Deaths of U.S. Citizens Undergoing Cosmetic Surgery - Dominican Republic, 2009-2022.

Although infections resulting from cosmetic surgery performed outside the United States have been regularly reported, deaths have rarely been identified. During 2009-2022, 93 U.S. citizens died after receiving cosmetic surgery in the Dominican Republic. The number of deaths increased from a mean of 4.1 per year during 2009-2018 to a mean of 13.0 during 2019-2022 with a peak in of 17 in 2020. A subset of post-cosmetic surgery deaths occurring during peak years was investigated, and most deaths were found to be the result of embolic events (fat emboli or venous thromboembolism) for which a high proportion of the patients who died had risk factors, including obesity and having multiple procedures performed during the same operation. These risk factors might have been mitigated or prevented with improved surgical protocols and postoperative medical care, including prophylactic measures against venous thromboembolism. U.S. citizens interested in receiving elective cosmetic surgery outside the United States should consult with their health care professionals regarding their risk for adverse outcomes. Public health authorities can support provider education on the importance of preoperative patient evaluation and the potential danger of performing multiple cosmetic procedures in one operation.

North-south pathways, emerging variants, and high climate suitability characterize the recent spread of dengue virus serotypes 2 and 3 in the Dominican Republic.

BACKGROUND: Dengue fever remains a significant public health challenge in tropical and subtropical regions, with its transmission dynamics being influenced by both environmental factors and human mobility. The Dominican Republic, a biodiversity hotspot in the Caribbean, has experienced recurrent dengue outbreaks, yet detailed understanding of the virus's transmission pathways and the impact of climatic factors remains limited. This study aims to elucidate the recent transmission dynamics of the dengue virus (DENV) in the Dominican Republic, utilizing a combination of genomic sequencing and epidemiological data analysis, alongside an examination of historical climate patterns. METHODS: We conducted a comprehensive study involving the genomic sequencing of DENV samples collected from patients across different regions of the Dominican Republic over a two-year period. Phylogenetic analyses were performed to identify the circulation of DENV lineages and to trace transmission pathways. Epidemiological data were integrated to analyze trends in dengue incidence and distribution. Additionally, we integrated historical climate data spanning several decades to assess trends in temperature and their potential impact on DENV transmission potential. RESULTS: Our results highlight a previously unknown north-south transmission pathway within the country, with the co-circulation of multiple virus lineages. Additionally, we examine the historical climate data, revealing long-term trends towards higher theoretical potential for dengue transmission due to rising temperatures. CONCLUSION: This multidisciplinary study reveals intricate patterns of dengue virus transmission in the Dominican Republic, characterized by the co-circulation of multiple DENV lineages and a novel transmission pathway. The observed correlation between rising temperatures and increased dengue transmission potential emphasizes the need for integrated climate-informed strategies in dengue control efforts. Our findings offer critical insights for public health authorities in the Dominican Republic and similar settings, guiding resource allocation and the development of preparedness strategies to mitigate the impacts of climate change on dengue transmission.

Monitoring Temporal Changes in SARS-CoV-2 Spike Antibody Levels and Variant-Specific Risk for Infection, Dominican Republic, March 2021-August 2022.

To assess changes in SARS-CoV-2 spike binding antibody prevalence in the Dominican Republic and implications for immunologic protection against variants of concern, we prospectively enrolled 2,300 patients with undifferentiated febrile illnesses in a study during March 2021-August 2022. We tested serum samples for spike antibodies and tested nasopharyngeal samples for acute SARS-CoV-2 infection using a reverse transcription PCR nucleic acid amplification test. Geometric mean spike antibody titers increased from 6.6 (95% CI 5.1-8.7) binding antibody units (BAU)/mL during March-June 2021 to 1,332 (95% CI 1,055-1,682) BAU/mL during May-August 2022. Multivariable binomial odds ratios for acute infection were 0.55 (95% CI 0.40-0.74), 0.38 (95% CI 0.27-0.55), and 0.27 (95% CI 0.18-0.40) for the second, third, and fourth versus the first anti-spike quartile; findings were similar by viral strain. Combining serologic and virologic screening might enable monitoring of discrete population immunologic markers and their implications for emergent variant transmission.

Stigma and HIV Treatment Outcomes Among Transgender Women Sex Workers in the Dominican Republic.

Trans women experience multiple forms of intersecting stigma due to trans identity, HIV, and sex work, which can negatively affect their health. There is limited understanding of the relationships between stigma and HIV care and treatment outcomes. We assessed associations between multiple forms and types of stigma and HIV treatment outcomes among trans women who conduct sex work in Santo Domingo, Dominican Republic using cross-sectional survey data. Most participants had received HIV care (91%) and were currently taking anti-retroviral therapy (ART) (84%). Only 64% were virally suppressed. Nearly one-third (32%) had interrupted ART at some point; those who had never interrupted ART were more likely to be suppressed. Drug use was associated with ART interruption. Higher enacted HIV stigma was associated with current ART use. Higher enacted HIV stigma and higher anticipated sex work stigma were associated with ART adherence. Higher trans stigma was associated with being virally suppressed. Findings highlight the importance of addressing multiple forms of stigma at the individual and clinic levels to improve and sustain viral suppression. Future research is needed to assess if unexpected associations between stigma and HIV outcomes reflect processes of resilience. Future research is also needed to assess the pathways between drug use, ART interruption, and viral suppression among trans women.

Substance Use and Depression Impede ART Adherence Among Female Sex Workers Living with HIV in the Dominican Republic.

Female sex workers (FSW) have worse HIV outcomes in part due to lower anti-retroviral therapy (ART) adherence. Substance use and depression are important barriers to ART adherence, yet few studies have assessed these relationships among FSW in longitudinal studies. Cross-Lagged Panel Models and autoregressive mediation analyses assessed substance use (illicit drug use and alcohol use disorders) in relation to ART non-adherence and the mediation role of depressive symptoms among 240 FSW living with HIV in the Dominican Republic. In annual visits (T1, T2, T3), the majority (70%, 66%, and 53%) reported at-risk drinking and 15%, 13% and 9% used illicit drug during the past 6 months. Most FSW (70%, 62% and 46%) had mild-to-severe depression. Illicit drug use predicted later ART non-adherence. This relationship was not mediated via depressive symptoms. Integrated substance use and HIV care interventions are needed to promote ART adherence and viral suppression among FSW.

RESUMEN: Las trabajadoras sexuales (TRSX) tienen peores resultados de VIH debido en parte a la menor adherencia a la terapia antirretroviral (TAR). El uso de sustancias y la depresión son barreras importantes para la adherencia; sin embargo, pocos estudios longitudinales han evaluado estas relaciones entre las TRSX. Utilizamos modelos de panel y análisis de mediación para evaluar el uso de sustancias en relación a la falta de adherencia al TAR y el papel de mediación de los síntomas depresivos entre 240 TRSX con VIH en la República Dominicana. En visitas anuales (T1, T2, T3), la mayoría (70%, 66%, and 53%) reportó consumo riesgoso de alcohol y 15%, 13% y 9% consumieron alguna droga ilícita durante los últimos 6 meses. La mayoría (70%, 62% y 46%) tenían depresión leve a grave. El uso de drogas ilícitas predijo la falta de adherencia al TAR. Esta relación no fue mediada por síntomas depresivos. Se necesitan intervenciones integradas de atención del VIH y el uso de sustancias para promover la adherencia al TAR y la supresión viral entre TRSX.

Exploring the natural history of intrinsic capacity impairments: longitudinal patterns in the 10/66 study.

BACKGROUND: intrinsic capacity (IC) is a construct encompassing people's physical and mental abilities. There is an implicit link amongst IC domains: cognition, locomotion, nutrition, sensory and psychological. However, little is known about the integration of the domains. OBJECTIVES: to investigate patterns in the presentation and evolution of IC domain impairments in low-and-middle-income countries and if such patterns were associated with adverse outcomes. METHODS: secondary analyses of the first two waves of the 10/66 study (population-based surveys conducted in eight urban and four rural catchment areas in Cuba, Dominican Republic, Puerto Rico, Venezuela, Peru, Mexico and China). We applied latent transition analysis on IC to find latent statuses (latent clusters) of IC domain impairments. We evaluated the longitudinal association of the latent statuses with the risk of frailty, disability and mortality, and tested concurrent and predictive validity. RESULTS: amongst 14,923 participants included, the four latent statuses were: high IC (43%), low deterioration with impaired locomotion (17%), high deterioration without cognitive impairment (22%), and high deterioration with cognitive impairment (18%). A total of 61% of the participants worsened over time, 35% were stable, and 3% improved to a healthier status.Participants with deteriorated IC had a significantly higher risk of frailty, disability and dementia than people with high IC. There was strong concurrent and predictive validity. (Mortality Hazard Ratio = 4.60, 95%CI 4.16; 5.09; Harrel's C = 0.73 (95%CI 0.72;0.74)). CONCLUSIONS: half of the study population had high IC at baseline, and most participants followed a worsening trend. Four qualitatively different IC statuses or statuses were characterised by low and high levels of deterioration associated with their risk of disability and frailty. Locomotion and cognition impairments showed other trends than psychological and nutrition domains across the latent statuses.

Body composition and nutritional status of school-aged Haitian children living in urban and peri-urban areas of Puerto Plata, Dominican Republic.

OBJECTIVES: This study examines body composition and nutritional status of Haitian children and adolescents living in urban and peri-urban communities in the Dominican Republic to provide estimates of stunting, underweight, overweight, and obesity for this under-researched population. METHODS: Anthropometric measures including height, weight, mid-upper arm circumference, and skinfold thicknesses (triceps and subscapular) were obtained for Kreyòl-speaking school-aged children (n  = 105, males = 51, females = 54, ages 4-17). Z-scores for height, body mass index (BMI), and upper arm muscle area by height were used to classify children's nutritional status. Variation among sex and age groups was assessed. RESULTS: Relatively low rates of stunting (4.8%) and thinness (2.9%) were identified. The total prevalence of overweight was 5.7% and 2.9% of children were classified as having obesity. Girls had a higher prevalence of overweight/obesity and risk of overweight (16.7%) than boys (3.9%, p = .033). CONCLUSIONS: The prevalence of overweight and obesity (8.6%) suggests that Haitian children in these urban and peri-urban communities are experiencing the nutrition transition. Interventions should address the development of excess weight, especially among girls, as well as persisting undernutrition and stunting.

Incidence of type 1 diabetes in children in Dominican Republic, 2010-2019: A national collaborative study.

The Dominican Republic has no recent data on type 1 diabetes (T1D) incidence in children. Therefore, a study was undertaken to determine this in persons aged <15 years (y). Data were collected on all new T1D diagnoses between 2010-2019 from the four institutions caring for children with T1D. Diagnosis was made according to standard criteria. No secondary ascertainment source was available. The trend and the effect of age and sex of T1D incidence was analyzed using Poisson regression. A total of 1224 new cases of T1D were diagnosed <15 y; mean ± standard deviation (range) 122 ± 12 (96-135) cases per year. Age at T1D diagnosis was 8.8 ± 3.7 y, with a significant female preponderance (n = 708, 57.8%, p < 0.001). When examined per 5-y age group, cases were consistently highest in 10-14 y, and lowest in 0-4 y in all study years. Mean crude T1D annual incidence was 4.3 (95% CI 3.5-5.1) per 100,000 population. There was no significant difference between incidence across the country's three departments (regions): Southeast (4.4 [3.4-5.7]/100,000 population), North (4.1 [2.9-5.6]), and Southwest (3.9 [2.4-5.9]). Mean standardized annual incidence was 4.1 (4.1-4.2) per 100,000 population, with no significant trend of increase over the study period. The incidence of T1D in children aged <15 y is relatively low in Dominican Republic, but consistent with the limited data from other countries in the region. However, the incidence is eight times higher than the previous estimate during 1995-1999. Ongoing surveillance is warranted.

Exploring antiretroviral therapy adherence, competing needs, and viral suppression among people living with HIV and food insecurity in the Dominican Republic.

Understanding factors related to suboptimal adherence to antiretroviral therapy (ART) and detectable viral load (VL), especially among vulnerable populations, is needed to improve HIV outcomes. The Caribbean is highly impacted by HIV and socioeconomic inequalities, but few studies have been conducted there to explore food insecurity among people with HIV and factors associated with viral suppression in this vulnerable population. Using baseline data from a pilot intervention trial among people living with HIV and food insecurity in the Dominican Republic, we examined psychosocial and behavioral factors associated with viral suppression, ART adherence, and competing needs. Among participants (n = 115), 61% had a detectable VL; the strongest factor associated with detectable VL was having missed taking ART in the last six months due to not having food (OR = 2.68, p = 0.02). Greater odds of reporting missed ART doses due to not having food were associated with severe food insecurity (OR = 4.60, p = 0.006), clinical depression (OR = 2.76, p = 0.018), Haitian background (OR = 6.62 p = 0.017), and internalized HIV stigma (OR = 1.09, p = 0.041), while lower odds were associated with social support (OR = 0.89, p = 0.03) and having health insurance (OR = 0.27, p = 0.017). Ensuring that people with HIV and food insecurity have food to take with their ART is essential for viral suppression.

Predictors of Secondhand Smoke Exposure During Pregnancy in Costa Rica, the Dominican Republic, and Honduras.

INTRODUCTION: Secondhand smoke (SHS) exposure poses risks to pregnant women and children. Though smoking among pregnant women in many low- and middle-income countries is low, exposure to SHS might be higher. We examined the prevalence and predictors of SHS among pregnant women from Costa Rica, the Dominican Republic, and Honduras. METHODS: Postpartum women 18+ years old who completed pregnancy in past 5 years were surveyed in health care and community settings. RESULTS: Data for 1,081 women indicated low tobacco use (1.0%-3.7%), frequent exposure to active smokers (29.0%-34.0%), often being close enough to breathe others' smoke (49.4%-66.5%), and most having smoke-free home policies (70.8%-76.2%). Women reporting unintended pregnancy (adjusted odds ratio [aOR]: 1.44, 95% confidence interval [CI] 1.03, 2.00) and alcohol consumption (aOR: 1.92, 95% CI 1.34, 2.77) were more likely to be close enough to breathe others' smoke. Women with health problems during pregnancy (aOR: 1.48 95% CI 1.07, 2.06) were more likely to have home smoking policies. Tobacco use was associated with all SHS exposure outcomes. CONCLUSIONS: SHS exposure was high during pregnancy; women with higher risk variables, that is, tobacco use, alcohol consumption, and unintended pregnancy were more likely to be exposed. Addressing SHS exposure in pregnancy in low- and middle-income countries can improve maternal health outcomes in vulnerable populations. IMPLICATIONS: The study results suggest a cluster of multiple risk factors associated with a high prevalence of exposure to SHS among pregnant women in LIMCs from Latin America and Caribbean Region. Interventions, regulations, and policies need to address specific high-risk factors to change behaviors and improve maternal and child health outcomes especially in vulnerable populations.

Exploring peer navigation and support in the quality of HIV care experiences of female sex workers in the Dominican Republic.

BACKGROUND: Despite evidence on peer navigation's association with positive HIV outcomes, such as engagement in HIV care and antiretroviral therapy (ART) initiation, the mechanisms through which peer navigation may influence these outcomes have been less explored. The purpose of this study is to describe the role of peer navigation and support on enhancing the quality of HIV treatment and care services experienced by female sex workers (FSWs). METHODS: Survey data was derived from a quantitative cohort (n = 211) of FSWs living with HIV in the Dominican Republic and complemented with data from two rounds of in-depth interviews (IDIs) from a qualitative subsample (n = 20 per round). Descriptive statistics and multivariable logistic regressions were used to explore the association between peer navigation and relational aspects of care and overall satisfaction of the quality of HIV treatment and care. Thematic analysis was employed to code and synthesize textual data from IDIs. RESULTS: 41.2% of the participants reported having had contact with a peer navigator in the last 6 months. Qualitative data revealed that peer navigation and support was instrumental in assisting FSWs linkage to HIV care after diagnosis, elevating FSWs' ability to access more comprehensive clinical care facilities, and promoting agency by improving FSWs' skills to more strategically and effectively engage with the clinic environment and health care providers. Peer navigation was positively associated with experiencing more respectful treatment by clinic staff (AOR: 6.65, 95% CI: 2.32-19.02), and greater satisfaction with overall HIV care services (AOR: 2.57, 95% CI: 1.77-3.74). CONCLUSION: Promoting the full integration of peer navigation into healthcare structures is a strategic approach to enhance the quality of HIV care experienced by FSWs and improve their HIV-related outcomes.

Characteristics of Women Receiving Emergency Caesarean Section: A Cross-Sectional Analysis from Ghana and Dominican Republic.

BACKGROUND: Significant inequalities still exist between low- and high-income countries regarding access to optimum emergency obstetric care including life-saving emergency caesarean section. These relationships are considerably stronger between population-based caesarean section rates and socio-economic characteristics with poorest households experiencing significant unmet needs persistently. OBJECTIVE: To explore the characteristics of women receiving emergency C-section using a new, validated definition in Ghana and the Dominican Republic. MATERIALS AND METHODS: This was a cross-sectional study conducted in Ghana and the Dominican Republic. Multivariable logistic regression analysis was used to determine women's characteristics associated with emergency C-section. RESULTS: This analysis included 2166 women who had recently delivered via C-section comprising 653 and 1513 participants from Accra and Santo Domingo, DR, respectively. Multivariable analyses showed that women, both in Ghana and the DR, were more likely to have an emergency C-section if they did not have a previous C-Section (adjusted Odds Ratio (aOR): 2.45, 95% CI [1.57-3.81]; and aOR: 15.5, 95% CI [10.5-22.90], respectively) and if they were having their first childbirth, compared to women with previous childbirth (aOR: 1.77, 95%CI [1.13-2.79]; and aOR: 1.46, 95%CI [1.04-2.04], respectively). Also, preterm birth was associated with significantly decreased likelihood of emergency C-section compared with childbirth occurring at term in both Ghana and the DR (aOR: 0.31, 95%CI [0.20-0.48]; and aOR: 0.43, 95%CI [0.32-0.58], respectively). Among the Ghanaian participants, having an emergency C-section was positively associated with being referred and negatively associated with being older than 35 years of age. Characteristics such as education, religion, marital status, and residence did not differ between women's emergency versus non-emergency C-section status. CONCLUSION: Emergency C-section was found to be significantly higher in women with no prior C-section or those having their first births but lower in those with preterm birth in both Ghana and the DR. Data from additional countries are needed to confirm the relationship between emergency C-section status and socio-economic and obstetric characteristics, given that the types of interventions required to assure equitable access to potentially life-saving C-section will be determined by how and when access to care is being denied or not available.

Impact of 13-Valent Pneumococcal Conjugate Vaccine on Nasopharyngeal Carriage Rates of Streptococcus pneumoniae in a Rural Community in the Dominican Republic.

BACKGROUND: Invasive pneumococcal disease (IPD) leads to thousands of pediatric deaths annually. Pneumococcal colonization precedes IPD. In 2013, the Dominican Republic introduced the 13-valent pneumococcal conjugate vaccine (PCV13) into its routine infant immunization program, with doses at ages 2, 4, and 12 months. Prevalence of pneumococcal nasopharyngeal colonization was evaluated post-PCV13 introduction. METHODS: A prospective cohort study of 125 children aged 2-35 months was conducted in a rural Dominican Republic community November 2016 through July 2017. Nasopharyngeal swabs and clinical and vaccination data were collected at enrollment and 4-6 months later. Serotypes included in PCV13 were defined as vaccine-type. Colonization rates and serotype distribution were compared at baseline and follow-up, and the association between colonization and vaccination status among the entire cohort was evaluated at each time point. RESULTS: Of 125 children enrolled, 118 (94%) completed follow-up. Overall and vaccine-type pneumococcal colonization rates were 62% and 25%, respectively, at baseline and 60% and 28% at follow-up. Among children age-eligible for 3 doses, 50% and 51% were fully vaccinated at baseline and follow-up, respectively. At baseline assessment, children up-to-date for age for PCV13 were less likely to be colonized with vaccine-type pneumococci than children not up-to-date, and the same was found for fully vaccinated children (3 doses) compared to those not fully vaccinated (odds ratios [ORs], 0.38 [95% confidence interval {CI}, .18-.79], and 0.14 [95% CI, .04-.45], respectively). The same associations were not found at follow-up assessment. CONCLUSIONS: Three years post -PCV13 introduction, vaccine-type colonization rates remained high. Low vaccination coverage for 3 PCV13 doses may have contributed. The protective effect of PCV13 on vaccine-type carriage suggests an increase in PCV13 coverage could lead to substantial declines in pneumococcal vaccine-type carriage.

High Prevalence of Vaccine-Type Infections Among Children with Pneumococcal Pneumonia and Effusion After 13-Valent Pneumococcal Conjugate Vaccine Introduction in the Dominican Republic.

BACKGROUND: In 2013, the Dominican Republic introduced 13-valent pneumococcal conjugate vaccine (PCV13) using a 3-dose schedule (at 2, 4 and 12 months of age). We evaluated the impact of PCV13 on serotypes causing pneumococcal pneumonia with pleural effusion. METHODS: Surveillance data after PCV13 introduction (July 2014 to June 2016) were compared with data before PCV13 introduction (July 2009 to June 2011). Cases were defined as radiologic evidence of pneumonia with pleural effusion in a child aged <15 years. Pneumococcus was detected in pleural fluid by either culture or polymerase chain reaction, and serotyping was performed. The Ministry of Health's PCV13 uptake data for 2014-2016 were obtained. RESULTS: The prevalence of pneumococcus among cases was similar before and after PCV13 introduction (56.4% and 52.8%, respectively). The proportion of pneumococcal cases caused by vaccine serotypes was 86% for children <2 years old both before and PCV13 introduction. Compared with before PCV13, serotype 14 accounted for a smaller (28% vs 13%, respectively; P = .02) and serotype 1 for a larger (23% vs 37%; P = .09) proportion of pneumococcal cases after PCV13 introduction. National uptake for the first, second, and third PCV13 doses was 94%, 81%, and 28%, respectively, in 2014 and 75%, 61%, and 26% in 2015. DISCUSSION: While the decrease in pneumococcal pneumonia with pleural effusion caused by serotype 14 may reflect an early effect of PCV13 implementation, other vaccine serotypes, including serotype 1, are not well controlled. Better PCV13 coverage for all 3 doses is needed.

Safety and immunogenicity of a tetravalent dengue vaccine in children aged 2-17 years: a randomised, placebo-controlled, phase 2 trial.

BACKGROUND: An unmet clinical need remains for an effective tetravalent dengue vaccine suitable for all age groups, regardless of serostatus. We assessed the immunogenicity and safety of three different dose schedules of a tetravalent dengue vaccine (TAK-003) over a 48-month period in children living in dengue-endemic countries. METHODS: We did a large, phase 2, double-blind, placebo-controlled trial at three sites in the Dominican Republic, Panama, and the Philippines. Healthy participants aged 2-17 years were randomly assigned 1:2:5:1 using an interactive web response system with stratification by age to receive either a two-dose primary series (days 1 and 91), one primary dose (day 1), one primary dose plus booster (days 1 and 365), or placebo. Participants and relevant study personnel were masked to the random assignment until completion of the study at month 48. To maintain masking, TAK-003 recipients were administered placebo doses when appropriate. The primary objective was assessment of neutralising geometric mean titres for each serotype to month 48 assessed in the per-protocol immunogenicity subset. Secondary safety endpoints included proportions of participants with serious adverse events and symptomatic virologically confirmed dengue. This study is registered with ClinicalTrials.gov, NCT02302066. FINDINGS: Between Dec 5, 2014, and Feb 13, 2015, 1800 children were randomly assigned to the following groups: two-dose primary series (n=201), one primary dose (n=398), one primary dose plus 1-year booster (n=1002), and placebo (n=199). Of them, 1479 (82%) participants completed the 48-month study. Immunogenicity endpoints were assessed in 562 participants enrolled in the immunogenicity subset, of whom 509 were included in the per-protocol subset. At month 48, antibody titres remained elevated in all TAK-003 groups compared with placebo, irrespective of baseline serostatus. At month 48, geometric mean titres were 378 (95% CI 226-632) in two-dose, 421 (285-622) in one-dose, 719 (538-960) in one-dose plus 1-year booster, and 100 (50-201) in placebo recipients against DENV 1; 1052 (732-1511), 1319 (970-1794), 1200 (927-1553), and 208 (99-437) against DENV 2; 183 (113-298), 201 (135-298), 288 (211-392), and 71 (37-139) against DENV 3; and 152 (97-239), 164 (114-236), 219 (165-290), and 46 (26-82) against DENV 4; and tetravalent seropositivity rate was 89% (79-96), 86% (80-92), 97% (93-99), and 60% (47-72), respectively. Virologically confirmed dengue was recorded in 37 (2%) TAK-003 and 13 (7%) placebo participants, with a relative risk of 0·35 (0·19-0·65). No vaccine-related serious adverse events or severe dengue virus disease were reported. INTERPRETATION: TAK-003 elicited antibody responses against all four serotypes, which persisted to 48 months post-vaccination, regardless of baseline serostatus. No important safety risks were identified. We observed a long-term reduction in risk of symptomatic dengue virus disease in vaccinees. Results from this study provide a long-term safety database and support assessment of the vaccine in the ongoing phase 3 efficacy study. FUNDING: Takeda Vaccines.

Efficacy of a tetravalent dengue vaccine in healthy children aged 4-16 years: a randomised, placebo-controlled, phase 3 trial.

BACKGROUND: A substantial unmet need remains for safe and effective vaccines against dengue virus disease, particularly for individuals who are dengue-naive and those younger than 9 years. We aimed to assess the efficacy, safety, and immunogenicity of a live attenuated tetravalent dengue vaccine (TAK-003) in healthy children aged 4-16 years. METHODS: We present data up to 18 months post-vaccination from an ongoing phase 3, randomised, double-blind trial of TAK-003 in endemic regions of Asia and Latin America (26 medical and research centres across Brazil, Colombia, Dominican Republic, Nicaragua, Panama, Philippines, Sri Lanka, and Thailand). Healthy children aged 4-16 years were randomly assigned 2:1 (stratified by age and region) to receive two doses of TAK-003 or two doses of placebo, 3 months apart. Investigators, participants and their parents or guardians, and sponsor representatives advising on trial conduct were masked to trial group assignments. Participants presenting with febrile illness were tested for virologically confirmed dengue (VCD) by serotype-specific RT-PCR. In timeframes beginning 30 days post-second dose, the primary endpoint (overall vaccine efficacy) was assessed in the first 11 months, and the secondary endpoints (efficacy by baseline serostatus, serotype, hospitalised dengue, and severe dengue) in the first 17 months. This study is registered with ClinicalTrials.gov, NCT02747927. FINDINGS: 20 099 participants were randomly assigned and vaccinated between Sept 7, 2016, and Aug 18, 2017; 19 021 (94·6%) were included in the per protocol analysis, and 20 071 (99·9%) in the safety set. The primary endpoint was achieved with an overall vaccine efficacy of 80·2% (95% CI 73·3 to 85·3; 61 cases of VCD in the TAK-003 group vs 149 cases of VCD in the placebo group). In the secondary endpoint assessment timeframe, an overall vaccine efficacy of 73·3% (95% CI 66·5 to 78·8) was observed. Analysis of secondary endpoints showed efficacies of 76·1% (95% CI 68·5 to 81·9) in individuals who were seropositive at baseline, 66·2% (49·1 to 77·5) in individuals who were seronegative at baseline, 90·4% (82·6 to 94·7) against hospitalised dengue, and 85·9% (31·9 to 97·1) against dengue haemorrhagic fever. Efficacy varied by individual serotypes (DENV 1, 69·8% [95% CI 54·8 to 79·9]; DENV 2, 95·1% [89·9 to 97·6]; DENV 3, 48·9% [27·2 to 64·1]; DENV 4, 51·0% [-69·4 to 85·8]). Cumulative rates of serious adverse events were similar in TAK-003 (4·0%) and placebo (4·8%) recipients, and were consistent with expected medical disorders in the study population. Infection was the most frequent reason leading to serious adverse events. 20 participants (<0·1% of the safety set) were withdrawn from the trial due to 21 adverse events by the end of part two; 14 of these participants received TAK-003 and six received placebo. INTERPRETATION: TAK-003 was well tolerated and efficacious against symptomatic dengue in children regardless of serostatus before immunisation. Vaccine efficacy varied by serotype, warranting continued follow-up to assess longer-term vaccine performance. FUNDING: Takeda Vaccines.

Performance of passive case detection for malaria surveillance: results from nine countries in Mesoamerica and the Dominican Republic.

BACKGROUND: In malaria elimination settings, available metrics for malaria surveillance have been insufficient to measure the performance of passive case detection adequately. An indicator for malaria suspected cases with malaria test (MSCT) is proposed to measure the rate of testing on persons presenting to health facilities who satisfy the definition of a suspected malaria case. This metric does not rely on prior knowledge of fever prevalence, seasonality, or external denominators, and can be used to compare detection rates in suspected cases within and between countries, including across settings with different levels of transmission. METHODS: To compute the MSCT, an operational definition for suspected malaria cases was established, including clinical and epidemiological criteria. In general, suspected cases included: (1) persons with fever detected in areas with active malaria transmission; (2) persons with fever identified in areas with no active transmission and travel history to, or residence in areas with active transmission (either national or international); and (3) persons presenting with fever, chills and sweating from any area. Data was collected from 9 countries: Belize, Colombia (in areas with active transmission), Costa Rica, Dominican Republic, El Salvador, Guatemala, Honduras, Nicaragua, and Panama (September-March 2020). A sample of eligible medical records for 2018 was selected from a sample of health facilities in each country. An algorithm was constructed to assess if a malaria test was ordered or performed for cases that met the suspected case definition. RESULTS: A sample of 5873 suspected malaria cases was obtained from 239 health facilities. Except for Nicaragua and Colombia, malaria tests were requested in less than 10% of all cases. More cases were tested in areas with active transmission than areas without cases. Travel history was not systematically recorded in any country. CONCLUSIONS: A statistically comparable, replicable, and standardized metric was proposed to measure suspected malaria cases with a test (microscopy or rapid diagnostic test) that enables assessing the performance of passive case detection. Cross-country findings have important implications for malaria and infectious disease surveillance, which should be promptly addressed as countries progress towards malaria elimination. Local and easy-to-implement tools could be implemented to assess and improve passive case detection.

Clinician Use of HIV-Related Infographics During Clinic Visits in the Dominican Republic is Associated with Lower Viral Load and Other Improvements in Health Outcomes.

We designed an infographic intervention to help clinicians provide health information to persons living with HIV. In this study, we assessed the extent to which our intervention may improve objectively and subjectively measured health outcomes (CD4 count, viral load, and engagement with clinician among others) when integrated into routine visits in the Dominican Republic. In this pretest-posttest study, we followed participants for 9 months at 3-month intervals. Physicians administered the intervention during participants' first 3 visits. Outcome measures, selected using a conceptual model, were assessed at 4 time points. We assessed changes in outcomes over time with general linear regressions and Wilcoxon Signed-Rank tests. Participants (N = 50) were mostly female (56%) and had been living with HIV for a mean of 6.3 years (SD = 6.1). All outcomes, except CD4 count, demonstrated statistically significant improvements by study end. This provides preliminary evidence our intervention may improve outcomes, but further testing is needed.

RESUMEN: Diseñamos una intervención infográfica para ayudar a los médicos brindar información médica a personas viviendo con el VIH. En este estudio, evaluamos en qué medida nuestra intervención puede mejorar los resultados de salud (conteo de CD4, carga viral, y compromiso con el médico entre otros), medidos de una manera objetiva y subjetiva, cuando se incorpora en las visitas médicas de rutina en la República Dominicana. En este estudio de prueba previo y posterior, seguimos los participantes durante 9 meses a intervalos de 3 meses. Los médicos administraron la intervención durante las primeras 3 visitas de los participantes. Seleccionamos las medidas de resultado utilizando un marco conceptual y las evaluamos en los 4 puntos de tiempo. Evaluamos cambios a lo largo del tiempo usando regresiones lineales generales y pruebas de asociación de Wilcoxon Signed-Rank. Los participantes (N = 50) fueron mayormente mujeres (56%) y habían estado viviendo con el VIH durante una media de 6,3 años (DE = 6,1). Todos los resultados, aparte del conteo de CD4, demostraron mejoras estadísticamente significativas al final del estudio. Esto proporciona evidencia preliminar de que nuestra intervención puede mejorar los resultados de la salud, pero se justifican pruebas adicionales.

Mindfulness, Mental Health and HIV Outcomes Among Female Sex Workers in the Dominican Republic and Tanzania.

We examined the relationship between mindfulness, mental health and HIV outcomes among female sex workers (FSW) from the Dominican Republic (DR) (n = 201) and Tanzania (n = 208) using cross-sectional survey and biologic data. We employed stratified multivariate linear and logistic regression. Depression was associated with lower odds of ART adherence in the DR (AOR 0.25, 95% CI: 0.08-0.78) and of viral suppression in Tanzania (AOR 0.49, 95% CI: 0.24-0.97). In both countries, mindfulness was associated with lower odds of moderate to severe depression (AOR 0.82, 95% CI: 0.76-0.88 for the DR; AOR 0.85, 95% CI: 0.77-0.95 for Tanzania). In the DR, mindfulness was associated with lower odds of anxiety (AOR 0.83, 95% CI: 0.77-0.89), lower HIV stigma (ß = - 0.28 per unit change, 95% CI: - 0.37 to - 0.19) and greater odds of viral suppression (AOR 1.09, 95% CI: 1.02-1.15). Findings demonstrate the potential of tailored mindfulness interventions to improve mental health and HIV outcomes among FSW.

RESUMEN: Examinamos la relación entre la atención plena, la salud mental y los resultados del VIH entre las trabajadoras sexuales (TRSX) de la República Dominicana (RD) (n = 201) y Tanzania (n = 208) utilizando una encuesta transversal y datos biológicos. Empleamos regresión lineal multivariada estratificada y regresión logística. La depresión se asoció con menores probabilidades de adherencia al terapia antiretroviral (TAR) en la República Dominicana (AOR 0.25, IC del 95%: 0.08­0.78) y de supresión viral en Tanzania (AOR 0.49, IC del 95%: 0.24­0.97). En ambos países, la atención plena se asoció con menores probabilidades de depresión moderada a grave (AOR 0.82, IC del 95%: 0.76­0.88 para la República Dominicana; AOR 0.85, IC del 95%: 0.77­0.95 para Tanzania). En la República Dominicana, la atención plena se asoció con menores probabilidades de ansiedad (AOR 0.83, IC del 95%: 0.77­0.89), menor estigma del VIH (ß = − 0.28 por unidad de cambio, IC del 95%: − 0.37 to − 0.19) y mayores probabilidades de supresión viral (AOR 1.09, 95% CI: 1.02­1.15). Los hallazgos demuestran el potencial de las intervenciones de atención plena para mejorar la salud mental y los resultados del VIH entre las TRSX.

"Todo se trata de a quién conoces": Social Networks and Drug Use Among Female Sex Workers Living with HIV in the Dominican Republic.

The purpose of this study was to characterize the social networks of female sex workers (FSWs) living with HIV in the Dominican Republic (DR) and to examine the association between daily drug use and network risk profile. The study employed a micro-longitudinal observational design using a 7-day mobile health (mHealth) daily diary to collect daily substance use behaviors and social network data was collected at study enrollment. A series of crude and adjusted modified log-Poisson repeated measures regression models with generalized estimating equations (GEE), clustering by individual with a compound symmetry working correlation structure were fit to estimate the relative risks and 95% confidence intervals. Controlling for individual level factors, findings revealed that FSWs with more network members who were drug users (≥ 3) and more network members who were sexual partners and also drugs users (≥ 2) were 8.89 (95% CI 2.62, 30.22) and 6.08 (95% CI 1.20, 30.92) times more likely to engage in daily drug use compared to women with small drug and sex and drug networks. Study findings demonstrate the role high risk networks have on risk behaviors. Results may be used to inform interventions that focus on modifying negative social ties, creating and/or improving existing positive support relationships, and integrating drug use harm reduction promotion within HIV treatment programs.

RESUMEN: El objetivo de este estudio era de caracterizar las redes sociales de las trabajadoras sexuales viviendo con VIH en la República Dominicana y examinar la asociación entre el uso diario de drogas y las características de la red de riesgo. El estudio utilizó un diseño observacional micro-longitudinal utilizando un diario móvil de 7 días para capturar los comportamientos diarios del uso de sustancias, y los datos de las redes sociales fue recolectado durante la inscripción al estudio. Una serie de modelos crudos y ajustados de regresión de log-Poisson con medidas repetidas y Ecuaciones de Estimación Generalizadas (EEG), agrupando por individuo con una estructura de correlación de simetría compuesta para estimar el riesgo relativo y los intervalos de confianza al 95%. Los hallazgos mostraron que las trabajadoras sexuales con mayor número de miembros de sus redes sociales que usaran drogas (>3) y parejas sexuales que usaran drogas (>2) fueron 8.89 (95% IC: 2.62, 30.33) y 6.08 (95% CI: 1.02, 30.92) veces más probables de participar en el consumo diario de drogas en comparación con las mujeres con pequeñas redes de consumo de drogas y sexo, controlando por factores a nivel individual. Los resultados del estudio demuestran el papel que las redes de alto riesgo tienen en los comportamientos de riesgo. Los resultados pueden ser utilizados para informar intervenciones que se enfoquen en el cambio de las relaciones negativas, creando o mejorando las relaciones de apoyo, e integrando la promoción de la reducción del uso de drogas dentro de los programas de tratamiento del VIH.