Summary of the Centers for Disease Control and Prevention/National Institute of Allergy and Infectious Diseases Joint Workshop on Genital Herpes: 3-4 November 2022.

Genital herpes is caused by infection with herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) and currently has no cure. The disease is the second-most common sexually transmitted infection in the United States, with an estimated 18.6 million prevalent genital infections caused by HSV-2 alone. Genital herpes diagnostics and treatments are not optimal, and no vaccine is currently available. The Centers for Disease Control and Prevention and the National Institute of Allergy and Infectious Diseases convened a workshop entitled "CDC/NIAID Joint Workshop on Genital Herpes." This report summarizes 8 sessions on the epidemiology of genital herpes, neonatal HSV, HSV diagnostics, vaccines, treatments, cures, prevention, and patient advocacy perspective intended to identify opportunities in herpes research and foster the development of strategies to diagnose, treat, cure, and prevent genital herpes.

COVID-19 SeroHub, an online repository of SARS-CoV-2 seroprevalence studies in the United States.

Seroprevalence studies provide useful information about the proportion of the population either vaccinated against SARS-CoV-2, previously infected with the virus, or both. Numerous studies have been conducted in the United States, but differ substantially by dates of enrollment, target population, geographic location, age distribution, and assays used. This can make it challenging to identify and synthesize available seroprevalence data by geographic region or to compare infection-induced versus combined infection- and vaccination-induced seroprevalence. To facilitate public access and understanding, the National Institutes of Health and the Centers for Disease Control and Prevention developed the COVID-19 Seroprevalence Studies Hub (COVID-19 SeroHub, https://covid19serohub.nih.gov/ ), a data repository in which seroprevalence studies are systematically identified, extracted using a standard format, and summarized through an interactive interface. Within COVID-19 SeroHub, users can explore and download data from 178 studies as of September 1, 2022. Tools allow users to filter results and visualize trends over time, geography, population, age, and antigen target. Because COVID-19 remains an ongoing pandemic, we will continue to identify and include future studies.

Estimating the population level impact of a gonococcal vaccine candidate: Predictions from a simple mathematical model.

BACKGROUND: Neisseria gonorrhoeae cross-protection was suggested in a New Zealand meningitis B vaccine. We modeled the potential impact of similar vaccines on gonorrhea prevalence in heterosexuals in the United States. METHODS: Our mathematical model incorporated infection, behavior, and vaccination dynamics. Approximate Bayesian Computation calibrated our model to US prevalence. Primary analyses assumed New Zealand vaccine characteristics: 30% efficacy and 2-year duration of protection. We estimated impact under two vaccine coverages (20%, 50%). RESULTS: Reduction in gonorrhea prevalence ranged from 4.8 to 39.4%, depending on vaccine coverage. Vaccine impact was correlated with both size of the highly sexually active subpopulation and sexual mixing between high and low activity subpopulations. CONCLUSIONS: A meningitis vaccine providing low efficacy cross-protection against gonorrhea acquisition and short duration of protection could result in a large reduction in gonorrhea prevalence in the United States. Potential dual protective effects can be considered when making vaccine recommendations.

Thorough QT Study To Evaluate the Effect of Zoliflodacin, a Novel Therapeutic for Gonorrhea, on Cardiac Repolarization in Healthy Adults.

Zoliflodacin is a novel spiropyrimidinetrione antibiotic being developed as single oral dose treatment to address the growing global threat of Neisseria gonorrhoeae. To evaluate the cardiac safety of zoliflodacin, a thorough QT/QTc (TQT) study was performed in healthy subjects. In this randomized, double-blind, placebo-controlled, 4-period crossover study, 72 subjects in a fasted state received a single dose of zoliflodacin at 2 g (therapeutic), zoliflodacin at 4 g (supratherapeutic), placebo, and moxifloxacin at 400 mg as a positive comparator. Cardiac repolarization was measured by duration of the corrected QT interval by Fridericia's formula (QTcF). At each time point up to 24 h after zoliflodacin administration, the upper limit of the one-sided 95% confidence interval (CI) for the placebo-corrected change from the predose baseline in QTcF (ΔΔQTcF) was less than 10 ms, indicating an absence of a clinically meaningful increase in QT prolongation. The lower limit of the one-sided multiplicity-adjusted 95% CI of ΔΔQTcF for moxifloxacin was longer than 5 ms at four time points from 1 to 4 h after dosing, demonstrating adequate sensitivity of the QTc measurement. There were no clinically significant effects on heart rate, PR and QRS intervals, electrocardiogram (ECG) morphology, or laboratory values. Treatment-emergent adverse events (AEs) were mild or moderate in severity and transient. This was a negative TQT study according to regulatory guidelines (E14) and confirms that a single oral dose of zoliflodacin is safe and well tolerated. These findings suggest that zoliflodacin is not proarrhythmic and contribute to the favorable assessment of cardiac safety for a single oral dose of zoliflodacin. (This study has been registered at ClinicalTrials.gov under registration no. NCT03613649.).

Pooling in a Pod: A Strategy for COVID-19 Testing to Facilitate a Safe Return to School.

The COVID-19 pandemic prompted widespread closures of primary and secondary schools. Routine testing of asymptomatic students and staff members, as part of a comprehensive mitigation program, can help schools open safely. "Pooling in a pod" is a public health surveillance strategy whereby testing cohorts (pods) are based on social relationships and physical proximity. Pooled testing provides a single laboratory test result for the entire pod, rather than a separate result for each person in the pod. During the 2020-2021 school year, an independent preschool-grade 12 school in Washington, DC, used pooling in a pod for weekly on-site point-of-care testing of all staff members and students. Staff members and older students self-collected anterior nares samples, and trained staff members collected samples from younger students. Overall, 12 885 samples were tested in 1737 pools for 863 students and 264 staff members from November 30, 2020, through April 30, 2021. The average pool size was 7.4 people. The average time from sample collection to pool test result was 40 minutes. The direct testing cost per person per week was $24.24, including swabs. During the study period, 4 surveillance test pools received positive test results for COVID-19. A post-launch survey found most parents (90.3%), students (93.4%), and staff members (98.8%) were willing to participate in pooled testing with confirmatory tests for pool members who received a positive test result. The proportion of students in remote learning decreased by 62.2% for students in grades 6-12 (P < .001) and by 92.4% for students in preschool to grade 5 after program initiation (P < .001). Pooling in a pod is a feasible, cost-effective surveillance strategy that may facilitate safe, sustainable, in-person schooling during a pandemic.

Toward Understanding COVID-19 Recovery: National Institutes of Health Workshop on Postacute COVID-19.

Over the past year, the SARS-CoV-2 pandemic has swept the globe, resulting in an enormous worldwide burden of infection and mortality. However, the additional toll resulting from long-term consequences of the pandemic has yet to be tallied. Heterogeneous disease manifestations and syndromes are now recognized among some persons after their initial recovery from SARS-CoV-2 infection, representing in the broadest sense a failure to return to a baseline state of health after acute SARS-CoV-2 infection. On 3 to 4 December 2020, the National Institute of Allergy and Infectious Diseases, in collaboration with other Institutes and Centers of the National Institutes of Health, convened a virtual workshop to summarize existing knowledge on postacute COVID-19 and to identify key knowledge gaps regarding this condition.

Doxycycline Versus Azithromycin for the Treatment of Rectal Chlamydia in Men Who Have Sex With Men: A Randomized Controlled Trial.

BACKGROUND: Azithromycin and doxycycline are both recommended treatments for rectal Chlamydia trachomatis (CT) infection, but observational studies suggest that doxycycline may be more effective. METHODS: This randomized, double-blind, placebo-controlled trial compared azithromycin (single 1-g dose) versus doxycycline (100 mg twice daily for 7 days) for the treatment of rectal CT in men who have sex with men (MSM) in Seattle and Boston. Participants were enrolled after a diagnosis of rectal CT in clinical care and underwent repeated collection of rectal swabs for nucleic acid amplification testing (NAAT) at study enrollment and 2 weeks and 4 weeks postenrollment. The primary outcome was microbiologic cure (CT-negative NAAT) at 4 weeks. The complete case (CC) population included participants with a CT-positive NAAT at enrollment and a follow-up NAAT result; the intention-to-treat (ITT) population included all randomized participants. RESULTS: Among 177 participants enrolled, 135 (76%) met CC population criteria for the 4-week follow-up visit. Thirty-three participants (19%) were excluded because the CT NAAT repeated at enrollment was negative. Microbiologic cure was higher with doxycycline than azithromycin in both the CC population (100% [70 of 70] vs 74% [48 of 65]; absolute difference, 26%; 95% confidence interval [CI], 16-36%; P < .001) and the ITT population (91% [80 of 88] vs 71% [63 of 89]; absolute difference, 20%; 95% CI, 9-31%; P < .001). CONCLUSIONS: A 1-week course of doxycycline was significantly more effective than a single dose of azithromycin for the treatment of rectal CT in MSM. CLINICAL TRIALS REGISTRATION: NCT03608774.

Acceptability and feasibility of dual HIV and syphilis point-of-care testing for early detection of infection among pregnant women in China: a prospective study.

OBJECTIVE: To assess the feasibility and acceptability of using WHO prequalified combined dual HIV/syphilis rapid diagnostic tests (RDT) for same-day results in antenatal care (ANC) clinics. METHODS: This is a pragmatic implementation study using quantitative approach to evaluate outcomes. Antenatal clinic attendees from 21 rural and urban township hospitals in two provinces of China were offered with free dual RDTs testing that included HIV and syphilis, in addition to the routine blood tests. Study outcomes included testing uptake before and during dual RDT use, test feasibility and acceptability among pregnant women. Regression model was used to assess acceptance of RDT testing. RESULTS: In total, 1787 out of 1828 pregnant women attending ANC received the RDT testing. Testing uptake among pregnant women in their first and second trimester increased from 76.0% (2438/3269) using standard blood testing to 90.1% (1626/1787) with concurrent RDT use (χ2=197.1, p<0.001). Among 1787 pregnant women who received RDT tests, 98.3% (1757/1787) participants were given test result the same day. Positive proportions of HIV and syphilis screened with RDT were 0.06% (1/1787) and 1.0% (18/1787), respectively. Regression analysis indicated that women who did not receive syphilis or HIV testing before were less likely to accept dual RDT (OR 0.28, 95% CI 0.10 to 0.75). Acceptance for dual RDT testing at second or third antenatal visit was lower compared with the first visit (OR 0.37, 95% CI 0.15 to 0.94). CONCLUSION: Combined dual HIV/syphilis RDT with same-day results increased uptake of HIV and syphilis testing among pregnant women at primary healthcare facilities. Given the diversity of testing capacities among health services especially in rural areas in China, the dual RDT kit is feasible tool to improve testing uptake among pregnant women.

First estimates of the global and regional incidence of neonatal herpes infection.

BACKGROUND: Neonatal herpes is a rare but potentially devastating condition with an estimated 60% fatality rate without treatment. Transmission usually occurs during delivery from mothers with herpes simplex virus type 1 (HSV-1) or type 2 (HSV-2) genital infection. However, the global burden has never been quantified to our knowledge. We developed a novel methodology for burden estimation and present first WHO global and regional estimates of the annual number of neonatal herpes cases during 2010-15. METHODS: We applied previous estimates of HSV-1 and HSV-2 prevalence and incidence in women aged 15-49 years to 2010-15 birth rates to estimate infections during pregnancy. We then applied published risks of neonatal HSV transmission according to whether maternal infection was incident or prevalent with HSV-1 or HSV-2 to generate annual numbers of incident neonatal infections. We estimated the number of incident neonatal infections by maternal age, and we generated separate estimates for each WHO region, which were then summed to obtain global estimates of the number of neonatal herpes infections. FINDINGS: Globally the overall rate of neonatal herpes was estimated to be about ten cases per 100 000 livebirths, equivalent to a best-estimate of 14 000 cases annually roughly (4000 for HSV-1; 10 000 for HSV-2). We estimated that the most neonatal herpes cases occurred in Africa, due to high maternal HSV-2 infection and high birth rates. HSV-1 contributed more cases than HSV-2 in the Americas, Europe, and Western Pacific. High rates of genital HSV-1 infection and moderate HSV-2 prevalence meant the Americas had the highest overall rate. However, our estimates are highly sensitive to the core assumptions, and considerable uncertainty exists for many settings given sparse underlying data. INTERPRETATION: These neonatal herpes estimates mark the first attempt to quantify the global burden of this rare but serious condition. Better collection of primary data for neonatal herpes is crucially needed to reduce uncertainty and refine future estimates. These data are particularly important in resource-poor settings where we may have underestimated cases. Nevertheless, these first estimates suggest development of new HSV prevention measures such as vaccines could have additional benefits beyond reducing genital ulcer disease and HSV-associated HIV transmission, through prevention of neonatal herpes. FUNDING: World Health Organization.

Global burden of maternal and congenital syphilis in 2008 and 2012: a health systems modelling study.

BACKGROUND: In 2007, WHO launched a global initiative for the elimination of mother-to-child transmission of syphilis (congenital syphilis). An important aspect of the initiative is strengthening surveillance to monitor progress towards elimination. In 2008, using a health systems model with country data inputs, WHO estimated that 1·4 million maternal syphilis infections caused 520 000 adverse pregnancy outcomes. To assess progress, we updated the 2008 estimates and estimated the 2012 global prevalence and cases of maternal and congenital syphilis. METHODS: We used a health systems model approved by the Child Health Epidemiology Reference Group. WHO and UN databases provided inputs on livebirths, antenatal care coverage, and syphilis testing, seropositivity, and treatment in antenatal care. For 2012 estimates, we used data collected between 2009 and 2012. We updated the 2008 estimates using data collected between 2000 and 2008, compared these with 2012 estimates using data collected between 2009 and 2012, and performed subanalyses to validate results. FINDINGS: In 2012, an estimated 930 000 maternal syphilis infections caused 350 000 adverse pregnancy outcomes including 143 000 early fetal deaths and stillbirths, 62 000 neonatal deaths, 44 000 preterm or low weight births, and 102 000 infected infants worldwide. Nearly 80% of adverse outcomes (274 000) occurred in women who received antenatal care at least once. Comparing the updated 2008 estimates with the 2012 estimates, maternal syphilis decreased by 38% (from 1 488 394 cases in 2008 to 927 936 cases in 2012) and congenital syphilis decreased by 39% (from 576 784 to 350 915). India represented 65% of the decrease. Analysis excluding India still showed an 18% decrease in maternal and congenital cases of syphilis worldwide. INTERPRETATION: Maternal and congenital syphilis decreased worldwide from 2008 to 2012, which suggests progress towards the elimination of mother-to-child transmission of syphilis. Nonetheless, maternal syphilis caused substantial adverse pregnancy outcomes, even in women receiving antenatal care. Improved access to quality antenatal care, including syphilis testing and treatment, and robust data are all important for achieving the elimination of mother-to-child transmission of syphilis. FUNDING: The UNDP-UNFPA-UNICEF-WHO-World Bank Special Programme of Research, Development and Research Training in Human Reproduction in WHO, and the US Centers for Disease Control and Prevention.

Global and Regional Estimates of Prevalent and Incident Herpes Simplex Virus Type 1 Infections in 2012.

BACKGROUND: Herpes simplex virus type 1 (HSV-1) commonly causes orolabial ulcers, while HSV-2 commonly causes genital ulcers. However, HSV-1 is an increasing cause of genital infection. Previously, the World Health Organization estimated the global burden of HSV-2 for 2003 and for 2012. The global burden of HSV-1 has not been estimated. METHODS: We fitted a constant-incidence model to pooled HSV-1 prevalence data from literature searches for 6 World Health Organization regions and used 2012 population data to derive global numbers of 0-49-year-olds with prevalent and incident HSV-1 infection. To estimate genital HSV-1, we applied values for the proportion of incident infections that are genital. FINDINGS: We estimated that 3709 million people (range: 3440-3878 million) aged 0-49 years had prevalent HSV-1 infection in 2012 (67%), with highest prevalence in Africa, South-East Asia and Western Pacific. Assuming 50% of incident infections among 15-49-year-olds are genital, an estimated 140 million (range: 67-212 million) people had prevalent genital HSV-1 infection, most of which occurred in the Americas, Europe and Western Pacific. CONCLUSIONS: The global burden of HSV-1 infection is huge. Genital HSV-1 burden can be substantial but varies widely by region. Future control efforts, including development of HSV vaccines, should consider the epidemiology of HSV-1 in addition to HSV-2, and especially the relative contribution of HSV-1 to genital infection.

Introduction of rapid syphilis testing in antenatal care: A systematic review of the impact on HIV and syphilis testing uptake and coverage.

BACKGROUND: Global guidelines recommend universal syphilis and HIV screening for pregnant women. Rapid syphilis testing (RST) may contribute toward achievement of universal screening. OBJECTIVES: To examine the impact of RST on syphilis and HIV screening among pregnant women. SEARCH STRATEGY: We searched MEDLINE for English- and non-English language articles published through November, 2014. SELECTION CRITERIA: We included studies that used a comparative design and reported on syphilis and HIV test uptake among pregnant women in low- and middle-income countries (LMICs) following introduction of RST. DATA COLLECTION AND ANALYSIS: Data were extracted from six eligible articles presenting findings from Asia, Africa, and Latin America. MAIN RESULTS: All studies reported substantial increases in antenatal syphilis testing following introduction of RST; the latter did not appear to adversely impact antenatal HIV screening levels at sites already offering rapid HIV testing and may increase HIV screening among pregnant women in some settings. Qualitative data revealed that women were highly satisfied with RST. Nevertheless, ensuring adequate training for healthcare workers and supplies of commodities were cited as key implementation barriers. CONCLUSIONS: RST may increase antenatal syphilis and HIV screening and contribute to the improvement of antenatal care in LMICs.

Laboratory evaluation of three dual rapid diagnostic tests for HIV and syphilis in China and Nigeria.

OBJECTIVE: To determine the laboratory-based performance and operational characteristics of three dual rapid diagnostic tests (RDTs) for testing HIV and syphilis. METHODS: Three dual RDTs (SD Bioline, Chembio, and MedMira) were evaluated using 1514 serum specimens archived at laboratories or collected from clinics in China and Nigeria to determine sensitivity and specificity, with 95% confidence intervals. Concordance of testing results read by two technicians, stability of testing results read at two time points, and test operation characteristics were also assessed. RESULTS: All three of the evaluated RDTs gave excellent performance with a combined sensitivity ranging from 99.0%-99.6% for HIV and 98.3%-99.0% for syphilis, and a combined specificity ranging from 97.9%-99.0% for HIV and 97.2%-99.6% for syphilis. Concordance of testing results between two technicians and stability of testing results read within and one hour past the recommended reading period showed excellent agreement, with Kappa greater than or equal to 0.98. CONCLUSIONS: All the tests were found to be very or fairly easy to use and easy to interpret the results. Further evaluations of these dual RDTs with whole blood in field settings, and more studies on the implication of introduction of these tests in HIV and syphilis control programs are needed.

Estimating disease burden of maternal syphilis and associated adverse pregnancy outcomes in India, Nigeria, and Zambia in 2012.

OBJECTIVE: To estimate maternal syphilis and its associated adverse pregnancy outcomes in India, Nigeria, and Zambia. METHODS: An online estimation tool was used to generate point estimates and uncertainty ranges of maternal syphilis and adverse pregnancy outcomes due to mother-to-child transmission (MTCT). The most recent data (2010-2012) on antenatal care coverage, syphilis seroprevalence, and syphilis screening and treatment coverage at the subnational level in India, Nigeria, and Zambia were used to estimate disease burden for 2012. Sensitivity analysis was conducted for three screening and treatment scenarios (current coverages, current coverages minus 20%, and ideal coverages consistent with WHO targets for eliminating MTCT of syphilis). RESULTS: A total of 103 960, 74 798, and 9072 pregnant women with probable active syphilis were estimated to occur in India, Nigeria, and Zambia, resulting in 53 187, 37 045, and 2973 adverse outcomes, respectively; approximately 1.6%, 4.8%, and 37.0% of these were averted under the current service coverages in India, Nigeria, and Zambia. The disease burden varied significantly in its subnational distribution within India and Nigeria, but was distributed evenly across Zambia. CONCLUSIONS: The obtained results suggest an ongoing, unaverted high burden of maternal syphilis and associated adverse outcomes in India, Nigeria, and Zambia. Screening and treatment for syphilis must be scaled-up significantly in these countries to achieve elimination of MTCT of syphilis.

Global estimates of prevalent and incident herpes simplex virus type 2 infections in 2012.

BACKGROUND: Herpes simplex virus type 2 (HSV-2) infection causes significant disease globally. Adolescent and adult infection may present as painful genital ulcers. Neonatal infection has high morbidity and mortality. Additionally, HSV-2 likely contributes substantially to the spread of HIV infection. The global burden of HSV-2 infection was last estimated for 2003. Here we present new global estimates for 2012 of the burden of prevalent (existing) and incident (new) HSV-2 infection among females and males aged 15-49 years, using updated methodology to adjust for test performance and estimate by World Health Organization (WHO) region. METHODS AND FINDINGS: We conducted a literature review of HSV-2 prevalence studies world-wide since 2000. We then fitted a model with constant HSV-2 incidence by age to pooled HSV-2 prevalence values by age and sex. Prevalence values were adjusted for test sensitivity and specificity. The model estimated prevalence and incidence by sex for each WHO region to obtain global burden estimates. Uncertainty bounds were computed by refitting the model to reflect the variation in the underlying prevalence data. In 2012, we estimate that there were 417 million people aged 15-49 years (range: 274-678 million) living with HSV-2 infection world-wide (11.3% global prevalence), of whom 267 million were women. We also estimate that in 2012, 19.2 million (range: 13.0-28.6 million) individuals aged 15-49 years were newly-infected (0.5% of all individuals globally). The highest burden was in Africa. However, despite lower prevalence, South-East Asia and Western Pacific regions also contributed large numbers to the global totals because of large population sizes. CONCLUSIONS: The global burden of HSV-2 infection is large, leaving over 400 million people at increased risk of genital ulcer disease, HIV acquisition, and transmission of HSV-2 to partners or neonates. These estimates highlight the critical need for development of vaccines, microbicides, and other new HSV prevention strategies.

Can the Perinatal Information System in Peru be used to measure the proportion of adverse birth outcomes attributable to maternal syphilis infection?

OBJECTIVE: To describe the capacity of Peru's Perinatal Information System (Sistema Informático Perinatal, SIP) to provide estimates for monitoring the proportion of stillbirths and other adverse birth outcomes attributable to maternal syphilis. METHODS: A descriptive study was conducted to assess the quality and completeness of SIP data from six Peruvian public hospitals that used the SIP continuously from 2000 - 2010 and had maternal syphilis prevalence of at least 0.5% during that period. In-depth interviews were conducted with Peruvian stakeholders about their experiences using the SIP. RESULTS: Information was found on 123 575 births from 2000 - 2010 and syphilis test results were available for 99 840 births. Among those 99 840 births, there were 1 075 maternal syphilis infections (1.1%) and 619 stillbirths (0.62%). Among women with syphilis infection in pregnancy, 1.7% had a stillbirth, compared to 0.6% of women without syphilis infection. Much of the information needed to estimate the proportion of stillbirths attributable to maternal syphilis was available in the SIP, with the exception of syphilis treatment information, which was not collected. However, SIP data collection is complex and time-consuming for clinicians. Data were unlinked across hospitals and not routinely used or quality-checked. Despite these limitations, the SIP data examined were complete and valid; in 98% of records, information on whether or not the infant was stillborn was the same in both the SIP and clinical charts. Nearly 89% of women had the same syphilis test result in clinical charts and the SIP. CONCLUSIONS: The large number of syphilis infections reported in Peru's SIP and the ability to link maternal characteristics to newborn outcomes make the system potentially useful for monitoring the proportion of stillbirths attributable to congenital syphilis in Peru. To ensure good data quality and sustainability of Peru's SIP, data collection should be simplified and information should be continually quality-checked and used for the benefit of participating facilities.

Can the Perinatal Information System in Peru be used to measure the proportion of adverse birth outcomes attributable to maternal syphilis infection? / ¿Se puede utilizar el Sistema Informático Perinatal del Perú para medir la proporción de resultados adversos del nacimiento atribuibles a sífilis materna?

OBJECTIVE: To describe the capacity of Peru's Perinatal Information System (Sistema Informático Perinatal, SIP) to provide estimates for monitoring the proportion of stillbirths and other adverse birth outcomes attributable to maternal syphilis. METHODS: A descriptive study was conducted to assess the quality and completeness of SIP data from six Peruvian public hospitals that used the SIP continuously from 2000 - 2010 and had maternal syphilis prevalence of at least 0.5% during that period. In-depth interviews were conducted with Peruvian stakeholders about their experiences using the SIP. RESULTS: Information was found on 123 575 births from 2000 - 2010 and syphilis test results were available for 99 840 births. Among those 99 840 births, there were 1 075 maternal syphilis infections (1.1%) and 619 stillbirths (0.62%). Among women with syphilis infection in pregnancy, 1.7% had a stillbirth, compared to 0.6% of women without syphilis infection. Much of the information needed to estimate the proportion of stillbirths attributable to maternal syphilis was available in the SIP, with the exception of syphilis treatment information, which was not collected. However, SIP data collection is complex and time-consuming for clinicians. Data were unlinked across hospitals and not routinely used or quality-checked. Despite these limitations, the SIP data examined were complete and valid; in 98% of records, information on whether or not the infant was stillborn was the same in both the SIP and clinical charts. Nearly 89% of women had the same syphilis test result in clinical charts and the SIP. CONCLUSIONS: The large number of syphilis infections reported in Peru's SIP and the ability to link maternal characteristics to newborn outcomes make the system potentially useful for monitoring the proportion of stillbirths attributable to congenital syphilis in Peru. To ensure good data quality and sustainability of Peru's SIP, data collection should be simplified and information should be continually quality-checked and used for the benefit of participating facilities.

OBJETIVO: Describir la capacidad del Sistema Informático Perinatal (SIP) del Perú para proporcionar estimaciones que permitan vigilar la proporción de mortinatos y otros resultados adversos del nacimiento atribuibles a sífilis materna. MÉTODOS: Se llevó a cabo un estudio descriptivo para evaluar la calidad y la integridad de los datos del SIP correspondientes a seis hospitales públicos peruanos que utilizaron el SIP de forma continuada del 2000 al 2010, y presentaron una prevalencia de sífilis materna de como mínimo 0,5% durante ese período. Se realizaron entrevistas exhaustivas con interesados directos de Perú acerca de sus experiencias con el uso del SIP. RESULTADOS: Se obtuvo información sobre 123 575 nacimientos ocurridos del 2000 al 2010 y se dispuso de resultados de pruebas serológicas de sífilis correspondientes a 99 840 nacimientos. Se produjeron 1 075 casos de sífilis materna (1,1%) y 619 mortinatos (0,62%). El 1,7% de las mujeres con sífilis gestacional tuvieron un mortinato, en comparación con el 0,6% de las mujeres sin infección sifilítica. En el SIP se disponía de gran parte de la información necesaria para calcular la proporción de mortinatos atribuibles a sífilis materna, a excepción de la información sobre el tratamiento de la sífilis, que no se recopiló. Sin embargo, la recopilación de datos del SIP es compleja y exige a los médicos clínicos dedicar tiempo. Los datos de los diferentes hospitales no estaban vinculados, no se utilizaban habitualmente ni se sometían a controles de calidad. A pesar de estas limitaciones, los datos del SIP analizados estaban completos y eran válidos; en 98% de los registros, la información sobre si se trataba o no de un mortinato coincidía entre el SIP y las historias clínicas. En casi 89% de las mujeres los resultados de las pruebas serológicas de sífilis eran los mismos en las historias clínicas y el SIP. CONCLUSIONES: El gran número de infecciones sifilíticas notificadas en el SIP del Perú y la capacidad de vincular las características maternas con los resultados de los recién nacidos hacen que el sistema sea potencialmente útil para vigilar la proporción de mortinatos atribuibles a sífilis congénita en Perú. Con objeto de garantizar la buena calidad de los datos y la sostenibilidad del SIP en Perú, es preciso simplificar la recopilación de datos y mantener un control permanente de la calidad de la información, que debe utilizarse en beneficio de los establecimientos participantes.

Toward global prevention of sexually transmitted infections (STIs): the need for STI vaccines.

An estimated 499 million curable sexually transmitted infections (STIs; gonorrhea, chlamydia, syphilis, and trichomoniasis) occurred globally in 2008. In addition, well over 500 million people are estimated to have a viral STI such as herpes simplex virus type 2 (HSV-2) or human papillomavirus (HPV) at any point in time. STIs result in a large global burden of sexual, reproductive, and maternal-child health consequences, including genital symptoms, pregnancy complications, cancer, infertility, and enhanced HIV transmission, as well as important psychosocial consequences and financial costs. STI control strategies based primarily on behavioral primary prevention and STI case management have had clear successes, but gains have not been universal. Current STI control is hampered or threatened by several behavioral, biological, and implementation challenges, including a large proportion of asymptomatic infections, lack of feasible diagnostic tests globally, antimicrobial resistance, repeat infections, and barriers to intervention access, availability, and scale-up. Vaccines against HPV and hepatitis B virus offer a new paradigm for STI control. Challenges to existing STI prevention efforts provide important reasons for working toward additional STI vaccines. We summarize the global epidemiology of STIs and STI-associated complications, examine challenges to existing STI prevention efforts, and discuss the need for new STI vaccines for future prevention efforts.

The cost and cost-effectiveness of scaling up screening and treatment of syphilis in pregnancy: a model.

BACKGROUND: Syphilis in pregnancy imposes a significant global health and economic burden. More than half of cases result in serious adverse events, including infant mortality and infection. The annual global burden from mother-to-child transmission (MTCT) of syphilis is estimated at 3.6 million disability-adjusted life years (DALYs) and $309 million in medical costs. Syphilis screening and treatment is simple, effective, and affordable, yet, worldwide, most pregnant women do not receive these services. We assessed cost-effectiveness of scaling-up syphilis screening and treatment in existing antenatal care (ANC) programs in various programmatic, epidemiologic, and economic contexts. METHODS AND FINDINGS: We modeled the cost, health impact, and cost-effectiveness of expanded syphilis screening and treatment in ANC, compared to current services, for 1,000,000 pregnancies per year over four years. We defined eight generic country scenarios by systematically varying three factors: current maternal syphilis testing and treatment coverage, syphilis prevalence in pregnant women, and the cost of healthcare. We calculated program and net costs, DALYs averted, and net costs per DALY averted over four years in each scenario. Program costs are estimated at $4,142,287 - $8,235,796 per million pregnant women (2010 USD). Net costs, adjusted for averted medical care and current services, range from net savings of $12,261,250 to net costs of $1,736,807. The program averts an estimated 5,754 - 93,484 DALYs, yielding net savings in four scenarios, and a cost per DALY averted of $24 - $111 in the four scenarios with net costs. Results were robust in sensitivity analyses. CONCLUSIONS: Eliminating MTCT of syphilis through expanded screening and treatment in ANC is likely to be highly cost-effective by WHO-defined thresholds in a wide range of settings. Countries with high prevalence, low current service coverage, and high healthcare cost would benefit most. Future analyses can be tailored to countries using local epidemiologic and programmatic data.