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

项目摘要/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，影响 近10亿人，其中绝大多数生活在低收入和中等收入国家。在临床上 研究已经确定了控制HTN的高效和廉价的选择，知晓率， HTN的治疗和控制率极低。实施战略，可以有效地覆盖和 迫切需要在脆弱的卫生系统的限制下，在可行的情况下让患者群体参与进来。在……里面 秘鲁，只有不到10%的HTN患者得到了最佳控制，因此可以避免的M&M继续增加 达到令人无法接受的水平。在拟议的安第斯战略中，我们将研究一个脆弱、贫穷的土著 安第斯人群HTN和T2D患病率高(18.5%)和T2D(7.4%)；生活在高海拔地区(类似 对全世界约1.4亿人来说--因此意义重大)。这项研究分为两个阶段：UG3/UH3。形成者 UG3阶段(24个月)将借鉴两项实施战略：a)健康博览会(HFs)，吸引整个 利用社区动员和娱乐将HTN快速诊断的社区扩展到活动 制定并与护理挂钩，以及b)基于社区卫生工作者(CHW)的多成分干预，以 克服治疗的后勤和结构障碍。在LMIC中，CHW用于间歇性条件，但 为了有效地解决HTN问题，需要进行调整。我们借鉴了综合框架 指导正式适应进程的实施研究，包括使用：a)关键利益攸关方定性 访谈，b)离散选择实验，c)以人为本的设计，以重塑HFs和CHW，以 满足社区需求并符合卫生系统的背景。UG3阶段将以为期12个月的试点结束 在两个社区对心力衰竭和妇幼保健员进行干预，重点关注实施成果。UH3阶段将 在整群随机试验中测试调整后的安第斯策略。我们将在HTN招收1,608人 (有/无2型糖尿病，T2D)，年龄55-，来自24个组(67个受试者/组)；所有24个组 接受HFs，但12个群组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个组的常规护理。我们将对实施、服务进行评估 分娩和临床结果。主要结果是12个月时SBP的变化。次要结果 包括受控HTN受试者比例(SBP/DBP和Lt；140/90毫米汞柱)和受控T2D (HgbA1c&lt；7%)。我们还将评估实施的保真度和适应性、护理参与度、成本和 早期可持续性。我们从秘鲁和美国组建了一支强大的研究团队，拥有良好的记录 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。我们在推进实施科学议程方面具有得天独厚的优势 解决秘鲁的HTN问题，这是扩大阶段的主要利益攸关方。务实的试验设计将提供 提供严谨和相关的证据，为国家和全球政策以及随后扩大干预提供信息。

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.