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例新诊断艾滋病毒患者的70%，占66% 在美国120万艾滋病毒感染者中，在这一高度优先的人群中，男男性接触者与 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 以及改善长期健康结果。此外，有艾滋病毒和药物使用障碍的诊断，如 以及作为种族/少数民族MSM，加剧了获得和完成亲自吸毒的障碍 治疗服务。Reset是FDA批准的第一款处方移动治疗软件，旨在 成人中的物质使用障碍。在最初诊断为兴奋剂使用障碍的患者中，RESET有 在减少兴奋剂使用方面被发现是有效的，对已经接受药物治疗的患者和作为 监禁人员的独立物质使用治疗。然而，重置尚未在任何 医疗环境，包括艾滋病毒护理环境，作为艾滋病毒携带者的全虚拟SUD治疗。至 为了有效缓解感染艾滋病毒的不同种族MSM中的艾滋病毒流行，我们提出了一种双臂 对接受抗逆转录病毒治疗的HIV携带者进行为期12周的全虚拟兴奋剂障碍治疗的随机对照试验 治疗(ART)。这项研究将包括426名不同种族/民族的MSM(约50%的非裔美国人和23%的非裔美国人 拉丁语)。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)分布在AHF使用兴奋剂的艾滋病毒病例最多的四个美国大都市地区 使用(亚特兰大、达拉斯/沃斯堡、劳德代尔堡和洛杉矶)。参与者的病情从中度到重度 兴奋剂使用障碍将随机分为两种情况：(1)转诊至门诊药物使用障碍 治疗(照常治疗/对照条件)或(2)将(实验条件)重置为：(目标1a)测试 独立全虚拟重置在3个月、9个月和15个月期间实现较低刺激性药物使用的有效性 与TAU相比；(目标1b)测试独立全虚拟重置的有效性，以增加 与TAU相比，在3个月、9个月和15个月的随访期内抑制病毒；(目标2)检查 种族/民族(黑人/非裔美国人、拉丁裔和白人)对男女之间关系的调节作用 条件和兴奋剂使用(主要结果)和VL抑制(次要结果)；(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、 AHF内试验性治疗的经济影响和实施维护。如果找到 在联合技术中实施的有效的重置可以在优化方面提供重大的可扩展的进步 艾滋病病毒携带者和兴奋剂使用障碍的性少数群体中的“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.