DOSE DETERMINATION TRIAL FOR IMPLEMENTING EVIDENCE-BASEDBEHAVIORAL INTERVENTIONS

实施循证行为干预的剂量确定试验

• 批准号: 10089484
• 负责人: SETH C KALICHMAN
• 金额: $ 59.04万
• 依托单位: UNIVERSITY OF CONNECTICUT STORRS
• 依托单位国家: 美国
• 财政年份: 2020
• 资助国家: 美国
• 起止时间: 2020-02-01 至 2024-11-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10089484
• 关键词: Adherence; Behavior Therapy; Behavioral; Behavioral Model; Behavioral Research; Benchmarking; Caring; Centers for Disease Control and Prevention (U.S.); Characteristics; Clinical; Clinical Trials; Cost Effectiveness Analysis; Counseling; Development; Dose; Emotional; Enrollment; Evidence based intervention; Glare; Goals; HIV; Health; Health Policy; Health Services; Individual; Informal Social Control; Intervention; Intervention Trial; Life; Link; Literature; Masks; Mental Health; Modeling; Monitor; Outcome; Participant; Patients; Plasma; Policies; Policy Maker; Population; Poverty; Randomized; Reporting; Research; Resource Allocation; Resources; Structure; Subgroup; Telephone; Testing; Time; Viral; Viral Load result; antiretroviral therapy; barrier to care; base; behavioral adherence; behavioral clinical trial; cost; cost effectiveness; design; effective intervention; evidence base; flexibility; follow up assessment; implementation intervention; implementation science; improved; longitudinal analysis; novel; patient response; patient subsets; primary endpoint; programs; resource guides; response; scale up; secondary outcome; service providers; skills; social; social factors; social structure; substance use; theories; therapy adherence; therapy design; viral rebound

The proposed research will conduct the first ever dose-determination trial of a behavioral intervention to improve engagement in HIV care, antiretroviral therapy (ART) adherence and HIV viral suppression. The trial is designed to inform the implementation of behavioral interventions, including several in CDC’s Compendium of Evidence-Based Interventions. Behavioral counseling has the flexibility and reach to overcome numerous challenges to HIV care, including social, emotional, and structural barriers. However, basic questions of how to best implement and scale-up interventions remain unanswered, such as “how much intervention is needed to achieve HIV suppression in subgroups of patients facing individual and social challenges?” There are currently no dose-determination trials in the HIV behavioral intervention literature to guide implementation decisions and health service policy. In the proposed research we specifically aim to: (a) determine the minimum effective dose of an evidence-based HIV treatment engagement and adherence intervention, (b) identify subgroups of patients requiring greater and fewer intervention resources to achieve and sustain viral suppression, and (c) the costs associated with intervention dose-response. Participants who are receiving ART and confirmed HIV unsuppressed (>200 copies/mL) will be randomized to either: (a) the dose determination condition of weekly evidence-based behavioral self-regulation counseling until achieving HIV suppression (<200 copies/mL), or (b) fixed dose 5-weekly sessions of evidence-based behavioral self-regulation counseling sessions. The dose determination condition adjusts to patient needs and determines the dose to achieve HIV suppression, in contrast to the fixed dose condition that does not adjust to patient response. The trial is therefore designed to determine the number of behavioral counseling intervention sessions needed to achieve and sustain HIV suppression. Once viral suppressed, counseling in the dose-determination condition is suspended. In contrast, the fixed-dose condition is delivered in five prescribed sessions as disseminated by the CDC. Follow-up assessments commence for 12-months from baseline with the primary endpoint of 12-month blood plasma HIV viral load and secondary outcome of ART adherence. Response to counseling is defined by achieving viral suppression (<200 copies/mL) and non-response is defined by not achieving viral suppression (>200 copies/mL). Participants in both the dose-determination and fixed-session conditions who initially respond and rebound to unsuppressed viral load will receive additional counseling with redose-response monitored and analyzed. Longitudinal analyses will examine intervention dose for key patient subgroups and dose-response cost-effectiveness analyses to guide resource allocation and implementation decisions. This research is aimed at informing health policy makers and programmatic decisions regarding intervention implementation to increase the likelihood of sustained HIV suppression.

这项拟议的研究将进行有史以来第一次行为干预的剂量决定试验 提高对艾滋病毒护理、抗逆转录病毒疗法(ART)坚持和艾滋病毒抑制的参与度。这个 试验旨在为行为干预的实施提供信息，包括疾控中心的几项干预措施 循证干预简编。行为咨询具有灵活性和可达性 克服艾滋病毒护理面临的众多挑战，包括社会、情感和结构障碍。然而， 关于如何最好地实施和扩大干预措施的基本问题仍然没有得到回答，例如“多少 需要干预措施，以实现在面对个人和社会的患者亚群中抑制艾滋病毒 挑战？“目前还没有关于艾滋病毒行为干预的剂量决定试验 指导实施决定和卫生服务政策的文献。在拟议的研究中，我们 具体目的是：(A)确定基于证据的艾滋病毒治疗的最低有效剂量 参与度和依从性干预，(B)确定需要更多和更少的患者亚群 用于实现和维持病毒抑制的干预资源，以及(C)与 干预剂量-反应。接受抗逆转录病毒治疗并确认艾滋病毒未被抑制的参与者(&gt；200 拷贝数/毫升)将随机分为：(A)每周循证的剂量确定条件 行为自律咨询，直到达到HIV抑制(&lt；200拷贝/毫升)，或(B)固定剂量 每周5次以证据为基础的行为自律咨询会议。剂量 检测条件根据患者的需要进行调整，并确定实现艾滋病毒抑制的剂量，在 与不适应患者反应的固定剂量条件形成对比。因此，设计了这项试验 确定实现和维持所需的行为咨询干预会话的数量 抑制艾滋病病毒。一旦病毒被抑制，剂量决定条件下的咨询就会暂停。在……里面 相比之下，固定剂量的情况是在疾病预防控制中心传播的五次规定会议中提供的。 跟踪评估从基线开始，为期12个月，主要终点为12个月 血浆HIV病毒载量和ART依从性的继发性结局。对咨询的反应是 定义为实现病毒抑制(&lt；200拷贝/毫升)，无应答定义为未实现 病毒抑制(&gt；200拷贝/毫升)。参加剂量测定和固定会议的人员 最初对未抑制的病毒载量有反应并反弹的情况将接受额外的咨询 并对红糖反应进行监测和分析。纵向分析将检查干预剂量 关键患者亚组和剂量反应成本效益分析，以指导资源分配和 实施决定。这项研究旨在为卫生政策制定者和规划人员提供信息 关于实施干预措施的决定，以增加持续抑制艾滋病毒的可能性。