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This work evaluated a serial blood sampling procedure to enhance the sensitivity of duplex real-time quantitative PCR (qPCR) for baseline detection and quantification of parasitic loads and posttreatment identification of failure in the context of clinical trials for treatment of chronic Chagas disease, namely, DNDi-CH-E1224-001 (ClinicalTrials.gov registration no. NCT01489228) and the MSF-DNDi PCR Sampling Optimization Study (NCT01678599). Patients from Cochabamba (n = 294), Tarija (n = 257), and Aiquile (n = 220) were enrolled. Three serial blood samples were collected at each time point, and qPCR triplicates were tested for each sample. The first two samples were collected during the same day and the third one 7 days later. A patient was considered PCR positive if at least one qPCR replicate was detectable. Cumulative results of multiple samples and qPCR replicates enhanced the proportion of pretreatment sample positivity from 54.8% to 76.2%, 59.5% to 77.8%, and 73.5% to 90.2% in Cochabamba, Tarija, and Aiquile cohorts, respectively. This strategy increased the detection of treatment failure from 72.9% to 91.7%, 77.8% to 88.9%, and 42.9% to 69.1% for E1224 low-, short-, and high-dosage regimens, respectively, and from 4.6% to 15.9% and 9.5% to 32.1% for the benznidazole arm in the DNDi-CH-E1224-001 and MSF-DNDi studies, respectively. The addition of the third blood sample and third qPCR replicate in patients with nondetectable PCR results in the first two samples gave a small, non-statistically significant improvement in qPCR positivity. No change in clinical sensitivity was seen with a blood volume increase from 5 to 10 ml. The monitoring of patients treated with placebo in the DNDi-CH-E1224-001 trial revealed fluctuations in parasitic loads and occasionally nondetectable results. In conclusion, a serial sampling strategy enhanced PCR sensitivity to detecting treatment failure during follow-up and has the potential for improving recruitment capacity in Chagas disease trials, which require an initial positive qPCR result for patient admission.
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Doença de Chagas/tratamento farmacológico , DNA de Protozoário/sangue , Monitorização Fisiológica/métodos , Carga Parasitária/métodos , Reação em Cadeia da Polimerase em Tempo Real/métodos , Adolescente , Adulto , Humanos , Pessoa de Meia-Idade , Nitroimidazóis/uso terapêutico , Placebos/administração & dosagem , Tiazóis/uso terapêutico , Resultado do Tratamento , Triazóis/uso terapêutico , Tripanossomicidas/uso terapêutico , Trypanosoma cruzi/efeitos dos fármacos , Adulto JovemRESUMO
BACKGROUND: Cardiovascular diseases (CVDs) are considered the number one cause of death worldwide, especially in low- and middle-income countries, Bolivia included. Lack of reliable estimates of risk factor distribution can lead to delay in implementation of evidence-based interventions. However, little is known about the prevalence of risk factors in the country. The aim of this study was to assess the prevalence of preventable risk factors associated with CVDs and to identify the demographic and socioeconomic factors associated with them in Cochabamba, Bolivia. METHODS: A cross-sectional community-based study was conducted among youth and adults (N = 10,704) with permanent residence in Cochabamba, selected through a multistage sampling technique, from July 2015 to November 2016. An adapted version of the WHO STEPS survey was used to collect information. The prevalence of relevant behavioural risk factors and anthropometric measures were obtained. The socio-demographic variables included were age, ethnicity, level of education, occupation, place of residence, and marital status. Proportions with 95% confidence intervals were first calculated, and prevalence ratios were estimated for each CVD risk factor, both with crude and adjusted models. RESULTS: More than half (57.38%) were women, and the mean age was 37.89 ± 18 years. The prevalence of behavioural risk factors were: current smoking, 11.6%; current alcohol consumption, 42.76%; low consumption of fruits and vegetables, 76.73%; and low level of physical activity, 64.77%. The prevalence of overweight was 35.84%; obesity, 20.49%; waist risk or abdominal obesity, 54.13%; and raised blood pressure, 17.5%. Indigenous populations and those living in the Andean region showed in general a lower prevalence of most of the risk factors evaluated. CONCLUSION: We provide the first CVD risk factor profile of people living in Cochabamba, Bolivia, using a standardized methodology. Overall, findings suggest that the prevalence of CVD risk factors in Cochabamba is high. This result highlights the need for interventions to improve early diagnosis, monitoring, management, and especially prevention of these risk factors.
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Doenças Cardiovasculares/epidemiologia , Adolescente , Adulto , Bolívia/epidemiologia , Estudos Transversais , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Prevalência , Fatores de Risco , Adulto JovemRESUMO
This study evaluates the level of underreporting of the National Program of Leishmaniasis Control (NPLC) in two communities of Cochabamba, Bolivia during the period 2013-2014. Montenegro skin test-confirmed cases of cutaneous leishmaniasis (CL) were identified through active surveillance during medical campaigns. These cases were compared with those registered in the NPLC by passive surveillance. After matching and cleaning data from the two sources, the total number of cases and the level of underreporting of the National Program were calculated using the capture-recapture analysis. This estimated that 86 cases of CL (95% confidence interval [CI]: 62.1-110.8) occurred in the study period in both communities. The level of underreporting of the NPLC in these communities was very high: 73.4% (95% CI: 63.1-81.5%). These results can be explained by the inaccessibility of health services and centralization of the NPLC activities. This information is important to establish priorities among policy-makers and funding organizations as well as implementing adequate intervention plans.
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Leishmaniose Cutânea/epidemiologia , Bolívia/epidemiologia , Métodos Epidemiológicos , Feminino , Humanos , Leishmaniose Cutânea/diagnóstico , Masculino , Vigilância da PopulaçãoRESUMO
BACKGROUND: Cutaneous leishmaniasis (CL) is an endemic disease in Bolivia, particularly in the rainforest of Cochabamba, in the municipality of Villa Tunari. The precarious, dispersed, and poorly accessible settlements in these farming communities make it difficult to study them, and there are no epidemiological studies in the area. The aim of the present study was to identify the risk factors associated with cutaneous leishmaniasis. METHODS: A cross-sectional study was conducted in August 2015 and August 2016 in two communities of Villa Tunari, Cochabamba. The cases were diagnosed through clinical examinations, identification of the parasite by microscopic examination, and the Montenegro skin test. Risk factors were identified through logistic regression. RESULTS: A total of 274 participants (40.9% female and 59.1% male) were surveyed, of which 43% were CL positive. Sex was the only factor associated with CL with three times more risk for men than for women; this finding suggests a sylvatic mechanism of transmission in the area. CONCLUSIONS: It is advisable to focus on education and prevention policies at an early age for activities related to either leisure or work. Further research is needed to assess the influence of gender-associated behavior for the risk of cutaneous leishmaniasis.
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[This corrects the article DOI: 10.1186/s41182-018-0089-6.].
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Research and research ethics (RE) capacity is a key element for addressing health priorities of low - and middle-income countries (LMICs). With support from a NIH/FIC Research Ethics Education and Curriculum Development grant, a RE Training of Trainers (TOT) was implemented in Bolivia. The Steering Committee, including representatives from four Bolivian universities and PAHO, developed the RE TOT that included face-to-face, online and practicum components. Twenty trainees including faculty, researchers and community leaders participated. Pre/Posttest results demonstrated significant increases in overall RE knowledge (13.1% improvement, p-value < 0.0001). An evaluation demonstrated participants valued participatory learning strategies and the flexibility of the online component. TOT participants during the practicum component delivered RE workshops to their university and civil society communities in four regions (n= 3,700 people). The goals of the grant were accomplished through the development of a Steering Committee and implementation of the TOT course. Next steps include the design and implementation of a masters level research ethics education program in Bolivia.
La capacidad de investigación y ética de la investigación (EI) es un elemento clave para hacer frente a las prioridades de salud de los países de ingresos bajos y medios (PIBM). Con el apoyo de la subvención de ética de la Investigación de NIH/FIC, una capacitación para capacitadores (CPC) fue implementado en Bolivia. El Comité Directivo, que incluye representantes de universidades y la OPS, desarrolló un CPC en EI que incluía componentes presenciales, virtuales y de práctica. Veinte participantes, incluyendo docentes, investigadores y líderes de la comunidad participaron. Los resultados de la pre/post prueba demostraron aumentos significativos en el conocimiento de EI (13,1% de mejora, valor de p< 0,0001). Una evaluación demostró que los participantes valoraron las estrategias de aprendizaje y la flexibilidad del componente virtual. Durante el componente de prácticas, los participantes hicieron talleres de EI que fueron presentados a sus comunidades universitarias y a la sociedad civil en cuatro regiones (n = 3,700 personas). Los objetivos de la subvención se llevaron a cabo mediante el desarrollo de un Comité Directivo y la implementación del CPC. Los próximos pasos incluyen el diseño e implementación de un programa de educación en ética de investigación a nivel de maestría en Bolivia.
Capacitação em pesquisa e ética em pesquisa (RE) de capacidade é um elemento-chave para abordar as prioridades de saúde em países de baixa e média renda (LMICs). Com o apoio de bolsa do NIH / FIC Research Ethics Education and Curriculum Development, uma RE Training of Trainers (TOT) foi implantada na Bolívia. O Comitê Dirigente, incluindo representantes das universidades bolivianas e PAHO, desenvolveu a RE TOT que envolveu modo presencial, online e componentes práticos. Participaram vinte estagiários, incluindo faculdades, pesquisadores e líderes comunitarios. Resultados pré / pós-teste demonstraram aumentos significativos no conhecimento RE geral (melhoria de 13,1%, p <0,0001). Uma avaliação demonstrou participantes valorizados por estratégias de aprendizagem participativa e a flexibilidade do componente online de participantes. Participantes TOT realizaram workshps da prática RE fornecida às suas comunidades universitárias e à sociedade civil em quatro regiões (n = 3.700 pessoas). Os objetivos da subvenção foram realizadas através do desenvolvimento de uma Comissão de Coordenação e implementação do curso TOT. Os próximos passos incluem a concepção e implementação de programa de educação em ética da investigação, ao nível de mestrado, na Bolívia.
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Humanos , Pesquisa Biomédica/ética , Países em Desenvolvimento , Ética em Pesquisa/educação , Bolívia , AprendizagemRESUMO
OBJETIVO: determinar los factores que influyen en el retraso del diagnóstico del VIH desde la percepción de los pacientes y del personal médico, en el municipio del Cercado. METODOS: estudio transversal descriptivo y cuantitativo, a través de entrevistas a pacientes VIH (+), encuestas a personal médico y revisión de historias clínicas. RESULTADOS: se revisó 121 historias clínicas de pacientes VIH(+), en distintos establecimientos de salud, observándose un Diagnóstico Tardío (DT) en el 65%, considerando la presencia de enfermedades oportunistas al momento inicial del diagnóstico y 60% considerando el recuento de linfocitos CD4 < 200. En la entrevista con los pacientes, 59% no tenía pareja estable; 80% no se consideraba vulnerable a la enfermedad y 44% tenía información incompleta o nula sobre el VIH/SIDA. En el análisis estadístico, se encontró relación: (variable edad y sexo respecto a entre quienes hay más posibilidad de transmisión) con un valor de p= 0,000000049 en la primera asociación y un valor de p= 0,000012 en la segunda; entre las variables (edad respecto a saber sobre VIH) con un valor de p= 0,000013; entre las variables (tener pareja estable respecto a considerarse a riesgo) con un valor de p= 0,00098; entre (Nivel de instrucción respecto al motivo de realización de la prueba rápida para VIH) con un valor de p= 0,00083. En la entrevista con los médicos el 39% de ellos tienen un conocimiento insuficiente sobre VIH/SIDA y la norma. CONCLUSIONES: en el retraso del diagnóstico del VIH influyen factores como: la percepción de riesgo, la oferta de la prueba y el conocimiento erróneo del VIH; además el nivel de instrucción y la edad influyen en el acceso a la información. Para mejorar el diagnóstico se debe mejorar la información, hacerla más completa, adecuada y accesible; buscando un cambio de actitud en la población.
OBJECTIVE: to determine the factors influencing the delay of HIV diagnosis from the perception of patients and medical staff, in the municipality of Cercado. METHOD: a descriptive and quantitative cross-sectional study through interviews with patients HIV (+), surveys of medical personnel and medical record review. RESULTS: it was the review of 121 clinical histories in different establishments, obtaining 65% of them, a diagnosis late (DT) for the presence of opportunistic disease at diagnosis; DT 60% for CD4 counts less than 200. Initial Among patients, 59% say they have a stable partner; 80% was not considered vulnerable to disease and 44% had incomplete or no information on HIV / AIDS. In the statistical analysis, we found relationship variables (age / if they thought HIV was for everyone) with a value of p = 0.000000049; (Sex / for whom thought was HIV) with a value of p = 0.000012; between (age / if they knew about HIV) with a value of p = 0.000013; (Having a stable partner / considered at risk) with a value of p = 0.00098; (Level of education / reason for performing HIV test) with a value of p = 0.00083. Among doctors 39% of them have insufficient knowledge about HIV / AIDS and the norm. CONCLUSIONS: the delay of HIV diagnosis influence the perception of risk, the offer of proof and the erroneous knowledge of HIV; further education level / age influence access to information. To improve diagnosis should improve information, make it more complete, adequate and accessible; looking for a change of attitude.