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，公众也无法得到足够的服务。 健康负担。虽然有效的抗逆转录病毒药物已广泛使用，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定期接受治疗。拉丁美洲人的艾滋病毒护理面临许多障碍， 多因素且动态的，例如对驱逐出境的恐惧、耻辱、恐同症、情绪健康和心理健康 健康状况、前往诊所就诊的交通不便、缺乏初级保健以及缺乏 经过培训的提供者可以用西班牙语提供符合文化的护理。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，并提高了患者的积极性、自我效能感和 情绪健康以及获得抑制病毒途径所需的核心社会服务。这 PI 最近由 NIMH 资助的 K23 奖项开发并评估了基于西班牙语的电视剧（电影）， 社区卫生工作者 (CHW) 提供了 5 个疗程的干预措施，称为 ADELANTE，这是一种基于理论的干预措施 旨在解决问题的干预措施，旨在增强拉丁裔艾滋病毒携带者的权能，并将他们与现有资源联系起来，例如 作为交通，以满足未满足的基本需求。拟议的 R01 由早期研究人员领导，将 在美国境内两家 Ryan White 资助的诊所测试 ADELANTE 结束艾滋病毒流行 (EHE) 计划确定 拉丁裔艾滋病毒发病率高的地理区域。以我们之前的研究为基础并立足于当地 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学 实现以下目标。在目标 1 中，我们将在对照试验中随机抽取 250 名感染 HIV 的拉丁美洲人，以进行对比 ADELANTE（5 个疗程、CHW 提供的基于电视剧的干预）与 加强护理条件（ECC、5 个提醒电话）。我们假设 ADELANTE 参与者将 在第 12 个月表现出较高的病毒抑制率（HIV RNA <200 拷贝/毫升），并且 ED 较少 与 ECC 相比，就诊次数和住院次数。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 的参与者将会增加 患者的积极性、保留护理的自我效能、情绪健康以及转诊至非患者的情况 临床服务和这些变量将调节 ADELANTE 与病毒抑制的关系。在 目标 3，我们将通过深入了解 ADELANTE 实施准备的障碍和促进因素 对 40 名 RCT 参与者和焦点小组以及当地利益相关者进行半结构化访谈 执行。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。该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。我们预计技术和社区卫生工作者的合并 文化相关的内容将改善感染艾滋病毒的拉丁美洲人的结果，以结束艾滋病毒的流行。