Improving Identification of Social Harm among Substance Abusers in HIV Trials

描述(由申请人提供)：大多数临床试验不会以任何系统的方式定期监测参与者经历的负面社会伤害。参与艾滋病毒试验往往使参与者面临更高的压迫、歧视和受害风险。当参与者是物质滥用者时，这些风险可能会加剧。虽然可预见的风险一般在同意书中列出，并在整个研究过程中受到监测，但许多社会危害是不可预见的，因此没有讨论或监测。如果没有系统的监测，大多数社会危害很可能没有被发现。认识到参与艾滋病毒疫苗试验可能造成的高度社会危害，几个由国家过敏和传染病研究所(NIAID)赞助的团体开始纳入一般评估，以衡量参与艾滋病毒疫苗试验的研究的社会影响。虽然这为临床研究中的社会危害监测提供了一个初步模型，但这些评估存在几个缺陷，限制了它们的可靠性、有效性和实用性。一般来说，他们是以采访的形式进行管理的，这可能会给研究团队带来麻烦。此外，参与者可能会感到不舒服或不愿直接向面试者报告社会伤害，导致对负面事件的不准确或漏报。面试项目通常针对的是大类行为，而不是具体的行为，这降低了评估的敏感性和结构效度，而且跨机构使用的问题也没有标准化。最后，这些评估不包括物质使用的具体危害，物质使用是艾滋病毒/艾滋病传播的一个主要风险因素。拟议的分两个阶段的项目旨在开发一个全面的、音频计算机辅助的自我管理访谈社会危害问卷(ACASI-SHQ)，使研究人员能够更容易地识别和监测参与艾滋病毒试验的药物滥用者经历的社会危害。ACASI-SHQ将(1)降低社会期望反应的可能性，(2)包括具有高度特异性的项目，以增加识别社会危害的可能性(结构效度)，以及(3)利用自我访谈的形式，将增加艾滋病毒研究人员采用该工具的可能性。然后，我们将评估其可行性、可接受性和初步效用，并在正在进行的HIV试验中构建有效性。这一创新和重要的R21应用程序的结果将作为未来R01应用程序的基础，以在更大的研究试验样本中检查社会危害评估的实用性和有效性。

DESCRIPTION (provided by applicant): Most clinical trials do not regularly monitor for negative social harms experienced by participants in any systematic way. Participation in HIV trials often place participants at a heightened risk of oppression, discrimination, and victimization. These risks may be compounded when participants are substance abusers. Although foreseen risks are generally outlined in the consent form and monitored throughout the study, many social harms are unforeseen and, consequently, are not discussed or monitored. Without systematic monitoring, the majority of social harms likely go undetected. Recognizing the high level of social harm that may arise as a result of participation in HIV vaccine trials, several National Institute of Allergy and Infectious Diseases (NIAID)-sponsored groups began to incorporate general assessments to measure the social impact of research participation in HIV vaccine trials. Although this has provided a preliminary model for monitoring social harms in clinical research, the assessments have several shortcomings that limit their reliability, validity and utility. In general, they are administered in an interview format that may be cumbersome to the research team. Furthermore, participants may feel uncomfortable or reluctant to report social harms directly to the interviewer, resulting in inaccuracies or underreporting of negative events. Interview items generally address large classes of behavior rather than specific behaviors, reducing the sensitivity and construct validity of the assessments, and questions used across agencies are not standardized. Finally, these assessments do not include harms specific to substance use, a major risk factor for HIV/AIDS transmission. The proposed two- phased project seeks to develop a comprehensive, audio computer assisted self-administered interview social harm questionnaire (ACASI-SHQ) that will allow researchers to more easily identify and monitor social harms experienced by substance abusers participating in HIV trials. The ACASI-SHQ will (1) reduce the likelihood of socially desirable responding, (2) include items with high levels of specificity to increase the likelihood of identifying social harms (construct validity), and (3) utilize a self-interview format that will increase the likelihood of its adoptio by HIV researchers. We will then evaluate its feasibility, acceptability, and preliminary utility and construct validity in an ongoing HIV trial. Findings from this innovative and significant R21 application will serve as the basis for a future R01 application to examine the utility and validit of the social harm assessment in a larger sample of research trials.