Developing a Theory of Change for Evaluating Participatory Practices in TB Trials

发展变革理论来评估结核病试验中的参与实践

• 批准号: 8602605
• 负责人: Kathleen M MacQueen
• 金额: $ 15.51万
• 依托单位: FAMILY HEALTH INTERNATIONAL
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-05 至 2015-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8602605
• 关键词: AIDS prevention; AIDS/HIV problem; Advocacy; Benefits and Risks; Centers for Disease Control and Prevention (U.S.); Clinical Research; Collaborations; Communities; Comorbidity; Costs and Benefits; Critical Pathways; Development; Diffusion; Effectiveness; Ethical Analysis; Ethical Issues; Ethics; Evaluation; Exercise; Focus Groups; Foundations; Funding; Future; Goals; Guidelines; HIV; HIV prevention trial; Maps; Measures; Modeling; Monitor; Outcome; Outcome Measure; Pathway interactions; Peru; Positioning Attribute; Practice Guidelines; Process; Prophylactic treatment; Regimen; Relative (related person); Reporting; Research; Resources; Site; Social Values; Solutions; Specific qualifier value; Staging; Testing; Translating; Uganda; Vietnam; Vulnerable Populations; Work; base; cost; design; evidence base; public health relevance; public health research; response; success; theories; tool; tuberculosis drugs

DESCRIPTION (provided by applicant): Ethical challenges and associated controversies have arisen repeatedly in the context of biomedical HIV prevention trials, leading to the development of intensive models of community and stakeholder participation as a means to finding ethical solutions to difficult dilemmas. Trials of new TB regimens raise challenges similar to those of HIV but have not resulted in the same kind of global controversies. In October 2012 the Stakeholder and Community Engagement Workgroup (SCE-WG) of the Critical Path to TB Drug Regimens (CPTR) issued Good Participatory Practice Guidelines for TB Drug Trials (GPP-TB), based on similar guidelines for HIV. Despite the acceptance of the importance of community engagement and participatory strategies for HIV prevention trials and diffusion of guidelines to the TB context, empirical assessment of the benefits and burdens has languished. We propose to use a Theory of Change (TOC) approach to develop an evaluation process for GPP-TB. First (Aim 1,) we will bring TB drug trials stakeholders together to map a GPP-TB Theory of Change and develop an associated evaluation strategy that is plausible, doable and testable. Second (Aim 2), we will work with a globally diverse group of TB trials implementing sites, conduct formative work to develop and pilot a set of priority outcome measures suitable for an ethical analysis of risks, benefits and social value in TB trials. Collaborating sites have been identified in Vietnam, Peru, and Uganda. This proposal has been developed in collaboration with representatives of the CPTR SCE-WG, the CDC-led TB Trials Consortium (TBTC) and its Community Research Advisory Group (CRAG), and AVAC. Through this study our understanding of how to evaluate GPP as an ethics tool for TB trials will be significantly advanced, positioning us to design and implement a rigorous evaluation of the benefits and costs of GPP-TB and its impact on ethics outcomes.

描述(由申请人提供)：在生物医学艾滋病毒预防试验的背景下，伦理挑战和相关争议一再出现，导致了社区和利益攸关方参与的密集模式的发展，以此作为找到解决难题的伦理解决方案的手段。新结核病疗法的试验提出了与艾滋病毒相似的挑战，但没有引起同样的全球争议。2012年10月，结核病药物疗法关键途径的利益攸关方和社区参与工作组在艾滋病毒类似指南的基础上发布了结核病药物试验良好参与性实践指南。尽管人们接受了社区参与和艾滋病毒预防试验的参与性战略的重要性，并将指南传播到结核病的背景下，但对其益处和负担的实证评估一直停滞不前。我们建议使用变化理论(TOC)方法来开发GPP-TB的评估程序。首先(目标1)我们将把结核病药物试验的利益相关者聚集在一起，绘制一份GPP-TB变化理论图，并制定一项可信、可行和可测试的相关评估战略。其次(目标2)，我们将与全球不同的结核病试验实施地点合作，开展形成性工作，开发和试点一套适用于对结核病试验的风险、收益和社会价值进行伦理分析的优先结果措施。已确定合作地点 在越南、秘鲁和乌干达。这项建议是与CPTRSCE-WG、疾控中心领导的结核病试验联合会(TBTC)及其社区研究咨询小组(CRAG)和AVAC的代表合作制定的。通过这项研究，我们将大大提高对如何评估GPP作为结核病试验伦理工具的理解，使我们能够设计和实施对GPP-TB的收益和成本及其对伦理结果的影响的严格评估。