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: 9927041
• 负责人: SETH C KALICHMAN
• 金额: $ 63.75万
• 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/9927041
• 关键词: Adherence; Alcohol or Other Drugs use; 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 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; 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.

拟议的研究将进行行为干预的首次剂量确定试验 改善参与HIV护理，抗逆转录病毒疗法（ART）依从性和HIV病毒抑制。这 试验旨在告知行为干预的实施，其中包括CDC中的一些 基于证据的干预措施的汇编。行为咨询具有灵活性并达到 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， 如何最好地实施和扩大干预措施的基本问题仍未得到答复，例如“多少 需要干预以在面对个人和社会的患者的亚组中抑制HIV 挑战吗？ 指导实施决策和卫生服务政策的文献。在拟议的研究中 特别针对：（a）确定基于证据的艾滋病毒治疗的最低有效剂量 参与和依从性干预，（b）确定需要更少和更少的患者的亚组 干预资源以实现和维持病毒抑制，以及（c） 干预剂量反应。接受艺术并确认艾滋病毒的参与者不受抑制（> 200 副本/ml）将随机分配给：（a）每周基于证据的剂量确定条件 行为自我调节咨询直到实现HIV抑制（<200份/mL）或（b）固定剂量 5周基于证据的行为自我调节咨询会议。剂量 确定状况适应患者需求，并确定剂量以实现HIV抑制， 与未适应患者反应的固定剂量状况形成对比。因此，试验是设计的 确定实现和维持所需的行为咨询干预会议的数量 HIV抑制。一旦抑制病毒，剂量确定条件下的咨询就会被暂停。在 对比度，固定剂量条件在CDC传播的五个规定会话中交付。 从基线开始的12个月的后续评估，主要终点为12个月 血浆HIV病毒载荷和艺术依从性的次要结果。对咨询的回应是 通过实现病毒抑制（<200份/ml）和无响应来定义 病毒抑制（> 200份/ml）。剂量确定和固定会议的参与者 最初对未受抑制病毒负荷反弹并反弹的条件将获得额外的咨询 通过重新响应监控和分析。纵向分析将检查干预剂量 关键患者亚组和剂量响应成本效益分析，以指导资源分配和 实施决策。这项研究旨在告知卫生政策制定者和程序化 有关实施干预的决定，以增加持续的HIV抑制可能性。