Exploring Health Beliefs for Community Engagement and Diversity in Clinical Trials

摘要 提高不同人群对临床研究的包容性和参与度可以扩大临床研究的相关性和 将研究成果转化为实践。许多社区在卫生研究中的代表性不足 致：缺乏临床研究知识、不信任、缺乏机会、地理位置和社会因素。缺乏 了解研究如何工作以及它如何造福社区是非 参与，特别是在学术医疗机构和地点进行研究时 相当大比例的人得不到医疗服务。提供者和社区卫生组织经常缺乏 关于临床研究的知识和培训，以及它如何与患者和社区保持一致 优先事项。据我们所知，没有旨在促进包容和参与的工具简编 临床研究中的多样化和少数族裔人群。在此补充应用程序中，我们建议开发 这样一个工具包。该工具包的目标将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要考虑个体、文化和结构的观点。我们是 特别对推动涉及物质使用的研究和试验的参与感兴趣，以及 特别是阿片类药物使用障碍(OUD)，与我们由国家药物研究所提供的治疗资金有关 滥用NIDA临床试验网络的西南临床试验节点。我们建议进行这项工作 在新墨西哥州南部工作，这是一个人口高度多样化的地区，在那里许多群体受到 而且临床试验参与度一直很低。利用现有的材料和资源，我们将 检查、调整和测试这些，以产生可用于增强的临床研究参与工具包 通过解决参与的个人和结构障碍，参与临床研究。这个 健康信念工具包包括可用于评估个人健康知识的项目，他们的 感觉到的疾病易感性，以及健康方面的障碍(包括个人价值观和信仰)或益处 投身于研究。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 用于工具包的包含。我们还将开发旨在加强临床沟通的组件 使用激励性面试技巧进行研究。最后，我们将制定一项结构评估 根据卫生保健提供者结构脆弱性核对表改编的脆弱性。我们的目标群体 将与以下人员合作以适应、开发和测试该工具包：初级保健提供者、促进者 (社区卫生工作者)、同伴辅导员、机构代表以及患者和非患者群体。我们 将采用混合方法对拟议的工具包进行调整和评价。涟漪效应 将进行测绘，作为最终评估的一部分。提议的Explore工具包项目将使用 为项目活动、社区参与和评估提供新的网络平台。

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.