The PFT Intervention: Linking triply-diagnosed inpatients to community care

描述（由申请人提供）：为了回应PA-12-281，美国的HIV/AIDS、药物使用和弱势人群（R 01），我们提议在从宾夕法尼亚大学卫生系统（UPHS）内的两个住院精神科招募的三重诊断（精神疾病、药物滥用、HIV）患者中进行有效性试验。尽管人们普遍认识到患有严重精神疾病（SMI）的人感染和传播人类免疫缺陷病毒（HIV）的风险更高，但在精神卫生环境中进行系统的HIV检测却很少。 我们的研究小组（Rothbard et al.，2008）在费城的两个住院精神病单位发现超过10%的HIV血清阳性率，长老会医院的Wright 4单位和宾夕法尼亚医院的4 Spruce单位，拟议的研究将在那里进行。我们当时认为，艾滋病毒检测应该在这些环境中进行例行检查。在一项为期五年的纵向有效性试验中，我们将通过快速检测来识别HIV阳性的SMI住院患者。 那些新诊断或以前诊断但目前没有从事艾滋病毒治疗的人以及使用药物的人将有机会参加随机社区试验。此前，我们已经进行了一项针对阳性患者的PATH（PFP）的II期试验，在该试验中，我们观察到了利用护士健康导航员（NHN）模型对HIV+ SMI客户进行干预的广泛而深远的影响。这项建议建立在我们以前所学到的提供一个护士健康导航员（NHN）模型作为综合治疗的目标个人在“真实的世界”的条件，并监测实施的路径为三倍（PFT）。可以说，目标人群是治疗结局较差的最高风险患者人群。根据过去的经验，我们预计将在滚动的基础上招募约75%的合格人员，或约240名参与者， 是随机的。这将在36个月的招募期内产生约120名PFT和约120名TAU受试者，然后进行自然减员。PFP中的类似人群导致17%的流失率，因此我们估计至少75%的参与者的完整数据，从而产生约180名参与者的完整数据集（90 PFT和90 TAU）。PFT参与者将获得12个月的NHN服务。将在基线、6个月、12个月和18个月时收集每名受试者的数据。参与者将被 在干预后再纵向随访6个月，以测量撤回后干预的任何衰减。实验参与者将开始PFT，同时仍接受住院服务，项目护士将参与出院计划，并促进与费城社区的精神健康（MH）、药物滥用（SA）和传染病（ID）护理的联系。NHN还将至少每周与实验参与者会面，使用针对个人的沟通和理解量身定制的方法实施PFT的依从性部分，包括记忆辅助，关于副作用和其他治疗方面的教育，参与者的社交网络和治疗提供者的参与，以及积极的社区外展。PFT将实施12个月，受试者将接受额外6个月的随访，以检查撤回后干预的潜在衰减。我们预计PFT参与者的治疗保留率更高，其他结果包括病毒载量，CD 4，心理和社会功能指标以及成本效益。

DESCRIPTION (provided by applicant): In response to PA-12-281, HIV/AIDS, Drug Use, and Vulnerable Populations in the US (R01), we propose an effectiveness trial among persons triply diagnosed (mental illness, substance abuse, HIV) recruited from two inpatient psychiatric units within the University of Pennsylvania Health System (UPHS). Despite general recognition that persons with serious mental illness (SMI) are at heightened risk to contract and transmit human immunodeficiency virus (HIV), systematic HIV testing in mental health settings is rare. Using discarded bloods samples over a six month period, our research team (Rothbard et al., 2008) found in excess of 10% HIV seroprevalence in two inpatient psychiatric units in Philadelphia, the Wright 4 Unit at Presbyterian Hospital and the 4 Spruce Unit of Pennsylvania Hospital where the proposed study will occur. We argued then that HIV testing should be routinely conducted in those settings. In a five year longitudinal effectiveness trial, we will identify HIV positive SMI inpatients through rapid testing. Those who are newly diagnosed or who were previously diagnosed but not currently engaged in HIV treatment and who also are substance using will be offered an opportunity to participate in a randomized community trial. Previously we have conducted a Phase II trial of PATH for Positives (PFP) in which we observed broad and far-reaching effects of an intervention utilizing a nurse health navigator (NHN) model for HIV+ SMI clients. This proposal builds on what we learned previously to provide a nurse health navigator (NHN) model as integrated treatment of the targeted individuals in "real world" conditions and to monitor the implementation of PATH for Triples (PFT). The target population is arguably among the highest risk patient populations for poor treatment outcomes. Based on past experience, we expect to enroll about 75% of those eligible on a rolling basis, or ~240 participants who will then be randomized. This will yield ~120 PFT and ~120 TAU participants over a 36 month recruitment before attrition. A similar population in PFP resulted in a 17% attrition rate, so we estimate complete data for at least 75% of participants resulting in a complete dataset of ~180 participants (90 PFT, and 90 TAU). PFT participants will receive NHN services for 12 months. Data will be collected at baseline, 6, 12, and 18 months for each participant. Participants will be followed longitudinally for an additional 6 months post intervention to measure any decay of the intervention after it is withdrawn. Experimental participants will begin PFT while still receiving inpatient services and the project nurses will participate in discharge planning and facilitate linkage to Mental Health (MH), Substance Abuse (SA), and Infectious Disease (ID) care in the Philadelphia community. The NHN will also meet at least weekly with the experimental participants to implement the adherence component of PFT using approaches tailored to the communication and comprehension of the person that includes memory aids, education regarding side effects and other treatment aspects, engagement with participants' social networks and treatment providers, and active community outreach. PFT will be implemented for 12 months and participants will be followed for an additional 6 months to allow examination of potential decay of the intervention after it is withdrawn. We expect better retention in treatment for PFT participants and other outcomes include viral load, CD4, indicators of psychological and social functioning, and cost effectiveness.