Abstract

Background

Hypertension is the most common cardiovascular disease in Peru despite the availability of cost-effective, evidence-based treatment. Here we describe the rationale and study design for a hybrid type 2 randomized controlled trial to test the implementation and effectiveness of a community health worker (CHW)-led hypertension control program within the national primary care system in Puno, Peru.

Methods

We will recruit 1068 adult participants with hypertension aged ≥ 18 years in Puno, Peru, via facility-based enrollment and community health fairs. Participants will be individually randomized (1:1) to either continue with usual care or participate in a 12-month CHW-led home-based hypertension control program consisting of blood pressure monitoring, medication adherence support, and healthy lifestyle counseling. Outcome development and reporting are guided by the Consolidated Framework for Implementation Research (CFIR), the Reach, Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework, and the Proctor et al. framework. Clinical effectiveness outcomes include mean change in systolic blood pressure (primary outcome), diastolic blood pressure, and HbA1C. Implementation outcomes include fidelity (i.e., CHW protocol adherence and dose), reach, adoption, sustainability, acceptability, and cost-effectiveness.

Discussion

The ANDES trial is testing the first CHW-led multicomponent strategy for hypertension and type 2 diabetes management in Peru. This type 2 hybrid trial will provide critical insights into the individual, community, and system-level factors necessary for successful implementation and effectiveness. These data can inform the future adaptation and scaling of the ANDES strategy in Peru and other LMICs, as well as influence policies at the system level to support this transition. Furthermore, by addressing both hypertension and diabetes, the ANDES strategy supports integrated care approaches advocated by the WHO HEARTS technical package, ultimately enhancing health outcomes and reducing morbidity and mortality in the region.

Trial registration

ClinicalTrials.gov, ID: NCT05524987, Addressing Hypertension and Diabetes through Community-Engaged Systems in Puno, Peru (ANDES study), prospectively registered on September 1, 2021.

Details

Title
Addressing Hypertension and Diabetes through Community-Engaged Systems (ANDES) in Puno, Peru: rationale and study protocol for a hybrid type 2 effectiveness and implementation randomized controlled trial
Author
Underhill, Lindsay J. 1 ; Williams, Kendra N. 2 ; Cordova-Ascona, Lucy 3 ; Campos, Karina 3 ; de las Fuentes, Lisa 4 ; Huffman, Mark D. 5 ; Gittelsohn, Joel 6 ; Schechtman, Kenneth B. 7 ; Vela-Clavo, Zoila 3 ; Tarazona-Meza, Carla 2 ; Beres, Laura K. 6 ; Acevedo, Parker K. 2 ; Barker, Abigail 8 ; Rajapakse, Nishadi 9 ; Williams, Makeda 10 ; Tonwe, Veronica 10 ; Mody, Aaloke 11 ; Hurtado, Raquel 12 ; Mendoza, Juan Carlos 13 ; Cuentas, Gonzalo 14 ; Geng, Elvin H. 11 ; Checkley, William 15 ; Dávila-Román, Victor G. 1 ; Hartinger-Peña, Stella M. 3   VIAFID ORCID Logo 

1  Washington University in St. Louis, Global Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, St. Louis, USA (GRID:grid.4367.6) (ISNI:0000 0001 2355 7002) 
2  Johns Hopkins University, Center for Global Non-Communicable Disease Research and Training, School of Medicine, Baltimore, USA (GRID:grid.21107.35) (ISNI:0000 0001 2171 9311); Bloomberg School of Public Health, Johns Hopkins University, Department of International Health, Baltimore, USA (GRID:grid.21107.35) (ISNI:0000 0001 2171 9311) 
3  Universidad Peruana Cayetano Heredia, Facultad de Salud Pública y Administración, Lima, Peru (GRID:grid.11100.31) (ISNI:0000 0001 0673 9488) 
4  Washington University in St. Louis, Global Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, St. Louis, USA (GRID:grid.4367.6) (ISNI:0000 0001 2355 7002); Center for Biostatistics and Data Science, Institute for Informatics, Data Science, and Biostatistics (I2BD), School of Medicine, Washington University, St Louis, USA (GRID:grid.4367.6) (ISNI:0000 0001 2355 7002) 
5  Washington University in St. Louis, Global Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, St. Louis, USA (GRID:grid.4367.6) (ISNI:0000 0001 2355 7002); The George Institute for Global Health, University of New South Wales, Sydney, Australia (GRID:grid.1005.4) (ISNI:0000 0004 4902 0432) 
6  Bloomberg School of Public Health, Johns Hopkins University, Department of International Health, Baltimore, USA (GRID:grid.21107.35) (ISNI:0000 0001 2171 9311) 
7  Center for Biostatistics and Data Science, Institute for Informatics, Data Science, and Biostatistics (I2BD), School of Medicine, Washington University, St Louis, USA (GRID:grid.4367.6) (ISNI:0000 0001 2355 7002) 
8  Washington University in St. Louis, Center for Advancing Health Services, Policy, & Economics Research, St. Louis, USA (GRID:grid.4367.6) (ISNI:0000 0004 1936 9350) 
9  National Institutes of Health, National Institute of Diabetes and Digestive and Kidney Diseases, Division of Diabetes, Endocrinology and Metabolic Diseases, Bethesda, USA (GRID:grid.94365.3d) (ISNI:0000 0001 2297 5165) 
10  National Heart, Lung and Blood Institute (NHLBI), NIH, Center for Translation Research and Implementation Science, Bethesda, USA (GRID:grid.279885.9) (ISNI:0000 0001 2293 4638) 
11  Washington University in St. Louis, Infectious Diseases Division, Department of Medicine and Dissemination and Implementation Center, Institute for Public Health, St. Louis, USA (GRID:grid.4367.6) (ISNI:0000 0004 1936 9350) 
12  Ministerio de Salud del Peru, Dirección General de Intervenciones Estratégicas en Salud Pública, Lima, Peru (GRID:grid.419858.9) (ISNI:0000 0004 0371 3700) 
13  Programa Presupuestal de Enfermedades No TransmisiblesDirección Regional de Salud, Puno, Peru (GRID:grid.419858.9) 
14  Hospital Base III, Puno, Peru (GRID:grid.419858.9) 
15  Johns Hopkins University School of Medicine, Pulmonary and Critical Care Medicine Division, Baltimore, USA (GRID:grid.21107.35) (ISNI:0000 0001 2171 9311); Johns Hopkins University, Center for Global Non-Communicable Disease Research and Training, School of Medicine, Baltimore, USA (GRID:grid.21107.35) (ISNI:0000 0001 2171 9311); Bloomberg School of Public Health, Johns Hopkins University, Department of International Health, Baltimore, USA (GRID:grid.21107.35) (ISNI:0000 0001 2171 9311) 
Pages
747
Publication year
2024
Publication date
Dec 2024
Publisher
Springer Nature B.V.
e-ISSN
17456215
Source type
Scholarly Journal
Language of publication
English
DOI
https://doi.org/10.1186/s13063-024-08586-9
ProQuest document ID
3126228433
Copyright
© The Author(s) 2024. This work is published under http://creativecommons.org/licenses/by-nc-nd/4.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.