HIV intervention development study

艾滋病毒费用和服务利用研究（HCSUS）的数据显示，少数民族和白人在接受高效抗逆转录病毒治疗（HAART）的比例、坚持抗逆转录病毒治疗（ARV）的比例和存活率方面存在差异。HCSUS还显示，少数群体的社会和医疗服务需求未得到满足的比例很高。与病例管理相关的这些未满足的服务需求水平较低，预示着抗逆转录病毒疗法的使用率有所提高。该提案基于HCSUS中的这些发现和Log Angeles中关于依从性障碍的研究结果（如蛋白酶抑制剂治疗的依从性和疗效[ADEPT]研究），以确定解释这些差异的可变因素。这些可变因素将成为一项新的随机干预临床试验的联合目标，该试验旨在通过加强病例管理和坚持治疗方案来帮助少数艾滋病毒感染者克服护理障碍。我们将使用以理论为基础的行为改变方法，以促进艾滋病毒感染的少数民族患者遵守其规定的方案。该提案的具体目标是：1）分析现有的艾滋病毒感染人群数据库（包括HCSUS和ADEPT），并确定依从性和结果的关键可变预测因素，以指导制定针对少数民族和白人艾滋病毒感染者之间依从性和结果差异的有效干预措施; 2）实施这种干预措施，作为艾滋病毒感染少数民族的病例管理和依从性咨询的随机试验，以：a）提高他们对医疗访问的依从性，以克服障碍; B）提高对处方治疗方案的依从性;最终，c）抑制HIV病毒复制并改善其他HIV相关的健康结果; 3）评估干预措施的成本效益。目标是通过个案管理帮助感染艾滋病毒的少数民族满足其社会需求，从而保持医疗预约（坚持服务）和坚持治疗（坚持医疗）。在基于初始测试完善程序和工具后，我们将实施完全随机干预，并与对照组相比，评估其在治疗组中的初始和后续影响，主要结局包括：服务依从性、药物治疗、依从性和病毒载量抑制。我们将评估基本的社会人口统计学、态度、信念和坚持的意图、预约保持的障碍、利用率（包括门诊和急诊就诊以及住院）、成本、处方备案、竞争性需求、未满足的支持性服务需求、病例管理、护理来源、障碍（包括信任、识字和歧视）、药物和酒精使用、症状、身心健康状况、效用（EuroQOL）、精神障碍和社会支持。我们将通过计算干预组与对照组抑制病毒载量的边际成本来评估成本效益。

The HIV Costs and Services Utilization Study (HCSUS) data show that thre are disparities between minorities and whites in the proportion taking highly active anti-retroviral therapy (HAART), the proportion adhering to anti-retroviral therapy (ARV), and in survival rates. HCSUS also shows high rates of unmet need for social and medical services for minorities. Lower levels of these unmet service needs associated with case- management predict improved rates of use of ARV therapy. This proposal builds on these findings in HCSUS and the findings of studies in Log Angeles (such as the Adherence and Efficacy of Protease inhibitor Therapy [ADEPT] study) on barriers to adherence in order to identify mutable factors explaining these differences. These mutable factors will be the combined targets of a new randomized intervention clinical trial designed to help minority patients with HIV infection to overcome barriers to care by enhancing case-management and adhere to treatment regimens. We will use theory-based behavior change methods to facilitate adherence of HIV infected minority patients to their prescribed regimens. The specific aims of this proposal are: 1) to analyze existing databases of HIV-infected populations (including HCSUS and ADEPT) and identify key mutable predictors of adherence and outcomes to guide development of a potent intervention targeting the disparities in adherence and outcomes between minorities and Whites with HIV infection; 2) to implement this intervention as a randomize trial of case management and adherence counseling in minorities with HIV infection to: a) improve their adherence to medical visits to overcome barriers; b) increase adherence to prescribed regimens; and ultimately, c) suppress HIV viral replication and improve other HIV-related health outcomes; 3) to assess the cost-effectiveness of the intervention. The goal is to assist minority persons with HIV infection to meet their social needs through case- management, and as result keep medical appointments (service adherence) and adhere to treatment (medical adherence). After refining the procedures and the instruments based on initial testing, we will implement a full randomized intervention and evaluate its initial and subsequent impact in the treatment arm compared to controls, for the main outcomes: service adherence, medication, adherence, and viral load suppression. We will assess basic sociodemographics, attitudes, beliefs, and intentions toward adhering, barriers to appointment keeping, utilization (including outpatient and ER visits, and hospitalizations), costs, prescription filing, competing needs, unmet needs for supportive services, case-management, sources of care, barriers (including trust, literacy, and discrimination), drug and alcohol use, symptoms, physical and mental health status, utilities (EuroQOL), mental disorders and social support. We will assess cost-effectiveness by computing the marginal costs associated with suppressing viral load for intervention vs. control groups.