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

项目总结 金黄色葡萄球菌是美国细菌感染的常见原因，导致非侵入性 皮肤和软组织感染以及侵袭性感染，包括败血症、肺炎和坏死症 筋膜炎。在美国西南部，美国印第安人人口不成比例地受到发病率和 与金黄色葡萄球菌感染有关的死亡率。现有的策略还不足以控制金黄色葡萄球菌。 迫切需要疾病和新的方法。通过白山和白山之间的合作 阿帕奇部落、印度卫生服务的惠特维尔服务单位和约翰·霍普金斯中心 美国印第安人健康，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非殖民化，以预防高危人群中的金黄色葡萄球菌疾病。在第一年， 将完成形成工作，以：1)开发针对文化定制的预防和早期教育材料 确认金黄色葡萄球菌感染；和2)评估#年非殖民化方案的可接受性和可行性。 一个美国印第安人的乡村社区。这将通过焦点小组讨论和深入讨论来实现 采访关键的利益相关者，包括医疗保健提供者和患者。在形成工作的最后， 我们将有为美国印第安人社区量身定做的教育材料和非殖民化议定书 优化可接受性、坚持性和可持续性。在2至4年级，教材和 非殖民化议定书将在随机对照试验中进行评估，以评估 与一次性非殖民化议定书相比，间歇性议定书在减少金黄色葡萄球菌定殖率和 预防金黄色葡萄球菌感染。金黄色葡萄球菌感染的高危成人到威立雅医院服务单元就诊 (指数参与者；n=200)将与其家庭成员(n=1000)一起登记，并跟踪12年 月份。指数参与者将按1：1的比例随机分配：1)教育+间歇性 非殖民化(E+ID)；或2)教育+一次性非殖民化(E+1D；对照组)。指数参与者 随机到E+1D组将收到教育材料和一次非殖民化管理 仅限基线探视时的礼仪。随机分配到E+ID组的指数参与者将接受教育 在基线访问时提供材料，并将向非殖民化议定书的六个行政当局提供 在基线访问时进行，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。主要结果将是指数参与者在6个月后被殖民 随机化。次要结果将包括：1)指数参与者在12岁时的殖民流行率 2)指数参与者在6个月和12个月时金黄色葡萄球菌和各种原因感染的发生率。如果 这种干预被发现是有效的，可以在高负担患者人群中广泛应用，以减少 并解决了美国人与健康相关的一个重要差距 印第安人社区。

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.