Project RETAIN: Providing Integrated Care for HIV-Infected Crack Cocaine Users

描述(申请人提供)：“检测和治疗”模式是最近出现的一种应对艾滋病毒/艾滋病流行的创新战略。这一战略假定，通过检测确定艾滋病毒感染者，并将他们与接受预防服务和抗逆转录病毒治疗的护理联系起来，既能改善健康结果，又能减少艾滋病毒在个人和人口一级的传播。迄今为止，围绕这一新战略的许多努力和讨论都侧重于解决日益增加的艾滋病毒检测问题，以确定新的艾滋病毒感染病例，并在某种程度上将新患者与艾滋病毒护理联系起来。然而，对留住护理的关注却少得多，这是参与护理的关键的“第四部分”，也是一个非常需要制定干预战略的领域。此外，还需要解决知道其诊断但从未从事艾滋病毒护理的个人、间歇性使用护理的人或退出护理的个人在艾滋病毒护理方面的保留问题。在艾滋病毒护理中留住一个特别困难的群体是艾滋病毒感染的强效可卡因使用者。在这一背景下，这项研究将以随机实验设计测试，在艾滋病毒初级保健环境中为艾滋病毒阳性强效可卡因使用者提供现场循证物质使用和患者导航服务的“保留诊所”是否将改善艾滋病毒感染强效可卡因使用者的艾滋病毒护理结果。我们拟议的试验将随机跟踪520名艾滋病毒阳性强效可卡因使用者，他们要么从未接受过艾滋病毒初级保健，要么在12个月内退出了艾滋病毒初级保健，以比较我们的综合模型与常规治疗的疗效。我们的具体目标是：1)评估综合护理模式“保留诊所”在艾滋病毒感染的强效可卡因使用者中实现病毒学抑制(定义为具有HIV-1病毒载量和400拷贝/毫升)的有效性。此外，我们还将研究“保留诊所”在以下方面的效果：a)增加艾滋病毒护理就诊的次数；b)增加对艾滋病毒治疗方案的遵守；c)增加药物滥用治疗的就诊次数；以及d)减少药物使用。拟议的方法将是针对这一人群的第一个将物质使用和患者导航与艾滋病毒初级保健相结合的随机对照试验。这项研究也是创新的，因为没有经过验证的干预策略来解决艾滋病毒阳性强效可卡因使用者对艾滋病毒护理的保留问题。这项研究代表了迈阿密大学艾滋病研究发展中心和埃默里大学艾滋病研究中心之间的合作。在过去的十年里，这两个中心一直在艾滋病毒预防和艾滋病毒感染者获得护理的相关问题上进行合作。 公共卫生相关性：成功地将艾滋病毒感染的强效可卡因吸毒者等难以治疗的人群保留在艾滋病毒初级保健中的新的创新战略将改善健康结果，并减少个人和人口层面的艾滋病毒传播。这项研究显然与国家艾滋病毒/艾滋病战略的第二个和第三个目标有关，即寻求“增加艾滋病毒携带者获得护理的机会，改善其健康状况”，并“减少与艾滋病毒有关的差距和健康不平等”。

DESCRIPTION (provided by applicant): The "Test and Treat" paradigm has recently emerged as an innovative strategy to address the HIV/AIDS epidemic. This strategy posits that identifying HIV infected individuals through testing and linking them to care to receive prevention services and antiretroviral therapy will both improve health outcomes and reduce HIV transmission at an individual and at a population level. To date, many of the efforts and discussion surrounding this new strategy have focused on addressing increasing HIV testing for the identification of new cases of HIV infection and, to some extent, linkage of new patients to HIV care. However, considerably less attention has been given to retention in care, the critical "fourth component" of the spectrum of engagement in care and an area in which there is great need to develop intervention strategies. Furthermore, retention in HIV care of individuals who are aware of their diagnosis and have never been engaged in HIV care, who are intermittent users of care, or who have dropped out of care also needs to be addressed. A particularly difficult group to retain in HIV care is HIV-infected crack cocaine users. Within this context, this study will test, in a randomized experimental design, if a "Retention Clinic" that provides onsite evidence-based substance use and patient navigation services to HIV-positive crack cocaine users in an HIV primary care setting will improve the HIV care outcomes of HIV-infected crack cocaine users. Our proposed trial will randomize and follow 520 HIV- positive crack cocaine users that either have never been in HIV primary care or have dropped out of HIV primary care over a 12 month period to compare our integrated model's efficacy with treatment as usual. Our specific aims are: 1) To evaluate the efficacy of an integrated care model, the "Retention Clinic", in achieving virologic suppression (defined as having an HIV-1 viral load < 400 copies/ml) among HIV-infected crack cocaine users. Additionally, we will also study the efficacy of the "Retention Clinic" in a) increasing attendance at HIV care visits; b) increasing adherence to HIV treatment regimens; c) increasing attendance at substance abuse treatment and, d) decreasing substance use. The proposed approach will represent the first randomized controlled trial of an integrated substance use and patient navigation with HIV primary care for this population. This study is also innovative because there are no proven intervention strategies that address retention to HIV care with HIV-positive crack cocaine users. This study represents a collaboration between the Developmental Center for AIDS Research at the University of Miami and the Center for AIDS Research at Emory University. For the past decade, these two centers have been collaborating on issues related to HIV prevention and access to care for HIV-infected drug users. PUBLIC HEALTH RELEVANCE: New and innovative strategies that successfully retain hard-to-treat populations such as HIV-infected crack cocaine users in HIV primary care will improve health outcomes and reduce HIV transmission at an individual and at a population level. This study has clear relevance to the National HIV/AIDS Strategy's second and third goals that seeks to "Increase access to care and improving health outcomes for people living with HIV" and "Reduce HIV-related disparities and health inequalities".