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.

在美国，感染艾滋病毒的拉丁美洲人一直得不到充分的服务，导致临床结果不佳， 健康负担。虽然有效的抗逆转录病毒药物广泛存在，但只有一半的拉丁美洲患者 艾滋病毒感染者继续接受护理，并定期接受治疗。拉丁美洲人获得艾滋病毒护理的障碍很多， 多因素和动态的，如担心被驱逐出境，耻辱，同性恋恐惧症，情感健康和精神健康， 卫生保健、前往诊所的交通工具不足、缺乏初级保健和缺乏 受过培训的提供者可以用西班牙语提供文化上协调的护理。使用文化上可接受的工具可以帮助 这些患者克服了现有的障碍，并发展了更大的患者激活，自我效能， 情绪健康和获得所需的核心社会服务的途径，以抑制病毒。的 PI最近的NIMH资助的K23奖开发和评估了一个西班牙语电视剧（电影）为基础， 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 解决问题的干预措施，旨在增强拉丁美洲艾滋病毒感染者的能力，并将他们与现有资源联系起来， 作为交通工具，来解决未满足的基本需求。拟议的R 01由一名早期研究人员领导，将 在美国终止艾滋病毒流行（EHE）计划范围内的两个Ryan White资助的诊所测试ADELANTE-确定 拉丁裔艾滋病高发地区。基于我们先前的研究，并立足于当地 EHE优先事项，我们将利用完善的社区合作伙伴关系和多学科专业知识， 临床试验，健康差异，心理健康和物质使用，社区参与和生物统计， 实现以下目标。在目标1中，我们将在对照试验中随机选择250名感染艾滋病毒的拉丁美洲人， ADELANTE（5次治疗，CHW提供的基于电视剧的干预）与 加强护理条件（ECC，5次提醒电话）。我们假设ADELANTE参与者将 在第12个月时显示出较高的病毒抑制率（HIV RNA <200拷贝/ml），并且艾德较少 与ECC相比，在目标2中，我们将研究潜在的机制， ADELANTE影响病毒抑制。我们假设ADELANTE的参与者将增加 患者激活率、自我效能感、情绪健康和非患者转诊率 临床服务和这些变量将介导ADELANTE与病毒抑制的关系。在 目标3，我们将通过深入研究， 对40名RCT参与者和当地利益相关者的焦点小组进行了半结构化访谈， 实施.这些定性数据将有助于解释调查结果，确保相关性， 未来的发展和普及。这种方法通过以下方式解决了NIH HIV/AIDS研究的高度优先领域： 推进研究以减少健康差距。我们预计，技术和CHW的合并， 与文化相关的内容将改善拉丁美洲艾滋病毒感染者的成果，以结束艾滋病毒的流行。