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

doi:10.1186/s13063-024-08586-9

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

Trials. 2024 Nov 9;25(1):747. doi: 10.1186/s13063-024-08586-9.

Authors

Lindsay J Underhill¹, Kendra N Williams^{2

3}, Lucy Cordova-Ascona⁴, Karina Campos⁴, Lisa de Las Fuentes^{1

5}, Mark D Huffman^{1

6}, Joel Gittelsohn³, Kenneth B Schechtman⁵, Zoila Vela-Clavo⁴, Carla Tarazona-Meza^{2

3}, Laura K Beres³, Parker K Acevedo^{2

3}, Abigail Barker⁷, Nishadi Rajapakse⁸, Makeda Williams⁹, Veronica Tonwe⁹, Aaloke Mody¹⁰, Raquel Hurtado¹¹, Juan Carlos Mendoza¹², Gonzalo Cuentas¹³, Elvin H Geng¹⁰, William Checkley^#^{14

2

3}, Victor G Dávila-Román^#¹, Stella M Hartinger-Peña^#¹⁵

Affiliations

¹ Global Health Center, Institute for Public Health and Cardiovascular Division, Department of Medicine, Washington University in St. Louis, St. Louis, MO, USA.
² Center for Global Non-Communicable Disease Research and Training, School of Medicine, Johns Hopkins University, Baltimore, MD, USA.
³ Department of International Health, Bloomberg School of Public Health, Johns Hopkins University, Baltimore, MD, USA.
⁴ Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Peru.
⁵ Center for Biostatistics and Data Science, Institute for Informatics, Data Science, and Biostatistics (I2BD), School of Medicine, Washington University, St Louis, MO, USA.
⁶ The George Institute for Global Health, University of New South Wales, Sydney, Australia.
⁷ Center for Advancing Health Services, Policy, & Economics Research, Washington University in St. Louis, St. Louis, MO, USA.
⁸ National Institute of Diabetes and Digestive and Kidney Diseases, Division of Diabetes, Endocrinology and Metabolic Diseases, National Institutes of Health, Bethesda, MD, USA.
⁹ Center for Translation Research and Implementation Science, National Heart, Lung and Blood Institute (NHLBI), NIH, Bethesda, MD, USA.
¹⁰ Infectious Diseases Division, Department of Medicine and Dissemination and Implementation Center, Institute for Public Health, Washington University in St. Louis, St. Louis, MO, USA.
¹¹ Dirección General de Intervenciones Estratégicas en Salud Pública, Ministerio de Salud del Peru, Lima, Peru.
¹² Programa Presupuestal de Enfermedades No TransmisiblesDirección Regional de Salud, Puno, Peru.
¹³ Hospital Base III, EsSalud, Puno, Peru.
¹⁴ Pulmonary and Critical Care Medicine Division, Johns Hopkins University School of Medicine, Baltimore, MD, USA.
¹⁵ Facultad de Salud Pública y Administración, Universidad Peruana Cayetano Heredia, Lima, Peru. stella.hartinger.p@upch.pe.

^# Contributed equally.

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.

Keywords: Community health workers; Hypertension; Implementation; LMICs; Peru; Task-shifting; Type 2 diabetes; WHO HEARTS.

Publication types

Clinical Trial Protocol

MeSH terms

Adult
Antihypertensive Agents / therapeutic use
Blood Pressure
Community Health Services
Community Health Workers*
Counseling
Diabetes Mellitus, Type 2*
Glycated Hemoglobin / metabolism
Healthy Lifestyle
Humans
Hypertension* / drug therapy
Medication Adherence
Peru
Primary Health Care
Randomized Controlled Trials as Topic*
Treatment Outcome

Substances

Antihypertensive Agents
Glycated Hemoglobin

Associated data

ClinicalTrials.gov/NCT05524987