Community-informed interventions to address the large burden of Staphylococcus aureus infections on the White Mountain Apache Tribal lands

社区知情干预措施，以解决白山阿帕奇部落土地上金黄色葡萄球菌感染的巨大负担

• 批准号: 10494072
• 负责人: Laura Hammitt
• 金额: $ 23.25万
• 依托单位: WHITE MOUNTAIN APACHE TRIBE
• 依托单位国家: 美国
• 财政年份: 2021
• 资助国家: 美国
• 起止时间: 2021-09-24 至 2026-01-31
• 项目状态: 未结题
• 来源: https://reporter.nih.gov/project-details/10494072
• 关键词: 2 year old; Address; Adherence; Adult; Affect; American Indians; Amputation; Apache Tribe; Applied Research; Bacterial Infections; Cessation of life; Clinic; Collaborations; Communicable Diseases; Communities; Control Groups; Data; Data Analyses; Development; Diabetes Mellitus; Disease; Disparity; Education; Educational Materials; Enrollment; Focus Groups; Goals; Health; Health Personnel; Healthcare Systems; Hospitalization; Household; Incidence; Individual; Infection; Intervention; Interview; Knowledge; Licensure; Local Anti-Infective Agents; Mentorship; Methodology; Morbidity - disease rate; Native American Research Center for Health; Necrotizing fasciitis; Outcome; Participant; Patients; Periodicals; Persons; Pneumonia; Population; Prevalence; Prevention; Protocols documentation; Public Health; Randomized; Randomized, Controlled Trials; Recording of previous events; Recurrence; Regimen; Reporting; Research; Resource-limited setting; Rural; Sepsis; Services; Skin Tissue; Soft Tissue Infections; Staphylococcus aureus; Staphylococcus aureus infection; Time; Training; United States; United States Indian Health Service; Vaccines; Visit; Water; White Mountain Apache; Work; acceptability and feasibility; antimicrobial; behavior change; cost; design; efficacy evaluation; experience; high risk; high risk population; hospitalization rates; inclusion criteria; indexing; member; methicillin resistant Staphylococcus aureus; mortality; novel strategies; patient population; prevent; primary outcome; recruit; recurrent infection; rural Americans; secondary outcome; trend; tribal community; tribal lands; tribal member

PROJECT SUMMARY Staphylococcus aureus is a common cause of bacterial infections in the United States, causing non-invasive skin and soft tissue infections as well as invasive infections, including sepsis, pneumonia and necrotizing fasciitis. In the Southwest US, the American Indian population is disproportionately affected by morbidity and mortality related to S. aureus infections. Existing strategies have not been sufficient to control S. aureus disease and new approaches are urgently needed. Through a partnership between the White Mountain Apache Tribe, the Whiteriver Service Unit of the Indian Health Service, and the Johns Hopkins Center for American Indian Health, the proposed research will design and evaluate a community-informed approach to education and S. aureus decolonization to prevent S. aureus disease in high-risk individuals. In Year 1, formative work will be completed to: 1) develop culturally tailored educational materials for prevention and early recognition of S. aureus infections; and 2) assess the acceptability and feasibility of decolonization regimens in a rural American Indian community. This will be accomplished through focus-group discussions and in-depth interviews with key stakeholders, including healthcare providers and patients. At the end of the formative work, we will have educational materials and a decolonization protocol tailored for American Indian communities to optimize acceptability, adherence, and sustainability. In Years 2 to 4, the educational materials and decolonization protocol will be evaluated in a randomized controlled trial to evaluate the efficacy of an intermittent compared to a one-time decolonization protocol in decreasing S. aureus colonization and preventing S. aureus infections. Adults at high risk for S. aureus infection attending the Whiteriver Service Unit (index participants; n=200) will be enrolled along with their household members (n=1000) and followed for 12 months. Index participants will be randomized in a ratio of 1:1 to either: 1) education plus intermittent decolonization (E+iD); or 2) education plus one-time decolonization (E+1D; control group). Index participants randomized to the E+1D group will receive educational materials and one administration of the decolonization protocol at the baseline visit only. Index participants randomized to the E+iD group will receive educational materials at the baseline visit and will be provided with six administrations of the decolonization protocol to be performed at the baseline visit and then every other month. Household members from groups will receive the E+1D intervention. The primary outcome will be colonization among index participants 6 months after randomization. Secondary outcomes will include: 1) prevalence of colonization among index participants at 12 months; and 2) incidence of S. aureus and all-cause infections among index participants at 6 and 12 months. If found to be efficacious, this intervention could be broadly used in high burden patient populations to decrease S. aureus-related morbidity and morbidity and address an important health-related disparity for American Indian communities.

项目摘要 金黄色葡萄球菌是美国细菌感染的常见原因，导致无创 皮肤和软组织感染以及侵入性感染，包括败血症，肺炎和坏死 筋膜炎。在美国西南部，美洲印第安人人口受发病率和 与金黄色葡萄球菌感染有关的死亡率。现有策略不足以控制金黄色葡萄球菌 迫切需要疾病和新方法。通过白山之间的伙伴关系 Apache Tribe，印度卫生服务部的怀特维尔服务部门和约翰·霍普金斯中心 拟议的研究将设计和评估社区信息的方法 教育和金黄色葡萄球菌非殖民化，以防止高风险个体的金黄色葡萄球菌疾病。在第一年， 形成性工作将完成：1）开发具有文化量身定制的教育材料，以预防和早期 识别金黄色葡萄球菌感染； 2）评估非殖民化方案的可接受性和可行性 一个乡村美洲印第安人社区。这将通过焦点组讨论和深入来完成 与主要利益相关者（包括医疗保健提供者和患者）的访谈。在形成性工作结束时， 我们将拥有为美洲印第安人社区量身定制的教育材料和非殖民化协议 优化可接受性，依从性和可持续性。在2至4年中，教育材料和 非殖民化协议将在一项随机对照试验中评估，以评估 与一次性非殖民化方案相比，间歇性在减少金黄色葡萄球菌定植和 防止金黄色葡萄球菌感染。在Whiteriver服务部门参加的金黄色葡萄球菌感染的高风险的成年人 （索引参与者; n = 200）将与他们的家庭成员一起参加（n = 1000），然后进行12 月份。索引参与者的比率将以1：1的比率随机分配：1）教育加上间歇性 非殖民化（E+ID）;或2）教育以及一次性非殖民化（E+1D；对照组）。索引参与者 随机分配到E+1D组将获得教育材料和一个非殖民化的管理 仅在基线访问时进行协议。索引参与者随机分配给E+ID组将获得教育 基线访问时的材料，并将提供六个非殖民化协议的政府 在基线访问，然后每隔一个月进行。小组的家庭成员将收到 E+1D干预。主要结果将是索引参与者的殖民 随机化。次要结果将包括：1）指数参与者的殖民率在12 月份； 2）在6和12个月的时间内，指数参与者的金黄色葡萄球菌和全因感染的发生率。如果 发现这是有效的，这种干预措施可广泛用于高负担患者人群以减少 S.金黄色葡萄球菌相关的发病率和发病率，并解决与美国的重要健康相关差异 印度社区。