当前位置： SCI文献检索 > Contemporary Clinical Trials期刊下所有文献 > 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.

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.

journal_name

Contemp Clin Trials

journal_title

Contemporary clinical trials

authors

van der Horst C,Chasela C,Ahmed Y,Hoffman I,Hosseinipour M,Knight R,Fiscus S,Hudgens M,Kazembe P,Bentley M,Adair L,Piwoz E,Martinson F,Duerr A,Kourtis A,Loeliger AE,Tohill B,Ellington S,Jamieson D,Breastfeeding, Ant

doi

10.1016/j.cct.2008.09.001

subject

Has Abstract

pub_date

2009-01-01 00:00:00

pages

24-33

issue

eissn

1551-7144

issn

1559-2030

pii

S1551-7144(08)00115-8

journal_volume

pub_type

杂志文章,随机对照试验

在线工具

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.