Developing an ART Adherence Intervention in South Central China

描述(由申请人提供)：这是一个开发项目，旨在设计和测试在中南部中国地区支持抗逆转录病毒治疗(ART)坚持的文化适当干预的可行性和初步疗效，在资源有限的情况下，国家疾病预防控制中心目前正在扩大抗逆转录病毒治疗的规模。我们将使理论驱动的ART依从性干预措施适应中国的文化和社会背景，该干预措施在美国进行的随机临床试验中证明了有效性。我们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来通知适应情况，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计划对90名初诊ART患者进行随机对照初步研究，以期进行全面的临床试验，并建立初步的效果规模。我们还将使用超深测序技术来描述基因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。通过这项研究获得的知识将有助于成功治疗艾滋病毒疾病，方法是增加对与抗逆转录病毒治疗相关的因素的了解，以及支持或改善依从性的干预措施，以及通过增加对包括低丰度物种在内的基因突变的临床意义的了解，以及将基因测试作为临床护理的一部分的价值。这些好处将惠及发达国家和发展中国家的患者。获得这些知识的机会是独一无二的，也是有限的，因为中国正处于雄心勃勃、组织严密的艺术推广的早期阶段。

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.