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: 10898254
• 负责人: Adam Wayne Carrico
• 金额: $ 10.95万
• 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/10898254
• 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; 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; 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

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.

抽象的 在美国（美国），甲基苯丙胺和其他兴奋剂的使用强烈复兴。艾滋病病毒- 与男性发生性关系的积极刺激性男性（艾滋病毒+ sumsm）可能有更大的困难 HIV护理连续体以及显示出大幅升高的病毒载荷（VL），放大的HIV传播 风险和更快的临床HIV进展。而行为干预却显示出实现持久的希望 随着时间的推移，艾滋病毒+ sumsm降低了不抑制的VL，居住在城市中心之外的VL 遇到难以获取艾滋病毒和药物使用服务的困难。由于这些原因，我们提出了两臂 HIV+ SUMSM的6个月MHealth干预措施的RCT，称为支持治疗依从性 韧性和繁荣（开始）。我们将测试开始在6个月时提高VL抑制的效率 （主要结果）并确定在第12个月（次要结果）是否保持任何收益。 开始将两个理论上的基于证据的干预措施（APP+和Artemis）与 优化治疗作为预防的有效性（TASP）的目标。 HIV+ sumsm（n = 350）将被招募 并随机启动或控制以评估以下目的：目标1A。测试开始的效率 比较在6个月时实际上被抑制的总比例（主要结果） 到网站，引用了艾滋病毒治疗信息和药物使用治疗资源（控制 健康）状况）。目标1B。测试在12个月内维持病毒抑制增长的起始效率， 减少刺激性使用和性风险，并增加基于理论的心理过程（例如， 行为技巧，积极影响）。目标2。评估起始的成本和成本效益 控制条件，实现和/或维持病毒抑制，包括有关 避免医疗保健利用。在第一阶段，我们将将App+和Artemis集成到一个开始 使用迭代集成过程的干预平台，包括通过在线焦点小组的反馈 与sumsm。第一阶段将在10个HIV+ sumsm中进行可用性测试，以确保平滑 过渡到II期，我们将进行RCT，以测试350 HIV+ sumsm中开始的效率。我们 将使用家庭基干点（DBS）收集来评估实验室定量VL。所有人都会收到他们的 相关条件6个月，季度评估直到第12个月。DBS标本以测量VL 将在基线，6个和12个月时收集。成本分析将从提供商的角度进行构建 估计提供的“现实世界”成本开始使利益相关者具有更广泛的可行性 实施，鉴于现有资源和报销机制。拟议的项目高度 重要的是，由于使用HIV+ SUMSM优化TASP是NIH和国家艾滋病毒/艾滋病战略之一 优先事项。开始是创新的，因为它可以扩展到更广泛的艾滋病毒+ sumsm，并且可以 适用于诊所和社区设置。

项目成果

I was like sh*t this is gonna hurt': Implementing Self-Sampling of Dried Blood Spots to Measure HIV Viral Load.

我当时就想，这会伤害人的。”：对干血点进行自我采样来测量 HIV 病毒载量。

• DOI: 10.21203/rs.3.rs-4132978/v1
• 发表时间: 2024
• 期刊: Research square
• 作者: Chavez,JenniferV;Ewart,LeahDavis;Ilyas,Ozair;Ghanooni,Delaram;Diaz,JoséE;Atkins,Lindsay;Ramos,Richard;Garayua,AdrianaHernandez;Stewart,Alex;Horvath,KeithJ;Hirshfield,Sabina;Carrico,AdamW
• 通讯作者: Carrico,AdamW