Brazilian Clinical Practice Guidelines for Sexually Transmitted Infections That Cause Urethral Discharge: Assessment According to the AGREE II and Critical Analysis Based on the WHO Recommendations.

BACKGROUND: Sexually transmitted infections (STI) can have severe consequences. In Brazil, case management is recommended by the Clinical Protocol and Therapeutical Guidelines for Comprehensive Care for People with STIs (PCDT-IST). This study assessed the quality of PCDT-IST (2021) and reviewed the main recommendations for the management of STI that cause urethral discharge compared with the World Health Organization (WHO) STI Guidelines. METHODS: The PCDT-IST (2021) quality was independently assessed by 4 appraisers using the Appraisal of Guidelines Research and Evaluation instrument, version II (AGREE II). The PCDT-IST (2021) and the WHO Guidelines for the Management of Symptomatic STI (2021) were compared considering 14 different assessment domains. RESULTS: The PCDT-IST (2021) scores in the AGREE II domains were: Rigor of Development (58%), Applicability (35%), Editorial Independence (38%), Scope and Purpose (78%), Stakeholder Involvement (74%), and Clarity and Presentation (82%). The overall score was 67%, and all appraisers recommended the Brazilian guideline. Regarding the PCDT-IST (2021) and the WHO STI Guidelines (2021) comparation, 10 domains would be relevant for further reviewing the Brazilian recommendations: Diagnostic tests; Etiological approach; Treatment for recurrent urethral discharge; Treatment for urethritis without etiological agent identification; Treatment for gonococcal urethritis; Treatment for chlamydial urethritis; Retreatment for gonococcal infections; Treatment for Mycoplasma genitalium urethritis; Treatment for Trichomonas vaginalis urethritis; 10. Flowcharts. CONCLUSIONS: The PCDT-IST (2021) has a reasonable degree of quality. However, the domains of Applicability, Rigor of Development, and Editorial Independence must be better ensured. The guidelines comparison will help to select key topics that should be addressed with priority in the following national STI guidelines updates.

Assessment of the Accuracy, Usability and Acceptability of a Rapid Test for the Simultaneous Diagnosis of Syphilis and HIV Infection in a Real-Life Scenario in the Amazon Region, Brazil.

We field-assessed the accuracy, acceptability, and feasibility of the SD BIOLINE HIV/Syphilis Duo rapid diagnostic test in three groups: pregnant women, female sex workers (FSW), and men who have sex with men (MSM). Venous blood samples collected in the field were compared with the respective gold standard methods: SD BIOLINE HIV/Syphilis Duo Treponemal Test versus FTA-abs (Wama brand) treponemal laboratory test for syphilis, and SD BIOLINE HIV/Syphilis Duo Test versus the fourth generation Genscreen Ultra HIV Ag-Ag (Bio-Rad brand) laboratory test for HIV. From a total of 529 participants, 397 (75.1%) were pregnant women, 76 (14.3%) FSW and 56 (10.6%) MSM. Sensitivity and specificity parameters of HIV were 100.0% (95% CI: 82.35-100.0%) and 100.0% (95% CI: 99.28-100.0%), respectively. Sensitivity and specificity parameters found for TP antibody detection were 95.00% (95% CI: 87.69-98.62%) and 100.0% (95% CI: 98.18-100.0%), respectively. The SD BIOLINE HIV/Syphilis Duo Test showed high acceptability among participants (85.87%) and health professionals (85.51%), as well as easy usability by professionals (91.06%). The usability of the SD BIOLINE HIV/Syphilis Duo Test kit would not be a barrier to accessing rapid testing, if the product were incorporated into the list of health service supplies.

Ending AIDS as a public health threat by 2030: Time to reset targets for 2025.

Paul De Lay and co-authors introduce a Collection on the design of targets for ending the AIDS epidemic.

The impact of socioeconomic status on HPV infection among young Brazilians in a nationwide multicenter study.

The aim of this study is to evaluate genital human papillomavirus (HPV) infection according to socioeconomic categories in Brazil. This cross-sectional, nationwide study included 7,694 sexually active women and men aged 16-25 years. Individuals of all socioeconomic groups in all 26 Brazilian capitals and the Federal District were enrolled through public primary care units between September 2016 and November 2017. All participants answered a standardized interview administered by trained primary care health professionals. Socioeconomic class was analyzed using a pricing classification system for the Brazilian public that divides the market exclusively in terms of economic class based on the ownership of assets and the education level. Cervical samples were obtained using a Digene® HC2 DNA Collection, and penile/scrotum samples were obtained using a wet Dacron swab. HPV typing (overall and high-risk) was performed in a central lab. Of the 7,694 participants (47.85% women), 17.92% belonged to class A-B, 56.08% to class C, and 26.00% to class D-E. The prevalence of overall HPV was similar among the social classes: 51.16% for classes A-B, 53.39% for class C, and 55.47% for classes D-E (P = 0.479). Similar results were found for high-risk HPV. After adjustments, the presence of HPV in individuals with a brown skin color belonging to classes A-B was 57.00% higher [prevalence ratio 1.57 (95%: 1.23, 2.01)] than that in whites and had no impact on the other social classes. In conclusion, HPV infection affects all socioeconomic classes in Brazil, evidencing the importance of offering the HPV vaccine to the entire population.

Adequacy of prenatal care, diagnosis and treatment of syphilis in pregnancy: a study with open data from Brazilian state capitals / Adequação de atendimento pré-natal, diagnóstico e tratamento da sífilis gestacional: um estudo com dados abertos de capitais brasileiras / Adecuación de la atención prenatal, diagnóstico y tratamiento de la sífilis en el embarazo: un estudio con datos abiertos en siete capitales brasileñas

Abstract: To assess the adequacy of prenatal care offered in the Brazilian capital cities and the diagnosis of gestational syphilis through public data from health information systems. The modified Kotelchuck index for adequacy of prenatal care was built using Brazilian Information System on Live Births (SINASC) data. Data on gestational syphilis, congenital syphilis, estimated population coverage by the Family Health Strategy (FHS), the Municipal Human Development Index (MHDI) and data from National Program for Access and Quality Improvement in Primary Care (PMAQ-AB) were accessed in public sites. The profile of pregnant women associated with inadequate care was assessed by logistic regression. In total, 685,286 births were analyzed. Only 2.3% of women did not attend prenatal appointments. The mean adequacy was 79.7%. No correlation was found between adequacy of prenatal care and FHS coverage (p = 0.172), but a positive correlation was found with the MHDI (p < 0.001). Inadequacy of prenatal care was associated with age below 20 years old, schooling less than 4 years, non-white skin color and not having a partner. Among the congenital syphilis cases, 17.2% of mothers did not attend prenatal care. Gestational syphilis more often affected vulnerable women, including a higher proportion of adolescents, women with low schooling, and women of non-white color. The PMAQ-AB showed a median availability of 27.3% for syphilis rapid tests, 67.7% for benzathine penicillin, and 86.7% for benzathine penicillin administration by health teams. The use of public data showed a low adequacy of prenatal care in Brazilian capitals, denoting insufficient quality for the diagnosis and treatment of gestational syphilis, despite the availability of supplies. Continuous monitoring can be carried out using public data, indicating to local strategies to eliminate congenital syphilis.

Resumo: O estudo buscou avaliar a adequação do atendimento pré-natal oferecido nas capitais brasileiras e o diagnóstico da sífilis gestacional através de dados públicos dos sistemas de informação de saúde. Foi construído o indicador de Kotelchuck modificado para adequação do atendimento pré-natal, usando dados do Sistema de Informações sobre Nascidos Vivos (SINASC). Foram acessados em sites públicos os dados sobre sífilis gestacional, sífilis congênita, estimativa da cobertura populacional pela Estratégia Saúde da Família (ESF), Índice de Desenvolvimento Humano (IDH) municipal e dados do Programa Nacional de Melhoria do Acesso e da Qualidade da Atenção Básica (PMAQ-AB). O perfil das gestantes associado ao atendimento inadequado foi avaliado com base na regressão logística. Foram analisados um total de 685.286 nascimentos. Apenas 2,3% das mulheres não receberam atendimento pré-natal. A taxa média de adequação foi de 79,7%. Não foi encontrada correlação entre a adequação do pré-natal e a cobertura pela ESF (p = 0,172), mas houve correlação com o IDH municipal (p < 0,001). A inadequação da assistência pré-natal mostrou associação com a idade < 20 anos, escolaridade < 4 anos, raça/cor não-branca e situação conjugal sem companheiro. Entre os casos de sífilis congênita, 17,2% das mães não haviam recebido atendimento pré-natal, e a sífilis gestacional afetava mais as gestantes vulneráveis, incluindo uma proporção maior de adolescentes, mulheres com baixa escolaridade e mulheres não brancas. O PMAQ-AB mostrou uma disponibilidade mediana de 27,3% de testes rápidos para sífilis, 67,7% para penicilina benzatina e 86,7% para administração de penicilina benzatina pela equipe de saúde. O uso de dados públicos revelou baixa adequação do atendimento pré-natal nas capitais brasileiras, denotando qualidade insuficiente para o diagnóstico e tratamento da sífilis gestacional, apesar da disponibilidade de insumos. O monitoramento contínuo pode ser realizado com o uso de dados públicos, indicando estratégias locais para eliminar a sífilis congênita.

Resumen: El objetivo de este trabajo ha sido evaluar la adecuación de la atención prenatal que se ofreció en capitales brasileñas, y el diagnóstico de sífilis gestacional, mediante datos públicos de los sistemas de información de salud. El indicador modificado de Kotelchuck para la adecuación de la atención prenatal se construyó usando datos del Sistema de Información sobre Nacidos Vivos (SINASC). La información sobre sífilis gestacional, sífilis congénita, así como la cobertura de población estimada por la Estrategia Salud de Familia (ESF), Índice de Desarrollo Humano (IDH) municipal y datos del Programa Nacional para el Acceso Mejorado y Calidad de la Atención Básica (PMAQ-AB) se recabaron de sitios web públicos. El perfil de las mujeres embarazadas asociado con el cuidado inadecuado fue evaluado mediante regresión logística. En total, se analizaron 685.286 nacimientos. Solamente un 2,3% de las mujeres no atendieron a citas prenatales. La adecuación media fue de un 79,7%. No se encontró correlación entre la adecuación del cuidado prenatal y la cobertura de la ESF (p = 0,172), pero se encontró una correlación positiva con el MHDI (p < 0,001). La inadecuación del cuidado prenatal estuvo asociada con una edad < 20 años, escolaridad < 4 años, raza no blanca y no tener pareja. Entre los casos de sífilis congénita, un 17,2% de las madres no asistieron a la atención prenatal. La sífilis gestacional afectó más a menudo a las mujeres vulnerables, incluyendo una más alta proporción de adolescentes, mujeres con baja escolaridad, y mujeres de color no blanco. La PMAQ-AB mostró un promedio de disponibilidad de un 27,3%, en el caso de test rápidos de sífilis, un 67,7% para la penicilina benzatínica, y un 86,7% para la administración penicilina benzatínica por equipos de salud. El uso de los datos públicos mostró una baja adecuación del cuidado prenatal en capitales brasileñas, denotando una insuficiente calidad para el diagnóstico y tratamiento de la sífilis gestacional, a pesar de la disponibilidad de suministros. La supervisión continua se puede llevar a cabo usando datos públicos, apuntando a estrategias locales para eliminar la sífilis congénita.

The case for a universal hepatitis C vaccine to achieve hepatitis C elimination.

BACKGROUND: The introduction of highly effective direct-acting antiviral (DAA) therapy for hepatitis C has led to calls to eliminate it as a public health threat through treatment-as-prevention. Recent studies suggest it is possible to develop a vaccine to prevent hepatitis C. Using a mathematical model, we examined the potential impact of a hepatitis C vaccine on the feasibility and cost of achieving the global WHO elimination target of an 80% reduction in incidence by 2030 in the era of DAA treatment. METHODS: The model was calibrated to 167 countries and included two population groups (people who inject drugs (PWID) and the general community), features of the care cascade, and the coverage of health systems to deliver services. Projections were made for 2018-2030. RESULTS: The optimal incidence reduction strategy was to implement test and treat programmes among PWID, and in settings with high levels of community transmission undertake screening and treatment of the general population. With a vaccine available, the optimal strategy was to include vaccination within test and treat programmes, in addition to vaccinating adolescents in settings with high levels of community transmission. Of the 167 countries modelled, between 0 and 48 could achieve an 80% reduction in incidence without a vaccine. This increased to 15-113 countries if a 75% efficacious vaccine with a 10-year duration of protection were available. If a vaccination course cost US$200, vaccine use reduced the cost of elimination for 66 countries (40%) by an aggregate of US$7.4 (US$6.6-8.2) billion. For a US$50 per course vaccine, this increased to a US$9.8 (US$8.7-10.8) billion cost reduction across 78 countries (47%). CONCLUSIONS: These findings strongly support the case for hepatitis C vaccine development as an urgent public health need, to ensure hepatitis C elimination is achievable and at substantially reduced costs for a majority of countries.

Antiretroviral treatment, government policy and economy of HIV/AIDS in Brazil: is it time for HIV cure in the country?

Brazil is a low-and-middle income country (LMIC) that, despite having a large population and continental dimensions, has been able to successfully fight HIV/AIDS through a number of governmental and societal measures. These included an early response to the epidemic, the development of a universal and free public health system, incisive discussions with pharmaceutical companies to reduce antiretroviral (ARV) drug prices, investments towards the development of generic drugs and compulsory licensing of ARVs. Through such measures, Brazil is among the leading LMIC towards achieving the 90-90-90 UNAIDS goals in the years to come. In this review, we analyze Brazil's progress throughout the HIV/AIDS epidemic to achieve state-of-the-art ARV treatment and to reduce AIDS mortality in the country. The top-quality HIV/AIDS research in Brazil towards HIV prophylactic and functional cure, the next step towards the economic sustainability of the battle against HIV, is also discussed.

Hepatitis C disease burden and strategies for elimination by 2030 in Brazil. A mathematical modeling approach

ABSTRACT Introduction and aim: Hepatitis C is a key challenge to public health in Brazil. The objective of this paper was to describe the Brazilian strategy for hepatitis C to meet the 2030 elimination goal proposed by World Health Organization (WHO). Methods: A mathematical modeling approach was used to estimate the current HCV-infected Brazilian population, and to evaluate the relative costs of two different scenarios to address HCV disease burden in Brazil: (1) if no further changes are made to the HCV treatment program in Brazil; (2) where the WHO targets for 2030 elimination are met through diagnosis and treatment efforts peaking before 2024. Results: An anti-HCV prevalence of 0.53% was calculated for the total population. It was estimated that the number of HCV-RNA+ individuals in Brazil in 2017 was 632,000 (0.31% of the population). Scale-up of treatment and diagnosis over time will be necessary in order to achieve WHO targets beginning in 2018. Direct costs (diagnostic, treatment and healthcare costs) are projected to increase significantly during the scale-up of treatment and diagnosis in the initial years of the intervention scenario, but then fall below the base case on an annual basis by 2025-2036, once HCV is eliminated, due to health sectors savings from the prevention of HCV liver-related morbidity and mortality. Conclusion: Achieving the WHO targets is technically feasible in Brazil with a scale-up of treatment and diagnosis over time, beginning in 2018. However, elimination of hepatitis C requires policy changes to substantially scale-up prevention, screening and treatment of HCV, together with public health advocacy to raise awareness among affected populations and healthcare providers.

Hepatitis C disease burden and strategies for elimination by 2030 in Brazil. A mathematical modeling approach.

INTRODUCTION AND AIM: Hepatitis C is a key challenge to public health in Brazil. The objective of this paper was to describe the Brazilian strategy for hepatitis C to meet the 2030 elimination goal proposed by World Health Organization (WHO). METHODS: A mathematical modeling approach was used to estimate the current HCV-infected Brazilian population, and to evaluate the relative costs of two different scenarios to address HCV disease burden in Brazil: (1) if no further changes are made to the HCV treatment program in Brazil; (2) where the WHO targets for 2030 elimination are met through diagnosis and treatment efforts peaking before 2024. RESULTS: An anti-HCV prevalence of 0.53% was calculated for the total population. It was estimated that the number of HCV-RNA+ individuals in Brazil in 2017 was 632,000 (0.31% of the population). Scale-up of treatment and diagnosis over time will be necessary in order to achieve WHO targets beginning in 2018. Direct costs (diagnostic, treatment and healthcare costs) are projected to increase significantly during the scale-up of treatment and diagnosis in the initial years of the intervention scenario, but then fall below the base case on an annual basis by 2025-2036, once HCV is eliminated, due to health sectors savings from the prevention of HCV liver-related morbidity and mortality. CONCLUSION: Achieving the WHO targets is technically feasible in Brazil with a scale-up of treatment and diagnosis over time, beginning in 2018. However, elimination of hepatitis C requires policy changes to substantially scale-up prevention, screening and treatment of HCV, together with public health advocacy to raise awareness among affected populations and healthcare providers.

Adequacy of prenatal care, diagnosis and treatment of syphilis in pregnancy: a study with open data from Brazilian state capitals.

To assess the adequacy of prenatal care offered in the Brazilian capital cities and the diagnosis of gestational syphilis through public data from health information systems. The modified Kotelchuck index for adequacy of prenatal care was built using Brazilian Information System on Live Births (SINASC) data. Data on gestational syphilis, congenital syphilis, estimated population coverage by the Family Health Strategy (FHS), the Municipal Human Development Index (MHDI) and data from National Program for Access and Quality Improvement in Primary Care (PMAQ-AB) were accessed in public sites. The profile of pregnant women associated with inadequate care was assessed by logistic regression. In total, 685,286 births were analyzed. Only 2.3% of women did not attend prenatal appointments. The mean adequacy was 79.7%. No correlation was found between adequacy of prenatal care and FHS coverage (p = 0.172), but a positive correlation was found with the MHDI (p < 0.001). Inadequacy of prenatal care was associated with age below 20 years old, schooling less than 4 years, non-white skin color and not having a partner. Among the congenital syphilis cases, 17.2% of mothers did not attend prenatal care. Gestational syphilis more often affected vulnerable women, including a higher proportion of adolescents, women with low schooling, and women of non-white color. The PMAQ-AB showed a median availability of 27.3% for syphilis rapid tests, 67.7% for benzathine penicillin, and 86.7% for benzathine penicillin administration by health teams. The use of public data showed a low adequacy of prenatal care in Brazilian capitals, denoting insufficient quality for the diagnosis and treatment of gestational syphilis, despite the availability of supplies. Continuous monitoring can be carried out using public data, indicating to local strategies to eliminate congenital syphilis.

External quality assessment for CD4 + T-lymphocyte count test: Performance of the Brazilian public health laboratories network.

The National Network for CD4+ T-lymphocyte counting of Brazil comprises 93 laboratories. This study reports the laboratory performances achieved in external quality assessment (EQA) rounds provides by Ministry of Health to evaluate the quality of the kits used and the performance of test by the technicians.Ten EQA rounds were analyzed according the EQA criteria aimed to evaluate individual laboratory performance on the basis of the accuracy of their results compared to the general mean obtained by all participating laboratories and the reproducibility of the results obtained between 2 samples from the same donor.The percentage of approved and failed laboratories in the EQAs tends to follow a uniform pattern. Since 2011, approval has remained above 80% and the failure rate has never exceeded 15%.EQA is very important to evaluate the performance of the laboratories, to identify monitor, and to resolve errors as quickly as possible.

PrEP adopted by the brazilian national health system: What is the size of the demand?

BACKGROUND: Brazil's response to the HIV epidemic now includes free access to preexposure prophylaxis (PrEP) to populations at substantial risk for HIV infection including men who have sex with men (MSM). We used nationally representative demographic, epidemiologic, and surveillance data to offer estimates for the number of MSM at substantial risk for HIV infection who might be eligible and willing to use PrEP in Brazil. METHODS: Starting from the age/sex-stratified population, we calculated the number of men aged 15 to 64 years, in 5-year age groups, and the proportion of those who report sex with other men during their lifetime. We focused on 11 cities (representing all regions) that are responsible for a significant fraction of the HIV burden of the country and used city-specific HIV prevalence estimates to infer the fraction of MSM who are HIV-negative. We then derived the proportion of HIV-negative MSM under substantial risk for HIV infection defined as having unprotected receptive anal intercourse in the 6 months before study participation. Finally, PrEP uptake among the eligible was inferred from the PrEP Brazil study. RESULTS: Our results show that PrEP demand in these 11 cities is of 66,120 men aged 15 to 64 years. When we consider the lower and upper bounds for the available parameters, we find that PrEP demand in these 11 cities might vary from 33,378 to 97,962 men. If PrEP is restricted to those aged 15 to 49 years, demand drops by 20%. PrEP demand varies considerably by city, mostly because of the differences in population size and city-specific HIV prevalence. DISCUSSION: We have shed light on the probable size of PrEP demand in Brazil certain that the incorporation of PrEP as part of Brazil's combination prevention for populations at substantial risk for HIV infection is a necessary challenge. PrEP will not only prevent HIV infections, it will also expand testing among the most vulnerable with the added benefit of offering combination prevention for the uninfected and immediate treatment for those already infected. As such, expected added benefits of PrEP will be earlier linkage to care, prompt treatment initiation leading to health benefits and decreased transmission.

Development, validation and testing costs of an in-house real-time PCR assay for the detection of Chlamydia trachomatis.

PURPOSE: To improve the screening of Chlamydia trachomatis(C. trachomatis) in Brazil, an accurate and affordable method is needed. The objective of this study was to develop and assess the performance and costs of a new in-house real-time PCR (qPCR) assay for the diagnosis of C. trachomatis infection. METHODOLOGY: Asymptomatic women aged 14-25 years who attended primary health services in Manaus, Brazil, were screened for C. trachomatis using the Digene Hybrid Capture II CT-ID (HCII CT-ID) DNA test. A subset of cervical specimens were tested using an in-house qPCR and a commercial qPCR, ArtusC. trachomatis Plus RG PCR 96 CE (Artus qPCR) kit, as a reference test. A primer/probe based on the sequence of cryptic plasmid (CP) was designed. An economic evaluation was conducted from the provider's perspective. RESULTS: The primers were considered specific for C. trachomatis because they did not amplify any product from non-sexually transmitted bacterial species tested. Overall, 292 specimens were tested by both the commercial kit (Artus qPCR) and the in-house qPCR. Of those, one resulted in no amplification and was excluded from the analysis. The sensitivity, specificity, and positive and negative predictive values of the in-house qPCR were 99.5 % [95 % confidence interval (CI): 97.1-100], 95.1 % (95 % CI: 89-98.4), 97.4 % (95 % CI: 94-99.1) and 99.0 % (95 % CI: 94.5-100), respectively. The cost per case of C. trachomatis was £0.44 ($0.55) for HCII CT-ID, £1.16 ($1.45) for Artus qPCR and £1.06 ($1.33) for in-house qPCR. CONCLUSION: We have standardized an in-house qPCR to detect cervical C. trachomatis targeting CP. The in-house qPCR showed excellent accuracy and was more affordable than the commercial qPCR kit.

The Brazilian comprehensive response to hepatitis C: from strategic thinking to access to interferon-free therapy.

BACKGROUND: Hepatitis C affects over 185 million people around the world. This silent disease is responsible for up to 700,000 deaths per year. Despite the scientific revolution in diagnosis and treatment, hepatitis C control remains a huge challenge due to the cost of effective medications. In response to the global outcry of hepatitis epidemic and the need to improve the nation's public health response, the Ministry of Health of Brazil revolutionized hepatitis C treatment by incorporating highly effective drugs that can be accessed through sustainable and universal means. DISCUSSION: This paper describes the unique process of implementing evidence-informed policy to respond to hepatitis C epidemic through the update of hepatitis C treatment in Brazil based on the estimate of disease prevalence, current international guidelines, and the cost-effectiveness impact in the Brazilian Unified Health System. Through a debate of an experience report, the authors underlie the strategic plan implemented according to the situation analysis that emphasized the need to improve its current response over a relatively short-term period. The comprehensive response is detailed comprising three main objectives: improve treatment outcomes by evaluating and incorporating new and effective medications at a sustainable price; elaborate on clinical guidelines to treat hepatitis C patients; and develop awareness and diagnosis campaigns targeted at the population of interest. In this scenario, Brazil was able to obtain an unprecedented discount for a high-medium income country; provided treatment to more than 7000 individuals in the last 2 months of 2015; and expects to treat 38,000 new patients in 2016. The remarkable process applied in Brazil was developed according to epidemiological data and scientific evidence, and it was motivated by the engagement of the country in the Sustainable Development Goals, which may inspire other developing countries to identify ways to achieve these goals by 2030.

Evaluation of screening for Chlamydia trachomatis among young women in primary health care services in Manaus, Amazonas State, Brazil / Avaliação de rastreamento de Chlamydia trachomatis em mulheres jovens em serviços de atenção primaria de Manaus, Amazonas, Brasil / Evaluación de los exámenes de control de Chlamydia trachomatis entre mujeres jóvenes en los servicios de salud de atención primaria en Manaus, Amazonas, Brasil

Abstract: Screening for Chlamydia trachomatis is not routinely offered to young asymptomatic women in Brazil. This study evaluated the performance, usefulness, and operational suitability of the Digene Hybrid Capture II (HCII) CT-ID DNA-test as an opportunistic screening tool to detect C. trachomatis in the public health system in Manaus, Amazonas State. Women aged 14-25 years who attended primary health care services were interviewed and one cervical specimen was collected during cytological screening. The HCII CT test was evaluated for its ability to detect the presence of C. trachomatis and against real-time PCR (q-PCR) in a subset of samples. Operational performance was assessed through interviews with providers and patients. Overall, 1,187 women were screened, and 1,169 had a HCII CT-ID test result (292 of these were also tested by q-PCR). Of those, 13.1% (n = 153) were positive. The sensitivity, specificity, positive and negative predictive values of HCII CT were 72.3% (95%CI: 65.4-78.6), 91.3% (95%CI: 84.1-95.9), 93.8% (95%CI: 88.5-97.1), and 64.4% (95%CI: 56.0-72.1), respectively. Sample collection caused discomfort in 19.7% of women. Among health professionals (n = 52), the main barriers reported included positive cases who did not return for results (56.4%), unwillingness to screen without an appointment (45.1%), and increase in their workload (38.8%). HCII CT-ID identified a high proportion of C. trachomatis cases among young women in Manaus. However, its moderate sensitivity limits its use as an opportunistic screening tool in primary health care settings in Manaus. Screening was well accepted although the barriers we identified, especially among health professionals, challenge screening detection and treatment efforts.

Resumo: O rastreamento de Chlamydia trachomatis não é feito de rotina em mulheres jovens assintomáticas no Brasil. O estudo avaliou o desempenho, utilidade e adequação operacional do teste de DNA Digene Hybrid Capture II (HCII) CT-ID como ferramenta de rastreamento oportunista para detectar C. trachomatis no sistema público de saúde em Manaus, Amazonas. Mulheres entre 14 e 25 anos de idade que frequentavam serviços de atenção básica foram entrevistadas, com a coleta de uma amostra cervicouterina durante o rastreamento citológico. O teste HCII CT foi avaliado em relação à capacidade de detectar a presença de C. trachomatis, e comparado à PCR em tempo real (q-PCR) em um sub-conjunto de amostras. O desempenho operacional foi avaliado através de entrevistas com profissionais e pacientes. Foram examinadas 1.187 mulheres, das quais 1.169 tiveram um resultado de teste HCII CT-ID (destas, 292 foram testadas também com q-PCR). Um total de 153 mulheres (13,1%) testaram positivas para C. trachomatis. A sensibilidade, especificidade e valores preditivos positivo e negativo do HCII CT foram 72,3% (IC95%: 65,4-78,6), 91,3% (IC95%: 84,1-95,9), 93,8% (IC95%: 88,5-97,1) e 64,4% (IC95%: 56,0-72,1), respectivamente. A coleta de amostras provocou desconforto em 19,7% das mulheres. As principais barreiras relatadas pelos profissionais de saúde (n = 52) eram casos positivos que não retornavam para os resultados (56,4%), falta de disponibilidade de realizar o rastreamento sem consulta agendada (45,1%) e aumento da carga de trabalho (38,8%). O HCII CT-ID identificou alta prevalência de C. trachomatis em mulheres jovens de Manaus. Entretanto, a sensibilidade moderada limita o uso como ferramenta de rastreamento oportunista em serviços de atenção básica naquela cidade. O rastreamento era bem-recebido, mas as barreiras identificadas, principalmente entre profissionais de saúde, limitam a detecção através do rastreamento e as iniciativas de tratamento.

Resumen: Los exámenes de control de Chlamydia trachomatis no se ofrecen habitualmente a las mujeres jóvenes asintomáticas en Brasil. Este estudio evaluó los resultados, utilidad e idoneidad operativa del test Digene Hybrid Capture II (HCII) CT-ID DNA como una herramienta de examen apropiada para detectar la C. trachomatis en el sistema de salud público de Manaus, Amazonas. Las mujeres con una edad comprendida entre los 14-25 años que asistieron a un centro de atención primaria fueron entrevistadas, y se recogió una muestra cervical durante el examen citológico. Se evaluó el test HCII CT, debido a su habilidad para detectar la presencia de C. trachomatis, frente al realtime PCR (q-PCR) en un subconjunto de muestras. El resultado operativo fue evaluado mediante entrevistas con proveedores y pacientes. Globalmente, se examinaron a 1.187 mujeres, y 1.169 de ellas contaban con los resultados de la prueba HCII CT-ID (a 292 de las cuales también se les aplicó el test q-PCR). Entre ellas, un 13,1% (n = 153) eran positivo. La sensibilidad, especificidad, los valores predictivos positivos y negativos del HCII CT fueron 72,3% (IC95%: 65,4-78,6), 91,3% (IC95%: 84,1-95,9), 93,8% (IC95%: 88,5-97,1), y 64,4% (IC95%: 56,0-72,1), respectivamente. La toma de muestras resultó incómoda en un 19,7% de las mujeres. Entre los profesionales de la salud (n = 52), las barreras principales informadas incluyeron casos positivos que no volvieron a recoger los resultados (56,4%), reticencia a realizarse el examen sin cita previa (45,1%), e incremento en su carga laboral (38,8%). El HCII CT-ID identificó un alto porcentaje de casos de C. trachomatis entre mujeres jóvenes en Manaus. No obstante, su moderada sensibilidad limita su uso como una herramienta idónea en los centros de atención primaria en Manaus. El examen fue bien aceptado, pese a que identificamos obstáculos, especialmente entre los profesionales de salud, lo que supone un desafío para la detección de la enfermedad que requiere esfuerzos para su tratamiento.

Point-of-care screening for syphilis and HIV in the borderlands: challenges in implementation in the Brazilian Amazon.

BACKGROUND: Point-of-care (POC) screening for HIV and syphilis using rapid testing was implemented in indigenous communities in the triple-border area of the Brazilian Amazon. We describe the context of the early introduction of POC screening, explore hindering and enabling factors for POC implementation, and recommend strategies for feasible, viable, and sustainable syphilis and HIV screening interventions. METHODS: This was a qualitative study based on grounded theory methodology. Data were collected using in-depth interviews, semi-structured questionnaires, and field observations and were analysed using the framework approach. Qualitative information was complemented by quantitative data for descriptive purposes. RESULTS: An overall high score for vulnerability to acquiring HIV and syphilis was observed among the indigenous communities. Health professionals reported satisfactory rapid testing acceptance, although concerns were raised about the pain of the fingerprick. Counselling-related challenges included ensuring the accuracy of translations, collaborating with translators and communicating positive test results. Over 3 months, 86.7% of the syphilis-positive individuals began treatment, and all of them notified their partners. Accessibility, measured as travel time via the local transportation network, was a barrier to health care access. A lack of gasoline for boats and other transportation was also a hindering factor at all levels of implementation. CONCLUSIONS: The recommendations address the preparation phase at the coordination level as well as at the training level. Tools such as strengths, weaknesses, opportunities, and threats (SWOT) analyses; checklists; context-adapted protocols; and fact sheets are very simple methods to facilitate implementation. The findings of this study are important because they may inform the implementation of new health technologies in low-resource national disease control programmes in remote communities.

External quality assessment in the voluntary counseling and testing centers in the Brazilian Amazon using dried tube specimens: results of an effectiveness evaluation.

INTRODUCTION: In 2011, the Brazilian Ministry of Health rolled out a program for the external quality assessment of rapid human immunodeficiency virus (HIV) tests using the dried tube specimen (DTS) method (EQA-RT/DTS-HIV). Our objective was to evaluate the implementation of this program at 71 voluntary counseling and testing centers (VCTCs) in the Brazilian Legal Amazonian area one year after its introduction. METHODS: Quantitative and qualitative study that analyzed secondary data and interviews with healthcare workers (HCWs) (n=39) and VCTC coordinators (n=32) were performed. The assessment used 18 key indicators to evaluate the three dimensions of the program's logical framework: structure, process, and result. Each indicator was scored from 1-4, and the aggregate results corresponding to the dimensions were expressed as proportions. The results were compared to the perceptions of the HCWs and coordinators regarding the EQA-RT/DTS-HIV program. RESULTS: The aggregate scores for the three dimensions of structure, process, and result were 91.7%, 78.6%, and 95%, respectively. The lowest score in each dimension corresponded to a different indicator: access to Quali-TR online system 39% (structure), registration in Quali-TR online system 38.7% (process), and VCTC completed the full process in the program's first round 63.4% (result). Approximately 36% of the HCWs and 52% of the coordinators reported enhanced trust in the program for its rapid HIV testing performance. CONCLUSIONS: All three program dimensions exhibited satisfactory results (>75%). Nevertheless, the study findings highlight the need to improve certain program components. Additionally, long-term follow-ups is needed to provide a more thorough picture of the process for external quality assessment.

External quality assessment in the voluntary counseling and testing centers in the Brazilian Amazon using dried tube specimens: results of an effectiveness evaluation

INTRODUCTION : In 2011, the Brazilian Ministry of Health rolled out a program for the external quality assessment of rapid human immunodeficiency virus (HIV) tests using the dried tube specimen (DTS) method (EQA-RT/DTS-HIV). Our objective was to evaluate the implementation of this program at 71 voluntary counseling and testing centers (VCTCs) in the Brazilian Legal Amazonian area one year after its introduction. METHODS : Quantitative and qualitative study that analyzed secondary data and interviews with healthcare workers (HCWs) (n=39) and VCTC coordinators (n=32) were performed. The assessment used 18 key indicators to evaluate the three dimensions of the program's logical framework: structure, process, and result. Each indicator was scored from 1-4, and the aggregate results corresponding to the dimensions were expressed as proportions. The results were compared to the perceptions of the HCWs and coordinators regarding the EQA-RT/DTS-HIV program. RESULTS: The aggregate scores for the three dimensions of structure, process, and result were 91.7%, 78.6%, and 95%, respectively. The lowest score in each dimension corresponded to a different indicator: access to Quali-TR online system 39% (structure), registration in Quali-TR online system 38.7% (process), and VCTC completed the full process in the program's first round 63.4% (result). Approximately 36% of the HCWs and 52% of the coordinators reported enhanced trust in the program for its rapid HIV testing performance. CONCLUSIONS: All three program dimensions exhibited satisfactory results (>75%). Nevertheless, the study findings highlight the need to improve certain program components. Additionally, long-term follow-ups is needed to provide a more thorough picture of the process for external quality assessment. .