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，甲基苯丙胺和其他兴奋剂的使用出现了强劲的复苏。 使用阳性兴奋剂、与男性发生性关系的男性（HIV+ SUMSM）可能会遇到更大的导航困难 HIV 护理连续性，并显示病毒载量 (VL) 大幅升高、HIV 传播扩大 风险和更快的临床艾滋病毒进展，而行为干预显示出实现持久的希望。 居住在城市中心以外的 HIV+ SUMSM 中未抑制的 VL 随着时间的推移而减少 因艾滋病毒和药物滥用而难以获得服务 出于这些原因，我们建议采用双臂治疗。 针对 HIV+ SUMSM 的 6 个月移动医疗干预的随机对照试验，称为支持治疗依从性 恢复力和繁荣 (START) 我们将在 6 个月时测试 START 对改善 VL 抑制的功效。 （主要结果）并确定在第 12 个月是否能保持任何收益（次要结果）。 START 将两种有理论依据、循证的干预措施（APP+ 和 ARTEMIS）与 将招募以优化治疗作为预防 (TasP) 的有效性为目标的 HIV+ SUMSM (n=350)。 并随机分配至 START 或对照以评估以下目标： 目标 1a 测试 START 的功效。 与相比，在 6 个月时获得病毒抑制的 SUMSM 比例更高（主要结果） 访问一个提供艾滋病毒治疗信息和药物滥用治疗资源推荐的网站（控制 目标 1b. 测试 START 在 12 个月时维持病毒抑制效果的功效， 减少兴奋剂的使用和性风险，并增加基于理论的心理过程（例如， 目标 2. 评估 START 相对于 控制条件，实现和/或维持病毒抑制，包括净节省 在第一阶段，我们将把 APP+ 和 ARTEMIS 集成到一个 START 中。 使用迭代集成流程的干预平台，其中包括通过在线焦点小组提供的反馈 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，我们将进行随机对照试验，以测试 START 在 350 名 HIV+ SUMSM 中的疗效。 将使用家庭干血斑 (DBS) 采集来评估实验室量化的 VL。 所有男性都将收到他们的 VL。 6 个月内的相应状况，每季度进行评估，直至第 12 个月。用于测量 VL 的 DBS 样本 将在基线、6 个月和 12 个月收集 成本分析将从提供商的角度进行。 估算提供 START 的“现实世界”成本，让利益相关者了解更广泛的可行性 考虑到现有资源和报销机制，拟议项目的实施成本很高。 意义重大，因为使用 HIV+ SUMSM 优化 TasP 是 NIH 和国家 HIV/AIDS 战略的最高级别之一 START 具有创新性，因为它可以扩展以覆盖更广泛的 HIV+ SUMSM 人群，并且可能 适应诊所和社区环境。

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