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

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，伦理挑战和相关的争议一再出现，导致社区和利益相关者参与的密集模式的发展，作为一种手段，找到道德解决方案，以解决困难的困境。新结核病治疗方案的试验提出了与艾滋病毒类似的挑战，但并未导致同样的全球争议。2012年10月，结核病药物治疗方案关键路径（CPTR）的利益相关者和社区参与工作组（SCE-WG）发布了结核病药物试验良好预防实践指南（GPP-TB），该指南基于艾滋病毒的类似指南。尽管人们承认社区参与和参与性战略对于艾滋病毒预防试验和传播结核病指导方针的重要性，但对益处和负担的经验性评估却停滞不前。我们建议使用变革理论（TOC）的方法来开发一个评估过程的GPP-TB。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GPP-TB变化理论，并制定一个合理、可行和可测试的相关评估策略。第二（目标2），我们将与全球多样化的结核病试验实施地点合作，开展形成性工作，以制定和试行一套适用于结核病试验风险、获益和社会价值伦理分析的优先结果指标。已确定协作地点 在越南、秘鲁和乌干达。该提案是与CPTR SCE-WG、CDC领导的结核病试验联盟（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，我们对如何评估GPP作为结核病试验伦理学工具的理解将大大提高，使我们能够设计和实施严格的评估GPP-TB的收益和成本及其对伦理结果的影响。

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.