Developing an ART Adherence Intervention in South Central China

描述（由申请人提供）：这是一个发展性项目，旨在设计和测试在资源有限的中国中南地区支持抗逆转录病毒治疗（ART）依从性的文化上适当的干预措施的可行性和初步效果，目前国家疾病预防控制中心正在扩大抗逆转录病毒治疗。我们将把在美国进行的随机临床试验中证明有效的理论驱动的抗逆转录病毒治疗依从性干预措施应用于中国的文化和社会背景。调整将根据我们在中国该地区的初步定量和定性工作结果，并将由患者、提供者和社区审查小组进行验证。我们将通过湖南省的中国国家抗逆转录病毒治疗计划对90名开始抗逆转录病毒治疗的患者进行一项随机、对照的试点研究，以确定干预措施的可行性和可接受性，并为全面的临床试验建立初步的效应值。我们还将使用超深度测序技术来描述基因型抗逆转录病毒耐药性的基线患病率和发生率，并探索依从性与抗逆转录病毒耐药性之间的关系。通过进一步了解与抗逆转录病毒治疗依从性相关的因素和支持或改善依从性的干预措施，以及通过进一步了解基因型突变（包括低丰度物种）的临床意义，以及基因型检测作为临床护理一部分的价值，从这项研究中获得的知识将有助于成功治疗艾滋病毒疾病。这些益处将惠及发达国家和发展中国家的患者。获得这方面知识的机会是独一无二的，而且时间有限，因为中国正处于雄心勃勃、组织良好的抗逆转录病毒药物推广的早期阶段。

Description (provided by the applicant): This is a developmental project to design and test the feasibility and preliminary efficacy of a culturally appropriate intervention for supporting antiretroviral therapy (ART) adherence in South Central China, in a resource-constrained setting where the national CDC is presently scaling up ART-treatment. We will adapt a theoretically driven ART adherence intervention, which demonstrated efficacy in a randomized clinical trial conducted in the United States, to the Chinese cultural and social context. The adaptation will be informed by the results of our preliminary quantitative and qualitative work in this region of China and will be validated by patient, provider, and community review groups. We will conduct a randomized, controlled pilot study of the feasibility and acceptability of the intervention among 90 patients beginning ART through the China national ART program in Hunan Province and establish a preliminary effect size in anticipation of a full-scale clinical trial. We will also use Ultra Deep Sequencing technology to describe baseline prevalence and incidence of genotypic ART resistance and explore the relationship between adherence and ART resistance. Knowledge acquired from this study will contribute to successful treatment of HIV disease through increased understanding of factors associated with ART adherence and interventions to support or improve adherence and through increased understanding of the clinical significance of genotypic mutations, including low abundance species, and the value of genotypic testing as part of clinical care. These benefits will accrue to patients in both the developed and developing world. The opportunity to acquire this knowledge is unique and time-limited, because China is in the early stages of an ambitious and well-organized ART roll out.