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

开发和可行性测试综合创伤后应激障碍（PTSD）和依从性干预认知处理疗法生命步骤（CPT-L）以改善艾滋病毒结果

• 批准号: 10379321
• 负责人: Cristina M Lopez
• 金额: $ 22.63万
• 依托单位: MEDICAL UNIVERSITY OF SOUTH CAROLINA
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-04-01 至 2024-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10379321
• 关键词: AIDS prevention; AIDS/HIV problem; Address; Adherence; Behavior; Behavior Therapy; Benchmarking; CD4 Lymphocyte Count; Caring; Clinic; Clinical Research; Cognitive; Communities; Country; Cues; Data; Death Rate; Development; Development Plans; Disease Progression; Distress; Ensure; Epidemic; Evaluation; Evidence based treatment; Feedback; General Population; HIV; HIV Infections; HIV Seronegativity; Health; Hospitalization; Impact evaluation; Incidence; Individual; Infrastructure; Intervention; Intervention Studies; Interview; Link; Manuals; Measurement; Medical; Mental Depression; Mental Health; Methods; Modeling; Modification; National Institute of Mental Health; Negative Reinforcements; Outcome; Participant; Patient-Focused Outcomes; Patients; Persons; Pharmaceutical Preparations; Population; Post-Traumatic Stress Disorders; Prevalence; Prevention Research; Protocols documentation; Randomized; Reporting; Research; Risk; Shapes; Site-Directed Mutagenesis; South Carolina; Symptoms; Testing; Time; United States National Institutes of Health; Universities; Viral; Viral Load result; acceptability and feasibility; antiretroviral therapy; comorbidity; coping; diagnostic criteria; efficacy testing; efficacy trial; evidence base; feasibility testing; follow-up; high risk; improved; innovation; interest; meetings; multidisciplinary; neglect; novel; physical assault; post intervention; post-traumatic symptoms; prevent; recruit; retention rate; satisfaction; sexual assault; social stigma; standard of care; substance misuse; substance use; success; therapy adherence; transmission process; trauma exposure; traumatic event; treatment as prevention; treatment effect; trial design

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.

项目总结/摘要 尽管艾滋病毒感染者（PLWH）的创伤后应激障碍（PTSD）发病率一直很高， 以及与创伤后应激障碍相关的艾滋病毒相关健康结果令人震惊，这是一个有效的循证医学 在PLWH中不存在减轻PTSD症状的治疗。负强化概念 模型表明，回避行为（创伤后应激障碍的标志性症状）表现为PLWH与共同发生 PTSD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 HIV感染人群中PTSD的循证治疗对HIV结果的影响是稀缺的。的 认知加工疗法（CPT）方案是一种基于证据的PTSD治疗，也可以解决 有针对性的修改艾滋病毒相关的交叉污名，并改善抗逆转录病毒疗法的坚持和随后的 通过减少回避应对来抑制病毒。拟议的3年研究将利用基础设施 通过瑞安白色网络，并成为第一个试点随机对照试验，以测试综合证据为基础的可行性 在Ryan白色诊所提供的PTSD治疗（CPT）和依从性干预（Lifesteps）， PTSD症状，坚持ART，并保留在艾滋病毒护理。具体目标是：（1）提供联合国- 适应CPT和Lifesteps与12 PLWH与并发PTSD，并收集定性反馈， 最大限度地提高综合CPT-L方案的可接受性和相关性; 2）确定 采用随机对照2（治疗类型）× 3（时间点）试验设计，在60名受试者中实施改良CPT方案 PLWH合并PTSD探讨CPT-L对PTSD症状的影响，回避应对（假设 作用机制）、物质使用、抑郁、ART依从性、CD 4计数、病毒载量和参与 与Lifesteps +标准护理条件相比。在目标1中，来自战区测试的定性数据， 在12个beta测试案例和社区咨询委员会的反馈后收集的离职访谈， 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 符合PTSD诊断标准。受试者将被随机分配至对照条件（生命步骤+ SOC; N=30）或干预条件（CPT-L; N=30），并将在基线、治疗后 干预（6周）和随机化后3个月。具体的可行性基准（例如，保留， 忠诚度、满意度），并获得估计值的可变性。这些数据对于 告知R 01申请，以严格评估CPT-L作为改善ART依从性的工具， 保持护理。如果成功的话，这项研究将PTSD治疗方法作为一种范例， 坚持ART的障碍，这是对既定行为干预的创新使用， 因为研究结果支持U=U运动，并有助于预防艾滋病毒感染的传播， 增强病毒抑制。