Evaluating a Multicomponent Program to Improve Hypertension Control in Guatemala: Study Protocol for an Effectiveness-implementation Cluster Randomized Trial

Background: The study aims to evaluate a multilevel and multicomponent hypertension control program in Guatemala in order to create a higher proportion of patients with hypertension who are aware, treated, and controlled. This program is an adapted version of a program that was proven effective and feasible in Argentina.

Methods: This study uses a hybrid type 2 effectiveness-implementation design to evaluate a multicomponent hypertension program in Guatemala over 18 months. It uses a cluster randomized trial involving 36 health districts across five departments, with 1584 total participants, and the primary clinical outcomes focus on hypertension control and blood pressure changes. The implementation aspect, guided by the RE-AIM/PRISM framework, uses a mixed-methods approach to assess various outcomes including acceptability, feasibility, and cost-effectiveness. This design aims to evaluate the clinical impact and implementation aspects of the program at patient, provider, and health system levels.

Discussion: Using findings from the studies, the program will be scaled up and scaled out if proven effective. The data will help to improve understanding of effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in low and middle income countries, specifically in Guatemala.