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: 10258696
• 负责人: Cristina M Lopez
• 金额: $ 22.58万
• 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/10258696
• 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; Diagnostic; 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; 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/文摘