Monitoring Study Participants and Implementation with Phone Calls to Support Hypertension Control during the COVID-19 Pandemic: The Case of a Multicomponent Intervention Trial in Guatemala

Background: The COVID-19 pandemic presents a challenge to health care for patients with chronic diseases, especially hypertension, because of the important association and increased risk of these patients with a severe presentation of COVID-19 disease. The Guatemalan Ministry of Health has been implementing a multi-component program aimed at improving hypertension control in rural communities since 2019 as a part of an intervention research cluster randomized trial. When the first cases of COVID-19 were reported (March 13, 2020) in Guatemala, our study paused all study field activities, and began monitoring participants through phone calls. The objective of this paper is to describe the approach used to monitor study participants during the COVID-19 pandemic and compare data obtained during phone calls for intervention and control group participants. Methods: We developed a cross-sectional study within the HyTREC (Hypertension Outcomes for T4 Research within Lower Middle-Income Countries) project ‘Multicomponent Intervention to Improve Hypertension Control in Central America: Guatemala’ in which phone calls were made to participants from both intervention and control groups to monitor measures important to the study: delivery of antihypertensive medications in both groups, receipt of coaching sessions and use of a home blood pressure monitor by intervention group participants, as well as reasons that they were not implemented. Results: Regarding the delivery of antihypertensive drugs by the MoH to participants, those in the intervention group had a higher level of medication delivery (73%) than the control group (51%), p<0.001. Of the total participants in the intervention group, 62% had received at least one health coaching session in the previous three months and 81% used a digital home blood pressure monitor at least twice a week. Intervention activities were lower than expected due to restricted public transportation on top of decreased availability of health providers. Conclusion: In Guatemala, specifically in rural settings, access to antihypertensive medications and health services during pandemic times was impaired and less than expected, even after accounting for the program’s implementation activities and actions.Fil: Hernández Galdamez, Diego. Institute Of Nutrition Of Central America And Panama Guatemala; GuatemalaFil: Mansilla, Kristyne. Institute Of Nutrition Of Central America And Panama Guatemala; GuatemalaFil: Peralta, Ana Lucía. Institute Of Nutrition Of Central America And Panama Guatemala; GuatemalaFil: Rodríguez Szaszdi, Javier. Institute Of Nutrition Of Central America And Panama Guatemala; GuatemalaFil: Ramírez, Juan Manuel. Institute Of Nutrition Of Central America And Panama Guatemala; GuatemalaFil: Roche, Dina. Institute Of Nutrition Of Central America And Panama Guatemala; GuatemalaFil: Gulayin, Pablo Elías. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Ramirez Zea, Manuel. Institute Of Nutrition Of Central America And Panama Guatemala; GuatemalaFil: He, Jiang. Tulane University School of Public Health and Tropical Medicine; Estados UnidosFil: Irazola, Vilma. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Fort, Meredith P.. Colorado School of Public Health; Estados Unido

Evaluating a multicomponent program to improve hypertension control in Guatemala: Study protocol for an effectiveness-implementation cluster randomized trial

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 low-income 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: acceptability, adoption, feasibility, fidelity, adaptation, reach, sustainability, and cost-effectiveness.Discussion: We will disseminate the study findings, and promote scale up and scale out of the program, if proven effective. This study will generate urgently needed data on effective, adoptable, and sustainable interventions and implementation strategies to improve hypertension control in Guatemala and other LMICs.Fil: Paniagua Avila, Alejandra. Columbia University; Estados UnidosFil: Fort, Meredith P.. Institute Of Nutrition Of Central America And Panamá; GuatemalaFil: Glasgow, Russell E.. University of Colorado; Estados UnidosFil: Gulayin, Pablo Elías. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Hernández Galdamez, Diego. institute of Nutrition of Central America and Panamá; GuatemalaFil: Mansilla, Kristyne. institute of Nutrition of Central America and Panamá; GuatemalaFil: Palacios, Eduardo. Ministerio de Salud y Asistencia Social; GuatemalaFil: Peralta, Ana Lucia. Institute of Nutrition of Central America and Panamá ; GuatemalaFil: Roche, Dina. Institute of Nutrition of Central America and Panamá ; GuatemalaFil: Rubinstein, Adolfo Luis. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: He, Jiang. University Translational Science Institute; Estados UnidosFil: Ramirez Zea, Manuel. Institute of Nutrition of Central America and Panamá ; GuatemalaFil: Irazola, Vilma. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentin

Hypertension in Guatemala’s Public Primary Care System: A Needs Assessment Using the Health System Building Blocks Framework

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.Fil: Fort, Meredith P.. University of Colorado; Estados UnidosFil: Mundo, William. University of Colorado; Estados UnidosFil: Paniagua Avila, Alejandra. No especifíca;Fil: Cardona, Sayra. No especifíca;Fil: Figueroa, Juan Carlos. No especifíca;Fil: Hernández Galdamez, Diego. No especifíca;Fil: Mansilla, Kristyne. No especifíca;Fil: Peralta García, Ana. No especifíca;Fil: Roche, Dina. No especifíca;Fil: Palacios, Eduardo Alberto. No especifíca;Fil: Glasgow, Russell E.. University of Colorado; Estados UnidosFil: Gulayin, Pablo Elías. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Irazola, Vilma. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: He, Jiang. University of Tulane; Estados UnidosFil: Ramirez Zea, Manuel. No especifíca

Factores de riesgo asociados a enfermedades cardiovasculares en la población adulta en cuatro estratos socioeconómicos del municipio de Guatemala

Describir el comportamiento epidemiológico de los factores de riesgo asociados a enfermedades cardiovasculares crónicas no transmisibles en población adulta de cuatro estratos socioeconómicos del municipio de Guatemala. Estudio de tipo descriptivo, transversal, con muestreo no probabilístico por conveniencia, en cuatro sectores cartográficos, 223 viviendas. Los datos se recolectaron por medio de una encuesta con base al cuestionario del método progresivo (STEPS) modificado. La prevalencia de factores de riesgo modificables asociados a enfermedad cardiovascular en población adulta de cuatro Estratos socioeconómicos del municipio de Guatemala fue de: consumo de cigarrillos (15%), consumo nocivo de alcohol (26%), sedentarismo (83%), obesidad central (47% y el consumo excesivo de sal (36%). La prevalencia de factores de riesgo no modificables asociados a enfermedad cardiovascular en población adulta, en 4 estratos socioeconómicos del municipio de Guatemala fue de: grupo etario femenino con mayor riesgo cardiovascular (36%), antecedente de diabetes mellitus (11%),antecedente de hipertensión arterial (35%) y antecedente de dislipidemia (17%). El comportamiento epidemiológico de los factores de riesgo asociado a enfermedad cardiovascular varía entre los estratos socioeconómico; de los factores de riesgo modificable el más prevalente en los cuatro estratos fue el sedentarismo; de los factores de riesgo no modificables el más prevalente en los cuatro estratos fue el antecedente personal de diabetes mellitus; el sedentarismo es el factor de riesgo más prevalente en las mujeres de cuatro estratos socioeconómicos y el consumo nocivo de alcohol es el factor de riesgo más prevalente en los hombres de los cuatro estratos socioeconómicos

Effectiveness of a multidrug therapy consisting of Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid to prevent hospitalization and death among ambulatory COVID-19 cases in Tlaxcala, Mexico.

ObjectiveThere is an urgent need for effective treatments to prevent or attenuate lung and systemic inflammation, endotheliitis, and thrombosis related to COVID-19. This study aimed to assess the effectiveness of a multidrug-therapy consisting of Ivermectin, Azithromycin, Montelukast, and Acetylsalicylic acid ("TNR4" therapy) to prevent hospitalization and death among ambulatory COVID-19 cases in Tlaxcala, Mexico.Design and methodsA comparative effectiveness study was performed among 768 confirmed SARS-CoV-2 cases aged 18-80 years, who received ambulatory care at the Ministry of Health of Tlaxcala. A total of 481 cases received the TNR4 therapy, while 287 received another treatment (comparison group). All participants received home visits and/or phone calls for clinical evaluation during the 14 days after enrollment.ResultsNearly 85% of cases who received the TNR4 recovered within 14 days compared to 59% in the comparison group. The likelihood of recovery within 14 days was 3.4 times greater among the TNR4 group than in the comparison group. Patients treated with TNR4 had a 75% and 81% lower risk of being hospitalized or death, respectively, than the comparison group.ConclusionsTNR4 therapy improved recovery and prevented the risk of hospitalization and death among ambulatory COVID-19 cases

Increased risk of hospitalization and death in Mexican children and adolescents with COVID-19 and comorbidities

Background: Although COVID-19 (coronavirus disease 2019) in children is usually mild, they need hospitalization and intensive care in exceptional cases. Adverse outcomes have been observed mainly among children with comorbidities, justifying their vaccination. This study aimed to assess the risk of hospitalization and death in Mexican children and adolescents with COVID-19 and comorbidities. Methods: A cross-sectional study was performed on 366,542 confirmed COVID-19 cases under 18 years, reported by the Mexican Ministry of Health up to July 9, 2022. Logistic regression models were performed. Results: The mean age was 10.98 years, 50.6% were male, and 7.3% reported at least one comorbidity. The percentage of hospitalization and death in COVID-19 patients with and without comorbidities was 3.52%, and 0.20%, respectively; children with comorbidities presented a higher percentage of hospitalization (14.0%) and death (1.9%). The probability of hospitalization was 5.6 times greater in pediatric patients with COVID-19 and comorbidities, and the comorbidities that showed the greatest risk were immunosuppression (odds ratio (OR) 22.06), chronic kidney disease (CKD) (11.36), and cardiovascular diseases (5.66). The probability of death in patients with comorbidities was 11.01 times higher than in those without diseases, and the highest risk was observed in those with CKD (OR 12.57), cardiovascular diseases (6.87), and diabetes (5.83). Conclusions: Pediatric patients with comorbidities presented a higher risk of severe COVID-19. It is suggested that vaccination should be promoted with greater emphasis on pediatric patients with comorbidities