Background: Hypertension is a major risk factor for cardiovascular disease (CVD). Despite advances in hypertension prevention and treatment, the proportion of patients who are aware, treated and controlled is low, particularly in lowincome and middle-income countries (LMICs). We will evaluate an adapted version of a multilevel and multicomponent hypertension control program in Guatemala, previously proven effective and feasible in Argentina. The program components are: protocol-based hypertension treatment using a standardized algorithm; team-based collaborative care; health provider education; health coaching sessions; home blood pressure monitoring; blood pressure audit; and feedback. Methods: Using a hybrid type 2 effectiveness-implementation design, we will evaluate clinical and implementation outcomes of the multicomponent program in Guatemala over an 18-month period. Through a cluster randomized trial, we will randomly assign 18 health districts to the intervention arm and 18 to enhanced usual care across five departments, enrolling 44 participants per health district and 1584 participants in total. The clinical outcomes are (1) the difference in the proportion of patients with controlled hypertension (< 130/80 mmHg) between the intervention and control groups at 18 months and (2) the net change in systolic and diastolic blood pressure from baseline to 18 months. The context-enhanced Reach, Efficacy, Adoption, Implementation, Maintenance (RE-AIM)/Practical Robust Implementation and Sustainability Model (PRISM) framework will guide the evaluation of the implementation at the level of the patient, provider, and health system. Using a mixed-methods approach, we will evaluate the following implementation outcomes:

Background Uncontrolled hypertension represents a substantial and growing burden in Guatemala and other low and middle-income countries. As a part of the formative phase of an implementation research study, we conducted a needs assessment to define short- and long-term needs and opportunities for hypertension services within the public health system. Methods We conducted a multi-method, multi-level assessment of needs related to hypertension within Guatemala’s public system using the World Health Organization’s health system building blocks framework. We conducted semi-structured interviews with stakeholders at national (n = 17), departmental (n = 7), district (n = 25), and community (n = 30) levels and focus groups with patients (3) and frontline auxiliary nurses (3). We visited and captured data about infrastructure, accessibility, human resources, reporting, medications and supplies at 124 health posts and 53 health centers in five departments of Guatemala. We conducted a thematic analysis of transcribed interviews and focus group discussions supported by matrix analysis. We summarized quantitative data observed during visits to health posts and centers. Results Major challenges for hypertension service delivery included: gaps in infrastructure, insufficient staffing and high turnover, limited training, inconsistent supply of medications, lack of reporting, low prioritization of hypertension, and a low level of funding in the public health system overall. Key opportunities included: prior experience caring for patients with chronic conditions, eagerness from providers to learn, and interest from patients to be involved in managing their health. The 5 departments differ in population served per health facility, accessibility, and staffing. All but 7 health posts had basic infrastructure in place. Enalapril was available in 74% of health posts whereas hydrochlorothiazide was available in only 1 of the 124 health posts. With the exception of one department, over 90% of health posts had a blood pressure monitor. Conclusions This multi-level multi-method needs assessment using the building blocks framework highlights contextual factors in Guatemala’s public health system that have been important in informing the implementation of a hypertension control trial. Long-term needs that are not addressed within the scope of this study will be important to address to enable sustained implementation and scale-up of the hypertension control approach.

No abstract

Issue Guatemala is a culturally and linguistically diverse country. Mayan languages are primarily spoken languages; few people know their written form. Health features and outcomes are difficult to assess due to the lack of validated instruments in these languages. Description of the Problem A cluster randomized trial to improve hypertension control is being conducted in 36 municipalities where Mayan languages are spoken in addition to Spanish. Instruments for measuring study outcomes were developed in Spanish and cross-culturally adapted into five Mayan languages following WHO's methodology. First, data were gathered on the proportion of people only fluent in a Mayan language in each district. We prioritized those Mayan languages spoken by more than 20% of the non-Spanish speaking population: Achí, K'iche', Kaqchikel, Tz'utujil and Mam. Second, forward translation to the Mayan languages was conducted by a local healthcare professional, who verbally recorded each instrument. The study team identified key words and concepts to guarantee content equivalence. Third, back-translation was conducted by two independent healthcare providers, who were blinded to the original instruments. The research team formally compared the original questionnaires with the back-translated versions to ensure they were conceptually equivalent and culturally adapted. Discrepancies were corrected as needed. Finally, local interviewers were trained on how to accurately use the written Spanish questionnaires and the Mayan language verbal recordings. Results By following this methodology, we achieved cross-culturally adapted instruments to improve the information-gathering process in communities where only Mayan languages are spoken. Lessons Having culturally adapted tools will allow researchers to reach a broader range of the target population, obtain more accurate information, and take into account participants' culture and cosmovision. Key messages Translating questionnaires to people’s native language allows researchers to obtain more accurate information in a standardized way and better understand participants’ culture and cosmovision. The described methodology is beneficial for conducting research in linguistically diverse countries. It promotes effective and inclusive communication among researchers and participants.