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
Lindsay J. Underhill,
Kendra N. Williams,
Lucy Cordova-Ascona,
Karina Campos,
Lisa de las Fuentes,
Mark D. Huffman,
Joel Gittelsohn,
Kenneth B. Schechtman,
Zoila Vela-Clavo,
Carla Tarazona-Meza,
Laura K. Beres,
Parker K. Acevedo,
Abigail Barker,
Nishadi Rajapakse,
Makeda Williams,
Veronica Tonwe,
Aaloke Mody,
Raquel Hurtado,
Juan Carlos Mendoza,
Gonzalo Cuentas,
Elvin H. Geng,
William Checkley,
Victor G. Dávila-Román,
Stella M. Hartinger-Peña
Affiliations
Lindsay J. Underhill
Global Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, Washington University in St. Louis
Kendra N. Williams
Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University
Lucy Cordova-Ascona
Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia
Karina Campos
Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia
Lisa de las Fuentes
Global Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, Washington University in St. Louis
Mark D. Huffman
Global Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, Washington University in St. Louis
Joel Gittelsohn
Department of International Health, Bloomberg School of Public Health, Johns Hopkins University
Kenneth B. Schechtman
Center for Biostatistics and Data Science, Institute for Informatics, Data Science, and Biostatistics (I2BD), School of Medicine, Washington University
Zoila Vela-Clavo
Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia
Carla Tarazona-Meza
Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University
Laura K. Beres
Department of International Health, Bloomberg School of Public Health, Johns Hopkins University
Parker K. Acevedo
Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University
Abigail Barker
Center for Advancing Health Services, Policy, & Economics Research, Washington University in St. Louis
Nishadi Rajapakse
National Institute of Diabetes and Digestive and Kidney Diseases, Division of Diabetes, Endocrinology and Metabolic Diseases, National Institutes of Health
Makeda Williams
Center for Translation Research and Implementation Science, National Heart, Lung and Blood Institute (NHLBI), NIH
Veronica Tonwe
Center for Translation Research and Implementation Science, National Heart, Lung and Blood Institute (NHLBI), NIH
Aaloke Mody
Infectious Diseases Division, Department of Medicine and Dissemination and Implementation Center, Institute for Public Health, Washington University in St. Louis
Raquel Hurtado
Dirección General de Intervenciones Estratégicas en Salud Pública, Ministerio de Salud del Peru
Juan Carlos Mendoza
Programa Presupuestal de Enfermedades No TransmisiblesDirección Regional de Salud
Gonzalo Cuentas
Hospital Base III
Elvin H. Geng
Infectious Diseases Division, Department of Medicine and Dissemination and Implementation Center, Institute for Public Health, Washington University in St. Louis
William Checkley
Pulmonary and Critical Care Medicine Division, Johns Hopkins University School of Medicine
Victor G. Dávila-Román
Global Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, Washington University in St. Louis
Stella M. Hartinger-Peña
Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia
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.
