Thapinta Darawan, Jenkins Richard A
Faculty of Nursing, Chiang Mai University, Chang Mai, Thailand.
Contemp Clin Trials. 2007 Jul;28(4):409-22. doi: 10.1016/j.cct.2006.11.005. Epub 2006 Nov 21.
Counseling for participants in preventive HIV vaccine trials has been an area of continuing concern because of the need to address possible behavioral side effects (e.g., increased risk behavior because trial participants believe they may have received an active, effective vaccine) and social harms (e.g., discrimination in health care or employment because of vaccine-induced seropositivity on commercial HIV tests). Yet, the data on behavioral effects and social harms are limited and rather little detail has been provided regarding the counseling provided in current or past trials. This paper summarizes conceptual, cultural, and practical considerations in the development of a counseling program for HIV vaccine trials and provides examples from work done in the context of Phase I/II vaccine trials in Thailand.
由于需要应对可能出现的行为副作用（例如，试验参与者认为自己可能接种了有效的活性疫苗，从而导致危险行为增加）和社会危害（例如，因商业性HIV检测中疫苗诱导的血清阳性而在医疗保健或就业方面受到歧视），为参与预防性HIV疫苗试验的人员提供咨询一直是一个持续受到关注的领域。然而，关于行为影响和社会危害的数据有限，而且对于当前或过去试验中提供的咨询，所提供的细节相当少。本文总结了在制定HIV疫苗试验咨询计划时的概念、文化和实际考虑因素，并提供了在泰国进行的I/II期疫苗试验背景下所开展工作的实例。
