Collaborative Clinical Research Branch, Division of Clinical Research, NIAID, NIH, 6700B Rockledge Drive, Bethesda, MD 20892, USA.
Vaccine. 2011 Oct 13;29(44):7794-800. doi: 10.1016/j.vaccine.2011.07.108. Epub 2011 Aug 5.
HIV vaccine clinical research occurs within a context where biomedical science and social issues are interlinked. Previous HIV vaccine research has considered behavioral and social issues, but often treated them as independent of clinical research processes. Systematic attention to the intersection of behavioral and social issues within a defined clinical research framework is needed to address gaps, such as those related to participation in trials, completion of trials, and the overall research experience. Rigorous attention to these issues at project inception can inform trial design and conduct by matching research approaches to the context in which trials are to be conducted. Conducting behavioral and social sciences research concurrent with vaccine clinical research is important because it can help identify potential barriers to trial implementation, as well as ultimate acceptance and dissemination of trial results. We therefore propose a conceptual framework for behavioral and social science in HIV vaccine clinical research and use examples from the behavioral and social science literature to demonstrate how the model can facilitate identification of significant areas meriting additional exploration. Standardized use of the conceptual framework could improve HIV vaccine clinical research efficiency and relevance.
HIV 疫苗临床研究发生在生物医学科学和社会问题相互关联的背景下。以前的 HIV 疫苗研究已经考虑了行为和社会问题，但往往将它们视为与临床研究过程无关。需要系统地关注行为和社会问题在一个明确的临床研究框架内的交叉点，以解决与参与试验、完成试验以及整体研究经验相关的差距。在项目开始时严格关注这些问题，可以通过将研究方法与将要进行试验的背景相匹配，为试验设计和实施提供信息。与 HIV 疫苗临床研究同时进行行为和社会科学研究很重要，因为它可以帮助确定试验实施的潜在障碍，以及最终对试验结果的接受和传播。因此，我们提出了 HIV 疫苗临床研究中行为和社会科学的概念框架，并使用行为和社会科学文献中的示例来说明该模型如何有助于确定值得进一步探索的重要领域。该概念框架的标准化使用可以提高 HIV 疫苗临床研究的效率和相关性。
