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

优化感染艾滋病毒的孕妇及其子女的伦理研究参与

基本信息

批准号：
10792212
负责人：
Megan Song McHenry
金额：
$ 28.06万
依托单位：
INDIANA UNIV-PURDUE UNIV AT INDIANAPOLIS
依托单位国家：
美国
项目类别：
财政年份：
2021
资助国家：
美国
起止时间：
2021-04-09 至 2026-01-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10792212
关键词：
Acquired Immunodeficiency Syndrome Address Africa African Anti-Retroviral Agents Area Bioethical Issues Bioethics Biomedical Research Caring Child Committee Members Communicable Diseases Communication Communication Methods Community Health Aides Data Security Databases Development Educational workshop Elderly Enrollment Ensure Epidemiology Equity Ethical Issues Ethics Ethics Committees Exposure to Foundations Future Goals Guidelines HIV Health Health Personnel Human Information Dissemination Informed Consent International Interview Kenya Maternal and Child Health Mission Modeling Morbidity - disease rate Mothers National Institute of Child Health and Human Development Outcome Outcomes Research Participant Policies Population Postpartum Period Pregnant Women Process Public Health Recommendation Regimen Research Research Activity Research Assistant Research Design Research Ethics Committees Research Personnel Research Project Summaries Resource-limited setting Resources Series United States National Institutes of Health Universities Vulnerable Populations Woman aged antenatal clinical care design disability evidence base exhibitions experience global health health care availability improved insight intersectionality mortality novel peer person centered poor health outcome pregnant programs recruit sound symposium

项目摘要

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.

项目概要近年来，涉及艾滋病毒感染者（PWLHIV）孕妇及其子女的研究有所增加更好地了解产前期间与新的抗逆转录病毒治疗方案相关的健康结果，与感染艾滋病毒的母亲所生的结果有关。虽然已经就以下问题达成了一些见解这些人群在从事研究时面临的问题，人们对它们的潜力知之甚少伤害源于他们的参与和他们交流研究结果的首选方法。所以，迫切需要一种以人为本的经验方法来理解可能出现的道德问题由于多种脆弱性的交叉性，涉及 PWLHIV 及其幼儿的研究在这些人群中。通过提供更多的经验证据来指导伦理研究活动，研究项目将获得关于如何让这一人群参与未来研究的关键指导。拟议的活动将在我们正在进行的 Tabiri 研究 (R01HD104552) 的背景下进行，该研究目前正在招募 1000 名怀孕或产后立即跟踪的肯尼亚妇女（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 PWLHIV 及其幼儿的生物医学研究的道德和公平进行的基础德伦，(2) 创建并传播利益相关者知情的生物伦理学工具包，以支持研究人员参与在对类似人群的研究中。在第一个目标中，我们将评估研究参与的观点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，我们将招募关键利益相关者，包括 PWLHIV 及其合作伙伴、村庄长者、医护人员、研究助理、社区卫生工作者和研究伦理委员会成员进行深入的定性访谈，以了解与研究参与相关的众多主题。在第二个目标中，我们将创建并传播一个生物伦理工具包，以吸引 PWLHIV 及其子女的参与。德伦正在研究。我们研究第一部分的主要利益相关者访谈的结果将告知为 PWLHIV 及其幼儿参与的研究制定道德准则。然后我们将利用一个系列参与式设计研讨会，包括 PWLHIV、大学伦理委员会成员和关键利益相关者在国际伦理框架的指导下开发生物伦理工具包。该工具包将概述研究的关键方面，从研究设计到结果传播。然后我们将向我们传播该工具包- 制定三个策略：（1）当地研讨会，邀请来自肯尼亚各地的道德委员会成员； (2) 重新国际流行病学数据库的搜索网络，以评估艾滋病区域联盟和提供医疗保健的学术模型 (AMPATH) 联盟； (3) 一个展位国际艾滋病毒会议。通过这些目标，我们将获得重要的见解来开发基于证据的优化利益相关者参与的、关注 PWLHIV 及其子女的伦理研究所需的资源。