Treatment of Retinopathy of Prematurity with topical ketorolac tromethamine: a preliminary study

BACKGROUND: Retinopathy of Prematurity (ROP) is a common retinal neovascular disorder of premature infants. It is of variable severity, usually heals with mild or no sequelae, but may progress to blindness from retinal detachments or severe retinal scar formation. This is a preliminary report of the effectiveness and safety of a new and original use of topical ketorolac in preterm newborn to prevent the progression of ROP to the more severe forms of this disease. METHODS: From January 2001 to December 2002, all fifty nine preterm newborns with birthweight less than 1250 grams or gestational age less than 30 weeks of gestational age admitted to neonatal intensive care were eligible for treatment with topical ketorolac (0.25 milligrams every 8 hours in each eye). The historical comparison group included all 53 preterm newborns, with the same inclusion criteria, admitted between January 1999 and December 2000. RESULTS: Groups were comparable in terms of weight distribution, Apgar score at 5 minutes, incidence of sepsis, intraventricular hemorrhage and necrotizing enterocolitis. The duration of oxygen therapy was significantly longer in the control group. In the ketorolac group, among 43 children that were alive at discharge, one (2.3%) developed threshold ROP and cryotherapy was necessary. In the comparison group 35 children survived, and six child (17%) needed cryotherapy (Relative Risk 0.14, 95%CI 0.00 to 0.80, p = 0.041). Adjusting by duration of oxygen therapy did not significantly change these results. Adverse effects attributable to ketorolac were not detected. CONCLUSIONS: This preliminary report suggests that ketorolac in the form of an ophthalmic solution can reduce the risk of developing severe ROP in very preterm newborns, without producing significant adverse side effects. These results, although promising, should be interpreted with caution because of the weakness of the study design. This is an inexpensive and simple intervention that might ameliorate the progression of a disease with devastating consequences for children and their families. We believe that next logical step would be to assess the effectiveness of this intervention in a randomized controlled trial of adequate sample size

Zika virus infection in pregnant women in Honduras: study protocol

Background: Although there is increasing evidence for a relationship between symptomatic Zika virus (ZIKV) maternal infection, and microcephaly, a firm causal relation has yet to be established by epidemiologic studies. Studies also need to be conducted in recently infected settings. Our objectives are to assess the frequency of ZIKV infection during pregnancy in Honduras and the association of microcephaly with ZIKV infection. Methods/Design: We will perform a prospective study enrolling pregnant women at their first antenatal visit and following them up until delivery. At the time of enrollment, women will be interviewed to collect socio-demographic data, data needed to locate them for potential additional follow-up, and data about ZIKV symptoms during pregnancy. We will also collect maternal blood as soon as possible after enrollment. A probable maternal ZIKV infection will be defined as positive for maternal ZIKV IgM. A confirmed maternal ZIKV infection will be defined as positive for ZIKV IgM confirmed by plaque reduction neutralization test. Microcephaly at birth will be defined as an occipito-frontal circumference <2SD for sex and gestational age. Our objective is to enroll 2000 pregnant women. In a first step, we will follow a case cohort design and only analyze blood samples for cases and a sub-cohort of 200 women randomly selected. Blood samples for the entire population will be analyzed at a later stage if funds are available. Discussion: This protocol was designed to be implemented with minimal resources. It allows a cohort to be built, which could be a foundation for future in-depth and follow-up studies.Fil: Buekens, Pierre. University of Tulane; Estados UnidosFil: Alger, Jackeline. Universidad Nacional Autónoma de Honduras; HondurasFil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Bustillo, Carolina. Hospital Escuela. Departamento de Ginecología y Obstetricia; HondurasFil: Cafferata, Maria Luisa. Hospital de Clínicas. Unidad de Investigación Clínica y Epidemiológica Montevideo; UruguayFil: Harville, Emily. University of Tulane; Estados UnidosFil: Rosales, Karla. Región Sanitaria Metropolitana Distrito Central de Francisco Morazán; HondurasFil: Wesson, Dawn M.. University of Tulane; Estados UnidosFil: Zuniga, Concepcion. Hospital Escuela Universitario. Instituto de Enfermedades Infecciosas y Parasitología Antonio Vidal; Hondura

Factors associated with HIV and syphilis screenings among pregnant women at first antenatal visit in Lusaka, Zambia

Objectives: To identify characteristics associated with obtaining HIV and syphilis screenings of pregnant women attending a first antenatal visit in Lusaka, Zambia. Results: Among 18,231 participants from April 2015 to January 2016, 95% obtained HIV screening, 29% obtained syphilis screening, and 4% did not obtain antenatal HIV or syphilis screenings. Divorced/separated women were associated with a moderate decrease in prevalence of obtaining HIV (adjusted prevalence ratio (aPR) 0.88, 95% confidence interval (95% CI) 0.82, 0.95) and syphilis (aPR 0.51, 95% CI 0.27, 0.96) screenings compared to married women. Women with previous pregnancies were associated with a slight decrease in prevalence of obtaining HIV screening (aPR 0.97, 95% CI 0.95, 0.99) compared to women without previous pregnancy. Older women ≥ 35 years were associated with a slight decrease in prevalence of obtaining HIV screening (aPR 0.96, 95% CI 0.92, 0.99) compared to younger women. The statistically significant differences were not of clinical relevance as defined by a proportional difference of 10 percent. Findings of this study show that a vast majority of pregnant women are obtaining HIV screenings but not syphilis screenings during first antenatal visit. Provision of antenatal HIV and syphilis screening at first visit is only weakly related to patient level factors.Fil: Davis, Rindcy. University of Tulane; Estados UnidosFil: Xiong, Xu. University of Tulane; Estados UnidosFil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; ArgentinaFil: Lefante, John. University of Tulane; Estados UnidosFil: Cafferata, Maria Luisa. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Mwenechanya, Musaku. University Teaching Hospital Lusaka; ZambiaFil: Mwanakalanga, Friday Habulembe. University Teaching Hospital Lusaka; ZambiaFil: Chomba, Elwyn. University Teaching Hospital Lusaka; ZambiaFil: Buekens, Pierre. University of Tulane; Estados Unido

Geographic Variations in Test Reactivity for the Serological Diagnosis of Trypanosoma cruzi Infection

Chagas disease is a neglected disease caused by Trypanosoma cruzi parasites. Most diagnosis is based on serological tests, but the lack of a gold standard test complicates the measurement of test performance. To overcome this limitation, we used samples from a cohort of well-characterized T. cruzi-infected women to evaluate the reactivity of two rapid diagnostic tests and one enzyme-linked immunosorbent assay (ELISA). Our cohort was derived from a previous study on congenital transmission of T. cruzi and consisted of 481 blood/plasma samples from Argentina (n = 149), Honduras (n = 228), and Mexico (n = 104), with at least one positive T. cruzi PCR. Reactivity of the three tests ranged from 70.5% for the Wiener ELISA to 81.0% for the T-Detect and 90.4% for the Stat-Pak rapid tests. Test reactivity varied significantly among countries and was highest in Argentina and lowest in Mexico. When considering at least two reactive serological tests to confirm seropositivity, over 12% of T. cruzi infection cases from Argentina were missed by serological tests, over 21% in Honduras, and an alarming 72% in Mexico. Differences in test performance among countries were not due to differences in parasitemia, but differences in antibody levels against ELISA antigens were observed. Geographic differences in T. cruzi parasite strains as well as genetic differences among human populations both may contribute to the discrepancies in serological testing. Improvements in serological diagnostics for T. cruzi infections are critically needed to ensure an optimum identification of cases.Fil: Truyens, Carine. Université Libre de Bruxelles; BélgicaFil: Dumonteil, Eric. University of Tulane; Estados UnidosFil: Alger, Jackeline. Universidad Nacional Autónoma de Honduras; HondurasFil: Cafferata, Maria Luisa. No especifíca;Fil: Ciganda, Alvaro. No especifíca;Fil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Herrera, Claudia. University of Tulane; Estados UnidosFil: Sosa-Estani, Sergio Alejandro. Consejo Nacional de Investigaciones Científicas y Técnicas. Oficina de Coordinación Administrativa Parque Centenario. Centro de Investigaciones en Epidemiología y Salud Pública. Instituto de Efectividad Clínica y Sanitaria. Centro de Investigaciones en Epidemiología y Salud Pública; Argentina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Buekens, Pierre. University of Tulane; Estados Unido

Implementation of evidence-based antenatal care in Mozambique: a cluster randomized controlled trial: study protocol

Background: Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher. WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country. Methods: This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected healthcare practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected healthcare practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices. This demonstration project is pragmatic in orientation and will be conducted under routine conditions. Discussion: There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries. This can only be accomplished by the engagement of the country’s health stakeholders at all levels. This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels: policy, organizational and health care delivery levels. The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in ‘habits’ will contribute to obtaining reliable health indicators, not only related to research issues, but also to health care outcomes derived from the new health care model. At policy level, the results of this study may suggest a need for revision of the supply chain management system. Given that supply chain management is a major challenge for many low-resource countries, we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings, will be drawn from this study

Implementation of evidence-based antenatal care in Mozambique : a cluster randomized controlled trial: study protocol

Background: Antenatal care (ANC) reduces maternal and perinatal morbidity and mortality directly through the detection and treatment of pregnancy-related illnesses, and indirectly through the detection of women at increased risk of delivery complications. The potential benefits of quality antenatal care services are most significant in low-resource countries where morbidity and mortality levels among women of reproductive age and neonates are higher. WHO developed an ANC model that recommended the delivery of services scientifically proven to improve maternal, perinatal and neonatal outcomes. The aim of this study is to determine the effect of an intervention designed to increase the use of the package of evidence-based services included in the WHO ANC model in Mozambique. The primary hypothesis is that the intervention will increase the use of evidence-based practices during ANC visits in comparison to the standard dissemination channels currently used in the country. Methods: This is a demonstration project to be developed through a facility-based cluster randomized controlled trial with a stepped wedge design. The intervention was tailored, based on formative research findings, to be readily applicable to local prenatal care services and acceptable to local pregnant women and health providers. The intervention includes four components: the provision of kits with all necessary medicines and laboratory supplies for ANC (medical and non-medical equipment), a storage system, a tracking system, and training sessions for health care providers. Ten clinics were selected and will start receiving the intervention in a random order. Outcomes will be computed at each time point when a new clinic starts the intervention. The primary outcomes are the delivery of selected health care practices to women attending the first ANC visit, and secondary outcomes are the delivery of selected health care practices to women attending second and higher ANC visits as well as the attitude of midwives in relation to adopting the practices. This demonstration project is pragmatic in orientation and will be conducted under routine conditions. Discussion: There is an urgent need for effective and sustainable scaling-up approaches of health interventions in low-resource countries. This can only be accomplished by the engagement of the country's health stakeholders at all levels. This project aims to achieve improvement in the quality of antenatal care in Mozambique through the implementation of a multifaceted intervention on three levels: policy, organizational and health care delivery levels. The implementation of the trial will probably require a change in accountability and behaviour of health care providers and we expect this change in 'habits' will contribute to obtaining reliable health indicators, not only related to research issues, but also to health care outcomes derived from the new health care model. At policy level, the results of this study may suggest a need for revision of the supply chain management system. Given that supply chain management is a major challenge for many low-resource countries, we envisage that important lessons on how to improve the supply chain in Mozambique and other similar settings, will be drawn from this study

Use of a rapid test on umbilical cord blood to screen for Trypanosoma cruzi infection in pregnant women in Argentina, Bolivia, Honduras, and Mexico

Fil: Sosa-Estani, Sergio. ANLIS Dr.C.G.Malbrán. Centro Nacional de Diagnóstico e Investigación en Endemo-Epidemias; Argentina.Fil: Gamboa-León, Miriam Rubi. Universidad Autónoma de Yucatán. Laboratorio de Parasitología; México.Fil: Del Cid-Lemus, Jaime. Intibucá. Región Sanitaria No. 10; Honduras.Fil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina.Fil: Alger, Jackeline. Instituto de Enfermedades Infecciosas y Parasitología Antonio Vidal; Honduras.Fil: Almendares, Olivia. Tulane University. School of Public Health and Tropical Medicine; Estados Unidos.Fil: Cafferata, María L. Hospital de Clínicas. Unidad de Investigación Clínica y Epidemiológica Montevideo; Uruguay.Fil: Chippaux, Jean-Philippe. L'Institut de recherche pour le développement (IRD); Bolivia.Fil: Dumonteil, Eric. Universidad Autónoma de Yucatán. Laboratorio de Parasitología; México.Fil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; Argentina.Fil: Schneider, Dominique. L'Institut de recherche pour le développement (IRD); Bolivia.Fil: Belizán, José M. Instituto de Efectividad Clínica y Sanitaria; Argentina.Fil: Buekens, Pierre. Tulane University. School of Public Health and Tropical Medicine; Estados Unidos.Fil: Padilla-Raygoza, Nicolás. Universidad de Guanajuato; México.Fil: Perinatal Chagas Disease Working Group; Estados Unidos.We conducted a cross-sectional study of Chagas disease in five endemic areas in Argentina, Bolivia, Honduras, and México to estimate the prevalence of Trypanosoma cruzi–specific antibodies in pregnant women, and to assess the use of a rapid test (Chagas Stat-Pak) to screen for T. cruzi infection at the time of delivery. The prevalence of antibodies to T. cruzi measured by enzyme-linked immunosorbent assay (ELISA) in maternal blood was 5.5% (a range of 0.8–28.8% among the countries) in 2,495 women enrolled. Compared with ELISA in maternal blood samples, the Chagas Stat-Pak rapid test sensitivity and specificity in umbilical cord blood were 94.6% and 99.0%, respectively. These results show the ability for a rapid determination of the presence of T. cruzi–specific antibodies in umbilical cord blood as a pragmatic strategy to screen for infection in pregnant women

Prospective multicenter evaluation of real time PCR Kit prototype for early diagnosis of congenital Chagas disease

Background: Current algorithm for Congenital Chagas Disease (cCD) diagnosis is unsatisfactory due to low sensitivity of the parasitological methods. Moreover, loss to follow-up precludes final serodiagnosis after nine months of life in many cases. A duplex TaqMan qPCR kit for Trypanosoma cruzi DNA amplification was prospectively evaluated in umbilical cord (UCB) and peripheral venous blood (PVB) of infants born to CD mothers at endemic and non-endemic sites of Argentina. Methods: We enrolled and followed-up 370 infants; qPCR was compared to gold-standard cCD diagnosis following studies of diagnostic accuracy guidelines. Findings: Fourteen infants (3·78%) had cCD. The qPCR sensitivity and specificity were higher in PVB (72·73%, 99·15% respectively) than in UCB (66·67%, 96·3%). Positive and negative predictive values were 80 and 98·73% and 50 and 98·11% for PVB and UCB, respectively. The Areas under the Curve (AUC) of ROC analysis for qPCR and micromethod (MM) were 0·81 and 0·67 in UCB and 0·86 and 0·68 in PVB, respectively. Parasitic loads ranged from 37·5 to 23,709 parasite equivalents/mL. Discrete typing Unit Tc V was identified in five cCD patients and in six other cCD cases no distinction among Tc II, Tc V or Tc VI was achieved. Interpretation: This first prospective field study demonstrated that qPCR was more sensitive than MM for early cCD detection and more accurate in PVB than in UCB. Its use, as an auxiliary diagnostic tool to MM will provide more accurate records on cCD incidence. Funding: FITS SALUD 001-CHAGAS (FONARSEC, MINCyT, Argentina) to the Public-Private Consortium (INGEBI-CONICET, INP-ANLIS MALBRAN and Wiener Laboratories); ERANET-LAC-HD 328 to AGS and PICT 2015-0074 (FONCYT, MinCyT) to AGS and FA.Fil: Benatar, Alejandro Francisco. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: Danesi, Emmaría. Dirección Nacional de Instituto de Investigación.Administración Nacional de Laboratorios e Institutos de Salud "Dr. Carlos G. Malbrán"; ArgentinaFil: Besuschio, Susana Alicia. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: Bortolotti, Santiago. Wiener Laboratorios SAIC; ArgentinaFil: Cafferata, María Luisa. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Ramirez Gomez, Juan Carlos. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: Lopez Albizu, Maria Constanza. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud “Dr. C. G. Malbrán”. Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben”; ArgentinaFil: Scollo, Karenina. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud “Dr. C. G. Malbrán”. Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben”; ArgentinaFil: Baleani, María. Wiener Laboratorios SAIC; ArgentinaFil: Lara, Laura. Instituto de Maternidad y Ginecología ''Nuestra Señora de las Mercedes''; ArgentinaFil: Agolti, Gustavo. Gobierno de la Provincia de Chaco. Hospital Julio César Perrando; ArgentinaFil: Seu, Sandra. Gobierno de la Provincia de Santiago del Estero. Hospital Regional Dr. Ramón Carrillo; ArgentinaFil: Adamo, Elsa. Provincia de Santiago del Estero. Centro Integral de Salud La Banda; ArgentinaFil: Lucero, Raul Horacio. Universidad Nacional del Nordeste. Instituto de Medicina Regional; ArgentinaFil: Irazu, Lucía. Dirección Nacional de Instituto de Investigación.Administración Nacional de Laboratorios e Institutos de Salud "Dr. Carlos G. Malbrán"; ArgentinaFil: Rodriguez, Marcelo. Dirección Nacional de Instituto de Investigación.Administración Nacional de Laboratorios e Institutos de Salud "Dr. Carlos G. Malbrán"; ArgentinaFil: Poeylaut Palena, Andrés Alberto. Wiener Laboratorios SAIC; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Longhi, Silvia Andrea. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: Esteva, Mónica Inés. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud “Dr. C. G. Malbrán”. Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben”; ArgentinaFil: Althabe, Fernando. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Rojkin, Federico. Wiener Laboratorios SAIC; ArgentinaFil: Bua, Jacqueline Elena. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud “Dr. C. G. Malbrán”. Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben”; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Sosa-Estani, Sergio Alejandro. Instituto de Efectividad Clínica y Sanitaria; Argentina. Dirección Nacional de Instituto de Investigación. Administración Nacional de Laboratorio e Instituto de Salud “Dr. C. G. Malbrán”. Instituto Nacional de Parasitología "Dr. Mario Fatala Chaben”; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Schijman, Alejandro Gabriel. Consejo Nacional de Investigaciones Científicas y Técnicas. Instituto de Investigaciones en Ingeniería Genética y Biología Molecular "Dr. Héctor N. Torres"; ArgentinaFil: Congenital Chagas Disease Study Group. No especifíca

Syphilis screening and treatment in pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia: a cross-sectional study [version 1; referees: 2 approved]

Background: Congenital syphilis is associated with perinatal deaths, preterm births and congenital malformations. Low rates of syphilis screening during pregnancy and treatment of those found seropositive have been reported in the Democratic Republic of the Congo (DRC) and Zambia. We report the rates on antenatal syphilis screening, the seroprevalence of syphilis infection, and the frequency of antibiotic treatment in pregnant women screened positive for syphilis during their attendance at antenatal care (ANC) clinics in Kinshasa, DRC and Lusaka, Zambia. Methods: Women attending their first ANC were enrolled consecutively during a 9-month period in 16 and 13 ANC clinics in Kinshasa and Lusaka respectively, in the context of the baseline period of a cluster trial. Study personnel collected data on women’s characteristics, the syphilis screening practices, the test results, and the frequency of treatment, that were done under routine ANC conditions and registered in the clinic records. Results: 4,153 women in Kinshasa and 18,097 women in Lusaka were enrolled. The frequency of screening at the first visit was 59.7% (n= 2,479) in Kinshasa, and 27.8% (n=5,025) in Lusaka. Screening test availability varied. In the periods in which tests were available the screening rates were 92.8% in Kinshasa and 52.0% in Lusaka. The frequency of women screened seropositive was 0.4% (n=10) in Kinshasa and 2.2% (n=109) in Lusaka. Respectively, 10% (n=1) and 11.9% (n= 13) among seropositive women received treatment at the first visit. Conclusions: The results of the study show that screening for syphilis in pregnancy is not universal even when supplies are available. Our ongoing trial will evaluate the impact of a behavioral intervention on changing health providers’ practices to increase screening and treatment rates when supplies are available

A multifaceted intervention to improve syphilis screening and treatment in pregnant women in Kinshasa, Democratic Republic of the Congo and in Lusaka, Zambia: a cluster randomised controlled trial

Background: Despite international recommendations, coverage of syphilis testing in pregnant women and treatment of those found seropositive remains limited in sub-Saharan Africa. We assessed whether combining the provision of supplies with a behavioural intervention was more effective than providing supplies only, to improve syphilis screening and treatment during antenatal care. Methods: In this 18-month, cluster randomised controlled trial, we randomly assigned (1:1) 26 urban antenatal care clinics in Kinshasa, Democratic Republic of the Congo, and Lusaka, Zambia, to receive a behavioural intervention (opinion leader selection, academic detailing visits, reminders, audits and feedback, and supportive supervision) plus supplies for syphilis testing and treatment (intervention group) or to receive supplies only (control group). The primary outcomes were proportion of pregnant women who had syphilis screening out of the total who attended the clinic; and the proportion of women who had treatment with benzathine benzylpenicillin out of those who tested positive for syphilis at their first antenatal care visit. This trial is registered at ClinicalTrials.gov, number NCT02353117. Findings: The 18-month study period was Feb 1, 2016, to July 14, 2017. 18 357 women were enrolled at the 13 intervention clinics and 17 679 women were enrolled at the 13 control clinics at their first antenatal care visit. Syphilis screening was done in a median of 99·9% (IQR 99·0–100·0) of women in the intervention clinics and 93·8% (85·0–98·9) in the control clinics (absolute difference 6·1% [95% CI 1·1–14·1]; p=0·00092). Syphilis treatment at the first visit was done in a median of 100% (IQR 99·7–100·0) of seropositive women in intervention clinics and 43·2% (2·6–83·2) of seropositive women in control clinics (absolute difference 56·8% [12·8–99·0]; p=0·0028). Interpretation: A behavioural intervention, together with the provision of supplies, can lead to more than 95% of women being screened and treated for syphilis. The sole provision of supplies is sufficient to reach such levels of screening coverage but is not sufficient to ensure high levels of treatment. Funding: Bill & Melinda Gates Foundation.Fil: Althabe, Fernando. Consejo Nacional de Investigaciones Científicas y Técnicas; Argentina. Instituto de Efectividad Clínica y Sanitaria; Argentina. Organizacion Mundial de la Salud; ArgentinaFil: Chomba, Elwyn. University Teaching Hospital of Lusaka; ZambiaFil: Tshefu, Antoinette K. University of Kinshasa; República Democrática del CongoFil: Banda, Ernest. University Teaching Hospital of Lusaka; ZambiaFil: Belizán, María Melina Eleonora. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Bergel, Eduardo. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Berrueta, Amanda Mabel. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Bertrand, Jane. University of Tulane; Estados UnidosFil: Bose, Carl. University of North Carolina; Estados UnidosFil: Cafferata, Maria Luisa. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Carlo, Waldemar A. University of Alabama at Birmingahm; Estados UnidosFil: Ciganda, Alvaro. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Donnay, France. University of Tulane; Estados UnidosFil: Garcia Elorrio, Ezequiel. Instituto de Efectividad Clínica y Sanitaria; Argentina. Consejo Nacional de Investigaciones Científicas y Técnicas; ArgentinaFil: Gibbons, Luz. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Klein, Karen. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Liljestrand, Jerker. Bill And Melinda Gates Foundation; Estados UnidosFil: Lusamba, Paul D. University of Kinshasa; República Democrática del CongoFil: Mavila, Arlette K. University of Kinshasa; República Democrática del CongoFil: Mazzoni, Agustina. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Nkamba, Dalau M. University of Kinshasa; República Democrática del CongoFil: Mwanakalanga, Friday H. University Teaching Hospital Lusaka; ZambiaFil: Mwapule Tembo, Abigail. University Teaching Hospital Lusaka; ZambiaFil: Mwenechanya, Musaku. University Teaching Hospital Lusaka; ZambiaFil: Pyne Mercier, Lee. Bill And Melinda Gates Foundation; Estados UnidosFil: Spira, Cintia. Instituto de Efectividad Clínica y Sanitaria; ArgentinaFil: Wetshikoy, Jean D. University of Kinshasa; República Democrática del CongoFil: Xiong, Xu. University of Tulane; Estados UnidosFil: Buekens, Pierre. University of Tulane; Estados Unido