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 注射毒品(PWID)的人不太可能保持病毒抑制，从而使艾滋病毒传播永久化 马萨诸塞州过去两年的PWID。而资源密集型干预策略(即， 以激励为基础的干预和直接观察疗法(DOT))已证明对 在短期内改善抗逆转录病毒治疗的依从性，它们并没有解决参与艾滋病毒的潜在障碍 关爱PWID，这种内化和预期的耻辱。可接受、可行且可扩展的干预措施 将这些干预策略与循证认知行为疗法相结合的策略 (CBT)干预措施，旨在解决与药物使用有关的内在化和预期的污名问题 因为针对PWID优化的其他相关耻辱(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。我们假设将基于应用程序的 视频提供的针对耻辱的优化CBT干预与基于APP的视频提供的短期干预相结合 与仅有短期激励DOT相比，激励性DOT将产生更持久的影响。为了测试这一点 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。在本R34中，我们将利用多阶段优化策略(MOST)来促进 以循证视频为基础、以污名为中心的CBT干预方案在艾滋病患者中的应用 没有受到病毒抑制的马萨诸塞州(目标1)。然后，我们将利用实施科学策略 一种同时进行先导随机对照试验(RCT)以测试其可行性的混合型设计 与激励性DOT相比，优化的以污名为中心的CBT干预与激励DOT相结合的可接受性 单独激励DOT，两者都通过定制的移动应用程序(emocha®；n=70；Aim 2)实施，而 严格测试实施战略，包括可伸缩性(目标3)。通过实现这些目标，我们 将制定和完善干预的关键组成部分，包括优化以污名为重点的CBT 并评估联合干预的可接受性、可行性和初步可扩展性。 这款R34将支持开发和完善全动力RCT的基础设施，这将 作为后续的R01提交，以检验干预的有效性和可扩展性。在整个过程中 R34和随后的R01，我们将与马萨诸塞州公共卫生部密切合作，给出 他们有兴趣实施这一干预战略和平台，如果它被确定为有效和 可扩展。