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

描述（由申请人提供）：为了响应PA-12-281，美国的艾滋病毒/艾滋病，药物使用和弱势群体（R01），我们建议在宾夕法尼亚大学卫生系统（UPHS）的两个住院精神科中招募三重诊断（精神疾病，药物滥用，艾滋病毒）的患者进行有效性试验。尽管人们普遍认识到，患有严重精神疾病的人感染和传播人类免疫缺陷病毒（艾滋病毒）的风险更高，但在精神卫生机构进行系统的艾滋病毒检测却很少。我们的研究小组（Rothbard et al., 2008）使用六个月的废弃血液样本发现，在费城的两个住院精神病病房，即长老会医院的Wright 4病房和宾夕法尼亚医院的4 Spruce病房，HIV血清阳性率超过10%，该研究将在这里进行。我们当时认为，艾滋病毒检测应该在这些环境中常规进行。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阳性的重度精神障碍住院患者。那些新诊断或以前被诊断但目前未从事艾滋病毒治疗的人以及正在使用药物的人将有机会参加一项随机社区试验。此前，我们进行了一项针对阳性患者的PATH （PFP）二期试验，在该试验中，我们观察到利用护士健康导航员（NHN）模型对HIV+ SMI患者进行干预的广泛而深远的影响。本建议建立在我们之前所学到的基础上，提供护士健康导航员（NHN）模型，作为“现实世界”条件下目标个体的综合治疗，并监测三胞胎适宜卫生技术方案（PFT）的实施情况。目标人群可以说是治疗效果差的风险最高的患者人群之一。根据过去的经验，我们预计在滚动基础上招收约75%的符合条件的参与者，或约240名参与者

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.