Prevalence and incidence estimates for syphilis, chlamydia, gonorrhea, and congenital syphilis in Colombia, 1995–2016

[ABSTRACT]. Objectives. To estimate adult (15–49 years old) prevalence and incidence of active syphilis, gonorrhea, and chlamydia, and incidence of congenital syphilis (CS) and adverse birth outcomes (ABOs) in Colombia, over 1995–2016. Methods. The Spectrum-STI epidemiological model tool estimated gonorrhea and chlamydia prevalences as moving averages across prevalences observed in representative general population surveys. For adult syphilis, Spectrum-STI applied segmented polynomial regression through prevalence data from antenatal care (ANC) surveys, routine ANC-based screening, and general population surveys. CS cases and ABOs were estimated from Spectrum’s maternal syphilis estimates and proportions of women screened and treated for syphilis, applying World Health Organization case definitions and risk probabilities. Results. The Spectrum model estimated prevalences in 2016 of 0.70% (95% confidence interval (CI): 0.15%-1.9%) in women and 0.60% (0.1%-1.9%) in men for gonorrhea and of 9.2% (4.4%-15.4%) in women and 7.4% (3.5%-14.7%) in men for chlamydia, without evidence for trends over 1995–2016. The prevalence of active syphilis in 2016 was 1.25% (1.22–1.29%) in women and 1.25% (1.1%-1.4%) in men, decreasing from 2.6% (2.1%-3.2%) in women in 1995. Corresponding CS cases in 2016 (including cases without clinical symptoms) totaled 3 851, of which 2 245 were ABOs. Annual CS and ABO estimates decreased over 2008–2016, reflecting decreasing maternal prevalence and increasing cases averted through ANC-based screening and treatment. Conclusions. The available surveillance and monitoring data synthesized in Spectrum-STI—and the resulting first-ever national STI estimates for Colombia—highlighted Colombia’s persistently high STI burden. Adult syphilis and congenital syphilis are estimated to be falling, reflecting improving screening efforts. Strengthened surveillance, including with periodic screening in low-risk populations and future refined Spectrum estimations, should support planning and implementation of STI prevention and control, including CS elimination.

[RESUMEN]. Objetivos. Estimar la prevalencia e incidencia en los adultos (de 15 a 49 años de edad) de sífilis activa, gonorrea y clamidiasis, así como la incidencia de sífilis congénita y resultados adversos del embarazo en Colombia durante el período de 1995 al 2016. Métodos. Usando las herramientas del modelo epidemiológico Spectrum-STI se estimó la prevalencia de gonorrea y clamidiasis como promedios móviles entre las distintas prevalencias observadas en encuestas representativas de la población general. En cuanto a la sífilis en los adultos, Spectrum-STI aplicó la regresión polinomial segmentada a los datos sobre prevalencia recopilados en encuestas de atención prenatal, el tamizaje sistemático en la atención prenatal y encuestas a la población general. Los casos de sífilis congénita y de resultados adversos del embarazo se estimaron a partir de las cifras de Spectrum sobre sífilis materna y proporciones de mujeres examinadas y tratadas por sífilis, aplicando las definiciones de casos y probabilidades de riesgo de la Organización Mundial de la Salud. Resultados. El modelo Spectrum estimó que en el 2016 la prevalencia de la gonorrea fue de 0,70% (intervalo de confianza de 95% [IC]: 0,15%-1,9%) en las mujeres y de 0,60% (0,1%-1,9%) en los hombres, y que la prevalencia de la clamidiasis fue de 9,2% (4,4%-15,4%) en las mujeres y de 7,4% (3,5%-14,7%) en los hombres, sin datos científicos acerca de las tendencias durante el período 1995-2016. La prevalencia de la sífilis activa en el 2016 fue de 1,25% (1,22-1,29%) en las mujeres y de 1,25% (1,1%-1,4%) en los hombres, con una reducción de 2,6% (2,1%-3,2%) en las mujeres con respecto a 1995. Los casos correspondientes de sífilis congénita en el 2016 (incluidos los asintomáticos) sumaron en total 3 851, de los cuales 2 245 fueron resultados adversos del embarazo. Las cifras anuales estimadas de sífilis congénita y resultados adversos del embarazo disminuyeron entre el 2008 y el 2016, lo que reflejó un descenso en la prevalencia materna y un aumento de casos evitados mediante el tamizaje y el tratamiento durante la atención prenatal. Conclusiones. Los datos disponibles sobre vigilancia y seguimiento sintetizados en Spectrum‑STI, así como los consiguientes estimados nacionales de infecciones de transmisión sexual (ITS) hechos por primera vez en Colombia, pusieron de relieve la carga de morbilidad por ITS persistentemente alta en ese país. Se estima que la sífilis en los adultos y la sífilis congénita van en descenso, lo que refleja mejoras en las actividades de tamizaje. Un fortalecimiento de la vigilancia, incluso con tamizaje periódico en las poblaciones de bajo riesgo, y estimaciones más refinadas con Spectrum en el futuro deberían brindar apoyo a la planificación y la ejecución de medidas para la prevención y el control de las infecciones de transmisión sexual, incluida la eliminación de la sífilis congénita.

[RESUMO]. Objetivos. Estimar a incidência e a prevalência na população adulta (com idade de 15–49 anos) de sífilis ativa, gonorreia e clamídia e a incidência de sífilis congênita (SC) e desfechos adversos congênitos na Colômbia no período de 1995 a 2016. Métodos. O modelo epidemiológico Spectrum-STI foi o instrumento usado para estimar a prevalência de gonorreia e clamídia como médias móveis nas prevalências observadas em pesquisas representativas da população geral. A sífilis em adultos foi estimada com a regressão polinomial segmentada aplicada ao modelo Spectrum-STI com dados de prevalência obtidos de pesquisas da atenção pré-natal, exames pré-natais de rotina de detecção precoce e pesquisas da população geral. Casos de SC e desfechos adversos congênitos foram estimados a partir das estimativas de sífilis materna do modelo Spectrum e percentuais de mulheres que fizeram testes de detecção e foram tratadas para sífilis, segundo as definições de casos da Organização Mundial da Saúde (OMS) e probabilidades de risco. Resultados. O modelo Spectrum estimou, para 2016, uma prevalência de gonorreia de 0,70% (intervalo de confiança de 95% [IC 95%] 0,15%–1,9%) no sexo feminino e 0,60% (0,1%–1,9%) no sexo masculino e uma prevalência de clamídia de 9,2% (4,4%–15,4%) no sexo feminino e 7,4% (3,5%–14.7%) no sexo masculino, sem evidência de tendências no período 1995–2016. A prevalência de sífilis ativa em 2016 foi de 1,25% (1,22–1,29%) no sexo feminino e 1,25% (1,1%–1,4%) no sexo masculino, demonstrando um declínio da prevalência de 2,6% (2,1%–3,2%) observada em 1995 para o sexo feminino. Houve, ao todo, 3.851 casos correspondentes de SC em 2016 (incluindo casos assintomáticos), dos quais 2.245 foram desfechos adversos congênitos. Observou-se uma redução nas estimativas anuais de SC e desfechos adversos congênitos em 2008–2016, refletindo a diminuição da prevalência materna e o número crescente de casos evitados com exames pré-natais de detecção e tratamento. Conclusões. Os dados disponíveis de vigilância e monitoramento condensados no modelo Spectrum-STI, e as resultantes estimativas nacionais de infeções sexualmente transmissíveis (IST) obtidas pela primeira vez na Colômbia, evidenciam a alta carga persistente de IST no país. Estima-se que a ocorrência de sífilis do adulto e sífilis congénita esteja diminuindo em decorrência da melhoria nos esforços de detecção precoce. A vigilância reforçada, consistindo também de exames periódicos de detecção precoce nas populações de baixo risco e estimavas futuras aprimoradas do instrumento Spectrum, deve sustentar o planejamento e a implementação de controle e prevenção de IST e a eliminação da SC.

Prevalence and incidence estimates for syphilis, chlamydia, gonorrhea, and congenital syphilis in Colombia, 1995-2016.

OBJECTIVES: To estimate adult (15-49 years old) prevalence and incidence of active syphilis, gonorrhea, and chlamydia, and incidence of congenital syphilis (CS) and adverse birth outcomes (ABOs) in Colombia, over 1995-2016. METHODS: The Spectrum-STI epidemiological model tool estimated gonorrhea and chlamydia prevalences as moving averages across prevalences observed in representative general population surveys. For adult syphilis, Spectrum-STI applied segmented polynomial regression through prevalence data from antenatal care (ANC) surveys, routine ANC-based screening, and general population surveys. CS cases and ABOs were estimated from Spectrum's maternal syphilis estimates and proportions of women screened and treated for syphilis, applying World Health Organization case definitions and risk probabilities. RESULTS: The Spectrum model estimated prevalences in 2016 of 0.70% (95% confidence interval (CI): 0.15%-1.9%) in women and 0.60% (0.1%-1.9%) in men for gonorrhea and of 9.2% (4.4%-15.4%) in women and 7.4% (3.5%-14.7%) in men for chlamydia, without evidence for trends over 1995-2016. The prevalence of active syphilis in 2016 was 1.25% (1.22-1.29%) in women and 1.25% (1.1%-1.4%) in men, decreasing from 2.6% (2.1%-3.2%) in women in 1995. Corresponding CS cases in 2016 (including cases without clinical symptoms) totaled 3 851, of which 2 245 were ABOs. Annual CS and ABO estimates decreased over 2008-2016, reflecting decreasing maternal prevalence and increasing cases averted through ANC-based screening and treatment. CONCLUSIONS: The available surveillance and monitoring data synthesized in Spectrum-STI- and the resulting first-ever national STI estimates for Colombia-highlighted Colombia's persistently high STI burden. Adult syphilis and congenital syphilis are estimated to be falling, reflecting improving screening efforts. Strengthened surveillance, including with periodic screening in low-risk populations and future refined Spectrum estimations, should support planning and implementation of STI prevention and control, including CS elimination.

Prevalence and incidence estimates for syphilis, chlamydia, gonorrhea, and congenital syphilis in Colombia, 1995-2016 / Estimaciones sobre la prevalencia y la incidencia de sífilis, clamidiasis, gonorrea y sífilis congénita en Colombia, 1995-2016 / Estimativas da incidência e prevalência de sífilis, clamídia, gonorreia e sífilis congênita na Colômbia, 1995-2016

ABSTRACT Objectives To estimate adult (15-49 years old) prevalence and incidence of active syphilis, gonorrhea, and chlamydia, and incidence of congenital syphilis (CS) and adverse birth outcomes (ABOs) in Colombia, over 1995-2016. Methods The Spectrum-STI epidemiological model tool estimated gonorrhea and chlamydia prevalences as moving averages across prevalences observed in representative general population surveys. For adult syphilis, Spectrum-STI applied segmented polynomial regression through prevalence data from antenatal care (ANC) surveys, routine ANC-based screening, and general population surveys. CS cases and ABOs were estimated from Spectrum's maternal syphilis estimates and proportions of women screened and treated for syphilis, applying World Health Organization case definitions and risk probabilities. Results The Spectrum model estimated prevalences in 2016 of 0.70% (95% confidence interval (CI): 0.15%-1.9%) in women and 0.60% (0.1%-1.9%) in men for gonorrhea and of 9.2% (4.4%-15.4%) in women and 7.4% (3.5%-14.7%) in men for chlamydia, without evidence for trends over 1995-2016. The prevalence of active syphilis in 2016 was 1.25% (1.22-1.29%) in women and 1.25% (1.1%-1.4%) in men, decreasing from 2.6% (2.1%-3.2%) in women in 1995. Corresponding CS cases in 2016 (including cases without clinical symptoms) totaled 3 851, of which 2 245 were ABOs. Annual CS and ABO estimates decreased over 2008-2016, reflecting decreasing maternal prevalence and increasing cases averted through ANC-based screening and treatment. Conclusions The available surveillance and monitoring data synthesized in Spectrum-STI— and the resulting first-ever national STI estimates for Colombia—highlighted Colombia's persistently high STI burden. Adult syphilis and congenital syphilis are estimated to be falling, reflecting improving screening efforts. Strengthened surveillance, including with periodic screening in low-risk populations and future refined Spectrum estimations, should support planning and implementation of STI prevention and control, including CS elimination.

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RESUMO Objetivos Estimar a incidência e a prevalência na população adulta (com idade de 15-49 anos) de sífilis ativa, gonorreia e clamídia e a incidência de sífilis congênita (SC) e desfechos adversos congênitos na Colômbia no período de 1995 a 2016. Métodos O modelo epidemiológico Spectrum-STI foi o instrumento usado para estimar a prevalência de gonorreia e clamídia como médias móveis nas prevalências observadas em pesquisas representativas da população geral. A sífilis em adultos foi estimada com a regressão polinomial segmentada aplicada ao modelo Spectrum-STI com dados de prevalência obtidos de pesquisas da atenção pré-natal, exames pré-natais de rotina de detecção precoce e pesquisas da população geral. Casos de SC e desfechos adversos congênitos foram estimados a partir das estimativas de sífilis materna do modelo Spectrum e percentuais de mulheres que fizeram testes de detecção e foram tratadas para sífilis, segundo as definições de casos da Organização Mundial da Saúde (OMS) e probabilidades de risco. Resultados O modelo Spectrum estimou, para 2016, uma prevalência de gonorreia de 0,70% (intervalo de confiança de 95% [IC 95%] 0,15%-1,9%) no sexo feminino e 0,60% (0,1%-1,9%) no sexo masculino e uma prevalência de clamídia de 9,2% (4,4%-15,4%) no sexo feminino e 7,4% (3,5%-14.7%) no sexo masculino, sem evidência de tendências no período 1995-2016. A prevalência de sífilis ativa em 2016 foi de 1,25% (1,22-1,29%) no sexo feminino e 1,25% (1,1%-1,4%) no sexo masculino, demonstrando um declínio da prevalência de 2,6% (2,1%-3,2%) observada em 1995 para o sexo feminino. Houve, ao todo, 3.851 casos correspondentes de SC em 2016 (incluindo casos assintomáticos), dos quais 2.245 foram desfechos adversos congênitos. Observou-se uma redução nas estimativas anuais de SC e desfechos adversos congênitos em 2008-2016, refletindo a diminuição da prevalência materna e o número crescente de casos evitados com exames pré-natais de detecção e tratamento. Conclusões Os dados disponíveis de vigilância e monitoramento condensados no modelo Spectrum-STI, e as resultantes estimativas nacionais de infeções sexualmente transmissíveis (IST) obtidas pela primeira vez na Colômbia, evidenciam a alta carga persistente de IST no país. Estima-se que a ocorrência de sífilis do adulto e sífilis congênita esteja diminuindo em decorrência da melhoria nos esforços de detecção precoce. A vigilância reforçada, consistindo também de exames periódicos de detecção precoce nas populações de baixo risco e estimavas futuras aprimoradas do instrumento Spectrum, deve sustentar o planejamento e a implementação de controle e prevenção de IST e a eliminação da SC.

Comparative effectiveness of single and dual rapid diagnostic tests for syphilis and HIV in antenatal care services in Colombia / Comparación de la eficacia de la prueba rápida individual y la prueba rápida dual para el diagnóstico de la sífilis y la infección por el VIH en los servicios de atención prenatal en Colombia

Objective. To assess the effectiveness of a dual rapid test compared to a single rapid test for syphilis and HIV screening. Methods. A cluster-randomized open-label clinical trial was performed in 12 public antenatal care (ANC) centers in the cities of Bogotá and Cali, Colombia. Pregnant women who were over 14 years of age at their first antenatal visit and who had not been previously tested for HIV and syphilis during the current pregnancy were included. Pregnant women were randomized to single HIV and single syphilis rapid diagnostic tests (Arm A) or to dual HIV and syphilis rapid diagnostic tests (Arm B). The four main outcomes measured were: (1) acceptability of the test, (2) uptake in testing, (3) treatment on the same day (that is, timely treatment), and (4) treatment at any time for positive rapid test cases. Bivariate and multivariate analyses were calculated to adjust for the clustering effect and the period. Results. A total of 1 048 patients were analyzed in Arm A, and 1 166 in Arm B. Acceptability of the rapid tests was 99.8% in Arm A and 99.6% in Arm B. The prevalence of positive rapid tests was 2.21% for syphilis and 0.36% for HIV. Timely treatment was provided to 20 of 29 patients (69%) in Arm A and 16 of 20 patients (80%) in Arm B (relative risk (RR), 1.10; 95% confidence interval (CI): (1.00 −1.20). Treatment at any time was given to 24 of 29 patients (83%) in Arm A and to 20 of 20 (100%) in Arm B (RR, 1.11; 95% CI: 1.01−1.22). Conclusions. There were no differences in patient acceptability, testing and timely treatment between dual rapid tests and single rapid tests for HIV and syphilis screening in the ANC centers. Same-day treatment depends also on the interpretation of and confidence in the results by the health providers.

Objetivo. Evaluar la eficacia de la prueba rápida dual en comparación con la prueba rápida individual para la detección sistemática de la sífilis y la infección por el VIH. Métodos. Se realizó un ensayo clínico sin enmascaramiento y aleatorizado por grupos en 12 centros públicos de atención prenatal en las ciudades de Bogotá y Cali (Colombia). Se incluyó a las mujeres embarazadas de 14 o más años de edad que asistían a su primera consulta prenatal y no se habían realizado pruebas en este embarazo. Las embarazadas se dividieron de forma aleatoria para realizarles las pruebas rápidas individuales para el diagnóstico de sífilis y de infección por el VIH (Grupo A) o la prueba rápida dual para el diagnóstico de la sífilis y la infección por el VIH (Grupo B). Se midieron principalmente cuatro resultados: (1) aceptabilidad de la prueba, (2) uso de los servicios de prueba, (3) tratamiento el mismo día (es decir, tratamiento oportuno) y (4) tratamiento en cualquier momento en los casos con resultados positivos en las pruebas rápidas. Se realizaron análisis bifactoriales y multifactoriales para hacer los ajustes pertinentes por el efecto de la división en grupos y el período. Resultados. Se estudió a 1 048 pacientes en el Grupo A y a 1 166 en el Grupo B. La aceptabilidad de las pruebas rápidas fue de 99,8% en el Grupo A y 99,6% en el Grupo B. La prevalencia de resultados positivos en las pruebas rápidas fue de 2,21% para la sífilis y 0,36% para la infección por el VIH. Se administró tratamiento oportuno a 20 de 29 pacientes (69%) del Grupo A y a 16 de 20 pacientes (80%) del Grupo B (riesgo relativo, 1,10; intervalo de confianza de 95% (IC): 1,00-1,20). Se administró tratamiento en cualquier momento a 24 de 29 pacientes (83%) del Grupo A y a 20 de 20 (100%) del Grupo B (riesgo relativo, 1,11; IC de 95%: 1,01-1,22). Conclusiones. No hubo diferencias en cuanto a la aceptabilidad por parte de los pacientes, y el uso de los servicios de cribaje y el tratamiento oportuno entre las pruebas rápidas duales y las pruebas rápidas individuales para la detección sistemática de la sífilis y la infección por el VIH en los centros de atención prenatal. El tratamiento el mismo día depende también de la interpretación y la confianza en los resultados del trabajador de salud.

Introducción de pruebas rápidas para sífilis y VIH en el control prenatal en Colombia: análisis cualitativo / Introduction of rapid syphilis and HIV testing in prenatal care in Colombia: qualitative analysis

Objetivo. Interpretar la percepción de profesionales sanitarios de Colombia sobre las barreras y los facilitadores para la introducción de las pruebas rápidas para sífilis y virus de la inmunodeficiencia humana (VIH) en los servicios de control prenatal. Métodos. Se aplicó una metodología cualitativa basada en entrevistas semiestructuradas. Se seleccionó una muestra de conveniencia de 37 participantes, que incluyó profesionales sanitarios vinculados a servicios de control prenatal, programas para gestantes, laboratorios clínicos y directores de unidades o centros asistenciales, así como representantes de las direcciones territoriales y del Ministerio de Salud y Protección Social. Resultados. En Colombia no hay un uso generalizado del tamizaje con pruebas rápidas para sífilis y VIH en el control prenatal. Los entrevistados manifestaron no tener experiencia previa en el uso de pruebas rápidas —excepto el personal de laboratorio— y sobre el curso de acción ante un resultado positivo. El sistema de aseguramiento de salud dificulta el acceso al diagnóstico y el tratamiento oportunos. Las autoridades de salud perciben como necesaria la revisión de la normativa existente, a fin de fortalecer el primer nivel de atención y promover el control prenatal integral. Los participantes recomendaron la capacitación del personal y la integración entre instancias de formulación de políticas de salud y académicas para actualizar los currículos de formación. Conclusiones. El enfoque de mercado y las características del sistema de salud colombiano constituyen la principal barrera para la implementación de las pruebas rápidas como estrategia para la eliminación de la transmisión materno-infantil de sífilis y VIH. Entre las medidas identificadas están: realizar cambios en la contratación entre las aseguradoras y las instituciones prestadoras de servicios, adecuar los tiempos y la organización de los procedimientos de atención, y capacitar al personal médico y de enfermería vinculado al control prenatal en la interpretación y acción con pruebas rápidas para sífilis y VIH.

Objective. Interpret perceptions of Colombian health professionals concerning factors that obstruct and facilitate the introduction of rapid syphilis and HIV testing in prenatal care services. Methods. A qualitative study based on semi-structured interviews was carried out. A convenience sample was selected with 37 participants, who included health professionals involved in prenatal care services, programs for pregnant women, clinical laboratories, and directors of health care units or centers, as well as representatives from regional departments and the Ministry of Health. Results. Colombia does not do widespread screening with rapid syphilis and HIV tests in prenatal care. The professionals interviewed stated they did not have prior experience in the use of rapid tests—except for laboratory staff—or in the course of action in response to a positive result. The insurance system hinders access to timely diagnosis and treatment. Health authorities perceive a need to review existing standards, strengthen the first level of care, and promote comprehensive prenatal care starting with contracts between insurers and health service institutional providers. Participants recommended staff training and integration between health-policymaking and academic entities for updating training programs. Conclusions. The market approach and the characteristics of the Colombian health system constitute the main barriers to implementation of rapid testing as a strategy for elimination of mother-to-child transmission of syphilis and HIV. Measures identified include making changes in contracts between insurers and health service institutional providers, adapting the timing and duration of prenatal care procedures, and training physicians and nurses involved in prenatal care.

Introducción de pruebas rápidas para sífilis y VIH en el control prenatal en Colombia: análisis cualitativo / Introduction of rapid syphilis and HIV testing in prenatal care in Colombia: qualitative analysis

RESUMEN Objetivo Interpretar la percepción de profesionales sanitarios de Colombia sobre las barreras y los facilitadores para la introducción de las pruebas rápidas para sífilis y virus de la inmunodeficiencia humana (VIH) en los servicios de control prenatal. Métodos Se aplicó una metodología cualitativa basada en entrevistas semiestructuradas. Se seleccionó una muestra de conveniencia de 37 participantes, que incluyó profesionales sanitarios vinculados a servicios de control prenatal, programas para gestantes, laboratorios clínicos y directores de unidades o centros asistenciales, así como representantes de las direcciones territoriales y del Ministerio de Salud y Protección Social. Resultados En Colombia no hay un uso generalizado del tamizaje con pruebas rápidas para sífilis y VIH en el control prenatal. Los entrevistados manifestaron no tener experiencia previa en el uso de pruebas rápidas —excepto el personal de laboratorio— y sobre el curso de acción ante un resultado positivo. El sistema de aseguramiento de salud dificulta el acceso al diagnóstico y el tratamiento oportunos. Las autoridades de salud perciben como necesaria la revisión de la normativa existente, a fin de fortalecer el primer nivel de atención y promover el control prenatal integral. Los participantes recomendaron la capacitación del personal y la integración entre instancias de formulación de políticas de salud y académicas para actualizar los currículos de formación. Conclusiones El enfoque de mercado y las características del sistema de salud colombiano constituyen la principal barrera para la implementación de las pruebas rápidas como estrategia para la eliminación de la transmisión materno-infantil de sífilis y VIH. Entre las medidas identificadas están: realizar cambios en la contratación entre las aseguradoras y las instituciones prestadoras de servicios, adecuar los tiempos y la organización de los procedimientos de atención, y capacitar al personal médico y de enfermería vinculado al control prenatal en la interpretación y acción con pruebas rápidas para sífilis y VIH.

ABSTRACT Objective Interpret perceptions of Colombian health professionals concerning factors that obstruct and facilitate the introduction of rapid syphilis and HIV testing in prenatal care services. Methods A qualitative study based on semi-structured interviews was carried out. A convenience sample was selected with 37 participants, who included health professionals involved in prenatal care services, programs for pregnant women, clinical laboratories, and directors of health care units or centers, as well as representatives from regional departments and the Ministry of Health. Results Colombia does not do widespread screening with rapid syphilis and HIV tests in prenatal care. The professionals interviewed stated they did not have prior experience in the use of rapid tests—except for laboratory staff—or in the course of action in response to a positive result. The insurance system hinders access to timely diagnosis and treatment. Health authorities perceive a need to review existing standards, strengthen the first level of care, and promote comprehensive prenatal care starting with contracts between insurers and health service institutional providers. Participants recommended staff training and integration between health-policymaking and academic entities for updating training programs. Conclusions The market approach and the characteristics of the Colombian health system constitute the main barriers to implementation of rapid testing as a strategy for elimination of mother-to-child transmission of syphilis and HIV. Measures identified include making changes in contracts between insurers and health service institutional providers, adapting the timing and duration of prenatal care procedures, and training physicians and nurses involved in prenatal care.

Comparative effectiveness of single and dual rapid diagnostic tests for syphilis and HIV in antenatal care services in Colombia / Comparación de la eficacia de la prueba rápida individual y la prueba rápida dual para el diagnóstico de la sífilis y la infección por el VIH en los servicios de atención prenatal en Colombia

ABSTRACT Objective To assess the effectiveness of a dual rapid test compared to a single rapid test for syphilis and HIV screening. Methods A cluster-randomized open-label clinical trial was performed in 12 public antenatal care (ANC) centers in the cities of Bogotá and Cali, Colombia. Pregnant women who were over 14 years of age at their first antenatal visit and who had not been previously tested for HIV and syphilis during the current pregnancy were included. Pregnant women were randomized to single HIV and single syphilis rapid diagnostic tests (Arm A) or to dual HIV and syphilis rapid diagnostic tests (Arm B). The four main outcomes measured were: (1) acceptability of the test, (2) uptake in testing, (3) treatment on the same day (that is, timely treatment), and (4) treatment at any time for positive rapid test cases. Bivariate and multivariate analyses were calculated to adjust for the clustering effect and the period. Results A total of 1 048 patients were analyzed in Arm A, and 1 166 in Arm B. Acceptability of the rapid tests was 99.8% in Arm A and 99.6% in Arm B. The prevalence of positive rapid tests was 2.21% for syphilis and 0.36% for HIV. Timely treatment was provided to 20 of 29 patients (69%) in Arm A and 16 of 20 patients (80%) in Arm B (relative risk (RR), 1.10; 95% confidence interval (CI): (1.00 −1.20). Treatment at any time was given to 24 of 29 patients (83%) in Arm A and to 20 of 20 (100%) in Arm B (RR, 1.11; 95% CI: 1.01−1.22). Conclusions There were no differences in patient acceptability, testing and timely treatment between dual rapid tests and single rapid tests for HIV and syphilis screening in the ANC centers. Same-day treatment depends also on the interpretation of and confidence in the results by the health providers.

RESUMEN Objetivo Evaluar la eficacia de la prueba rápida dual en comparación con la prueba rápida individual para la detección sistemática de la sífilis y la infección por el VIH. Métodos Se realizó un ensayo clínico sin enmascaramiento y aleatorizado por grupos en 12 centros públicos de atención prenatal en las ciudades de Bogotá y Cali (Colombia). Se incluyó a las mujeres embarazadas de 14 o más años de edad que asistían a su primera consulta prenatal y no se habían realizado pruebas en este embarazo. Las embarazadas se dividieron de forma aleatoria para realizarles las pruebas rápidas individuales para el diagnóstico de sífilis y de infección por el VIH (Grupo A) o la prueba rápida dual para el diagnóstico de la sífilis y la infección por el VIH (Grupo B). Se midieron principalmente cuatro resultados: (1) aceptabilidad de la prueba, (2) uso de los servicios de prueba, (3) tratamiento el mismo día (es decir, tratamiento oportuno) y (4) tratamiento en cualquier momento en los casos con resultados positivos en las pruebas rápidas. Se realizaron análisis bifactoriales y multifactoriales para hacer los ajustes pertinentes por el efecto de la división en grupos y el período. Resultados Se estudió a 1 048 pacientes en el Grupo A y a 1 166 en el Grupo B. La aceptabilidad de las pruebas rápidas fue de 99,8% en el Grupo A y 99,6% en el Grupo B. La prevalencia de resultados positivos en las pruebas rápidas fue de 2,21% para la sífilis y 0,36% para la infección por el VIH. Se administró tratamiento oportuno a 20 de 29 pacientes (69%) del Grupo A y a 16 de 20 pacientes (80%) del Grupo B (riesgo relativo, 1,10; intervalo de confianza de 95% (IC): 1,00-1,20). Se administró tratamiento en cualquier momento a 24 de 29 pacientes (83%) del Grupo A y a 20 de 20 (100%) del Grupo B (riesgo relativo, 1,11; IC de 95%: 1,01-1,22). Conclusiones No hubo diferencias en cuanto a la aceptabilidad por parte de los pacientes, y el uso de los servicios de cribaje y el tratamiento oportuno entre las pruebas rápidas duales y las pruebas rápidas individuales para la detección sistemática de la sífilis y la infección por el VIH en los centros de atención prenatal. El tratamiento el mismo día depende también de la interpretación y la confianza en los resultados del trabajador de salud.

Comparative effectiveness of single and dual rapid diagnostic tests for syphilis and HIV in antenatal care services in Colombia.

OBJECTIVE: To assess the effectiveness of a dual rapid test compared to a single rapid test for syphilis and HIV screening. METHODS: A cluster-randomized open-label clinical trial was performed in 12 public antenatal care (ANC) centers in the cities of Bogotá and Cali, Colombia. Pregnant women who were over 14 years of age at their first antenatal visit and who had not been previously tested for HIV and syphilis during the current pregnancy were included. Pregnant women were randomized to single HIV and single syphilis rapid diagnostic tests (Arm A) or to dual HIV and syphilis rapid diagnostic tests (Arm B). The four main outcomes measured were: (1) acceptability of the test, (2) uptake in testing, (3) treatment on the same day (that is, timely treatment), and (4) treatment at any time for positive rapid test cases. Bivariate and multivariate analyses were calculated to adjust for the clustering effect and the period. RESULTS: A total of 1 048 patients were analyzed in Arm A, and 1 166 in Arm B. Acceptability of the rapid tests was 99.8% in Arm A and 99.6% in Arm B. The prevalence of positive rapid tests was 2.21% for syphilis and 0.36% for HIV. Timely treatment was provided to 20 of 29 patients (69%) in Arm A and 16 of 20 patients (80%) in Arm B (relative risk (RR), 1.10; 95% confidence interval (CI): (1.00 -1.20). Treatment at any time was given to 24 of 29 patients (83%) in Arm A and to 20 of 20 (100%) in Arm B (RR, 1.11; 95% CI: 1.01-1.22). CONCLUSIONS: There were no differences in patient acceptability, testing and timely treatment between dual rapid tests and single rapid tests for HIV and syphilis screening in the ANC centers. Same-day treatment depends also on the interpretation of and confidence in the results by the health providers.

[Introduction of rapid syphilis and HIV testing in prenatal care in Colombia: qualitative analysis]. / Introducción de pruebas rápidas para sífilis y VIH en el control prenatal en Colombia: análisis cualitativo.

OBJECTIVE: Interpret perceptions of Colombian health professionals concerning factors that obstruct and facilitate the introduction of rapid syphilis and HIV testing in prenatal care services. METHODS: A qualitative study based on semi-structured interviews was carried out. A convenience sample was selected with 37 participants, who included health professionals involved in prenatal care services, programs for pregnant women, clinical laboratories, and directors of health care units or centers, as well as representatives from regional departments and the Ministry of Health. RESULTS: Colombia does not do widespread screening with rapid syphilis and HIV tests in prenatal care. The professionals interviewed stated they did not have prior experience in the use of rapid tests-except for laboratory staff-or in the course of action in response to a positive result. The insurance system hinders access to timely diagnosis and treatment. Health authorities perceive a need to review existing standards, strengthen the first level of care, and promote comprehensive prenatal care starting with contracts between insurers and health service institutional providers. Participants recommended staff training and integration between health-policymaking and academic entities for updating training programs. CONCLUSIONS: The market approach and the characteristics of the Colombian health system constitute the main barriers to implementation of rapid testing as a strategy for elimination of mother-to-child transmission of syphilis and HIV. Measures identified include making changes in contracts between insurers and health service institutional providers, adapting the timing and duration of prenatal care procedures, and training physicians and nurses involved in prenatal care.

Reducción de la transmisión madre hijo del VIH en Colombia: dos años de experiencia nacional, 2003-2005 / Reduction of VIH mother-to-child transmission in Colombia, two years of experience, 2003-2005

Introducción. Desde el 2003, en Colombia se desarrolla el Proyecto Nacional de Reducción de la Transmisión Madre Hijo de VIH, cuyo objetivo es prevenir la transmisión vertical de VIH mediante la incorporación de la prueba voluntaria de VIH durante el control prenatal, el tratamiento y la profilaxis antirretroviral en la gestante infectada y el niño expuesto, el parto por cesárea y la sustitución de la leche materna. Objetivo. Describir los resultados de la implementación de la estrategia de prevención de la transmisión madre hijo 2003-2005. Materiales y métodos. Se hizo el estudio descriptivo de la cobertura alcanzada, la probabilidad de transmisión vertical y los factores asociados y prevalencias registradas en cada departamento. Se exploró la probabilidad de transmisión según tratamiento y se identificaron las diferencias por regiones. Resultados. El proyecto se implementó en 757 municipios (68 por ciento), en los cuales se realizó la prueba de VIH a 200.853 gestantes, y se detectaron 377 infectadas (0,19 por ciento en la región Caribe, en Quindío y en Santander. Se completó el seguimiento a 285 mujeres y sus hijos, y se registraron 12 casos en niños. La probabilidad de transmisión con el suministro oportuno del protocolo (n=170) fue de 1,78 por ciento(IC95 por ciento: 0,37 a 5,13 por ciento). Los factores relacionados con la transmisión fueron: carga viral inicial mayor de 10.000/mm3, ausencia de control prenatal y captación tardía en el embarazo. No se encontraron diferencias estadísticas entre los esquemas antirretrovirales utilizados. La región Caribe tuvo menor cobertura del control prenatal py mayor captación tardía. Conclusiones. La reducción de la transmisión madre hijo de VIH es una intervención preventiva eficaz que favorece el fortalecimiento de los servicios de control prenatal. El sostenimiento de la estrategia con cobertura nacional debe ser una meta de los gobiernos nacional y regionales y de las entidades aseguradoras

[Reduction of HIV mother-to-child transmission in Colombia, two years of experience, 2003-2005]. / Reducción de la transmisión madre hijo del VIH en Colombia: dos años de experiencia nacional, 2003-2005.

INTRODUCTION: A national initiative on reduction of HIV mother-to-child-transmission is being implemented since 2003 in Colombia, including HIV counseled and voluntary testing as part of the routine antenatal care, comprehensive care with ARV treatment to HIV-positive pregnant women and their infected children, caesarian delivery, and replacement of breast milk. OBJECTIVE: To describe the achievements in the implementation of the prevention strategy of mother-to-child HIV transmission, 2003-2005. MATERIALS AND METHODS: The implementation procedures of the Project are described, as well as the coverage percentages achieved, the prevention of vertical transmission and its associated factors, and the six-month prevalence by geographical departments. The probability of transmission adjusted to the ARV treatment offered and the differences by regions are also analyzed. RESULTS: The Project was implemented in 757 municipalities (68%); diagnostic tests were performed to 200,853 pregnant women, 377 of whom were diagnosed as HIV positive (0.19%), with higher prevalences in the Caribbean region, and in the Departments of Quindio and Santander. Complete six-month follow-up after delivery was provided to 285 women and their neonates (12 of whom were HIV-positive). The probability of transmission with the use of ARV schemes during pregnancy (n=170) was 1.78% (IC 95%: 0.37-5.13%). Factors related to probability of transmission were: initial viral load > 10,000/mm3, absence of antenatal care, and late recruitment of pregnant women. No statistical differences were found between the ARV schemes used. In the Caribbean region, antenatal care was lower, and late recruitment of pregnant women was higher. CONCLUSIONS: Reduction of HIV mother-to-child-transmission is an effective preventive intervention, which also strengthens the quality of antenatal care services. Sustainability of this initiative, with nationwide coverage, must be a target for national and regional public health authorities, and for health care providers.