title: 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.
abstract: 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.
authors.affiliation: University of North Carolina at Chapel Hill, North Carolina, USA. cvdh@med.unc.edu
authors.forename: Charles
authors.initials: C
authors.lastname: van der Horst
authors.forename: Charles
authors.initials: C
authors.lastname: Chasela
authors.forename: Yusuf
authors.initials: Y
authors.lastname: Ahmed
authors.forename: Irving
authors.initials: I
authors.lastname: Hoffman
authors.forename: Mina
authors.initials: M
authors.lastname: Hosseinipour
authors.forename: Rodney
authors.initials: R
authors.lastname: Knight
authors.forename: Susan
authors.initials: S
authors.lastname: Fiscus
authors.forename: Michael
authors.initials: M
authors.lastname: Hudgens
authors.forename: Peter
authors.initials: P
authors.lastname: Kazembe
authors.forename: Margaret
authors.initials: M
authors.lastname: Bentley
authors.forename: Linda
authors.initials: L
authors.lastname: Adair
authors.forename: Ellen
authors.initials: E
authors.lastname: Piwoz
authors.forename: Francis
authors.initials: F
authors.lastname: Martinson
authors.forename: Ann
authors.initials: A
authors.lastname: Duerr
authors.forename: Athena
authors.initials: A
authors.lastname: Kourtis
authors.forename: A Edde
authors.initials: AE
authors.lastname: Loeliger
authors.forename: Beth
authors.initials: B
authors.lastname: Tohill
authors.forename: Sascha
authors.initials: S
authors.lastname: Ellington
authors.forename: Denise
authors.initials: D
authors.lastname: Jamieson
mesh_terms: D044966:Anti-Retroviral Agents / Q000008:administration & dosage / Q000627:therapeutic use*; D001942:Breast Feeding; D002985:Clinical Protocols; D005260:Female; D015658:HIV Infections / Q000175:diagnosis / Q000517:prevention & control* / Q000635:transmission*; D006801:Humans; D007231:Infant, Newborn; D018445:Infectious Disease Transmission, Vertical / Q000517:prevention & control*; D008295:Malawi / Q000453:epidemiology; D044342:Malnutrition / Q000178:diet therapy; D019829:Nevirapine / Q000627:therapeutic use; D018529:Nutritional Support / Q000379:methods*; D018579:Patient Selection; D011203:Poverty; D012107:Research Design
chemical_list: D044966:Anti-Retroviral Agents; D019829:Nevirapine