DOSE DETERMINATION TRIAL FOR IMPLEMENTING EVIDENCE-BASEDBEHAVIORAL INTERVENTIONS

拟议的研究将进行有史以来第一次行为干预的剂量确定试验 提高对艾滋病毒护理、抗逆转录病毒治疗 (ART) 依从性和艾滋病毒病毒抑制的参与度。的 试验旨在为行为干预措施的实施提供信息，包括 CDC 的多项干预措施 循证干预概要。行为咨询具有灵活性和覆盖面 克服艾滋病毒护理方面的众多挑战，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解答，例如“多少” 需要进行干预，以在面临个人和社会问题的患者亚群中实现艾滋病毒抑制 挑战？”目前尚无艾滋病毒行为干预的剂量确定试验 指导实施决策和卫生服务政策的文献。在拟议的研究中，我们 具体目标是： (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) 确定需要更多和更少的患者亚组 实现和维持病毒抑制的干预资源，以及 (c) 相关成本 干预剂量反应。正在接受 ART 并确认 HIV 未受抑制的参与者 (>200 拷贝/mL）将被随机化为：（a）每周基于证据的剂量确定条件 行为自我调节咨询，直至实现 HIV 抑制（<200 拷贝/mL），或 (b) 固定剂量 每周 5 次基于证据的行为自我调节咨询课程。剂量 确定条件根据患者需求进行调整，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。因此本次试验设计 确定实现和维持所需的行为咨询干预课程的数量 艾滋病毒抑制。一旦病毒被抑制，剂量确定条件的咨询就会暂停。在 相比之下，固定剂量条件是按照 CDC 公布的五次规定疗程进行的。 随访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 依从性的次要结果。对咨询的反应是 定义为实现病毒抑制（<200 拷贝/mL），无反应定义为未实现 病毒抑制（>200 拷贝/mL）。剂量确定和固定会议的参与者 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 监测和分析重剂量反应。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，以指导资源分配和 实施决定。这项研究旨在为卫生政策制定者和规划者提供信息 有关实施干预措施的决定，以增加持续抑制艾滋病毒的可能性。

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.