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.

这项拟议中的研究将进行有史以来第一次行为干预的剂量确定试验， 改善对艾滋病毒护理、抗逆转录病毒疗法坚持和艾滋病毒抑制的参与。的 一项试验旨在为实施行为干预提供信息，包括CDC的几项 循证干预措施简编。行为咨询具有灵活性和可达性， 克服艾滋病毒护理的众多挑战，包括社会，情感和结构性障碍。然而，在这方面， 如何最好地实施和扩大干预措施的基本问题仍然没有答案，例如“多少”， 需要采取干预措施，以实现艾滋病毒的抑制，在亚组的患者面临的个人和社会 挑战？”目前在HIV行为干预中还没有剂量确定试验 指导实施决策和卫生服务政策的文献。在拟议的研究中， 具体目标是：（a）确定循证艾滋病毒治疗的最低有效剂量 参与和依从性干预，（B）确定需要更多和更少干预的患者亚组 实现和维持病毒抑制的干预资源，以及（c）与 干预剂量反应。正在接受抗逆转录病毒治疗并确认艾滋病毒未受抑制的参与者（>200 拷贝/mL）将被随机分配至：（a）每周一次循证剂量测定条件 行为自我调节咨询，直至达到HIV抑制（<200拷贝/mL），或（B）固定剂量 5-每周一次的循证行为自我调节咨询会议。剂量 确定条件根据患者需要进行调整，并确定实现HIV抑制的剂量， 与不根据患者反应进行调整的固定剂量条件形成对比。因此，该试验旨在 以确定实现和维持所需的行为咨询干预会议的数量， 抑制艾滋病毒。一旦病毒被抑制，在剂量确定条件下的咨询就暂停了。在 相比之下，固定剂量的条件是在五个规定的会议，由疾病预防控制中心传播。 从基线开始随访评估12个月，主要终点为12个月 血浆HIV病毒载量和ART依从性的次要结局。对咨询的回应是 定义为达到病毒抑制（<200拷贝/mL），无应答定义为未达到 病毒抑制（>200拷贝/mL）。剂量确定和固定疗程的参与者 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 并监测和分析其再剂量反应。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， 执行决定。这项研究旨在为卫生政策制定者和方案制定者提供信息。 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。