Stigma-Treatment Enhanced Incentivized Directly Observed Therapy for People with HIV who Inject Drugs

针对注射吸毒艾滋病毒感染者的耻辱治疗强化激励直接观察治疗

• 批准号: 10227320
• 负责人: Abigail Winston Batchelder
• 金额: $ 22.84万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10227320
• 关键词: Address; Adherence; Adoption; Anti-Retroviral Agents; Caring; Cognitive Therapy; Communities; Continuity of Patient Care; Coupled; Data; Development; Directly Observed Therapy; Dose; Effectiveness; Effectiveness of Interventions; Ensure; Frequencies; HIV; Health; Incentives; Infrastructure; Injecting drug user; Intervention; Interview; Lead; Massachusetts; Methods; Monitor; Participant; Persons; Pharmaceutical Preparations; Provider; Public Health; Randomized Controlled Trials; Resources; Substance Use Disorder; Testing; Therapeutic Intervention; Time; Viral; Visit; Work; acceptability and feasibility; avoidance behavior; base; behavioral adherence; contingency management; design; effectiveness testing; evidence base; experience; feasibility testing; follow-up; hybrid type 1 design; implementation science; implementation strategy; improved; incentive-based intervention; informant; interest; mobile application; multiphase optimization strategy; public health priorities; social stigma; substance use; therapy design; transmission process; virtual delivery

PROJECT ABSTRACT People who inject drugs (PWID) are less likely to maintain viral suppression, perpetuating HIV transmission among PWID over the past two years in Massachusetts. While resource intensive intervention strategies (i.e., incentive-based interventions and directly observed therapy (DOT)) have demonstrated effectiveness for improving ART adherence in the short-term, they do not address underlying barriers to engagement in HIV care for PWID, such internalized and anticipated stigma. Acceptable, feasible, and scalable intervention strategies that combine these intervention strategies with an evidence-based cognitive behavioral therapy (CBT) intervention designed to address internalized and anticipated stigma related to substance use, as well as other related stigmas (e.g., HIV) and their sequelae (e.g., avoidance behaviors) optimized for PWID may result in sustained adherence and viral suppression over time. We hypothesize that combining an app-based video-delivered optimized stigma-focused CBT intervention coupled with app-based video-delivered short-term incentivized DOT will have longer lasting effects than short-term incentivized DOT alone. To test this hypothesis, data on the feasibility, acceptability, and scalability of a combined intervention, optimized for PWID, is needed. In this R34 we will leverage the multiphase optimization strategy (MOST) to facilitate the optimization of an evidence-based video-delivered stigma-focused CBT intervention for PWID living with HIV in Massachusetts who are not virally suppressed (aim 1). We will then utilize implementation science strategies in a Hybrid Type 1 design to simultaneously conduct a pilot randomized controlled trial (RCT) to test the feasibility and acceptability of the optimized stigma-focused CBT intervention paired with incentivized DOT compared to incentivized DOT alone, both implemented through a tailored mobile app (emocha®; n=70; aim 2), while rigorously testing the implementation strategy, including scalability (aim 3). By accomplishing these aims, we will develop and refine critical components of the intervention, including optimizing the stigma-focused CBT intervention and assessing the acceptability, feasibility, and preliminary scalability of combined intervention. This R34 will enable the development and refinement of the infrastructure for a fully powered RCT, which will be submitted as a subsequent R01 to test the effectiveness of the intervention and scalability. Throughout this R34 and the subsequent R01, we will work closely with the Massachusetts Department of Public Health, given their interest in implementing this intervention strategy and platform should it be identified as effective and scalable.

项目摘要 注射药物（PWID）的人不太可能维持病毒抑制，使HIV传播永存 在过去两年中，在马萨诸塞州的PWID中。而资源密集型干预策略（即 基于激励的干预措施和直接观察到的治疗（DOT）表现出有效性 在短期内改善艺术依从性，他们没有解决参与艾滋病毒的潜在障碍 照顾PWID，这种内在和预期的污名。可接受，可行和可扩展的干预措施 将这些干预策略与循证认知行为疗法结合起来的策略 （CBT）旨在解决与物质使用相关的内部和预期污名的干预措施 作为其他相关的污名（例如，艾滋病毒）及其后遗症（例如，避免行为），可针对PWID优化 随着时间的流逝，导致持续的依从性和病毒抑制。我们假设结合基于应用的 视频交付优化的以污名为重点的CBT干预以及基于应用的视频延伸的短期 激励点比仅短期激励点具有更长的持久效应。测试这个 关于PWID优化的合并干预措施的可行性，可接受性和可伸缩性的假设，可接受性和可伸缩性的数据， 需要。在此R34中，我们将利用多相优化策略（大多数）来促进 优化以循证视频为基础的以污名为中心的CBT干预用于PWID的HIV生活 马萨诸塞州实际上没有被抑制的马萨诸塞州（AIM 1）。然后，我们将利用实施科学策略 简单地进行试验的随机对照试验（RCT）以测试可行性的混合动力1型设计 与优化的以污名为中心的CBT干预与激励点相比的可接受性 仅通过量身定制的移动应用程序（emocha®; n = 70; aim 2）实施，仅激励点。 严格测试实施策略，包括可伸缩性（AIM 3）。通过完成这些目标，我们 将开发和完善干预措施的关键组成部分，包括优化以污名为中心的CBT 干预和评估组合干预的可接受性，可行性和初步可扩展性。 该R34将使基础架构的开发和完善能够为完全动力的RCT提供 作为后续R01提交以测试干预和可伸缩性的有效性。通过这个 R34和随后的R01，我们将与马萨诸塞州公共卫生部紧密合作 他们对实施此干预策略和平台的兴趣，如果将其确定为有效，并且 可扩展。