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: 10223757
• 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/10223757
• 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; 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; Methicillin Resistance; Methodology; Morbidity - disease rate; Native American Research Center for Health; Necrotizing fasciitis; Outcome; Participant; Patients; Periodicity; Pneumonia; Population; Prevalence; Prevention; Protocols documentation; Public Health; Randomized; Randomized Controlled Trials; Recording of previous events; Recurrence; Regimen; Reporting; Research; Research Training; Resources; Rural; Sepsis; Services; Skin Tissue; Soft Tissue Infections; Staphylococcus aureus; Staphylococcus aureus infection; Time; United States; United States Indian Health Service; Vaccines; Visit; Water; White Mountain Apache; Work; acceptability and feasibility; antimicrobial; behavior change; cost; design; efficacious intervention; efficacy evaluation; experience; high risk; 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.

项目概要 金黄色葡萄球菌是美国细菌感染的常见原因，可导致非侵入性感染 皮肤和软组织感染以及侵袭性感染，包括败血症、肺炎和坏死性感染 筋膜炎。在美国西南部，美洲印第安人人口受到发病率和疾病的影响尤为严重 与金黄色葡萄球菌感染相关的死亡率。现有策略不足以控制金黄色葡萄球菌 迫切需要针对疾病和新方法。通过白山公司之间的合作 阿帕奇部落、印第安人卫生服务局怀特河服务单位和约翰·霍普金斯中心 美洲印第安人健康中心，拟议的研究将设计和评估一种社区知情的方法 教育和金黄色葡萄球菌去定植，以预防高危人群的金黄色葡萄球菌疾病。在第一年， 将完成形成性工作：1）开发针对文化的预防和早期教育材料 识别金黄色葡萄球菌感染； 2) 评估去殖民化方案的可接受性和可行性 美洲印第安人乡村社区。这将通过焦点小组讨论和深入的讨论来完成 采访主要利益相关者，包括医疗保健提供者和患者。在形成工作结束时， 我们将为美洲印第安人社区量身定制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。在第二年至第四年，教育材料和 去殖民化方案将在随机对照试验中进行评估，以评估去殖民化方案的有效性 与一次性去定植方案相比，间歇性方案可减少金黄色葡萄球菌定植，并且 预防金黄色葡萄球菌感染。在怀特河服务中心就诊的金黄色葡萄球菌感染高危成年人 （指数参与者；n=200）将与其家庭成员（n=1000）一起登记并跟踪 12 几个月。指数参与者将以 1:1 的比例随机分配至：1) 教育加间歇性 非殖民化（E+iD）；或 2) 教育加一次性非殖民化（E+1D；对照组）。指数参与者 随机分配到 E+1D 组将收到教育材料和一次非殖民化管理 仅在基线访视时的方案。随机分配到 E+iD 组的指数参与者将接受教育 基线访问时提供的材料，并将提供给非殖民化议定书的六个主管部门 在基线访视时进行，然后每隔一个月进行一次。来自团体的家庭成员将获得 E+1D 干预。主要结果将是 6 个月后指数参与者中的殖民化 随机化。次要结果将包括：1）指数参与者 12 岁时的定植发生率 月； 2) 指数参与者在 6 个月和 12 个月时金黄色葡萄球菌和全因感染的发生率。如果 该干预措施被证明是有效的，可广泛应用于高负担患者群体，以减少 金黄色葡萄球菌相关的发病率和发病率，并解决美国人与健康相关的重要差异 印度社区。