Development and Feasibility Testing of an Integrated PTSD and Adherence Intervention Cognitive Processing Therapy-Lifesteps (CPT-L) to Improve HIV Outcomes

项目摘要/摘要 尽管艾滋病毒携带者(PLWH)创伤后应激障碍(PTSD)的发生率一直很高 以及与创伤后应激障碍相关的令人震惊的糟糕的艾滋病毒相关健康结局，这是一个有效的循证证据 目前尚不存在减轻PLWH患者PTSD症状的治疗方法。负钢筋概念性 模型认为，回避行为(创伤后应激障碍的一个标志症状)在PLWH表现出的同时发生 创伤后应激障碍可能导致抗逆转录病毒治疗(ART)依从性差。然而，评估影响的研究 关于艾滋病毒感染人群中创伤后应激障碍的循证治疗对艾滋病毒结局的影响的研究很少。这个 认知处理疗法(CPT)是一种基于证据的创伤后应激障碍治疗方案，也可以解决 通过有针对性的修改和改善抗逆转录病毒治疗的依从性和后续 通过减少回避性应对来抑制病毒。拟议的3年研究将利用基础设施 通过瑞安·怀特网络并成为第一个试验RCT来测试基于综合证据的可行性 瑞安·怀特诊所通过依从性干预(LifeSteps)改善PTSD治疗(CPT) 创伤后应激障碍症状，对抗逆转录病毒药物的坚持，以及在艾滋病毒护理中的保留。具体目标是：1)交付联合国- 调整CPT和LIFESTES，12个PLWH合并PTSD，并收集定性反馈以 最大限度地提高CPT-L综合议定书的可接受性和相关性；2)确定 改良CPT方案采用随机对照2(治疗类型)×3(时间点)试验设计 慢性精神分裂症患者伴发创伤后应激障碍的临床研究L持续干预对创伤后应激障碍症状、回避性应对的影响 作用机制)、物质使用、抑郁、ART依从性、CD4计数、病毒载量和参与 护理与生命步骤+护理标准条件的比较。在目标1中，来自大区测试和 在12个测试版测试和社区咨询委员会的反馈后收集的离职访谈和 专题专家将为研究方案的完善提供信息。在目标2中，CPT-L将以60 PLWH符合创伤后应激障碍诊断标准。参与者将被随机分配到控制条件(生命步骤+ SOC；N=30)或干预条件(CPT-L；N=30)，并将在基线、后 干预(6周)，随机化后3个月。具体的可行性基准(例如，保留、 将对保真度、满意度)进行检查，并获得估计的可变性。这些数据对于 通知R01申请严格评估CPT-L作为提高ART依从性和 留守在看护中心。如果成功，这项研究将创伤后应激障碍的治疗方法扩展为一种范例，以减少 坚持抗逆转录病毒治疗的障碍，这是对既定行为干预的创新使用，具有重要意义 因为结果支持U=U运动，并有助于防止艾滋病毒感染通过 加强对病毒的抑制。

PROJECT SUMMARY/ABSTRACT Despite consistently high rates of Post-Traumatic Stress Disorder (PTSD) in persons living with HIV (PLWH) and the alarmingly poor HIV-related health outcomes associated with PTSD, an effective evidence-based treatment for reduction of PTSD symptoms in PLWH does not exist. Negative reinforcement conceptual models posit that avoidant behavior (a hallmark symptom of PTSD) demonstrated by PLWH with co-occurring PTSD can contribute to poor antiretroviral therapy (ART) adherence. However, research evaluating the impact of evidence-based treatment for PTSD among HIV infected populations on HIV outcomes is scarce. The Cognitive Processing Therapy (CPT) protocol is an evidence-based PTSD treatment that may also address HIV-related intersectional stigma with targeted modifications and improve ART adherence and subsequent viral suppression through reduction of avoidant coping. The proposed 3 year study will leverage infrastructure through the Ryan White network and be the first pilot RCT to test feasibility of an integrated evidence based PTSD treatment (CPT) with an adherence intervention (Lifesteps) delivered in a Ryan White clinic to improve PTSD symptoms, adherence to ART, and retention in HIV care. The specific aims are: 1) To deliver un- adapted CPT and Lifesteps with 12 PLWH with co-occurring PTSD and collect qualitative feedback to maximize acceptability and relevance of the integrated CPT-L protocol; 2) To determine feasibility of the modified CPT protocol using a randomized controlled 2 (treatment type) x 3 (time points) trial design in 60 PLWH with comorbid PTSD exploring impact of CPT-L on PTSD symptoms, avoidant coping (posited mechanism of action), substance use, depression, ART adherence, CD4 count, viral load, and engagement in care compared to a Lifesteps +Standard of Care condition. In Aim 1, qualitative data from theater testing and exit interviews collected after 12 cases of beta testing and feedback from the Community Advisory Board and topical experts will inform refinement of the research protocol. In Aim 2, CPT-L will then be piloted with 60 PLWH meeting PTSD diagnostic criteria. Participants will be randomized to the control condition (Lifesteps+ SOC; N=30) or the intervention condition (CPT-L; N=30) and will complete assessments at baseline, post- intervention (6 weeks), and 3 months post-randomization. Specific feasibility benchmarks (e.g., retention, fidelity, satisfaction) will be examined and variability of estimates will be obtained. This data are critical to informing an R01 application for rigorous evaluation of CPT-L as a vehicle for improving ART adherence and retention in care. If successful, this research extends PTSD treatment approaches as a paradigm to reduce barriers to ART adherence, which is an innovative use of established behavioral interventions and significant because results support the U=U campaign and can help prevent the transmission of HIV infection through increased viral suppression.