reSET for the Treatment of Stimulant Use in HIV Clinics: Care Optimization Supporting Treatment Adherence (COSTA)

摘要 2019年，男男性行为者（MSM）占34，800例新艾滋病毒诊断的70%，占66%。 在美国120万艾滋病感染者中。在这一高度优先的人群中， 艾滋病毒，兴奋剂的使用是实现病毒载量控制的主要障碍，这是减少艾滋病毒传播所必需的 改善长期健康状况。此外，有艾滋病毒和物质使用障碍的诊断， 以及种族/少数民族的男男性接触者，加剧了获得和完成面对面药物的障碍 治疗服务。reSET是第一个FDA批准的处方移动的治疗软件， 成人物质使用障碍。在初步诊断为兴奋剂使用障碍的患者中， 已经发现有效减少兴奋剂的使用，无论是对已经在药物治疗的患者， 为被监禁者提供独立的药物使用治疗。然而，reSET尚未在任何 医疗机构，包括艾滋病毒护理机构，作为艾滋病毒感染者的全虚拟SUD治疗。到 有效地减轻艾滋病毒流行的种族多样化的男男性接触者感染艾滋病毒，我们提出了一个双臂 对正在接受抗逆转录病毒治疗的HIV感染MSM进行全虚拟12周刺激性障碍治疗的RCT 治疗（ART）。这项研究将包括426名种族/民族多样化的男男性行为者（约50%为非洲裔美国人，约23%为男性）。 Latinx）。参与者将是艾滋病保健基金会（AHF）艾滋病毒治疗中心的患者（10 参与诊所）位于美国四个大都市地区，AHF的兴奋剂艾滋病毒病例数最高 使用（亚特兰大、达拉斯/沃斯堡、劳德代尔堡和洛杉矶）。中度至重度受试者 兴奋剂使用障碍将随机分为两种情况：（1）转诊到门诊物质使用障碍 治疗（照常治疗/对照条件）或（2）重新设置（实验条件），以：（目的1a）测试 独立全虚拟reSET在3个月、9个月和15个月内实现较低兴奋剂使用的有效性 与TAU相比;（目标1b）测试独立全虚拟重置在增加以下可能性方面的有效性 与TAU相比，在3个月、9个月和15个月随访期间的病毒抑制;（目的2）检查 种族/民族（黑人/非裔美国人、拉丁裔和白人）对 条件和兴奋剂使用（主要结局）和VL抑制（次要结局）;以及（目标3） 在RE-AIM框架的背景下评估，覆盖范围，有效性，采用，实施， 经济影响，并在AHF内实施维持实验治疗。如果发现 与ART结合实施的有效的reSET可以在优化方面呈现出重大的可扩展的进步， 在感染艾滋病毒和兴奋剂使用障碍的性少数群体中，"治疗即预防"。

Abstract In 2019 men who have sex with men (MSM) accounted for 70% of the 34,800 new HIV diagnoses and 66% of the 1.2 million total HIV infections in the United States. Among this high priority population, MSM living with HIV, stimulant use is a major barrier to achieving viral load control, necessary for reducing HIV transmission and improving long term health outcomes. Additionally, having HIV and substance use disorder diagnoses, as well as being racial/ethnic minority MSM, exacerbate the barriers to accessing and completing in-person drug treatment services. reSET is the first FDA approved prescription mobile therapeutic software designed to treat substance use disorders in adults. In patients with a primary diagnosis of stimulant use disorder, reSET has been found efficacious in reducing stimulant use, both for patients who are already in drug treatment and as a standalone substance use treatment for incarcerated persons. However, reSET has not been tested in any medical settings, including HIV care settings, as an all-virtual SUD treatment for patients living with HIV. To effectively mitigate the HIV epidemic among ethnically diverse MSM living with HIV, we propose a two-arm RCT of an all-virtual 12-week stimulant disorder treatment for MSM living with HIV who are on antiretroviral therapy (ART). The study will include 426 racial/ethnically diverse MSM (~50% African American and ~23% Latinx). Participants will be patients of the AIDS Healthcare Foundation (AHF) HIV treatment centers (10 participating clinics) located in four US metro areas with AHF’s highest numbers of HIV cases with stimulant use (Atlanta, Dallas/Fort Worth, Fort Lauderdale and Los Angeles). Participants with moderate to severe stimulant use disorder will be randomized to two conditions: (1) referral to outpatient substance use disorder treatment (treatment as usual/ control condition) or (2) reSET (experimental condition) to: (Aim 1a) test the effectiveness of standalone all-virtual reSET in achieving lower stimulant use across 3-, 9- and 15-months compared to TAU; (Aim 1b) test the effectiveness of standalone all-virtual reSET in increasing the likelihood of viral suppression across the 3-, 9- and 15-months follow-up periods compared to TAU; (Aim 2) examine the moderating effect of race/ethnicity (Blacks/African Americans, Latinx, and Whites) on the relationship between condition and stimulant use (primary outcome) and VL suppression (secondary outcome); and (Aim 3) to evaluate in the context of the RE-AIM framework, the reach, effectiveness, adoption, implementation, economic impact, and implementation maintenance of the experimental treatment within AHF. If found effective, reSET implemented in conjunction ART could, present a major scalable advancement in optimizing ‘treatment as prevention’ among sexual minorities living with HIV and stimulant use disorder.