Skip to main page content
U.S. flag

An official website of the United States government

Dot gov

The .gov means it’s official.
Federal government websites often end in .gov or .mil. Before sharing sensitive information, make sure you’re on a federal government site.

Https

The site is secure.
The https:// ensures that you are connecting to the official website and that any information you provide is encrypted and transmitted securely.

Access keys NCBI Homepage MyNCBI Homepage Main Content Main Navigation
. 2024 Nov 9;25(1):747.
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

Lindsay J Underhill  1 , Kendra N Williams  2   3 , Lucy Cordova-Ascona  4 , Karina Campos  4 , Lisa de Las Fuentes  1   5 , Mark D Huffman  1   6 , Joel Gittelsohn  3 , Kenneth B Schechtman  5 , Zoila Vela-Clavo  4 , Carla Tarazona-Meza  2   3 , Laura K Beres  3 , Parker K Acevedo  2   3 , Abigail Barker  7 , Nishadi Rajapakse  8 , Makeda Williams  9 , Veronica Tonwe  9 , Aaloke Mody  10 , Raquel Hurtado  11 , Juan Carlos Mendoza  12 , Gonzalo Cuentas  13 , Elvin H Geng  10 , William Checkley #  14   2   3 , Victor G Dávila-Román #  1 , Stella M Hartinger-Peña #  15
Affiliations

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 et al. Trials. .

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.

PubMed Disclaimer

Conflict of interest statement

MDH has received travel support from the American Heart Association and World Heart Federation. MDH has an appointment at The George Institute for Global Health, which has a patent, license, and has received investment funding with intent to commercialize fixed-dose combination therapy through its social enterprise business, George Medicines. MDH has pending patents for heart failure polypills.

Figures

Fig. 1
Fig. 1
Study site location and health facilities in Puno, Peru
Fig. 2
Fig. 2
ANDES Logic model. Adaptation of Implementation Research Logic Model template from Smith et al. [18]
Fig. 3
Fig. 3
Overview of ANDES trial design. Schedule of enrollment, intervention, and follow-up assessments. 1Screening will be conducted at the health facilities and health fairs; 2ANDES study team will conduct all study outcome assessments, including the baseline outcome assessment and the follow-up assessments (represented by diamond shapes). 3CHW workers will conduct all participant home visits
See this image and copyright information in PMC

References

    1. Mills KT, Stefanescu A, He J. The global epidemiology of hypertension. Nat Rev Nephrol. 2020;16(4):223–37. - PMC - PubMed
    1. World Health Organization. Fact sheets: hypertension. https://www.who.int/news-room/fact-sheets/detail/hypertension. Accessed 13 Mar 2024.
    1. Mills KT, Bundy JD, Kelly TN, Reed JE, Kearney PM, Reynolds K, et al. Global disparities of hypertension prevalence and control: a systematic analysis of population-based studies from 90 countries. Circulation. 2016;134(6):441–50. - PMC - PubMed
    1. Mills KT, Rubinstein A, Irazola V, Chen J, Beratarrechea A, Poggio R, et al. Comprehensive approach for hypertension control in low-income populations: rationale and study design for the hypertension control program in Argentina. Am J Med Sci. 2014;348(2):139–45. - PMC - PubMed
    1. Hypertension in Diabetes Study (HDS): II. Increased risk of cardiovascular complications in hypertensive type 2 diabetic patients. J Hypertens. 1993;11(3):319–25. - PubMed

Publication types

Substances

Associated data