ADELANTE: A Randomized Controlled Trial of an Intervention to Improve Engagement in Care for Latinos with HIV

ADELANTE：一项旨在提高拉丁裔艾滋病毒感染者护理参与度的干预措施的随机对照试验

• 批准号: 10757099
• 负责人: Julie Levison
• 金额: $ 82.23万
• 依托单位: MASSACHUSETTS GENERAL HOSPITAL
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-07-25 至 2028-05-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10757099
• 关键词: 2 arm randomized control trial; Acute; Address; Adherence; Affect; Anti-Retroviral Agents; Area; Biometry; Caring; Clinic; Clinical; Clinical Trials; Clinical effectiveness; Communication Tools; Community Health Aides; Consolidated Framework for Implementation Research; Cultural Diversity; Data; Development; Discrimination; Disparity; Education; Effectiveness; Emergency department visit; Ensure; Epidemic; Evidence based intervention; Film; Focus Groups; Fright; Funding; Future; Geographic Locations; Geography; HIV; HIV/AIDS; Health; Health Services Accessibility; Health system; Homophobia; Hospitalization; Immigrant; Implementation readiness; Incidence; Individual; Intervention; Intervention Trial; Interview; Language; Latino; Latino Population; Leadership; Link; Massachusetts; Mediating; Mediation; Medicine; Mental Health; Mental disorders; Mentored Patient-Oriented Research Career Development Award; Migrant; Modeling; National Institute of Mental Health; Outcome; Participant; Pathway interactions; Patient Self-Report; Patients; Persons; Pharmaceutical Preparations; Poverty; Prevalence; Primary Care; Principal Investigator; Printing; Problem Solving; Provider; Public Health; RNA; Randomized; Randomized, Controlled Trials; Reduce health disparities; Research; Research Personnel; Research Support; Resources; Self Efficacy; Services; Site; Social Work; Structure; Technology; Telephone; Testing; Time; Training; Transportation; Treatment outcome; Underserved Population; United States National Institutes of Health; Viral; Viral Load result; Well in self; Work; acceptability and feasibility; community engagement; community partnership; empowerment; enhanced care; epidemic preparedness; future implementation; health care service utilization; health communication; health disparity; implementation facilitators; improved; improved outcome; intersectionality; multidisciplinary; patient retention; programs; social stigma; substance use; theories; therapy design; tool; transportation access; uptake

Latinos with HIV are persistently underserved in the U.S., contributing to poor clinical outcomes and public health burden. While effective antiretroviral medications are widely available, only half of Latino patients with HIV are retained in care and have regular access to treatment. Barriers to HIV care for Latinos are numerous, multi-factorial, and dynamic, such as fear of deportation, stigma, homophobia, emotional well-being and mental health, inadequate access to transportation to attend clinics, lack of access to primary care, and shortage of trained providers who can provide culturally attuned care in Spanish. Using culturally acceptable tools can help these patients overcome existing impediments and develop greater patient activation, self-efficacy, and emotional well-being and access to the needed core social services on the pathway to viral suppression. The PI’s recent NIMH-funded K23 award developed and evaluated a Spanish language telenovela-(film) based, community health worker (CHW)-delivered 5-session intervention, called ADELANTE, which is a theory-based problem-solving intervention designed to empower Latinos with HIV and link them to existing resources, such as transportation, to address unmet basic needs. The proposed R01, led by an Early Stage Investigator, will test ADELANTE in two Ryan White-funded clinics within US Ending the HIV Epidemic (EHE) Plan-identified geographic areas that have high HIV incidence in Latinos. Building on our prior research and grounded in local EHE priorities, we will leverage well-established community partnerships and multidisciplinary expertise in clinical trials, health disparities, mental health and substance use, community engagement, and biostatistics to accomplish the following aims. In Aim 1, we will randomize 250 Latinos with HIV in a controlled trial to contrast clinical effectiveness of ADELANTE (5-session, CHW-delivered telenovela-based intervention) versus enhanced care condition (ECC, 5 reminder phone calls). We hypothesize that ADELANTE participants will demonstrate higher rates of viral suppression (HIV RNA <200 copies/ml) at month-12 and will have fewer ED visits and hospitalizations compared with ECC. In Aim 2, we will examine potential mechanisms by which ADELANTE impacts viral suppression. We hypothesize that participants in ADELANTE will have increased rates of patient activation, self-efficacy for retention in care, emotional well-being, and referrals for non- clinical services and these variables will mediate the relationship of ADELANTE with viral suppression. In Aim 3, we will identify barriers and facilitators to implementation readiness of ADELANTE through in-depth semi-structured interviews with 40 RCT participants and focus groups with local stakeholders involved with implementation. This qualitative data will add value in explaining findings, ensuring relevance, and facilitating future uptake and reach. This approach addresses high priority areas for NIH HIV/AIDS research by advancing research to reduce health disparities. We anticipate that the merger of technology and CHWs with culturally relevant content will improve outcomes for Latinos with HIV towards ending the HIV epidemic.

拉美裔艾滋病毒携带者在美国一直得不到足够的服务，这导致了糟糕的临床结果和公共卫生 健康负担。虽然有效的抗逆转录病毒药物随处可得，但只有一半的拉丁裔患者患有 艾滋病毒被保留在护理中，并有机会定期接受治疗。拉美裔艾滋病护理的障碍很多， 多因素和动态的，如对驱逐出境的恐惧、耻辱、同性恋恐惧症、情绪健康和精神健康 卫生保健、就诊的交通工具不足、缺乏获得初级保健的机会以及缺乏 训练有素的提供者，他们可以用西班牙语提供符合文化要求的护理。使用文化上可接受的工具可以有所帮助 这些患者克服了现有的障碍，并发展出更大的患者积极性、自我效能感和 情绪健康和在病毒抑制的道路上获得所需的核心社会服务。这个 派最近由NIMH资助的K23奖开发和评估了一部以西班牙语为基础的电视连续剧(电影)， 社区卫生工作者(CHW)提供的5次干预，称为Adelante，这是一种基于理论的 旨在增强拉丁裔艾滋病毒携带者能力并将他们与现有资源联系起来的解决问题干预措施，如 作为运输，以解决未得到满足的基本需求。拟议的R01由一名早期调查员领导，将 在美国境内两家瑞安·怀特资助的诊所测试阿德兰特终止艾滋病毒流行(EHE)计划-确定 拉美裔艾滋病毒发病率高的地理区域。以我们先前的研究为基础，立足于当地 在每个优先事项中，我们将利用成熟的社区伙伴关系和多学科的专业知识 临床试验、健康差异、精神健康和物质使用、社区参与和生物统计 实现以下目标。在目标1中，我们将在一项对照试验中随机选择250名感染艾滋病毒的拉美人作为对照 阿德兰特(5个疗程，由CHW提供的基于Telenovela的干预)与 加强护理条件(ECC，5个提醒电话)。我们假设阿德兰特的参赛者 在12个月时表现出更高的病毒抑制率(HIV RNA和200拷贝/毫升)，并将有更少的ED 就诊和住院情况与ECC比较。在目标2中，我们将研究潜在的机制， 阿德兰特影响病毒抑制。我们假设阿德兰特的参与者将会增加 患者活跃率、保留护理的自我效能、情绪幸福感和非患者转诊 临床服务和这些变量将调解阿德兰特与病毒抑制的关系。在……里面 目标3，我们将通过深入了解阿德兰特的实施准备情况，找出障碍和促进因素 对40名随机对照研究参与者和当地利益攸关方参与的焦点小组进行了半结构化访谈 实施。这些定性数据将在解释调查结果、确保相关性和促进 未来的吸收和覆盖范围。这一方法解决了NIH艾滋病毒/艾滋病研究的高度优先领域，通过 推进缩小健康差距的研究。我们预计，技术和CHW与 与文化相关的内容将改善感染艾滋病毒的拉丁裔人在结束艾滋病毒流行方面的结果。