Participatory Interventions to Reduce Arsenic in American Indian Communities

描述（由申请人提供）：背景：在强心研究（SHS）中，来自亚利桑那州、俄克拉荷马州和北/南达科他州的美洲印第安人（AI）中，饮用水中慢性低至中度砷暴露与心血管疾病、糖尿病、肾脏疾病和癌症风险增加相关。迫切需要采取有效的干预措施，以减轻依赖私人威尔斯作为饮用和烹饪主要水源的AI社区的砷暴露。目的：这项研究的目的是设计，实施和评估多层次的参与性干预措施，可以导致持续减少在北/南达科他州，仍然暴露于饮用水中砷含量升高的AI社区砷暴露。初步研究：在最近的一项试点研究中，来自Spirit Lake（北达科他州）和Pine Ridge（南达科他州）的超过50%的私人威尔斯的饮用水砷含量超过了美国环境保护署的标准（10微克/升）。设计和设置：这项研究将分为三个阶段：（1）形成性研究和规划;（2）实施和评价多层次干预措施;（3）在家庭、部落、区域和国家各级传播。形成性研究和规划阶段将通过深入访谈和焦点小组讨论、社区咨询委员会讲习班和试点研究来制定和试点砷干预措施。我们将建立地方能力，确保干预计划的长期可持续性，为社区成员制定培训计划，使用快速现场套件测试水源中的砷，安装和维护使用点除砷设备，并传播制定的健康信息。在干预阶段，我们将进行一项两组随机对照试验，前瞻性随访300个家庭和600名参与者（每个家庭2名），以评估开发的多水平干预在6个月期间降低尿砷浓度和心血管疾病（细胞粘附分子）和糖尿病（糖化血红蛋白）生物标志物的有效性。第一组将在社区推广员的一次家访期间接受水砷检测和除砷装置（标准方案）。第二组将接受水砷检测、除砷装置和社区推广员5次家访的强化健康促进计划（强化健康促进计划）。为了评估长期可持续性，我们将测量尿液和水中的砷含量，并收集基线后1至3年基于水表的用水和自我报告的设备维护数据。在传播阶段，我们将与部落领导人和印度卫生局密切合作，传播研究结果，并制定可持续的砷减排政策，以扩大已制定的干预计划，包括其他AI社区。重要性：这项研究将是第一个开发，实施和评估参与式多层次干预，以减少砷暴露于私人威尔斯在AI社区，并确定干预是否可以减少砷暴露和心血管疾病和糖尿病的早期生物标志物。

DESCRIPTION (provided by applicant): Background: In the Strong Heart Study (SHS), chronic low-to-moderate arsenic exposure in drinking water is associated with an increased risk of cardiovascular disease, diabetes, kidney disease, and cancer in American Indians (AI) from Arizona, Oklahoma, and North/South Dakota. Effective interventions are urgently needed to mitigate arsenic exposure in AI communities who rely on private wells as the main source of water for drinking and cooking. Objective: The purpose of the study is to design, implement, and evaluate multi-level participatory interventions that can lead to a sustained reduction in arsenic exposure in AI communities in North/South Dakota that remained exposed to elevated arsenic levels in drinking water. Preliminary studies: In a recent pilot study, >50% of private wells from Spirit Lake (North Dakota) and Pine Ridge (South Dakota) had arsenic levels in drinking water exceeding the US Environmental Protection Agency standard (10 μg/L). Design and setting: This study will be divided into 3 phases: (1) Formative research and planning; (2) Implementation and evaluation of the multi-level intervention; and (3) Dissemination at the household, tribal, regional, and national levels. The formative research and planning phase will develop and pilot arsenic interventions through in- depth interviews and focus group discussions, a community advisory board workshop, and a pilot study. We will build local capacity to ensure the long-term sustainability of the intervention program by developing a training program for community members to test water sources for arsenic using rapid field kits, installing and maintaining point of use arsenic removal devices, and disseminating the developed health messages. During the intervention phase we will conduct a two-arm cluster-randomized controlled trial to prospectively follow 300 households and 600 participants (2 per household) to evaluate the effectiveness of the developed multi- level intervention in reducing urine arsenic concentrations and biomarkers of cardiovascular disease (cell adhesion molecules) and diabetes (glycated hemoglobin) during a 6 month period. The first arm will receive water arsenic testing and an arsenic removal device during one home visit by a community promoter (standard program). The second arm will receive water arsenic testing, an arsenic removal device, and an intensive health promotion program of 5 home visits by a community promoter (intensive health promotion program). To assess the long-term sustainability, we will measure arsenic in urine and water, and collect meter-based water use and self-reported device maintenance data 1 to 3 years after baseline. During the dissemination phase, we will work closely with tribal leaders and the Indian Health Service to disseminate study findings and develop sustainable arsenic mitigation policies to upscale the developed intervention programs to include other AI communities. Significance: This study will be the first to develop, implement, and evaluate a participatory multi-level intervention to reduce arsenic exposure from private wells in AI communities and to determine if the intervention can reduce arsenic exposure and early biomarkers of cardiovascular disease and diabetes.