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

项目摘要 金黄色葡萄球菌是一种常见的原因，细菌感染在美国，造成非侵入性 皮肤和软组织感染以及侵袭性感染，包括败血症、肺炎和坏死性 筋膜炎在美国西南部，美洲印第安人的发病率不成比例， 死亡率与S.金黄色葡萄球菌感染现有的防治策略尚不足以控制S.金黄色 疾病和新的方法是迫切需要的。通过与白色山 阿帕奇部落，印第安人卫生服务中心的怀特里弗服务单位，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社区知情的方法， 教育和S.金黄色葡萄球菌的非殖民化，以防止S.金黄色葡萄球菌病的高危人群。在第一年， 将完成以下初步工作：（1）编制适合文化特点的预防和早期教育材料， 认识S。金黄色葡萄球菌感染;和2）评估在 美国印第安人的一个乡村社区。这将通过焦点小组讨论和深入 与关键利益相关者的访谈，包括医疗保健提供者和患者。在形成工作的最后， 我们将为美洲印第安人社区提供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年级， 将在随机对照试验中评价去殖民化方案，以评价 间歇性相比，一次去殖民化协议在减少S。金黄色葡萄球菌定植， 预防S.金黄色葡萄球菌感染成年人患S.金黄色葡萄球菌感染到怀特韦尔服务单位 （索引受试者; n=200）将与其家庭成员（n=1000）一起入组沿着，并随访12 个月索引受试者将以1：1的比例随机分配至：1）教育加间歇性 去殖民化（E+iD）;或2）教育加一次性去殖民化（E+1D;对照组）。指数参与者 随机分配到E+1D组的人将获得教育材料和一次非殖民化管理 仅在基线访视时接受方案。随机分配至E+iD组的指数受试者将接受教育 将在基线访问时提供材料，并将提供非殖民化议定书的六次行政管理， 在基线访视时进行，然后每隔一个月进行。参加小组的家庭成员将获得 E+1D干预。主要结局将是指数受试者在接种后6个月的定植 随机化。次要结局将包括：1）12岁时指数参与者中的定植率 2）S.在6个月和12个月时，指数参与者中的金黄色葡萄球菌和全因感染。如果 这种干预措施被发现是有效的，可以广泛用于高负担的患者人群，以减少 S.金相关的发病率和发病率，并解决一个重要的健康相关的差距，为美国 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.