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

项目摘要 注射毒品的人（PWID）不太可能维持病毒抑制，使艾滋病毒传播永久化 在马萨诸塞州的残疾人中。虽然资源密集型干预战略（即， 基于激励的干预措施和直接观察治疗（DOT））已证明有效， 虽然短期内改善了ART依从性，但它们并没有解决参与艾滋病毒的潜在障碍， 照顾PWID，这种内在的和预期的耻辱。可接受、可行和可扩展的干预措施 将这些干预策略与基于证据的认知行为疗法结合起来的联合收割机策略 (CBT)旨在解决与药物使用有关的内在和预期污名化的干预措施，以及 作为其他相关的污名（例如，HIV）及其后遗症（例如，回避行为）可以 随着时间的推移导致持续的依从性和病毒抑制。我们假设，结合基于应用程序的 视频交付优化的以污名为重点的CBT干预，结合基于应用程序的视频交付短期 刺激的DOT将具有比单独的短期刺激的DOT更持久的效果。为了验证这一 假设，关于联合干预的可行性、可接受性和可扩展性的数据，针对PWID进行优化， 是必要的。在此R34中，我们将利用多相优化策略（MOST）来促进 优化以证据为基础的视频交付的以艾滋病毒感染者为重点的CBT干预， 马萨诸塞州没有受到病毒抑制（目标1）。然后，我们将利用实施科学战略， 混合1型设计，同时进行初步随机对照试验（RCT），以检验可行性 和可接受性的优化的耻辱为重点的CBT干预配对激励DOT相比， 单独激励DOT，均通过定制的移动的应用程序（emocha®; n=70; aim 2）实施，而 严格测试执行战略，包括可伸缩性（目标3）。通过实现这些目标，我们 将开发和完善干预的关键组成部分，包括优化以污名为重点的CBT 干预和评估的可接受性，可行性，和初步的可扩展性的综合干预。 该R34将使开发和完善的基础设施，为一个完全动力的RCT，这将 作为后续R 01提交，以测试干预的有效性和可扩展性。贯穿本 R34和随后的R 01，我们将与马萨诸塞州公共卫生部密切合作， 如果确定这一干预战略和平台有效， 可扩展的

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.