Evaluating ART for All HIV Seropositives: Can it work with the hardest cases?

评估所有艾滋病毒血清阳性者的抗逆转录病毒疗法：它可以用于最困难的病例吗？

• 批准号: 8816068
• 负责人: Aimee N Campbell
• 金额: $ 61.05万
• 依托单位: ST. LUKE'S-ROOSEVELT INST FOR HLTH SCIS
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2015-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/8816068
• 关键词: Accounting; Acquired Immunodeficiency Syndrome; Adopted; Adoption; African American; Alcohol or Other Drugs use; Alcohols; Anti-Retroviral Agents; Area; CD4 Lymphocyte Count; CD4 Positive T Lymphocytes; Caring; Cities; Clinic; Clinical; Communities; Data; Data Analyses; Data Set; Data Sources; Diagnosis; Disease; Early treatment; Ecosystem; Education; Epidemic; Ethnic Origin; Evaluation; Feedback; Funding; Generations; Goals; HIV; HIV Infections; HIV diagnosis; HIV-1; Health; Healthcare; Illicit Drugs; Individual; Information Dissemination; International AIDS; Lead; Life; Link; Maintenance; Mental Health; Methods; Minority Groups; Modeling; New York City; Newly Diagnosed; Outcome; Patients; Persons; Pharmaceutical Preparations; Plasma; Policies; Prevention; Primary Health Care; Provider; Public Health; RNA; Race; Recommendation; Recruitment Activity; Reporting; Research; Research Personnel; Resource Allocation; Resources; Risk; Sampling; Services; Sexual Transmission; Sexually Transmitted Diseases; Social Conditions; System; Testing; Treatment Protocols; Viral; Viral Load result; Virus; Work; base; cohesion; cohort; design; high risk; improved; primary outcome; public health relevance; racial and ethnic disparities; seropositive; social; socioeconomics; surveillance data; symposium; transmission process; treatment adherence

DESCRIPTION (provided by applicant): On World AIDS Day, December 1, 2011, the NYC Department of Health and Mental Hygiene (NYCDOHMH) announced a new policy that all HIV seropositives should be offered antiretroviral treatment (ART) regardless of CD4 cell count. The new policy was based primarily on "treatment as prevention" as a method for not only improving the health of people living with HIV who initiate ART early, but also as a means of reducing transmission of the virus. The NYCDOHMH set an ambitious goal for this new policy: by one year post HIV diagnosis, 80% of new HIV diagnoses will have reached viral suppression. There are over 3,400 new HIV infections occurring annually in NYC; recent data indicate 38% reached durable viral suppression in 2006-07 (i.e., all viral loads 400 copies/mL). The policy goal is ambitious, but if it were to be achieved, it would almost certainly lead to an "AIDS-free generation" - the central theme of the 2012 International AIDS Conference - in the city with the largest local HIV epidemic in the US. There are serious difficulties in achieving this policy goal, notably the persistent racial/ethnic disparities in HIV infection in the city, especially among African-Americans, and drug-related sexual transmission. The overarching purpose of this research is to provide multisystem data to evaluate the implementation of the policy and help determine the most efficient use of available resources for achieving the policy goal. The design and methods are informed by the ecological systems model, while the RE-AIM model guides the overall assessment of the implementation of the new policy. The study aims are: 1) to assess durable viral suppression (i.e., two consecutive viral load tests 400 HIV-1 RNA copies per mL of plasma) within 12 months of diagnosis among a) STD clinic cohort (N = 300) with problem substance use, and b) all new HIV diagnoses in NYC occurring during the project funding period (N=approximately 3,400/year); 2) to assess key indicators along the HIV treatment cascade among the STD clinic cohort as the percentage who (a) link to HIV care; (b) receive a recommendation to initiate ART; (c) initiate ART treatment; and (d) adhere to ART treatment; 3) to assess multisystem predictors of durable viral load suppression and other HIV treatment cascade indicators among the STD clinic cohort and cohort of all new HIV diagnoses in NYC, to include individual (e.g., race/ethnicity, substance use) and geospatial factors (e.g., socioeconomic conditions, social disorder, social cohesion, and spatial access to HIV-related healthcare); 4) to describe and contextualize quantitative outcomes in Aims 1-3 using STD cohort qualitative data; and 5) to describe the adoption, implementation, and maintenance of HIV treatment policies among HIV primary care providers. The endpoint of durable viral suppression increases

描述（由申请人提供）：2011 年 12 月 1 日世界艾滋病日，纽约市健康和心理卫生局 (NYCDOHMH) 宣布了一项新政策，即所有 HIV 血清阳性者都应接受抗逆转录病毒治疗 (ART)，无论 CD4 细胞计数如何。新政策主要基于“治疗即预防”，这不仅是改善早期开始抗逆转录病毒治疗的艾滋病毒感染者健康的一种方法，也是减少病毒传播的一种手段。 NYCDOHMH 为这项新政策设定了一个雄心勃勃的目标：到 HIV 诊断一年后，80% 的新 HIV 诊断将达到病毒抑制。纽约市每年新增 3,400 多例 HIV 感染病例；最近的数据表明，2006-07 年，38% 的病毒达到了持久的病毒抑制（即所有病毒载量为 400 拷贝/mL）。这一政策目标雄心勃勃，但如果能够实现，几乎肯定会在美国当地艾滋病毒流行最严重的城市带来“无艾滋病一代”——2012年国际艾滋病大会的中心主题。实现这一政策目标存在严重困难， 值得注意的是，该市艾滋病毒感染方面持续存在的种族/民族差异，尤其是非裔美国人，以及与毒品有关的性传播。这项研究的首要目的是提供多系统数据来评估政策的实施情况，并帮助确定如何最有效地利用可用资源来实现政策目标。设计和方法以生态系统模型为基础，而RE-AIM模型则指导新政策实施的总体评估。该研究的目的是：1) 评估诊断后 12 个月内的持久病毒抑制（即，在 a) 使用问题药物的 STD 诊所队列 (N = 300) 和 b) 纽约市在项目资助期间发生的所有新的 HIV 诊断（N = 约 3,400/年）中，进行两次连续的病毒载量测试，每毫升血浆 400 个 HIV-1 RNA 拷贝）； 2) 评估 STD 诊所队列中 HIV 治疗级联的关键指标，即 (a) 与 HIV 护理相关的百分比； (b) 收到启动 ART 的建议； (c) 开始抗逆转录病毒治疗； (d) 坚持接受 ART 治疗； 3) 评估纽约市 STD 诊所队列和所有新 HIV 诊断队列中持久病毒载量抑制和其他 HIV 治疗级联指标的多系统预测因素，包括个人（例如种族/族裔、物质使用）和地理空间因素（例如社会经济条件、社会混乱、社会凝聚力和获得 HIV 相关医疗保健的空间机会）； 4) 使用 STD 队列定性数据描述目标 1-3 中的定量结果并加以背景化； 5) 描述艾滋病毒初级保健提供者对艾滋病毒治疗政策的采用、实施和维持情况。持久病毒抑制的终点增加