MACS/WIHS -CCS

MACS/WIHS-CCS

基本信息

批准号：
10220502
负责人：
MARIA LUISA ALCAIDE
金额：
$ 2.52万
依托单位：
UNIVERSITY OF MIAMI SCHOOL OF MEDICINE
依托单位国家：
美国
项目类别：
财政年份：
2019
资助国家：
美国
起止时间：
2019-04-01 至 2026-03-31
项目状态：
未结题

来源：
https://reporter.nih.gov/project-details/10220502
关键词：
Address Affect Alcohol or Other Drugs use Area Award Behavioral Biological Biological Markers Bisexual Cardiovascular Diseases Cardiovascular system Caring Cells Clinical Cohort Studies Communities Consent Consequences of HIV Country Data Data Collection Development Disease Outcome Disease Progression Enrollment Epidemic Exposure to Female Florida Fostering Frequencies Funding Goals HIV HIV Infections Health Policy Heterosexuals Hispanics Immune Immunologic Markers Incidence Inflammation Inflammatory Knowledge Laboratories Lead Leadership Mental Depression Mentors Mentorship Minority Names Natural History Neurocognitive Neurocognitive Deficit Oral Outcome Pathogenesis Pathway interactions Phenotype Pilot Projects Plasma Prospective cohort study Protocols documentation Psychosocial Factor Public Health Research Research Personnel Risk Role Science Sex Differences Site Specimen Surveys Testing The Multicenter AIDS Cohort Study Tobacco United States Visit Woman Women’s Interagency HIV Study amyloid pathology antiretroviral therapy base behavioral outcome cardiovascular disorder risk clinical research site cohort comorbidity data centers ethnic minority population follow-up genital microbiome gut microbiome health care disparity immune activation improved inflammatory marker innovation men men who have sex with men outreach programs protocol development psychosocial racial and ethnic recruit research and development research study resilience sample collection social stigma stimulant use

项目摘要

ABSTRACT Nearly half the men and women with HIV infection are racial/ethnic minorities living in the South. HIV infection remains a major public health problem despite the availability of treatments. The purpose of this proposal is to advance the knowledge of the consequences of HIV infection, with a focus on HIV-related comorbidities, by participating as a Clinical Research Sites (CRS) of the Multi-Center AIDS Cohort Study (MACS) and Women's Interagency HIV Study (WIHS) Combined Cohort Study (MACS/WIHS-CCS). To meet this goal, Miami will provide expertise to lead important components of the CCS unified science agenda with protocol development and laboratory support to protocols and sub studies, as well as implementing the full CCS unified science agenda. To accomplish this, we will enroll and follow 500 men and women with HIV infection or at risk for HIV. We will enroll approximately 250 men reflective of the HIV epidemic in Miami, and follow men who have sex with men, bisexual men, and heterosexual men including men who are black or Hispanic representing a large minority proportion. As a current Southern WIHS site we will continue to follow the 149 women enrolled in WIHS who have HIV infection or at risk for HIV and are largely minority reflecting the Miami HIV epidemic. With availability of the CCS protocol, we will enroll additional 100 women from the community to reach a goal of approximately 250 women. The men and women enrolled will be consistent with protocol requirements of the MACS/WIHS consortium for new enrollments. Miami will continue its strong leadership, as we provided for the WIHS. Dr. Fischl as lead PI for this multiple PI proposal is the Vice Chair of the WIHS and has had an active role, along with colleagues, in the development of the unified science agenda, including the specific aims, frequency of core protocol visits, and timing of clinical tests, specimen collections, surveys, assessments and clinical tests. The Miami CRS will focus on protocols and sub studies in several innovative areas.1. Explore cardiovascular outcomes and HIV progression in the syndemic of HIV, tobacco, stimulant use, and depression, and investigate inflammatory biomarkers of cardiovascular disease risk and immune activation, including sex differences. 2. Explore the effects of the oral, female genital, and gut microbiome on the HIV reservoir and on exposure to antiretroviral therapy. 3. Evaluate comorbidities and effect of HIV persistence, inflammation and immune markers on comorbidity outcomes and plasma markers of inflammation, amyloid pathology and innate immune cell phenotypes on disease outcomes. 4. Examine the trajectories of vulnerabilities and resiliencies and relationship to HIV outcomes and comorbidities, and mechanisms by which psychosocial and behavioral predictors affect outcomes. 5. Examine the biological pathway whereby psychosocial factors and substance use may increase cardiovascular disease, impair neurocognitive function and contribute to HIV persistence. 5. Utilize developmental funds to support early stage and established investigators to develop innovative pilot studies. These findings will lead to improved understanding of HIV, treatment of HIV and guide future research.

抽象的近一半感染艾滋病毒的男性和女性是生活在南方的少数民族。艾滋病毒感染尽管有治疗方法，但仍然是一个主要的公共卫生问题。该提案的目的是增进对艾滋病毒感染后果的了解，重点关注与艾滋病毒相关的合并症，方法是作为多中心艾滋病队列研究 (MACS) 和妇女研究的临床研究中心 (CRS) 参与机构间艾滋病毒研究 (WIHS) 联合队列研究 (MACS/WIHS-CCS)。为了实现这一目标，迈阿密将提供专业知识，通过协议开发来领导 CCS 统一科学议程的重要组成部分和实验室对协议和子研究的支持，以及实施完整的 CCS 统一科学议程。为了实现这一目标，我们将招募并跟踪 500 名感染艾滋病毒或有感染艾滋病毒风险的男性和女性。我们将招募大约 250 名反映迈阿密艾滋病毒流行情况的男性，并对发生性行为的男性进行追踪男性、双性恋男性和异性恋男性，包括黑人或西班牙裔男性，代表了很大一部分人少数比例。作为当前南方 WIHS 网站，我们将继续关注 149 名注册的女性感染艾滋病毒或有感染艾滋病毒风险的 WIHS 人群大多属于少数群体，反映了迈阿密艾滋病毒流行情况。和 CCS 协议的可用性，我们将从社区招募另外 100 名女性，以实现以下目标：大约 250 名女性。报名的男性和女性将符合协议要求 MACS/WIHS 新注册联盟。迈阿密将继续保持强有力的领导地位，正如我们为 WIHS。 Fischl 博士作为这项多项 PI 提案的首席 PI 是 WIHS 的副主席，并积极参与与同事一起在制定统一科学议程（包括具体目标）中发挥的作用，核心方案访问的频率以及临床测试、样本采集、调查、评估和临床测试。迈阿密 CRS 将重点关注几个创新领域的方案和子研究。1．探索 HIV、烟草、兴奋剂使用和抑郁症综合征中的心血管结局和 HIV 进展，并研究心血管疾病风险和免疫激活的炎症生物标志物，包括性别差异。 2. 探索口腔、女性生殖器和肠道微生物组对 HIV 储存库和艾滋病病毒感染的影响接受抗逆转录病毒治疗。 3. 评估合并症以及 HIV 持续性、炎症和感染的影响共病结果的免疫标记物以及炎症、淀粉样蛋白病理学和先天性的血浆标记物免疫细胞表型对疾病结果的影响。 4. 检查漏洞和弹性的轨迹与艾滋病毒结果和合并症的关系，以及心理社会和行为的机制预测因素影响结果。 5. 检查心理社会因素和物质的生物学途径使用可能会增加心血管疾病、损害神经认知功能并导致艾滋病毒持续存在。 5. 利用发展资金支持早期和已建立的研究人员开展创新试点研究。这些发现将增进对艾滋病毒的了解、艾滋病毒的治疗并指导未来的研究。