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

基本信息

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
项目类别：
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

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

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项目摘要

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，患有艾滋病毒的拉丁美洲人持续服务不足，导致临床结果不佳和公众健康伯恩。虽然有效的抗逆转录病毒药物广泛可用，但只有一半的拉丁裔患者艾滋病毒保留在护理中，并定期获得治疗。艾滋病毒护理对拉丁美洲人的障碍很多，多因素和动态，例如害怕被驱逐出境，污名，同性恋恐惧症，情感幸福和精神健康，无法获得交通运输诊所，无法获得初级保健以及缺乏训练有素的提供者可以提供西班牙语的文化调整护理。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，并发展出更大的患者激活，自我有效，并且情感幸福感，并在病毒抑制的途径上获得所需的核心社会服务。 PI最近获得的NIMH资助的K23奖开发并评估了西班牙语Telenovela-（电影） - 基于电影，社区卫生工作者（CHW）提供了5条干预措施，称为阿德兰特（Adelante），这是一个基于理论的解决问题的干预措施旨在使拉丁美洲人与艾滋病毒赋予能力，并将其链接到现有资源，例如作为运输，以满足未满足的基本需求。拟议的R01由早期阶段调查员领导，将在我们内部的两个Ryan白人资助的诊所中测试Adelante，结束了艾滋病毒流行（EHE）计划识别在拉丁美洲人中有高艾滋病毒的地理区域。基于我们先前的研究，并以本地为基础优先事项，我们将利用公认的社区伙伴关系和多学科专业知识临床试验，健康分配，心理健康和药物使用，社区参与和生物统计学完成以下目标。在AIM 1中，我们将在对照试验中随机将250个拉丁美洲人与HIV进行对比 Adelante（5条，基于CHW的基于Telenovela的干预措施）的临床有效性与增强的护理状况（ECC，5个提醒电话）。我们假设阿德兰特参与者将在12个月中显示出更高的病毒抑制率（HIV RNA <200份/mL），并且ED的较少与ECC相比，就诊和住院治疗。在AIM 2中，我们将研究潜在的机制阿德兰特会影响病毒抑制。我们假设阿德兰特的参与者将增加患者激活的速度，保留护理的自我效能感，情绪健康以及非 - 临床服务和这些变量将介导阿德兰特与病毒抑制的关系。在目标3，我们将确定障碍和促进者，以实施阿德兰特的准备。与40名RCT参与者和焦点小组的半结构化访谈与涉及的本地利益相关者执行。这些定性数据将在解释发现，确保相关性和支持方面增加价值未来的吸收和触及。这种方法解决了NIH HIV/AIDS研究的高优先领域推进研究以减少健康差异。我们预计技术和CHW与具有文化相关的内容将改善患有艾滋病毒的拉丁美洲人的结局，以结束艾滋病毒的流行。