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

支持治疗依从性以促进复原力和繁荣 (START)：一项移动医疗干预措施，旨在提高使用兴奋剂的 HIV 阳性男性的 ART 依从性

• 批准号: 10895784
• 负责人: Adam Wayne Carrico
• 金额: $ 65.32万
• 依托单位: FLORIDA INTERNATIONAL UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-08-01 至 2024-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10895784
• 关键词: 2 arm randomized control trial; Address; Adherence; Affect; Behavior Therapy; Behavioral; Blood; Caring; Cellular Phone; Clinic; Clinical; Cocaine; Cognitive Therapy; Collection; Communities; Continuity of Patient Care; Cost Analysis; Crack Cocaine; Devices; Dryness; Ensure; Epidemic; Evidence based intervention; Feedback; Focus Groups; Goals; Graph; HIV; HIV Seropositivity; HIV/AIDS; Home; Individual; Intervention; Measures; Methamphetamine; Modeling; Monitor; Motivation; Patient Self-Report; Persons; Phase; Population; Positioning Attribute; Powder dose form; Process; Provider; Public Health; Randomized; Randomized, Controlled Trials; Reimbursement Mechanisms; Resources; Risk; Sampling; Savings; Services; Social Network; Specimen; Spottings; Stimulant; Stress and Coping; Substance Use Disorder; Tablets; Technology; Testing; Time; Treatment Effectiveness; United States; United States National Institutes of Health; Viral; Viral Load result; antiretroviral therapy; contingency management; cost; cost effective; cost effectiveness; efficacy testing; evidence base; experience; fictional works; health care service utilization; improved; incremental cost; innovation; intervention delivery; laptop; mHealth; men; men who have sex with men; mobile application; primary outcome; psychologic; recruit; resilience; secondary outcome; sexually active; skills; stimulant use; substance use; substance use treatment; substance user; theories; therapy adherence; transmission process; treatment adherence; treatment as prevention; treatment optimization; usability; web site

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. 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.

在美国，甲基苯丙胺和其他兴奋剂的使用正强劲复苏。艾滋病毒-- 使用阳性兴奋剂的男男性行为(HIV+SUMSM)可能会有更大的导航困难 艾滋病毒护理连续体以及表现为显著增加的病毒载量(VL)、放大的艾滋病毒传播 风险，以及更快的临床艾滋病毒进展。虽然行为干预显示出实现持久目标的希望 居住在城市中心以外的HIV+SUMSM患者中未抑制的VL随着时间的推移而减少 在获得艾滋病毒和药物使用服务方面遇到困难。出于这些原因，我们建议使用双臂 对HIV+SUMSM进行为期6个月的移动健康干预的随机对照试验，称为支持坚持治疗 韧性和欣欣向荣(START)。我们将在6个月后测试START改善VL抑制的效果 (主要结果)，并确定是否在第12个月保持任何收益(次要结果)。 START将两种有理论基础、基于证据的干预措施(APP+和ARTEMIS)与 优化治疗作为预防(TasP)的有效性的目标。将招募HIV+SUMSM(n=350) 并随机开始或对照评估以下目标：目标1a。测试Start对以下各项的有效性 在6个月时获得病毒抑制的SUMSM的比例更高(主要结果) 提供艾滋病毒治疗信息和药物使用治疗资源(对照)的网站 条件)。目标1b。测试START在12个月内维持病毒抑制成果的有效性， 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、积极情感)。目标2.评估《削减战略武器条约》的成本和成本效益 控制条件，在实现和/或保持病毒抑制方面，包括在以下方面的净节省 避免了医疗保健利用率。在第一阶段，我们将把APP+和Artemis集成到一次启动中 使用迭代整合过程的干预平台，该过程包括通过在线焦点小组提供反馈 使用SUMSM。第一阶段将在10个HIV+SUMSM中进行可用性测试，以确保顺利进行 过渡到第二阶段，在那里我们将进行随机对照试验，以测试START的效果。我们将使用基于家庭的 采集干血斑(DBS)以评估实验室量化的VL。所有人都会收到他们各自的条件 6个月，每季度评估至第12个月。用于测量VL的DBS样本将在 基线、6个月和12个月。成本分析将从供应商的角度进行框定，以估算“真实” 提供Start的成本使利益攸关方有一种更广泛实施的可行性感觉，给定 现有资源和偿还机制。建议的项目具有很高的意义，因为优化 艾滋病毒+SUMSM的TASP是NIH和国家艾滋病毒/艾滋病战略的最高优先事项之一。开始时间为 创新是因为它可扩展到更广泛的HIV+SUMSM人群，并可能适用于临床- 和基于社区的设置。