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

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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.