Developing an ART Adherence Intervention in South Central China

描述（由申请方提供）：这是一个发展性项目，旨在设计和测试一种文化上适当的干预措施的可行性和初步疗效，以支持中国中南部抗逆转录病毒治疗（ART）的依从性，在资源有限的环境中，国家CDC目前正在扩大ART治疗。我们将调整理论驱动的ART依从性干预，在美国进行的随机临床试验中证明了其有效性，以适应中国的文化和社会背景。适应将根据我们在中国这一地区的初步定量和定性工作的结果进行，并将由患者、提供者和社区审查小组进行验证。我们将在湖南省通过中国国家ART项目开始ART治疗的90例患者中进行一项随机对照的初步研究，探讨干预的可行性和可接受性，并建立一个初步的效应量，以期待全面的临床试验。我们还将使用超深度测序技术来描述基因型ART耐药的基线患病率和发生率，并探索依从性和ART耐药之间的关系。从本研究中获得的知识将有助于成功治疗HIV疾病，通过增加对与ART依从性和干预措施相关因素的理解，以支持或改善依从性，并通过增加对基因型突变（包括低丰度物种）的临床意义的理解，以及基因型检测作为临床护理一部分的价值。发达国家和发展中国家的患者都将获得这些益处。获得这些知识的机会是独一无二的，也是有时间限制的，因为中国正处于雄心勃勃、组织良好的抗逆转录病毒疗法推广的早期阶段。

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.