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

描述（由申请人提供）：在艾滋病毒生物医学预防试验的背景下，伦理挑战和相关争议一再出现，导致社区和利益相关者参与的密集模式的发展，作为寻找困难困境的伦理解决方案的手段。结核病新疗法的试验提出了与艾滋病类似的挑战，但没有引起同样的全球争议。2012年10月，结核病药物治疗关键途径（CPTR）的利益相关者和社区参与工作组（SCE-WG）在类似的艾滋病毒指南的基础上发布了结核病药物试验良好参与实践指南（GPP-TB）。尽管人们承认社区参与和参与性战略对艾滋病毒预防试验的重要性，并将指导方针推广到结核病领域，但对益处和负担的经验评估却停滞不前。我们建议使用变化理论（TOC）方法来开发GPP-TB的评估过程。首先（目标1），我们将把结核病药物试验利益相关者聚集在一起，绘制GPP-TB变化理论，并制定一项合理、可行和可测试的相关评估战略。第二（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，制定和试点一套适用于结核病试验风险、收益和社会价值伦理分析的优先结果措施。已经确定了协作站点

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.