Phase II trial evaluating the clinical efficacy of cefixime for treatment of active syphilis in non-pregnant women in Brazil (CeBra).

BACKGROUND: Syphilis is a sexually and vertically transmitted infection caused by the bacteria Treponema pallidum for which there are few proven alternatives to penicillin for treatment. For pregnant women infected with syphilis, penicillin is the only WHO-recommended treatment that will treat the mother and cross the placenta to treat the unborn infant and prevent congenital syphilis. Recent shortages, national level stockouts as well as other barriers to penicillin use call for the urgent identification of alternative therapies to treat pregnant women infected with syphilis. METHODS: This prospective, randomized, non-comparative trial will enroll non-pregnant women aged 18 years and older with active syphilis, defined as a positive rapid treponemal and a positive non-treponemal RPR test with titer ≥1:16. Women will be a, domized in a 2:1 ratio to receive the oral third generation cephalosporin cefixime at a dose of 400 mg two times per day for 10 days (n = 140) or benzathine penicillin G 2.4 million units intramuscularly based on the stage of syphilis infection (n = 70). RPR titers will be collected at enrolment, and at three, six, and nine months following treatment. Participants experiencing a 4-fold (2 titer) decline by 6 months will be considered as having an adequate or curative treatment response. DISCUSSION: Demonstration of efficacy of cefixime in the treatment of active syphilis in this Phase 2 trial among non-pregnant women will inform a proposed randomized controlled trial to evaluate cefixime as an alternative treatment for pregnant women with active syphilis to evaluate prevention of congenital syphilis. TRIAL REGISTRATION: Trial identifier: www.Clinicaltrials.gov, NCT03752112. Registration Date: November 22, 2018.

Social representations of the health care of the Mbyá-Guarani indigenous population by health workers.

Objective: to analyze the social representations of health care of the Mbyá-Guarani ethnic group by multidisciplinary teams from the Special Indigenous Health District in the south coast of Rio Grande do Sul state (Distrito Sanitário Especial Indígena Litoral Sul do Rio Grande do Sul), Brazil. Method: a qualitative method based on the theory of social representations was used. Data were collected via semi-structured interviews with 20 health workers and by participant observation. The interviews were analyzed with ALCESTE software, which conducts a lexical content analysis using quantitative techniques for the treatment of textual data. Results: there were disagreements in the health care concepts and practices between traditional medicine and biomedicine; however, some progress has been achieved in the area of intermedicality. The ethnic boundaries established between health workers and indigenous peoples based on their representations of culture and family, together with the lack of infrastructure and organization of health actions, are perceived as factors that hinder health care in an intercultural context. Conclusion: a new basis for the process of indigenous health care needs to be established by understanding the needs identified and by agreement among individuals, groups, and health professionals via intercultural exchange.

Social representations of the health care of the Mbyá-Guarani indigenous population by health workers / As representações sociais dos trabalhadores sobre o cuidado à saúde da população indígena Mbyá-Guarani / Representaciones sociales de la atención sanitaria de la población indígena Mbyá-Guaraní por parte de trabajadores de la salud

ABSTRACT Objective: to analyze the social representations of health care of the Mbyá-Guarani ethnic group by multidisciplinary teams from the Special Indigenous Health District in the south coast of Rio Grande do Sul state (Distrito Sanitário Especial Indígena Litoral Sul do Rio Grande do Sul), Brazil. Method: a qualitative method based on the theory of social representations was used. Data were collected via semi-structured interviews with 20 health workers and by participant observation. The interviews were analyzed with ALCESTE software, which conducts a lexical content analysis using quantitative techniques for the treatment of textual data. Results: there were disagreements in the health care concepts and practices between traditional medicine and biomedicine; however, some progress has been achieved in the area of intermedicality. The ethnic boundaries established between health workers and indigenous peoples based on their representations of culture and family, together with the lack of infrastructure and organization of health actions, are perceived as factors that hinder health care in an intercultural context. Conclusion: a new basis for the process of indigenous health care needs to be established by understanding the needs identified and by agreement among individuals, groups, and health professionals via intercultural exchange.

RESUMO Objetivo: analisar as representações sociais do cuidado em saúde entre trabalhadores que atuam em equipes multidisciplinares no Distrito Sanitário Especial Indígena Litoral Sul do Rio Grande do Sul, junto à etnia Mbyá-Guarani. Método: utilizou-se método qualitativo, fundamentado na teoria das Representações Sociais. Os dados foram coletados por meio de entrevistas semiestruturadas com 20 trabalhadores e da observação participante. As entrevistas analisadas com o software ALCESTE, o qual realiza a análise lexical de conteúdo por meio de técnicas quantitativas de tratamento de dados textuais. Resultados: verificou-se que existe tensão entre as concepções e práticas de cuidado da medicina tradicional e da biomedicina, mas observam-se alguns avanços na perspectiva da intermedicalidade. Fronteiras étnicas estabelecidas entre os trabalhadores e os indígenas, baseadas em suas representações de cultura e família, da mesma maneira que a falta de infraestrutura e os modos de organização do trabalho em saúde são percebidos como fatores que dificultam o cuidado em contextos de interculturalidade. Conclusão: é preciso estabelecer novas bases para o processo de cuidar em saúde indígena, a partir da compreensão das necessidades representadas, negociadas entre sujeitos individuais e coletivos e os profissionais nas instituições de saúde em um diálogo intercultural de múltiplas vozes.

RESUMEN Objetivo: analizar las representaciones sociales de la atención de la salud del grupo étnico Mbyá-Guaraní por equipos multidisciplinarios del Distrito Sanitario Especial Indígena en la costa sur del estado de Rio Grande do Sul (Distrito Sanitário Especial Indígena Litoral Sul do Rio Grande do Sul), Brasil. Método: se utilizó un método cualitativo basado en la teoría de las representaciones sociales. Los datos fueron recogidos a través de entrevistas semi-estructuradas con 20 trabajadores de la salud y por observación de los participantes. Las entrevistas fueron analizadas con el programa ALCESTE, que realiza un análisis de contenido léxico utilizando técnicas cuantitativas para el tratamiento de datos textuales. Resultados: hubo desacuerdos en los conceptos y prácticas de atención médica entre medicina tradicional y biomedicina; sin embargo, se han logrado algunos avances en el área de la intermedicina. Las barreras étnicas establecidas entre los trabajadores de la salud y los pueblos indígenas basados en sus representaciones de la cultura y la familia, junto con la falta de infraestructura y organización de las acciones de salud, son percibidas como factores que obstaculizan la atención sanitaria en un contexto intercultural. Conclusión: es necesario establecer una nueva base para el proceso de atención de salud indígena mediante la comprensión de las necesidades identificadas y por acuerdo entre individuos, grupos y profesionales de la salud a través del intercambio intercultural.