Addressing HyperteNsion and Diabetes through Community-Engaged Systems in Puno Peru (ANDES study)

项目总结/摘要 高血压（HTN）已成为全球发病率和死亡率（M & M）的最大驱动因素， 近10亿人，其中绝大多数生活在低收入和中等收入国家。虽然临床 研究已经确定了控制HTN，知晓率， HTN的治疗和控制非常低。能够有效地达到和 迫切需要在脆弱的卫生系统的限制下，在可行的情况下让病人参与。在 在秘鲁，只有不到10%的HTN患者得到了最佳控制，因此可避免的M & M继续增加 无法接受的程度。在拟议的安第斯山脉战略中，我们将研究一个脆弱、贫穷的土著国家， 高血压（18.5%）和2型糖尿病（7.4%）患病率高的安第斯人口;生活在高海拔地区（类似 全球约1.4亿人，因此意义重大）。该研究分为两个阶段：UG3/UH3。形成性 UG3阶段（24个月）将借鉴两个实施战略： 利用社区动员和娱乐活动，社区可以迅速进行HTN诊断， 和B）基于社区卫生工作者（CHW）的多成分干预， 克服治疗的后勤和结构障碍。CHW在LMIC中用于偶发性条件，但 需要进行调整以有效地解决HTN问题。我们从《综合框架》中汲取了 指导正式适应进程的执行研究，包括使用： 访谈，B）离散选择实验，以及c）以人为中心的设计，以重新塑造HF和CHW， 满足社区需求并适应卫生系统的环境。UG3阶段将以12个月的试点结束 在两个社区开展保健中心和社区保健工作者的干预活动，重点关注实施成果。UH3阶段将 在一项随机分组试验中检验适应的安第斯山脉策略。我们将招募1，608名HTN患者 (with/无2型糖尿病，T2D），年龄55 - 89岁，来自24个聚类（67例受试者/聚类）;所有24个聚类 接受HF，但12个集群将被随机分配到基于CHW的多组分干预（即，饮食， 行为，药物）与其他12个集群中的常规护理。我们将评估实施、服务 交付和临床结果。主要结局是12个月时SBP的变化。次要结局 包括具有受控HTN（SBP/DBP <140/90 mmHg）和受控T2D的受试者比例 （HgbA1c <7%）。我们还将评估实施保真度和适应性，参与护理，成本和 早期的可持续性。我们拥有一支来自秘鲁和美国的强大的研究团队，拥有强大的跟踪记录 在HTN、实施科学和临床试验方面的合作和专业知识，并与 秘鲁卫生部。我们处于独特的地位，可以推进实施科学议程， 解决秘鲁的HTN问题，这是扩大规模阶段的一个主要利益攸关方。务实的试验设计将提供 为国家和全球政策以及随后的扩大干预措施提供有力和相关的证据。

PROJECT SUMMARY/ABSTRACT Hypertension (HTN) and has become the largest driver of morbidity and mortality (M&M) worldwide, affecting nearly 1 billion persons, the vast majority living in low- and middle-income countries (LMICs). While clinical research has identified highly-efficacious and inexpensive options to control HTN, rates of awareness, treatment and control of HTN are abysmally low. Implementation strategies that can effectively reach and engage patient populations while feasible within the constraints of frail health systems are urgently needed. In Peru, less than 10% of those with HTN are optimally controlled and thus avoidable M&M continues to increase at unacceptable levels. In the proposed ANDES strategy, we will study a vulnerable, impoverished indigenous Andean population that has a high prevalence of HTN (18.5%) and T2D (7.4%); living at high altitude (similar to ~140 million people worldwide–thus highly significant). The study has two phases: UG3/UH3. The formative UG3 phase (24 months) will draw from two implementation strategies: a) health fairs (HFs) that draw an entire community to an event using community mobilization and entertainment where HTN diagnoses can be rapidly made and linked to care, and b) community health worker (CHW)-based multicomponent intervention to overcome logistical and structural barriers to treatment. CHWs are used in LMIC for episodic conditions, but adaptations are required to effectively address HTN. We draw from the Consolidated Framework for Implementation Research to guide a formal adaptation process including using: a) key stakeholder qualitative interviews, b) discrete choice experiments, and c) human centered design to re-shape the HFs and CHWs to meet community needs and fit health system context. The UG3 phase will end with a 12-month pilot intervention of HF and CHWs in two communities focusing on implementation outcomes. The UH3 phase will test the adapted ANDES strategy in a cluster-randomized trial. We will enroll 1,608 individuals with HTN (with/without type 2 diabetes, T2D), aged 55-89 years, from 24 clusters (67 subjects/cluster); all 24 clusters receive the HFs, but 12 clusters will be randomized to a CHW-based multicomponent intervention (i.e., diet, behavioral, medications) vs. usual care in the other 12 clusters. We will assess the implementation, service delivery and clinical outcomes. The primary outcome is change in SBP at 12 months. Secondary outcomes include proportion of subjects with controlled HTN (SBP/DBP<140/90 mmHg) and controlled T2D (HgbA1c<7%). We will also assess implementation fidelity and adaptations, engagement in care, costs and early sustainability. We have assembled a strong research team from Peru and USA with a robust track record of collaboration and expertise in HTN, implementation science and clinical trials, and have partnered with the Peruvian Ministry of Health. We are uniquely positioned to advance the implementation science agenda to address HTN in Peru, a major stakeholder for the scale-up phase. The pragmatic trial design will provide rigorous and relevant evidence to inform national and global policies and subsequent intervention scaling-up.