Optimizing the ethical research engagement for pregnant women living with HIV and their children

项目摘要 近年来，涉及感染艾滋病毒的孕妇及其子女的研究有所增加 更好地了解产前阶段与新的抗逆转录病毒疗法有关的健康结果， 艾滋病毒感染者母亲所生的孩子的健康状况。虽然已经达成了一些见解， 这些人群在从事研究时所面临的问题，很少有人知道什么是潜在的 他们的参与和他们更喜欢的研究结果交流方法会造成伤害。因此，我们认为， 迫切需要一种经验的、以人为本的方法来理解可能出现的伦理问题 由于多重脆弱性的交叉性， 在这些人群中。通过提供更多的经验证据来指导伦理研究活动， 项目将获得关于如何在未来的研究中吸引这一人群的重要指导。拟议活动 将在我们正在进行的Tabiri研究（R 01 HD 104552）中进行，该研究目前招募了1000名 怀孕或刚产后及产后的肯尼亚妇女（其中一半感染艾滋病毒） 和他们的孩子24个月。本申请的具体目的是：（1）提供证据 指导涉及艾滋病毒感染者及其年幼子女的生物医学研究的道德和公平行为的基础， （2）创建和传播一个知情的生物伦理学工具包，以支持调查人员参与 在类似人群的研究中。在第一个目标中，我们将评估研究参与的前景 来自主要利益相关者，包括积极参与持续母婴健康成果的PWLHIV 肯尼亚的研究。为此，我们将招募关键的利益相关者，包括PWLHIV及其合作伙伴， 长者、医护人员、研究助理、社区医护人员及研究伦理委员会 成员，进行深入的定性访谈，以了解与研究参与有关的无数主题。 在第二个目标中，我们将创建和传播一个生物伦理工具包，让艾滋病病毒携带者及其子女参与进来， 在研究中。我们研究第一部分的主要利益相关者访谈结果将为 为艾滋病毒携带者及其幼儿参与的研究制定道德准则。然后我们将使用一个 一系列参与式设计研讨会，包括PWLHIV，大学伦理委员会成员，以及关键的 在国际伦理框架的指导下，教科文组织与所有利益攸关方合作，开发一套生物伦理工具包。该工具包将概述 研究的关键方面，从研究设计到结果的传播。我们将把工具包分发给我们- 采取三种策略：（1）当地研讨会，邀请来自肯尼亚各地的伦理委员会成员;（2）重新 国际流行病学数据库评价艾滋病区域联合会的搜索网络， 学术模式提供医疗保健（AMPATH）财团;以及（3）在一个展览摊位 国际艾滋病大会。通过这些目标，我们将获得关键的见解，以发展基于证据的 优化以PWLHIV及其子女为重点的、受资助者参与的伦理研究所需的资源。

PROJECT SUMMARY Research involving pregnant women living with HIV (PWLHIV) and their children has increased in recent years to better understand the health outcomes related to new antiretroviral regimens within the antenatal period and outcomes related to being born to a mother living with HIV. While some insights have been reached regarding the issues faced by these populations when engaging in research, very little is known about what potential harms arise from their participation and their preferred method for communication of study results. Therefore, there is a critical need for an empiric, person-centered approach to understand the ethical issues that can arise from research involving PWLHIV and their young children due to the intersectionality of multiple vulnerabilities within these populations. By providing more empirical evidence to inform ethical research activities, research programs will gain critical guidance on how to engage this population in future studies. The proposed activities will occur within the context of our ongoing Tabiri Study (R01HD104552), which is currently enrolling 1000 Kenyan women (half of whom live with HIV) who are pregnant or immediately post-partum and following them and their children for 24 months. The specific objectives of this application are to: (1) provide an evidentiary basis to guide the ethical and equitable conduct of biomedical research involving PWLHIV and their young chil- dren, and (2) create and disseminate a stakeholder-informed bioethics toolkit to support investigators engaging in research with similar populations. Within the first aim, we will evaluate perspectives on research participation from key stakeholders, including PWLHIV who are actively enrolled in ongoing maternal-child health outcomes research in Kenya. To do this, we will recruit key stakeholders, including PWLHIV and their partners, village elders, healthcare workers, research assistants, community health workers, and research ethics committee members, for in-depth, qualitative interviews to understand a myriad of topics related to research participation. Within the second aim, we will create and disseminate a bioethical toolkit for engaging PWLHIV and their chil- dren in research. The results from the key stakeholder interviews from the first part of our study will inform the creation of ethical guidelines for research engaging PWLHIV and their young children. We will then utilize a series of participatory design workshops, including PWLHIV, university ethics committee members, and key stakeholders, guided by an international ethics framework, to develop a bioethical toolkit. The toolkit will outline key aspects of research, from study design to dissemination of results. We will then disseminate the toolkit us- ing three strategies: (1) a local symposium, inviting ethics committee members from across Kenya; (2) the re- search networks of the International epidemiological Databases to Evaluate AIDS Regional Consortium and the Academic Model Providing Access to Healthcare (AMPATH) consortium; and (3) an exhibition booth at an international HIV conference. Through these aims, we will gain critical insights to develop the evidence-based resources needed to optimize stakeholder-engaged, ethical research focused on PWLHIV and their children.