevention|Centers for Disease Control and Prevention
order evaluate strategies reduce hiv transmission breast milk optimize maternal infant health among hivinfected women infants designed implemented large randomized clinical trial lilongwe malawi development protocols large randomized clinical trials complicated lengthy process often requiring alterations original research design many factors lead delays changes including study sitespecific priorities new scientific information becoming available involvement national international human subject committees monitoring boards alterations medical practice guidance local national international levels planning implementing clinical study resourcelimited setting additional factors must taken account including local customs program needs language sociocultural barriers high background rates malnutrition endemic diseases extreme poverty lack personnel limited infrastructure investigators must prepared modify protocol necessary order ensure participant safety successful implementation study procedures paper describes process designing implementing subsequently modifying breastfeeding antiretrovirals nutrition ban study large ongoing randomized breastfeeding intervention trial hivinfected women infants conducted singlesite lilongwe malawi highlight successes challenges lessons learned different stages conduct trial