Whole-Genome Sequencing to Predict Antimicrobial Susceptibility Profiles in Neisseria gonorrhoeae.

BACKGROUND: Neisseria gonorrhoeae is a major public health problem due to increasing incidence and antimicrobial resistance. Genetic markers of reduced susceptibility have been identified; the extent to which those are representative of global antimicrobial resistance is unknown. We evaluated the performance of whole-genome sequencing (WGS) used to predict susceptibility to ciprofloxacin and other antimicrobials using a global collection of N. gonorrhoeae isolates. METHODS: Susceptibility testing of common antimicrobials and the recently developed zolifodacin was performed using agar dilution to determine minimum inhibitory concentrations (MICs). We identified resistance alleles at loci known to contribute to antimicrobial resistance in N. gonorrhoeae from WGS data. We tested the ability of each locus to predict antimicrobial susceptibility. RESULTS: A total of 481 N. gonorrhoeae isolates, collected between 2004 and 2019 and making up 457 unique genomes, were sourced from 5 countries. All isolates with demonstrated susceptibility to ciprofloxacin (MIC ≤0.06 µg/mL) had a wild-type gyrA codon 91. Multilocus approaches were needed to predict susceptibility to other antimicrobials. All isolates were susceptible to zoliflodacin, defined by an MIC ≤0.25 µg/mL. CONCLUSIONS: Single marker prediction can be used to inform ciprofloxacin treatment of N. gonorrhoeae infection. A combination of molecular markers may be needed to determine susceptibility for other antimicrobials.

Effectiveness of Cefixime for the Treatment of Neisseria gonorrhoeae Infection at 3 Anatomic Sites: A Systematic Review and Meta-Analysis.

BACKGROUND: To treat Neisseria gonorrhoeae infection, the Centers for Disease Control and Prevention recommends a single oral dose of cefixime as an alternative to injectable ceftriaxone. METHODS: We conducted a systematic review and meta-analysis to describe the effectiveness of cefixime in treating N. gonorrhoeae infection at 3 different anatomic sites.We searched PubMed and Embase database to abstract treatment success rates and cefixime dosage/frequency for studies that reported the anatomical site of infection. We included reports published between January 1, 1980, and December 7, 2021. Twenty studies published between 1989 and 2015 were included in our meta-analysis. We calculated pooled treatment success percentages and 95% confidence intervals (CIs) using random-effects models. RESULTS: Of patients who received a 400-mg single dose of cefixime, 824 of 846 (97%; 95% CI, 96%-98%) patients with urogenital infection, 107 of 112 (97%; 95% CI, 84%-100%) patients with rectal infection, and 202 of 242 (89%; 95% CI, 76%-96%) patients with pharyngeal infection were cured. Of patients who received an 800-mg single dose of cefixime, 295 of 301 (98%; 95% CI, 96%-99%) patients with urogenital infection and 21 of 26 (81%; 95% CI, 61%-92%) patients with pharyngeal infection were cured. CONCLUSIONS: Our meta-analysis found that cefixime is highly effective at treating urogenital infections and less effective at treating pharyngeal infections. We recommend more investigation into the effectiveness of cefixime in treating rectal infections and studying multidose therapy for the cefixime treatment of pharyngeal infection.

Clinical Factors Associated With Accurate Presumptive Treatment of Neisseria gonorrhoeae Infections in Men Who Have Sex with Men and Transgender Women.

BACKGROUND: Neisseria gonorrhoeae (N. gonorrhoeae) infections have increased among men who have sex with men and are high among transgender women. Presumptive treatment guidelines may lead to inaccurate treatments and possible antibiotic resistance. Using patient data from AIDS Healthcare Foundation sexually transmitted infection (STI) testing clinics in California and Florida, we identified clinical factors associated with accurate presumptive N. gonorrhoeae treatment. METHODS: Multivariable logistic regression analyses were conducted using patient visit data from 2013 to 2017. A sample of 42 050 patient encounters were analyzed. The primary outcome variable included accurate versus inaccurate presumptive treatment. Risk ratios were generated for particular symptoms, high-risk sexual behavior, and history of N. gonorrhoeae. RESULTS: Twelve percent (5051/42 050) of patients received presumptive N. gonorrhoeae treatment, and 46% (2329/5051) of presumptively treated patients tested positive for N. gonorrhoeae infection. Patients presenting with discharge or patients presenting with dysuria were more likely to receive accurate presumptive treatment. CONCLUSIONS: Providers should continue to follow the Centers for Disease Control and Prevention guidelines and consider presumptive N. gonorrhoeae treatment based on specific symptoms. As the STI epidemic continues to rise in the United States, along with increased antibiotic resistance, it is imperative to accurately test, diagnose, and treat populations at risk for N. gonorrhoeae and other STIs.

Resistance-Guided Treatment of Gonorrhea: A Prospective Clinical Study.

BACKGROUND: Novel treatment strategies to slow the continued emergence and spread of antimicrobial resistance in Neisseria gonorrhoeae are urgently needed. A molecular assay that predicts in vitro ciprofloxacin susceptibility is now available but has not been systematically studied in human infections. METHODS: Using a genotypic polymerase chain reaction assay to determine the status of the N. gonorrhoeae gyrase subunit A serine 91 codon, we conducted a multisite prospective clinical study of the efficacy of a single oral dose of ciprofloxacin 500 mg in patients with culture-positive gonorrhea. Follow-up specimens for culture were collected to determine microbiological cure 5-10 days post-treatment. RESULTS: Of the 106 subjects possessing culture-positive infections with wild-type gyrA serine N. gonorrhoeae genotype, the efficacy of single-dose oral ciprofloxacin treatment in the per-protocol population was 100% (95% 1-sided confidence interval, 97.5-100%). CONCLUSIONS: Resistance-guided treatment of N. gonorrhoeae infections with single-dose oral ciprofloxacin was highly efficacious. The widespread introduction and scale-up of gyrA serine 91 genotyping in N. gonorrhoeae infections could have substantial medical and public health benefits in settings where the majority of gonococcal infections are ciprofloxacin susceptible. CLINICAL TRIALS REGISTRATION: NCT02961751.

The Performance of Pooled 3 Anatomic Site Testing for Chlamydia trachomatis and Neisseria gonorrhoeae Among Men Who Have Sex With Men and Transgender Women.

BACKGROUND: Although molecular testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) is highly sensitive, the cost can be prohibitive. Those high costs are amplified when the recommended screening approach is used, which requires separate testing of specimens from 3 anatomic sites (rectal, pharyngeal and urogenital). Although individual molecular testing is standard of care, pooled testing may offer a cost-saving alternative. METHODS: Using the Xpert® CT/NG assay (Cepheid, Sunnyvale, CA) we tested urine, rectal and pharyngeal swabs for CT and NG in a high-risk cohort of participants assigned male at birth who reported sex with other persons who were assigned male at birth. Remnant specimens (0.34 mL from each anatomic site) were combined to perform a single 'pooled' test. We calculated positive and negative percent agreement between the pooled testing results with standard of care Xpert CT/NG test results as the reference. RESULTS: We conducted 644 pooled tests. Of those, 598 (92.3%) gave CT and NG results. The CT-positive and -negative percent agreement were 90.1% (95% confidence interval [CI], 80.7-95.9%) and 99.2% (98.1-99.8%), respectively. The NG-positive and -negative percent agreement were 96.2% (95% CI, 86.8-99.5%) and 99.8% (95% CI, 99.0-100%), respectively. Pooled testing identified 4 CT and 1 NG infections that were negative at all anatomic sites by individual testing. CONCLUSIONS: Three-site pooled CT and NG testing performs similarly to single anatomic site testing among tests providing a valid result. Future cost analyses should evaluate the cost effectiveness of pooled 3-site testing to determine if such a strategy improves the feasibility and accessibility of molecular sexually transmitted infection testing.

Collateral Damage: A Narrative Review on Epidemics of Substance Use Disorders and Their Relationships to Sexually Transmitted Infections in the United States.

ABSTRACT: Associations between substance use disorders and outbreaks of HIV and acute viral hepatitis have received considerable attention, but less research has focused on links between substance use disorders and sexually transmitted infections, apart from alcohol misuse. This narrative review describes the history of this public health crisis in the United States and direct and indirect effects opioids and specific stimulants have on high-risk sexual behaviors. We also review the epidemiology of sexually transmitted infections associated with opioids and stimulants in the United States and discuss opportunities for integrated interventions.

Pooled 3-Anatomic-Site Testing for Chlamydia trachomatis and Neisseria gonorrhoeae: A Systematic Review and Meta-Analysis.

BACKGROUND: Pooled testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) may be a cost-saving solution to increase screening by simplifying testing procedures and reducing resource burdens. We conducted a systematic review and meta-analysis to examine the performance of pooled 3-anatomic-site testing (pharyngeal, rectal, and urogenital sites) for CT and NG in comparison with single-anatomic-site testing. METHODS: We conducted a systematic literature search in PubMed, Embase, and Web of Science to identify original evaluation studies of the performance of pooled testing for CT and NG infections and identified 14 studies for inclusion. Each study was systematically evaluated for bias. We conducted bivariate fixed-effects and random-effects meta-analyses using a full Bayesian method of the positive percent agreement and negative percent agreement. RESULTS: The combined positive percent agreement for CT was 93.11% (95% confidence interval [CI], 91.51%-94.55%), and the negative percent agreement was 99.44% (95% CI, 99.18%-99.65%). For NG, the combined positive percent agreement was 93.80% (95% CI, 90.26%-96.61%), and the negative percent agreement was 99.73% (95% CI, 99.30%-99.97%). CONCLUSIONS: We found that pooled 3-anatomic-site tests performed similarly to single-anatomic-site tests for the detection of CT and NG. The pooled 3-anatomic-site tests have the added potential benefit of reduced cost and resource requirement, which could lead to improved testing access and screening uptake.

Clinical Test Performance of a Rapid Point-of-Care Syphilis Treponemal Antibody Test: A Systematic Review and Meta-analysis.

We reviewed relevant syphilis diagnostic literature and conducted a meta-analysis to address the question, "What is the sensitivity and specificity of the Syphilis Health Check, a rapid qualitative test for the detection of human antibodies to Treponema pallidum." The Syphilis Health Check is the only rapid syphilis test currently cleared by the Food and Drug Administration (FDA). We conducted a systematic review and a meta-analysis using Bayesian bivariate random-effects and fixed-effect models to create pooled estimates of sensitivity and specificity of the Syphilis Health Check. We identified 5 test evaluations published in the literature and 10 studies submitted to the FDA and for a Clinical Laboratory Improvement Amendments waiver application. The pooled sensitivity (95% CI) from the laboratory evaluations (n = 5) was 98.5% (92.1-100%), while pooled specificity was 95.9% (81.5-100.0%). The pooled sensitivity for prospective studies (n = 10) was 87.7% ( 71.8-97.2%), while pooled specificity was 96.7% (91.9-99.2%). Using nontreponemal supplemental testing, the sensitivity improved to a pooled sensitivity of 97.0% (94.8-98.6%). The Syphilis Health Check may provide accurate detection of treponemal antibody.

Sexually Transmitted Infections in Pregnancy and Reproductive Health: Proceedings of the STAR Sexually Transmitted Infection Clinical Trial Group Programmatic Meeting.

The goal of the STAR Sexually Transmitted Infection Clinical Trial Group (STI CTG) Programmatic meeting on Sexually Transmitted Infections (STIs) in Pregnancy and Reproductive Health in April 2018 was to review the latest research and develop recommendations to improve prevention and management of STIs during pregnancy. Experts from academia, government, nonprofit, and industry discussed the burden of STIs during pregnancy; the impact of STIs on adverse pregnancy and birth outcomes; interventions that work to reduce STIs in pregnancy, and the evidence, policy, and technology needed to improve STI care during pregnancy. Key points of the meeting are as follows: (i) alternative treatments and therapies for use during pregnancy are needed; (ii) further research into the relationship between the vaginal microbiome and STIs during pregnancy should be supported; (iii) more research to determine whether STI tests function equally well in pregnant as nonpregnant women is needed; (iv) development of new lower cost, rapid point-of-care testing assays could allow for expanded STI screening globally; (v) policies should be implemented that create standard screening and treatment practices globally; (vi) federal funding should be increased for STI testing and treatment initiatives supported by the Centers for Disease Control and Prevention (CDC), the Centers of Excellence in STI Treatment, public STD clinics, and the President's Emergency Plan for AIDS Relief (PEPFAR).

Antimicrobial Resistance in Neisseria gonorrhoeae: Proceedings of the STAR Sexually Transmitted Infection-Clinical Trial Group Programmatic Meeting.

The goal of the Sexually Transmitted Infection Clinical Trial Group's Antimicrobial Resistance (AMR) in Neisseria gonorrhoeae (NG) meeting was to assemble experts from academia, government, nonprofit and industry to discuss the current state of research, gaps and challenges in research and technology and priorities and new directions to address the continued emergence of multidrug-resistant NG infections. Topics discussed at the meeting, which will be the focus of this article, include AMR NG global surveillance initiatives, the use of whole genome sequencing and bioinformatics to understand mutations associated with AMR, mechanisms of AMR, and novel antibiotics, vaccines and other methods to treat AMR NG. Key points highlighted during the meeting include: (i) US and International surveillance programs to understand AMR in NG; (ii) the US National Strategy for combating antimicrobial-resistant bacteria; (iii) surveillance needs, challenges, and novel technologies; (iv) plasmid-mediated and chromosomally mediated mechanisms of AMR in NG; (v) novel therapeutic (eg, sialic acid analogs, factor H [FH]/Fc fusion molecule, monoclonal antibodies, topoisomerase inhibitors, fluoroketolides, LpxC inhibitors) and preventative (eg, peptide mimic) strategies to combat infection. The way forward will require renewed political will, new funding initiatives, and collaborations across academic and commercial research and public health programs.

Meta-analysis of the Cepheid Xpert® CT/NG assay for extragenital detection of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections.

Background Most studies evaluating extragenital testing performance for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) detection by the Xpert® CT/NG show high per cent agreement with comparison assays; however, the precision around positive per cent agreement is low and thus the values that have been reported are not highly informative. Therefore, a systematic review was conducted and data from five studies were combined to better assess positive per cent agreement. METHODS: The literature indexed on PubMed.gov was searched. Included studies were those that were an evaluation of the Xpert CT/NG assay with rectal and/or pharyngeal specimen types compared with another nucleic acid amplification test (NAAT), the Aptima transcription mediated amplification assay. A full Bayesian method was used for bivariate fixed-effect meta-analysis of positive and negative per cent agreement and pooled estimates (and 95% confidence intervals (CI)) were presented for each. RESULTS: The pooled positive and negative per cent agreement for detection of CT in rectal specimens was 89.72% (95% CI: 84.97%, 93.64%) and 99.23% (95% CI: 98.74%, 99.60%), and in pharyngeal specimens, they were 89.96% (95% CI: 66.38%, 99.72%) and 99.62% (95% CI: 98.95%, 99.95%) respectively. For NG detection in rectal specimens, the pooled positive and negative per cent agreement was 92.75% (95% CI: 87.91%, 96.46%) and 99.75% (95% CI: 99.46%, 99.93%), and in pharyngeal specimens, they were 92.51% (95% CI: 85.84%, 97.18%) and 98.56% (95% CI: 97.69%, 99.23%) respectively. CONCLUSIONS: It was found that the Xpert CT/NG assay performed similarly to the Aptima transcription mediated amplification assay for the detection of CT and NG in extragenital specimens. The Xpert assay has the benefit of providing faster results at the point-of-care, thus reducing the turnaround time for results, potentially enabling same-day treatment.

Using Treponemal Assay Signal Strength Cutoff Ratios To Predict Syphilis Infection.

Syphilis screening with the reverse algorithm, a treponemal test for screening followed by a nontreponemal test if reactive, is increasingly being used. That algorithm has several advantages, including use of an automated screening test, saving on laboratory time and costs, as well as detection of very early syphilis infection. However, under that algorithm, in situations where the treponemal result is positive and the nontreponemal result is nonreactive a second treponemal test must be performed, which may actually lead to inefficiencies in the laboratory. In this issue of the Journal of Clinical Microbiology, Y. F. Fakile et al. (J Clin Microbiol 56:e01165-17, 2017, https://doi.org/10.1128/JCM.01165-17) report the results of their study, which demonstrates the capability of signal strength ratio cutoffs for automated treponemal immunoassays to predict the outcome of repeat treponemal testing. Their findings suggest that anti-treponemal signal strength ratio values above a cutoff value can be used in lieu of repeat treponemal tests.

Use of Oral Fluid With a Rapid Treponemal Test for Syphilis Evaluation.

We aimed to determine if rapid treponemal tests intended for whole-blood specimens could be used to detect treponemal antibody in oral fluid. We found a high sensitivity of oral fluid rapid testing, which increased with increasing rapid plasma reagin titer, suggesting potential for the development of accurate rapid oral syphilis tests.

Factors in the HIV risk environment associated with bacterial vaginosis among HIV-negative female sex workers who inject drugs in the Mexico-United States border region.

BACKGROUND: Bacterial vaginosis (BV) is the most common cause of vaginitis among women worldwide and is associated with increased susceptibility to sexually transmitted infections (STIs), including HIV. We aimed to determine the impact of the HIV risk environment on BV among female sex workers who inject drugs (FSW-PWIDs) in Tijuana and Ciudad Juarez, Mexico. METHODS: We performed a cross-sectional analysis utilizing baseline data from a randomized controlled trial evaluating a behavioral HIV prevention intervention. Participants underwent testing for BV using the OSOM BVBlue® Rapid Test (Genzyme Diagnostics, San Diego, CA) and completed a survey eliciting information on the HIV risk environment, sexual risk behaviors, and substance use. We applied logistic regression to identify correlates of BV in the physical, social, economic, and political HIV risk environments stratified by study site (Ciudad Juarez vs. Tijuana). RESULTS: In total, 584 HIV-negative FSW-PWIDs (300 Ciudad Juarez; 284 Tijuana) were enrolled. The prevalence of BV was 39% (n = 228), which was higher in Ciudad Juarez (56.7%) compared to Tijuana (20.4%). In both cities, micro-level components of the physical HIV risk environment were associated with BV. In Ciudad Juarez, BV was associated with past experiences or threats of physical violence in response to proposed condom use (adjusted odds ratio [aOR] = 3.66, 95% confidence interval [CI]: 1.74-7.69, p = 0.001) and lifetime residence in Ciudad Juarez (aOR = 1.74, 95% CI: 1.05-2.87, p = 0.031). In Tijuana, BV was associated with the number of hours spent on the street daily in the past six months looking for, using, or dealing drugs, engaging in other income generating activities, or sleeping (aOR = 1.05, 95% CI: 1.001-1.097, p = 0.045). CONCLUSIONS: Our findings suggest that FSW-PWIDs' risk of BV may be shaped by the microphysical HIV risk environment. Addressing components of the physical risk environment, including interventions to reduce gender-based violence, may alleviate the burden of BV and subsequent susceptibility to HIV/STIs among FSW-PWIDs in the Mexico/US border region. TRIAL REGISTRATION: National Institute of Health (NIH) Clinical Trials Identifier NCT00840658 , and date of NIH trial registration February 7, 2009.

Comparative Evaluation of 2 Nucleic Acid Amplification Tests for the Detection of Chlamydia trachomatis and Neisseria gonorrhoeae at Extragenital Sites.

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are frequently asymptomatic, requiring highly accurate diagnostic tests and proper management to prevent further transmission. We compared two nucleic acid tests, Xpert® CT/NG (Cepheid, Sunnyvale, CA) point-of-care platform and at an offsite clinical laboratory with Aptima Combo 2® (Hologic, Inc., San Diego, CA) assay, for the detection of extragenital infection in patients at an STI clinic in Hollywood, CA.We calculated concordance between the two assays and used the exact binomial method to calculate 95% confidence intervals (CIs) for each specimen type and pathogen.The concordance between the two assays was 97.7% (95% CI: 95.7%,99.0%) for 393 paired CT rectal results, 98.2% (95% CI: 96.4%,99.3%) for 391 paired NG rectal results and 98.4% (95% CI: 96.8%,99.4%) for 448 paired NG pharyngeal results.The performance of Xpert® CT/NG assay in point-of-care testing in extragenital specimens was highly similar to the laboratory-based platform.

Laboratory Evaluation of a Smartphone-Based Electronic Reader of Rapid Dual Point-of-Care Tests for Antibodies to Human Immunodeficiency Virus and Treponema pallidum Infections.

BACKGROUND: Dual point-of-care tests for antibodies to human immunodeficiency virus (HIV) and Treponema pallidum allow for same-day testing and treatment and have been demonstrated to be cost-effective in preventing the adverse outcomes of HIV infection and syphilis. By recording and transmitting data as they are collected, electronic readers address challenges related to the decentralization of point-of-care testing. METHODS: We evaluated a smartphone-based electronic reader using 201 sera tested with 2 dual rapid tests for detection of antibodies to HIV and T. pallidum in Los Angeles, USA, and Lima, Peru. Tests were read both visually and with the electronic reader. Enzyme immunoassay followed by Western blot and T. pallidum particle agglutination were the reference tests for HIV and T. pallidum, respectively. RESULTS: The sensitivities of the 2 rapid tests for detection of HIV were 94.1% and 97.0% for electronic readings. Both tests had a specificity of 100% for detection of HIV by electronic reading. The sensitivities of the 2 rapid tests for detection of T. pallidum were 86.5% and 92.4% for electronic readings. The specificities for detection of T. pallidum were 99.1% and 99.0% by electronic reading. There were no significant differences between the accuracies of visual and electronic readings, and the performance did not differ between the 2 study sites. CONCLUSIONS: Our results show the electronic reader to be a promising option for increasing the use of point-of-care testing programs.

Point-of-Care Sexually Transmitted Infection Diagnostics: Proceedings of the STAR Sexually Transmitted Infection-Clinical Trial Group Programmatic Meeting.

The goal of the point-of-care (POC) sexually transmitted infection (STI) Diagnostics meeting was to review the state-of-the-art research and develop recommendations for the use of POC STI diagnostics. Experts from academia, government, nonprofit, and industry discussed POC diagnostics for STIs such as Chlamydia trachomatis, human papillomavirus, Neisseria gonorrhoeae, Trichomonas vaginalis, and Treponema pallidum. Key objectives included a review of current and emerging technologies, clinical and public health benefits, POC STI diagnostics in developing countries, regulatory considerations, and future areas of development. Key points of the meeting are as follows: (i) although some rapid point-of-care tests are affordable, sensitive, specific, easy to perform, and deliverable to those who need them for select sexually transmitted infections, implementation barriers exist at the device, patient, provider, and health system levels; (ii) further investment in research and development of point-of-care tests for sexually transmitted infections is needed, and new technologies can be used to improve diagnostic testing, test uptake, and treatment; (iii) efficient deployment of self-testing in supervised (ie, pharmacies, clinics, and so on) and/or unsupervised (ie, home, offices, and so on) settings could facilitate more screening and diagnosis that will reduce the burden of sexually transmitted infections; (iv) development of novel diagnostic technologies has outpaced the generation of guidance tools and documents issued by regulatory agencies; and (v) questions regarding quality management are emerging including the mechanism by which poor-performing diagnostics are removed from the market and quality assurance of self-testing is ensured.

Implementing and sustaining a mobile medical clinic for prenatal care and sexually transmitted infection prevention in rural Mysore, India.

BACKGROUND: In rural India, mobile medical clinics are useful models for delivering health promotion, education, and care. Mobile medical clinics use fewer providers for larger catchment areas compared to traditional clinic models in resource limited settings, which is especially useful in areas with shortages of healthcare providers and a wide geographical distribution of patients. METHODS: From 2008 to 2011, we built infrastructure to implement a mobile clinic system to educate rural communities about maternal child health, train community health workers in common safe birthing procedures, and provide comprehensive antenatal care, prevention of mother-to-child transmission (PMTCT) of human immunodeficiency virus (HIV), and testing for specific infections in a large rural catchment area of pregnant women in rural Mysore. This was done using two mobile clinics and one walk-in clinic. Women were tested for HIV, hepatitis B, syphilis, and bacterial vaginosis along with random blood sugar, urine albumin, and anemia. Sociodemographic information, medical, and obstetric history were collected using interviewer-administered questionnaires in the local language, Kannada. Data were entered in Microsoft Excel and analyzed using Stata SE 14.1. RESULTS: During the program period, nearly 700 community workers and 100 health care providers were trained; educational sessions were delivered to over 15,000 men and women and integrated antenatal care and HIV/sexually transmitted infection testing was offered to 3545 pregnant women. There were 22 (0.6%) cases of HIV, 19 (0.5%) cases of hepatitis B, 2 (0.1%) cases of syphilis, and 250 (7.1%) cases of BV, which were identified and treated. Additionally, 1755 (49.5%) cases of moderate to severe anemia and 154 (4.3%) cases of hypertension were identified and treated among the pregnant women tested. CONCLUSIONS: Patient-centered mobile medical clinics are feasible, successful, and acceptable models that can be used to provide quality healthcare to pregnant women in rural and hard-to-reach settings. The high numbers of pregnant women attending mobile medical clinics show that integrated antenatal care with PMTCT services were acceptable and utilized. The program also developed and trained health professionals who continue to remain in those communities.

The PICASSO Cohort: baseline characteristics of a cohort of men who have sex with men and male-to-female transgender women at high risk for syphilis infection in Lima, Peru.

BACKGROUND: Men who have sex with men (MSM) and male-to-female transgender women (transwomen) are disproportionately at risk of syphilis infection in Peru. METHODS: From 2013 to 2014, MSM and transwomen seeking human immunodeficiency virus (HIV) or sexually transmitted infection (STI) testing and/or treatment were recruited into a 2-year observational cohort study to determine predictors of recently acquired syphilis infection (defined as a rapid plasma reagin [RPR] titer ≥1:16 and a reactive treponemal antibody test) in Lima, Peru. At baseline, interviewers collected sociodemographic, behavioral, and medical characteristics from participants. All cohort participants were tested for syphilis, HIV, Chlamydia trachomatis (CT), and Neisseria gonorrhoeae (NG) infection. Using cross-sectional analyses, bivariate and multivariate models were used to determine factors associated with recently acquired syphilis infection and calculate adjusted prevalence ratios. RESULTS: We recruited 401 participants, 312 MSM and 89 transwomen, with median ages of 29.0 and 32.5 years old (interquartile ranges: 23.3, 37.4 and 27.2, 39.5, respectively). The prevalence of recently acquired syphilis infection at baseline was 16.8% for MSM and 6.7% for transwomen. Among MSM and transwomen, 30.1 and 33.7% were infected with HIV, 18.6 and 24.7% were infected with CT, and 14.2 and 19.1% were infected with NG, respectively. Co-infection rates among MSM with recently acquired syphilis infection included: 44.2% with HIV, 40.4% with CT (32.7% with anal CT and 7.7% with pharyngeal CT), and 19.2% with NG (11.5% with anal NG and 7.7% with pharyngeal NG). Co-infection rates among transwomen with recently acquired syphilis infection included: 66.7% with HIV, 0% with CT, and 16.7% with anal NG. In multivariate analysis among the entire cohort, recently acquired syphilis infection was independently associated with younger age (adjusted prevalence ratio [aPR] = 0.96, 95% confidence interval [CI] = 0.93-0.99), receptive role during anal sex (aPR = 2.56, 95% CI = 1.05-6.25), prior HIV diagnosis (aPR = 1.70, 95% CI = 1.11-2.61), anal CT or NG infection (aPR = 1.69, 95% CI = 1.09-2.60), and prior syphilis diagnosis (aPR = 3.53, 95% CI = 2.20-5.68). CONCLUSIONS: We recruited a cohort of MSM and transwomen who had a high prevalence of recently acquired syphilis infection in Lima, Peru. Recently acquired syphilis infection was associated with socio-demographic characteristics, sexual risk, and sexually transmitted co-infections.

Cost-effectiveness of HIV and syphilis antenatal screening: a modelling study.

OBJECTIVES: The WHO called for the elimination of maternal-to-child transmission (MTCT) of HIV and syphilis, a harmonised approach for the improvement of health outcomes for mothers and children. Testing early in pregnancy, treating seropositive pregnant women and preventing syphilis reinfection can prevent MTCT of HIV and syphilis. We assessed the health and economic outcomes of a dual testing strategy in a simulated cohort of 100 000 antenatal care patients in Malawi. METHODS: We compared four screening algorithms: (1) HIV rapid test only, (2) dual HIV and syphilis rapid tests, (3) single rapid tests for HIV and syphilis and (4) HIV rapid and syphilis laboratory tests. We calculated the expected number of adverse pregnancy outcomes, the expected costs and the expected newborn disability-adjusted life years (DALYs) for each screening algorithm. The estimated costs and DALYs for each screening algorithm were assessed from a societal perspective using Markov progression models. Additionally, we conducted a Monte Carlo multiway sensitivity analysis, allowing for ranges of inputs. RESULTS: Our cohort decision model predicted the lowest number of adverse pregnancy outcomes in the dual HIV and syphilis rapid test strategy. Additionally, from the societal perspective, the costs of prevention and care using a dual HIV and syphilis rapid testing strategy was both the least costly ($226.92 per pregnancy) and resulted in the fewest DALYs (116 639) per 100 000 pregnancies. In the Monte Carlo simulation the dual HIV and syphilis algorithm was always cost saving and almost always reduced DALYs compared with HIV testing alone. CONCLUSIONS: The results of the cost-effectiveness analysis showed that a dual HIV and syphilis test was cost saving compared with all other screening strategies. Updating existing prevention of mother-to-child HIV transmission programmes in Malawi and similar countries to include dual rapid testing for HIV and syphilis is likely to be advantageous.