Exploring Health Beliefs for Community Engagement and Diversity in Clinical Trials

摘要 提高临床研究中不同人群的包容性和参与度可以扩大相关性， 将研究成果转化为实践。许多社区在健康研究中的代表性不足， 原因：缺乏对临床研究的了解、不信任、缺乏访问、地理位置和社会因素。缺乏 了解研究如何运作以及如何使社区受益是不进行研究的一个常见原因。 参与，特别是如果研究是在学术医疗机构和地点进行， 很大一部分人得不到保健。提供者和社区卫生组织往往缺乏 关于临床研究的知识和培训，以及如何与患者和社区保持一致 优先事项据我们所知，目前还没有旨在促进包容和参与的工具汇编。 临床研究中的多样性和少数群体。在本补充申请中，我们建议开发 这样的工具包。该工具包的目标是为研究人员和社区合作伙伴提供一个指南， 在提出临床研究建议时，应考虑个人、文化和结构的观点。我们 特别有兴趣推动参与涉及药物使用的研究和试验， 特别是阿片类药物使用障碍（OUD），与我们的国家药物研究所的HEAL基金有关 NIDA临床试验网络西南临床试验节点的滥用。我们建议进行这项工作， 我在新墨西哥州南部工作，这是一个人口高度多样化的地区，许多群体受到 OUD并且临床试验参与度较低。利用现有的材料和资源， 检查，调整和测试这些，以产生一个临床研究参与工具包，可用于增强 通过解决参与的个人和结构性障碍来参与临床研究。的 健康信念工具包包括可用于评估个人健康知识的项目， 对疾病的易感性和障碍（包括个人价值观和信仰）或对健康的益处 研究参与。我们将审查和调整健康素养工具，以开发“临床研究素养”工具 纳入工具包。我们还将开发旨在加强临床沟通的组件 用动机访谈技术进行研究。最后，我们将制定一项结构评估， 脆弱性改编自卫生保健提供者的结构脆弱性清单。我们的目标群体 将与适应，开发和测试工具包将包括：初级保健提供者，promotora/es （社区卫生工作者）、同伴咨询师、机构代表以及患者和非患者群体。我们 将采用混合方法来调整和评价拟议的工具包。涟漪效应 绘图将作为最终评价的一部分进行。拟议的EXPLORE工具包项目将使用 新的基于网络的平台，用于项目活动、社区参与和评估。

ABSTRACT Improving inclusion and engagement of diverse populations in clinical research can broaden the relevance and translation of research findings into practice. Many communities are under-represented in health research due to: lack of knowledge about clinical research, mistrust, lack of access, geo-location, and social factors. Lack of knowledge about how research works and how it can benefit communities is a common reason for non- engagement, especially if research is carried out in academic medical institutions and locations where a significant proportion of people do not access care. Providers and community health groups often lack knowledge and training about clinical research and how it may or may not align with patients’ and community priorities. To our knowledge, there is no compendium of tools aimed at advancing inclusion and engagement of diverse and minority populations in clinical research. In this supplemental application, we propose to develop such a toolkit. The goal of the toolkit will be to provide researchers and community partners a guide to taking the individual, cultural, and structural perspectives into consideration when proposing clinical research. We are specifically interested in advancing engagement in research and trials that deal with substance use, and especially opioid use disorder (OUD), in association with our HEAL funding from the National Institute on Drug Abuse for the Southwest Clinical Trial Node of the NIDA Clinical Trials Network. We propose to conduct this work in southern New Mexico, an area with a highly diverse population, where many groups are impacted by OUD and there has been low clinical trial engagement. Using existing materials and resources, we will examine, adapt, and test these to produce a clinical research engagement toolkit that can be used to enhance engagement in clinical research by addressing both individual and structural barriers to engagement. The Health Beliefs Toolkit includes items that can be adapted to assess individuals’ knowledge of health, their perceived susceptibility to illness, and barriers (including personal values and beliefs) or benefits to health research engagement. We will review and adapt health literacy tools to develop ‘clinical research literacy’ tools for toolkit inclusion. We will also develop components that aim to enhance communication about clinical research with motivational interviewing techniques. Finally, we will develop an assessment of structural vulnerability adapted from the structural vulnerability checklist for health care providers. The target groups we will work with to adapt, develop and test the toolkit will include: primary care providers, promotora/es (community health workers), peer counselors, agency representatives, and patient and non-patient groups. We will use a mixed-methods approach to adaptation and evaluation of the proposed toolkit. Ripple Effects Mapping will be conducted as part of the final evaluation. The proposed EXPLORE toolkit project will use a novel web-based platform for project activities, community engagement, and evaluation.