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Background: Increased pediatric COVID-19 occurrence due to the SARS-CoV-2 Omicron variant has raised concerns about the effectiveness of existing vaccines. The protection provided by the SOBERANA-02-Plus vaccination scheme against this variant has not yet been studied. We aimed to evaluate the scheme's effectiveness against symptomatic Omicron infection and severe disease in children. Methods: In September 2021, Cuba implemented a mass pediatric immunization with the heterologous SOBERANA-02-Plus scheme: 2 doses of conjugated SOBERANA-02 followed by a heterologous SOBERANA-Plus dose. By December, before the Omicron outbreak, 95.4% of 2-18 years-old had been fully immunized. During the entire Omicron wave, we conducted a nationwide longitudinal post-vaccination case-population study to evaluate the real-world effectiveness of the SOBERANA-02-Plus scheme against symptomatic infection and severe disease in children without previous SARS-CoV-2 infection. The identification of COVID-19 cases relied on surveillance through first line services, which refer clinical suspects to pediatric hospitals where they are diagnosed based on a positive RT-PCR test. We defined the Incidence Rate ratio (IRR) as IRvaccinated age group/IRunvaccinated 1-year-old and calculated vaccine effectiveness as VE = (1-IRR)∗100%. 24 months of age being the 'eligible for vaccination' cut-off, we used a regression discontinuity approach to estimate effectiveness by contrasting incidence in all unvaccinated 1-year-old versus vaccinated 2-years-old. Estimates in the vaccinated 3-11 years-old are reported from a descriptive perspective. Findings: We included 1,098,817 fully vaccinated 2-11 years-old and 98,342 not vaccinated 1-year-old children. During the 24-week Omicron wave, there were 7003/26,241,176 person-weeks symptomatic COVID-19 infections in the vaccinated group (38.2 per 105 person-weeks in 2-years-old and 25.5 per 105 person-weeks in 3-11 years-old) against 3577/2,312,273 (154.7 per 105 person-weeks) in the unvaccinated group. The observed overall vaccine effectiveness against symptomatic infection was 75.3% (95% CI, 73.5-77.0%) in 2-years-old children, and 83.5% (95% CI, 82.8-84.2%) in 3-11 years-old. It was somewhat lower during Omicron BA.1 then during Omicron BA.2 variant circulation, which took place 1-3 and 4-6 months after the end of the vaccination campaign. The effectiveness against severe symptomatic disease was 100.0% (95% CI not estimated) and 94.6% (95% CI, 82.0-98.6%) in the respective age groups. No child death from COVID-19 was observed. Interpretation: Immunization of 2-11 years-old with the SOBERANA-02-Plus scheme provided strong protection against symptomatic and severe disease caused by the Omicron variant, which was sustained during the six months post-vaccination follow-up. Our results contrast with the observations in previous real-world vaccine effectiveness studies in children, which might be explained by the type of immunity a conjugated protein-based vaccine induces and the vaccination strategy used. Funding: National Fund for Science and Technology (FONCI-CITMA-Cuba).

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BACKGROUND: The rate of pulmonary tuberculosis (TB) recurrence is substantial. Identifying risk factors can support the development of prevention strategies. METHODS: We retrieved studies published between 1 January 1980 and 31 December 2022 that assessed factors associated with undifferentiated TB recurrence, relapse or reinfection. For factors reported in at least four studies, we performed random-effects meta-analysis to estimate a pooled relative risk (RR). We assessed heterogeneity, risk of publication bias and certainty of evidence. RESULTS: We included 85 studies in the review; 81 documented risk factors for undifferentiated recurrence, 17 for relapse and 10 for reinfection. The scope for meta-analyses was limited given the wide variety of factors studied, inconsistency in control for confounding and the fact that only few studies employed molecular genotyping. Factors that significantly contributed to moderately or strongly increased pooled risk and scored at least moderate certainty of evidence were: for undifferentiated recurrence, multidrug resistance (MDR) (RR 3.49; 95% CI 1.86 to 6.53) and fixed-dose combination TB drugs (RR 2.29; 95% CI 1.10 to 4.75) in the previous episode; for relapse, none; and for reinfection, HIV infection (RR 4.65; 95% CI 1.71 to 12.65). Low adherence to treatment increased the pooled risk of recurrence 3.3-fold (95% CI 2.37 to 4.62), but the certainty of evidence was weak. CONCLUSION: This review emphasises the need for standardising methods for TB recurrence research. Actively pursuing MDR prevention, facilitating retention in treatment and providing integrated care for patients with HIV could curb recurrence rates. The use of fixed-dose combinations of TB drugs under field conditions merits further attention. PROSPERO REGISTRATION NUMBER: CRD42018077867.

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To better guide dengue prevention and control efforts, the use of routinely collected data to develop risk maps is proposed. For this purpose, dengue experts identified indicators representative of entomological, epidemiological and demographic risks, hereafter called components, by using surveillance data aggregated at the level of Consejos Populares (CPs) in two municipalities of Cuba (Santiago de Cuba and Cienfuegos) in the period of 2010-2015. Two vulnerability models (one with equally weighted components and one with data-derived weights using Principal Component Analysis), and three incidence-based risk models were built to construct risk maps. The correlation between the two vulnerability models was high (tau > 0.89). The single-component and multicomponent incidence-based models were also highly correlated (tau ≥ 0.9). However, the agreement between the vulnerability- and the incidence-based risk maps was below 0.6 in the setting with a prolonged history of dengue transmission. This may suggest that an incidence-based approach does not fully reflect the complexity of vulnerability for future transmission. The small difference between single- and multicomponent incidence maps indicates that in a setting with a narrow availability of data, simpler models can be used. Nevertheless, the generalized linear mixed multicomponent model provides information of covariate-adjusted and spatially smoothed relative risks of disease transmission, which can be important for the prospective evaluation of an intervention strategy. In conclusion, caution is needed when interpreting risk maps, as the results vary depending on the importance given to the components involved in disease transmission. The multicomponent vulnerability mapping needs to be prospectively validated based on an intervention trial targeting high-risk areas.

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Background: SOBERANA-02 is a COVID-19 conjugate vaccine (recombinant RBD conjugated to tetanus toxoid). Phases 1/2 clinical trials demonstrated high immunogenicity, promoting neutralising IgG and specific T-cell response. A third heterologous dose of SOBERANA-Plus (RBD-dimer) further increased neutralising antibodies. The aim of this study is to evaluate the safety and efficacy of two immunisation regimes: two doses of SOBERANA-02 and a heterologous three-dose combination with SOBERANA-Plus added to it. Methods: From March 8th to June 24th, 2021 we conducted in Havana, Cuba a multicentre randomised, double-blind, placebo-controlled, phase-3 trial evaluating a two doses SOBERANA-02 scheme and a heterologous scheme with one dose SOBERANA-Plus added to it (RPCEC00000354). Participants 19-80 years were randomly assigned to receiving 28 days apart either the two or three dose scheme or placebo. The main endpoint was vaccine efficacy in preventing the occurrence of RT-PCR confirmed symptomatic COVID-19 at least 14 days after the second or third dose in the per-protocol population. We also assessed efficacy against severe disease and, in all participants receiving at least one vaccine/placebo dose, safety for 28 days after each dose. Findings: We included 44,031 participants (52.0% female, 48.0% male; median age 50 years, range 19-80 years; 7.0% black, 24.0% mixed-race, 59.0% white) in a context of initial Beta VOC predominance, with this variant being partially replaced by Delta near the trial's end. Vaccine efficacy in the heterologous combination was 92.0% (95%CI 80.4-96.7) against symptomatic disease. There were no severe COVID-19 cases in the vaccine group against 6 in the placebo group. Two doses of SOBERANA-02 was 69.7% (95%CI 56.5-78.9) and 74.9% (95%CI 33.7-90.5) efficacious against symptomatic and severe COVID-19, respectively. The occurrence of serious and severe adverse events (AE) was very rare and equally distributed between placebo and vaccine groups. Solicited AEs were slightly more frequent in the vaccine group but predominantly local and mostly mild and transient. Interpretation: Our results indicate that the straightforward to manufacture SOBERANA vaccines are efficacious in a context of Beta and Delta VOC circulation, have a favourable safety profile, and may represent an attractive option for use in COVID-19 vaccination programmes. Funding: This study received funds from the National Fund for Science and Technology (FONCI-CITMA-Cuba, contract 2020-20) of the Ministry of Science, Technology and Environment of Cuba.

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BACKGROUND: Implementation research to improve hypertension control is scarce in Latin America. We assessed the effectiveness of an intervention aimed at primary care practitioners and hypertensive patients in a setting that provides integrated care through an accessible network of family practices. METHODS: We conducted in Cardenas and Santiago, Cuba, a controlled before-after study in 122 family practices, which are staffed with a doctor and a nurse. The intervention comprised a control arm (usual care), an arm with a component targeting providers (hypertension management workshops), and an arm with, on top of the latter, a component targeting patients (hypertension schools). To evaluate the effect, we undertook a baseline survey before the intervention and an endline survey sixteen months after its start. In each survey, we randomly included 1400 hypertensive patients. Controlled hypertension, defined as a mean systolic and diastolic blood pressure below 140 and 90 mmHg, respectively, was the primary endpoint assessed. We performed linear and logistic regression with a Generalized Estimating Equations approach to determine if the proportion of patients with controlled hypertension changed following the intervention. RESULTS: Seventy-three doctors, including substitutes, and 54 nurses from the 61 intervention family practices attended the provider workshops, and 3308 patients -51.6% of the eligible ones- participated in the hypertension schools. Adherence to anti-hypertensive medication improved from 42% at baseline to 63% at the endline in the intervention arms. Under the provider intervention, the proportion of patients with controlled hypertension increased by 18.9%, from 48.7% at baseline to 67.6% at endline. However, adding the component that targeted hypertensive patients did not augment the effect. Compared to patients in the control arm, the adjusted OR of having controlled hypertension was 2.36 (95% CI, 1.73-3.22) in the provider and 2.00 (95% CI, 1.68-2.37) in the provider plus patient intervention arm. CONCLUSIONS: The intervention's patient component remains to be fine-tuned. Still, we demonstrate that it is feasible to substantially improve hypertension outcomes by intervention at the primary care level, despite an already relatively high control rate.

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INTRODUCTION: Research on public health interventions to improve hypertension care and control in low-income and middle-income countries remains scarce. This study aims to evaluate the effectiveness and assess the process and fidelity of implementation of a multi-component intervention to reduce the gaps in hypertension care and control at a population level in low-income communes of Medellin, Colombia. METHODS AND ANALYSIS: A multi-component intervention was designed based on international guidelines, cross-sectional population survey results and consultation with the community and institutional stakeholders. Three main intervention components integrate activities related to (1) health services redesign, (2) clinical staff training and (3) patient and community engagement. The effectiveness of the intervention will be evaluated in a controlled before-after quasi-experimental study, with two deprived communes of the city selected as intervention and control arms. We will conduct a baseline and an endline survey 2 years after the start of the intervention. The primary outcomes will be the gaps in hypertension diagnosis, treatment, follow-up and control. Effectiveness will be evaluated with the difference-in-difference measures. Generalised estimation equation models will be fitted considering the clustered nature of data and adjusting for potential confounding variables. The implementation process will be studied with mixed methods. Implementation fidelity will be documented to assess to which degree the intervention components were implemented as intended. ETHICS AND DISSEMINATION: The study protocol has been approved by the Ethics Research Committee of Metrosalud in Colombia (reference 1400/5.2), the Medical Ethics Committee of the Antwerp University Hospital (reference 18/40/424) and the Institutional Review Board of the Antwerp Institute of Tropical Medicine (reference 1294/19). We will share and discuss the study results with the community, institutional stakeholders and national health policymakers. We will publish them in national and international peer-reviewed scientific journals. TRIAL REGISTRATION NUMBER: NCT05011838.

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INTRODUCTION: People with tuberculosis experience long-term health effects beyond cure, including chronic respiratory diseases. We investigated whether tuberculosis is a risk factor for subsequent lung cancer. METHODS: We searched PubMed, Scopus, Cochrane, Latin American and Caribbean Health Sciences Literature and the Scientific Electronic Library Online for cohort and case-control studies providing effect estimates for the association between tuberculosis and subsequent lung cancer. We pooled estimates through random-effects meta-analysis. The study was registered in PROSPERO (CDR42020178362). RESULTS: Out of 6240 records, we included 29 cohort and 44 case-control studies. Pooled estimates adjusted for age and smoking (assessed quantitatively) were hazard ratio (HR) 1.51 (95% CI 1.30-1.76, I2=81%; five studies) and OR 1.74 (95% CI 1.42-2.13, I2=59%; 19 studies). The occurrence of lung cancer was increased for 2 years after tuberculosis diagnosis (HR 5.01, 95% CI 3.64-6.89; two studies), but decreased thereafter. Most studies were retrospective, had moderate to high risk of bias, and did not control for passive smoking, environmental exposure and socioeconomic status. Heterogeneity was high. CONCLUSION: We document an association between tuberculosis and lung cancer occurrence, particularly in, but not limited to, the first 2 years after tuberculosis diagnosis. Some cancer cases may have been present at the time of tuberculosis diagnosis and therefore causality cannot be ascertained. Prospective studies controlling for key confounding factors are needed to identify which tuberculosis patients are at the highest risk, as well as cost-effective approaches to mitigate such risk.

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RESUMEN Fundamento las evidencias sobre intervenciones de Salud Pública para mejorar las deficiencias en la atención y control de las personas hipertensas continúan siendo insuficientes. Objetivo implementar una intervención multicomponente para reducir dichas brechas en el Policlínico Julio Antonio Mella del municipio de Guanabacoa, evaluar el proceso de intervención, su efectividad y la fidelidad de su implementación. Método en relación a los resultados obtenidos en el estudio de base y recomendaciones técnicas nacionales e internacionales, se diseñó una intervención multicomponente que contará con los siguientes componentes: reorganización de los servicios de salud, capacitación del personal de salud, empoderamiento de los pacientes y participación de la comunidad. La efectividad de la intervención se evaluará por medio de un estudio cuasi-experimental (antes y después). La intervención cubrirá el policlínico antes mencionado, los diez consultorios del estudio de base y la población atendida por ellos. A los dos años de iniciada la implementación se aplicará nuevamente una encuesta poblacional y se estimará la diferencia en la magnitud de las brechas poblacionales pre-post intervención, además se monitoreará el proceso y se evaluará la fidelidad de la implementación de la intervención. Resultados reducir las brechas existentes en el proceso de atención al paciente hipertenso, identificar su magnitud en relación a la línea base. Conclusiones el estudio brindará evidencias al Ministerio de Salud Pública cubano y a otros países, especialmente de América Latina, para mejorar el cuidado del paciente con padecimientos crónicos.

ABSTRACT Background: the evidence on Public Health interventions to improve deficiencies in the care and control of hypertensive people continues to be insufficient. Objective: to implement a multicomponent intervention to reduce these gaps in the Julio Antonio Mella Polyclinic in the Guanabacoa municipality, to evaluate the intervention process, its effectiveness and the fidelity of its implementation. Method: in relation to the results obtained in the baseline study, national and international technical recommendations, a multicomponent intervention was designed that will have the following components: reorganization of health services, training of health personnel, empowerment of patients and community participation. The effectiveness of the intervention will be evaluated through a quasi-experimental study (before and after). The intervention will cover the aforementioned polyclinic, the ten baseline study clinics, and the population served by them. Two years after the start of implementation, a population survey will be applied again and the difference in the magnitude of the pre-post intervention population gaps will be estimated. In addition, the process will be monitored and the fidelity of the implementation of the intervention will be evaluated. Results: reduce existing gaps in the process of care for hypertensive patients, identify their magnitude in relation to the baseline. Conclusions: the study will provide evidence to the Cuban Ministry of Public Health and other countries, especially in Latin America, to improve the care of chronic patients.

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Optimal hypertension care and control at population level significantly reduces cardiovascular morbidity and mortality. The study objective was to measure the gaps in the diagnosis, care, and control of hypertension in residents of an urban community in Quito, Ecuador. A cross-sectional population-based study with a sample of 2160 persons was performed using a survey and direct blood pressure measurement. Logistical regression models were used for analyzing factors associated with the gaps, expressed as percentages. The prevalence of hypertension was 17.6% [CI 95% 17.3-17.9%]. The diagnosis gap was 6.1% [CI 95% 5.9-6.2%] among the entire population and 34.5% [CI 95% 33.7-35.3%] among persons with hypertension. No access gaps were detected; whereas the follow-up gap was 22.7% [CI 95% 21.8-23.6%] and control gap reached 43.5% [CI 95% 42.6-44.2%]. Results indicated that being male, older than 64 years, an employee, without health insurance, and not perceiving a need for healthcare, increased the risk of experiencing these gaps. Data showed appropriate access to health services and high coverage in the diagnosis was due to the application of a community and family healthcare model. Notwithstanding, we found significant gaps in the follow-up and control of hypertensive patients, especially among older males, which should warrant the attention of the Ministry of Health.

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BACKGROUND: Following earlier trials indicating that their potential in dengue vector control was constrained by housing structure, a large-scale cluster-randomized trial of insecticide treated curtains (ITCs) and water jar covers (ITJCs) was undertaken in Venezuela. METHODS: In Trujillo, Venezuela, 60 clusters (6223 houses total) were randomized so that 15 clusters each received either PermaNet insecticide-treated window curtains (ITCs), permanent insecticide-treated water storage jar covers (ITJCs), a combination of both ITCs and ITJCs, or no insecticide treated materials (ITMs). A further 15 clusters located at least 5km from the edge of the study site were selected to act as an external control. Entomological surveys were carried out immediately before and after intervention, and then at 6-month intervals over the following 27 months. The Breteau and House indices were used as primary outcome measures and ovitrap indices as secondary. Negative binomial regression models were used to compare cluster-level values of these indices between the trial arms. RESULTS: Reductions in entomological indices followed deployment of all ITMs and throughout the trial, indices in the external control arm remained substantially higher than in the ITM study arms including the internal control. Comparing the ratios of between-arm means to summarise the entomological indices throughout the study, the combined ITC+ITJC intervention had the greatest impact on the indices, with a 63% difference in the pupae per person indices between the ITC+ITJC arm and the internal control. However, coverage had fallen below 60% by 14-months post-intervention and remained below 40% for most of the remaining study period. CONCLUSIONS: ITMs can impact dengue vector populations in the long term, particularly when ITCs and ITJCs are deployed in combination. TRIAL REGISTRATION: ClinicalTrials.gov ISRCTN08474420; www.isrctn.com.

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