Improving Identification of Social Harm among Substance Abusers in HIV Trials

描述（由申请人提供）：大多数临床试验没有以任何系统的方式定期监测参与者所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大的压迫、歧视和受害风险。当参与者是药物滥用者时，这些风险可能会加剧。虽然可预见的风险通常在同意书中列出，并在整个研究过程中进行监测，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，大多数社会危害可能不会被发现。认识到参与艾滋病毒疫苗试验可能造成严重的社会危害，由国家过敏和传染病研究所（NIAID）赞助的几个小组开始纳入一般评估，以衡量研究人员参与艾滋病毒疫苗试验的社会影响。虽然这为监测临床研究中的社会危害提供了一个初步的模型，但评估存在一些缺点，限制了其可靠性、有效性和实用性。一般来说，他们以访谈的形式进行管理，这对研究团队来说可能很麻烦。此外，参与者可能会感到不舒服或不愿意直接向面试官报告社会危害，从而导致负面事件的不准确或少报。访谈项目通常针对大类别的行为，而不是特定的行为，这降低了评估的敏感性和结构有效性，并且跨机构使用的问题没有标准化。最后，这些评估不包括药物使用的具体危害，这是艾滋病毒/艾滋病传播的一个主要风险因素。拟议的两个阶段的项目寻求开发一个全面的、音频计算机辅助的自我管理访谈社会危害问卷（ACASI-SHQ），这将使研究人员能够更容易地识别和监测参与艾滋病试验的药物滥用者所经历的社会危害。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)利用自我访谈格式，这将增加HIV研究人员采用该格式的可能性。然后，我们将评估其可行性、可接受性和初步效用，并在正在进行的艾滋病毒试验中构建有效性。这一创新和重要的R21申请的结果将作为未来R01申请的基础，以在更大的研究试验样本中检查社会危害评估的效用和有效性。

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.