Supporting Treatment Adherence for Resilience and Thriving (START): A mHealth intervention to improve ART adherence for HIV-positive stimulant-using men

摘要 在美国，甲基苯丙胺和其他兴奋剂的使用有一个强劲的复苏。艾滋病毒- 与男性发生性关系的阳性兴奋剂使用男性（HIV+ SUMSM）可能在导航方面有更大的困难 艾滋病毒护理连续体以及显示病毒载量（VL）显著升高，艾滋病毒传播扩大 风险，以及更快的临床HIV进展。虽然行为干预显示出实现持久 HIV+ SUMSM（居住在城市中心以外的人群）中未抑制的VL随时间推移而减少 在获得艾滋病毒和药物使用服务方面遇到困难。基于这些原因，我们提出了一个双臂 针对HIV+ SUMSM的6个月移动健康干预的RCT，称为支持治疗依从性， 恢复和繁荣（START）。我们将在6个月时测试START改善VL抑制的疗效 （主要结局）并确定是否在第12个月保持任何增益（次要结局）。 START将两种有理论基础的循证干预措施（APP+和ARTEMIS）与 优化治疗预防的有效性（TasP）。将招募HIV+ SUMSM（n=350） 并随机分为START组或对照组，以评估以下目标：目标1a。测试START的有效性， 在6个月时达到病毒抑制的SUMSM比例更高（主要结局）， 访问一个网站，其中介绍了艾滋病毒治疗信息和药物使用治疗资源（控制 条件）。目标1b。测试START在12个月时维持病毒抑制增益的功效， 减少兴奋剂使用和性风险，增加基于理论的心理过程（例如， 行为技能，积极影响）。目标2.评估《裁减战略武器条约》的成本和成本效益， 控制条件，实现和/或维持病毒抑制，包括净节省 避免了医疗保健的使用。在第一阶段，我们将把APP+和ARTEMIS整合到一个START中， 干预平台，使用迭代整合过程，包括通过在线焦点小组提供反馈 关于SUMMSM第一阶段将在10个HIV+ SUMSM中进行可用性测试，以确保 过渡到II期，我们将进行一项随机对照试验，以测试START在350例HIV+ SUMSM中的疗效。我们 将使用家庭干血斑（DBS）采集来评估实验室定量VL。所有的人都会得到他们的 6个月，每季度评估一次，直到第12个月。测量VL的DBS样本 将在基线、6个月和12个月时采集。成本分析将从供应商的角度进行 估计提供START的“真实的世界”成本，使利益相关者了解更广泛的可行性， 鉴于现有资源和偿还机制，该项目建议高度 这一结果意义重大，因为使用HIV+ SUMSM优化TasP是NIH和国家艾滋病毒/艾滋病战略中最高的 优先事项START具有创新性，因为它可以扩展到更广泛的HIV+ SUMSM人群， 适应诊所和社区环境。

Abstract There is a strong resurgence of methamphetamine and other stimulant use in the United States (US). HIV- positive stimulant-using men who have sex with men (HIV+ SUMSM) may have greater difficulties navigating the HIV care continuum as well as display substantially elevated viral load (VL), amplified HIV transmission risk, and faster clinical HIV progression. While behavioral interventions show promise for achieving durable reductions in unsuppressed VL over time among HIV+ SUMSM, those residing outside of urban centers experience difficulties accessing services for HIV and substance use. For these reasons we propose a two-arm RCT of a 6-month mHealth intervention for HIV+ SUMSM, called Supporting Treatment Adherence for Resilience and Thriving (START). We will test the efficacy of START to improve VL suppression at 6 months (primary outcome) and determine whether any gains are maintained at month 12 (secondary outcome). START integrates two theoretically-grounded, evidence-based interventions (APP+ and ARTEMIS) with the goal of optimizing the effectiveness of treatment as prevention (TasP). HIV+ SUMSM (n=350) will be recruited and randomized to START or control to assess the following aims: Aim 1a. Test the efficacy of START for achieving a higher proportion of SUMSM who are virally suppressed at 6 months (primary outcome) compared to a website with referrals to HIV treatment information and substance use treatment resources (control condition). Aim 1b. Test the efficacy of START for maintaining viral suppression gains at 12 months, decreasing stimulant use and sexual risk, and increasing theory-based psychological processes (e.g., behavioral skills, positive affect). Aim 2. To assess the cost and cost-effectiveness of START, relative to the control condition, in achieving and/or maintaining viral suppression, including net savings with respect to averted healthcare utilization. During Phase I, we will integrate APP+ and ARTEMIS into a single START intervention platform using an iterative integration process that includes feedback through online focus groups with SUMSM. Phase I will conclude with usability testing among 10 HIV+ SUMSM to ensure a smooth transition to Phase II where we will conduct an RCT to test the efficacy of START in 350 HIV+ SUMSM. We will use home-based dried blood spot (DBS) collection to assess lab-quantified VL. All men will receive their respective condition for 6 months, with quarterly assessments until month 12. DBS specimens to measure VL will be collected at baseline, 6, and 12 months. The cost analysis will be framed from the provider perspective to estimate “real world” costs of providing START to give stakeholders a sense of feasibility for broader implementation, given existing resources and reimbursement mechanisms. The proposed project is highly significant since optimizing TasP with HIV+ SUMSM is among the highest NIH and National HIV/AIDS Strategy priorities. START is innovative because it is scalable to reach a broader population of HIV+ SUMSM and may be adapted to clinic- and community-based settings.