RESUMO
BACKGROUND: In South Africa, 7-valent pneumococcal conjugate vaccine (PCV7) was introduced in 2009 and 13-valent PCV (PCV13) was introduced in 2011, both in a two plus one schedule. We evaluated the ongoing effects of PCV on the prevention of invasive pneumococcal disease (IPD) over 15 years of sustained surveillance in South Africa before the COVID-19 pandemic. METHODS: We conducted national, active, laboratory-based surveillance for IPD among all ages in South Africa, including isolate serotyping and susceptibility testing. We fitted linear regression models with vaccine covariates to imputed IPD case counts each year by serotype and age to compare expected and actual IPD cases in 2019, which was the main outcome. Vaccine effects were set to zero to identify expected incidence after the introduction of PCV7 and PCV13. FINDINGS: From Jan 1, 2005, to Dec 31, 2019, surveillance identified 52â957 IPD cases. Among the 50â705 individuals with age data available, 9398 (18·5%) were infants aged younger than 2 years. Compared with expected case numbers (no vaccination) predicted using all available data, overall IPD rates among children younger than 2 years declined by 76·0% (percentage risk difference; 95% CI -79·0 to -72·8%) in 2019; notably, PCV7 and additional PCV13 serotype IPD rates declined by 95·5% (-97·0 to -93·4%) and 93·8% (-96·2 to-90·5%), respectively, whereas non-vaccine serotypes (NVTs) did not change significantly. Among adults aged 25-44 years, overall IPD declined by 50·4% (-54·2 to -46·3%), and PCV7 and additional PCV13 serotype IPD rates declined by 86·1% (-88·7 to -83·1%) and 77·2% (-80·9 to -73·0%), respectively, whereas NVTs increased by 78·5% (56·8 to 103·4%). Individuals aged older than 64 years also benefited from declines in IPD (-30·2%; -41·9 to -16·2%), but NVTs increased (234·9%; 138·1 to 379·4%). INTERPRETATION: We documented sustained direct and indirect benefits of PCV across age groups, and NVT increases in adults older than 24 years. Higher valency PCVs would have the added benefit of preventing this residual disease. FUNDING: National Institute for Communicable Diseases of the National Health Laboratory Service (South Africa) and US Agency for International Development Antimicrobial Resistance Initiative, US Centers for Disease Control and Prevention.
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Infecções Pneumocócicas , Vacinas Pneumocócicas , Humanos , África do Sul/epidemiologia , Infecções Pneumocócicas/prevenção & controle , Infecções Pneumocócicas/epidemiologia , Adulto , Incidência , Vacinas Pneumocócicas/administração & dosagem , Lactente , Pré-Escolar , Adulto Jovem , Criança , Adolescente , Pessoa de Meia-Idade , Feminino , Masculino , Idoso , Vacinas Conjugadas , Estudos de Coortes , Streptococcus pneumoniae/imunologia , Streptococcus pneumoniae/isolamento & purificação , Streptococcus pneumoniae/classificação , Recém-Nascido , Vacina Pneumocócica Conjugada Heptavalente/administração & dosagemRESUMO
INTRODUCTION: In 2016, WHO estimated there were roughly 374 million new infections among adults of the following four curable sexually transmitted infections (STIs): chlamydia (caused by Chlamydia trachomatis (CT)), gonorrhoea (Neisseria gonorrhoeae (NG)), syphilis (Treponema pallidum) and trichomoniasis (Trichomonas vaginalis (TV)). Accurate point-of-care tests (POCTs) for screening of genital and extragenital CT, NG and TV infections are of great value and have been developed during recent decade. Several tests are commercially available and have shown encouraging performance compared with 'gold-standard' reference tests in laboratory-based studies. However, there is limited data on their clinical performance, including at the POC. Key populations, such as men who have sex with men (MSM), are at higher risk of these STIs at genital and extragenital sites and these STIs are often asymptomatic, especially in extragenital sites and in women. We will conduct a clinical-based evaluation to assess the performance characteristics and acceptability to end-users of molecular-based diagnostic technology for POC/near patient use of the Xpert CT/NG (Cepheid, Sunnyvale, California, USA) test for screening of genital, anorectal and pharyngeal CT and NG infections in MSM and the Xpert CT/NG and Xpert TV (Cepheid, Sunnyvale, California, USA) for screening of genital CT, NG and TV among women at risk for these STIs compared with gold-standard reference nucleic acid amplification tests. This master protocol outlines the overall research approach that will be used in seven countries. METHOD AND ANALYSES: Consecutive MSM and women at risk presenting at the clinical sites in high, and low- and middle-income countries will be enrolled. The POCTs to be evaluated are Xpert CT/NG and Xpert TV. All procedures will be carried out by trained healthcare staff and tests performed in strict accordance with the manufacturer's instructions. The sensitivity, specificity, positive and negative predictive values for each POCT will be calculated. The study is ongoing with recruitment expected to be completed in all countries by mid-2022 to late-2022. ETHICS AND DISSEMINATION: Prior to enrolment, this core protocol was independently peer-reviewed and approved by the research project review panel (RP2) of the WHO Department of Sexual and Reproductive Health and Research and by the WHO Ethics Review Committee (ERC). The core protocol has been slightly adapted accordingly to individual countries and adaptations approved by both RP2 and ERC, as well as all relevant institutional review boards at each participating site. Results will be disseminated through peer-reviewed journals and presented at relevant national/international conferences.
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Infecções por Chlamydia , Gonorreia , Homossexualidade Masculina , Testes Imediatos , Humanos , Masculino , Feminino , Infecções por Chlamydia/diagnóstico , Gonorreia/diagnóstico , Estudos Prospectivos , Programas de Rastreamento/métodos , Trichomonas vaginalis/isolamento & purificação , Infecções Sexualmente Transmissíveis/diagnóstico , Vaginite por Trichomonas/diagnóstico , Vaginite por Trichomonas/epidemiologia , Estudos Multicêntricos como Assunto , Sensibilidade e Especificidade , Adulto , Sistemas Automatizados de Assistência Junto ao LeitoRESUMO
BACKGROUND: Southern African countries have the largest global burden of HIV and syphilis, with a high prevalence among women of reproductive age. Although antenatal screening is standard of care, syphilis screening has generally lagged behind HIV screening. We aimed to evaluate the performance and operational characteristics of two commercial dual HIV/syphilis point-of-care tests (POCTs) for simultaneous maternal HIV/syphilis screening. METHODS: A clinic-based evaluation of dual HIV/syphilis POCTs (SD Bioline and Chembio) was conducted at five primary healthcare centres (PHCs) in South Africa and Zambia. POCT results using capillary fingerprick blood were compared to reference laboratory syphilis and HIV serological assays. RESULTS: Three thousand four hundred twelve consenting pregnant women aged ≥ 18 years were enrolled. The prevalence of treponemal antibody seropositivity and HIV infection ranged from 3.7 to 9.9% (n = 253) and 17.8 to 21.3% (n = 643), respectively. Pooled sensitivity for syphilis compared to the reference assay was 66.0% (95%CI 57.7-73.4) with SD Bioline and 67.9% (95%CI 58.2-76.3) with Chembio. Pooled specificity for syphilis was above 98% with both POCTs. The sensitivities of SD Bioline and Chembio assays were 78.0% (95%CI 68.6-85.7) and 81.0% (95%CI 71.9-88.2), respectively compared to an active syphilis case definition of treponemal test positive with a rapid plasma reagin titre of ≥ 8. The negative predictive values (NPVs) based on various prevalence estimates for syphilis with both assays ranged from 97 to 99%. The pooled sensitivity for HIV was 92.1% (95%CI 89.4-94.2) with SD Bioline; and 91.5% (95%CI 88.2-93.9) with Chembio. The pooled specificities for HIV were 97.2% (95%CI 94.8-98.5) with SD Bioline and 96.7% (95%CI 95.1-97.8) with Chembio. The NPV based on various prevalence estimates for HIV with both assays was approximately 98%. Most participating women (91%) preferred dual POCTs over two single POCTs for HIV and syphilis, and healthcare providers gave favourable feedback on the utility of both assays at PHC level. CONCLUSIONS: Based on the need to improve antenatal screening coverage for syphilis, dual HIV/syphilis POCTs could be effectively incorporated into antenatal testing algorithms to enhance efforts towards elimination of mother-to-child transmission of these infections.
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Infecções por HIV , Complicações Infecciosas na Gravidez , Sensibilidade e Especificidade , Sífilis , Humanos , Zâmbia/epidemiologia , Feminino , Sífilis/diagnóstico , Sífilis/epidemiologia , Infecções por HIV/diagnóstico , Infecções por HIV/epidemiologia , Gravidez , África do Sul/epidemiologia , Adulto , Adulto Jovem , Complicações Infecciosas na Gravidez/diagnóstico , Complicações Infecciosas na Gravidez/epidemiologia , Adolescente , Sistemas Automatizados de Assistência Junto ao Leito , Atenção Primária à Saúde , Testes Imediatos , Prevalência , Programas de Rastreamento/métodos , Cuidado Pré-Natal , Testes Diagnósticos de Rotina/métodos , Testes de Diagnóstico RápidoRESUMO
BACKGROUND: In South Africa, extragenital etiological sexually transmitted infection (STI) screening among men who have sex with men (MSM) is not routinely available. We aimed to determine the prevalence of STI pathogens at rectal and pharyngeal sites, syphilis seroprevalence, and associated risk factors among a selection of high-risk MSM without symptomatic urethritis attending a men's health clinic in Johannesburg, South Africa. METHODS: A cross-sectional study was conducted in 2022. Enrolled clients self-reported demographic, sexual behavioral risks, and clinical information. Client or clinician-collected rectal and pharyngeal swabs were tested for Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis. C. trachomatis-positive rectal samples were reflex tested for lymphogranuloma venereum. Blood specimens were screened for syphilis. Univariate and multivariate regression models were used to determine factors independently associated with the presence of an extragenital STI or syphilis. RESULTS: Among the 97 participants (median age, 29 years), 24.7% had an extragenital STI and 9.4% had high nontreponemal antibody titers (rapid plasma reagin ≥1:16). Rectal STIs were detected in 26.4% participants: N. gonorrhoeae (14.3%), C. trachomatis (9.9%), and M. genitalium (5.5%). Pharyngeal STIs were less prevalent (4.1%). Overall, the prevalence of any STI was 41%. Sex under the influence of drugs (adjusted odds ratio, 4.94; 95% confidence interval, 1.56-15.69) and engaging in condomless receptive anal intercourse with a casual partner (adjusted odds ratio, 8.36; 95% confidence interval, 1.73-40.28) were independent risk factors for having an extragenital STI. CONCLUSIONS: The high burden of extragenital STIs and active syphilis in asymptomatic MSM underscores the importance of routine etiological screening in this key population, as the syndromic approach would not enable detection or treatment of these infections.
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Infecções por Chlamydia , Gonorreia , Infecções por HIV , Minorias Sexuais e de Gênero , Infecções Sexualmente Transmissíveis , Sífilis , Masculino , Humanos , Adulto , Homossexualidade Masculina , Sífilis/epidemiologia , Gonorreia/epidemiologia , África do Sul , Estudos Transversais , Estudos Soroepidemiológicos , Infecções por Chlamydia/epidemiologia , Infecções Sexualmente Transmissíveis/epidemiologia , Neisseria gonorrhoeae , Chlamydia trachomatis , Prevalência , Infecções por HIV/epidemiologiaRESUMO
BACKGROUND: In 2018, the World Health Organization commenced a multi-country validation study of the Cepheid GeneXpert for a range of molecular-based point-of-care (POC) tests in primary care settings. One study arm focused on the evaluation of POC tests for screening 'women at risk' for chlamydia (CT), gonorrhoea (NG) and trichomonas (TV) in four countries - Australia, Guatemala, Morocco and South Africa. METHODS: Study participants completed a pre-test questionnaire which included demographics, clinical information and general questions on POC testing (POCT). Two vaginal swab samples (either self-collected or clinician collected) from each patient were tested on the GeneXpert at the POC and at a reference laboratory using quality-assured nucleic acid amplification tests (NAATs). RESULTS: One thousand three hundred and eighty-three women were enrolled: 58.6% from South Africa, 29.2% from Morocco, 6.2% from Guatemala, and 6.0% from Australia. 1296 samples for CT/NG and 1380 samples for TV were tested by the GeneXpert and the reference NAAT. The rate of unsuccessful tests on the GeneXpert was 1.9% for CT, 1.5% for NG and 0.96% for TV. The prevalence of CT, NG and TV was 31%, 13% and 23%, respectively. 1.5% of samples were positive for all three infections; 7.8% were positive for CT and NG; 2.4% were positive for NG and TV; and 7.3% were positive for CT and TV. Compared to reference NAATs, pooled estimates of sensitivity for the GeneXpert tests were 83.7% (95% confidence intervals 69.2-92.1) for CT, 90.5% (85.1-94.1) for NG and 64.7% (58.1-70.7) for TV (although estimates varied considerably between countries). Estimates for specificity were ≥96% for all three tests both within- and between-countries. Pooled positive and negative likelihood ratios were: 32.7 ([CI] 21.2-50.5) and 0.17 (0.08-0.33) for CT; 95.3 (36.9-245.7) and 0.10 (0.06-0.15) for NG; and 56.5 (31.6-101.1) and 0.35 (0.27-0.47) for TV. CONCLUSION: This multi-country evaluation is the first of its kind world-wide. Positive likelihood ratios, as well as specificity estimates, indicate the GeneXpert POC test results for CT, NG and TV were clinically acceptable for ruling in the presence of disease. However, negative likelihood ratios and variable sensitivity estimates from this study were poorer than expected for ruling out these infections, particularly for TV. TRIAL REGISTRATION: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee, as well as local ethics committees from all participating countries.
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Gonorreia , Trichomonas vaginalis , Feminino , Humanos , Trichomonas vaginalis/genética , Chlamydia trachomatis/genética , Gonorreia/diagnóstico , Gonorreia/epidemiologia , Guatemala/epidemiologia , Marrocos/epidemiologia , África do Sul/epidemiologia , Neisseria gonorrhoeae/genética , Austrália , Testes ImediatosRESUMO
BACKGROUND: Sexually transmitted infections caused by Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG) and Trichomonas vaginalis (TV) remain significant global health problems. The World Health Organization (WHO) has recently conducted a multi-faceted, multi-country validation study (ProSPeRo), which included an evaluation of the Xpert CT/NG and Xpert TV assays on the GeneXpert system (Cepheid, Sunnyvale, Ca., USA) in clinic-based settings across eight countries. To support the study, a training and quality management system was implemented and evaluated. METHODS: A comprehensive training program for the study was developed. Quality control (QC) and external quality assessment (EQA) samples were provided by an accredited quality assurance provider. QC testing was conducted at 14 point-of-care testing (POCT) clinics, while EQA samples were tested by the POCT sites and a reference laboratory supporting each clinic. RESULTS: For QC testing, concordance with the expected results for CT and NG was > 99% and rates of unsuccessful tests were < 4%. For TV testing, concordance was similar (97%), but rates of unsuccessful tests were high (18%), particularly in the 'TV negative' sample. For EQA testing initially conducted in 2018, concordance was 100% for CT and NG, and 90% for TV for the reference laboratory group (which used non-GeneXpert systems). Concordance for the POCT group was also high (> 94%) for all analytes, but this cohort (which used GeneXpert systems) exhibited a high rate of unsuccessful TV tests. All but one of these unsuccessful tests was subcategorised as 'invalid'. CONCLUSIONS: The high level of concordance for QC and EQA testing confirm that the trained operators at the POC clinical sites were competent to conduct POC testing and that the training and quality systems implemented for the ProSPeRo study were effective. The quality materials used were satisfactory for CT and NG but exhibited poor performance for TV testing on the GeneXpert system. The WHO should continue to work with industry and EQA providers to provide improved materials that are reliable, stable and cost effective for quality management, as it seeks to rollout molecular-based STI POCT in non-laboratory-based settings. TRIAL REGISTRATION: Ethics approval to conduct the ProSPeRo study was granted by the WHO Ethics Review Committee.
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Infecções por Chlamydia , Gonorreia , Infecções Sexualmente Transmissíveis , Trichomonas vaginalis , Humanos , Trichomonas vaginalis/genética , Neisseria gonorrhoeae/genética , Chlamydia trachomatis/genética , Gonorreia/diagnóstico , Infecções por Chlamydia/diagnóstico , Infecções Sexualmente Transmissíveis/diagnóstico , Testes ImediatosRESUMO
BACKGROUND: Sexually transmitted infections (STIs) such as syphilis and HIV remain to be a significant public health issue worldwide. Dual rapid point-of-care tests (POCTs) have shown promise for detecting antibodies to HIV and syphilis but have not been fully evaluated in the field. Our study supported the WHO ProSPeRo study on Sexually Transmitted Infection Point-of-Care Testing (STI POCT) by providing external quality assessment (EQA) for HIV and syphilis testing in reference laboratories and their associated clinical sites in seven countries. METHODS: HIV/syphilis serum liquid and dried tube specimen (DTS) panels were prepared by CDC. Liquid panels were distributed to the reference laboratories for three rounds of testing using commercially and locally available laboratory-based serological tests. DTS panels were sent to the clinical testing sites for 8 rounds of POC testing using the Abbott SD BIOLINE HIV/Syphilis Duo test (hereafter referred to as SD BIOLINE) and the Chembio Dual Path Platform (DPP) HIV-Syphilis assay. EQA panels were tested at CDC using the Rapid Plasma Reagin (RPR) test and the Treponema pallidum Particle Agglutination assay (TP-PA) for syphilis antibodies. Genetic Systems HIV-1/HIV-2 Plus O EIA, Geenius HIV Supplemental Assay and the Oraquick Advance HIV test were used to detect HIV antibodies in the EQA panels. Results from the reference laboratories and POCT sites were compared to those obtained at the CDC and a percentage agreement was calculated. RESULTS: Qualitative RPR and TP-PA performed at the reference laboratories demonstrated 95.4-100% agreement with CDC results while quantitative RPR and TP-PA tests demonstrated 87.7% and 89.2% agreement, respectively. A 93.8% concordance rate was observed for qualitative HIV testing in laboratories. EQA testing at clinical sites using dual tests showed 98.7% and 99.1% agreement for detection of HIV antibodies and eight out of 10 sites had > 95.8% agreement for syphilis testing. However, two clinical sites showed only 65.0-66.7% agreement for SD BIOLINE and 84.0-86.7% for DPP, respectively, for syphilis testing. CONCLUSIONS: Overall, laboratories demonstrated high EQA performance in this study. Both HIV/syphilis POCTs gave expected results in the clinic-based evaluations using DTS. However, testing errors were identified in a few testing sites suggesting the necessity for continuous training and monitoring the quality of POC testing.
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Infecções por HIV , HIV-1 , Sífilis , Humanos , Treponema pallidum , Anticorpos Anti-HIV , Infecções por HIV/diagnóstico , Sensibilidade e Especificidade , Anticorpos Antibacterianos , Testes Imediatos , Sorodiagnóstico da Sífilis/métodos , HIV-2 , Organização Mundial da Saúde , Sistemas Automatizados de Assistência Junto ao LeitoRESUMO
BACKGROUND: In South Africa, Neisseria gonorrhoeae , which is the predominant cause of male urethritis, is treated syndromically using dual ceftriaxone and azithromycin therapy. We determined antimicrobial susceptibilities of N. gonorrhoeae isolates from urethral discharge specimens, and genetically characterised those with elevated minimum inhibitory concentrations (MICs) for first-line antimicrobials. METHODS: Routine antimicrobial susceptibility testing (AST) of N. gonorrhoeae isolates included E-test for ceftriaxone, cefixime and gentamicin and agar dilution for azithromycin and spectinomycin. Neisseria gonorrhoeae Sequence Typing for Antimicrobial Resistance (NG-STAR) was performed for isolates with elevated MICs to identify antimicrobial resistance (AMR) determinants, and Neisseria gonorrhoeae Multi-Antigen Sequence Typing (NG-MAST) was used to determine strain relatedness. RESULTS: N. gonorrhoeae was cultured from urethral discharge swab specimens obtained from 196 of 238 (82.4%) men presenting to a primary healthcare facility in Johannesburg in 2021. All viable isolates were susceptible to extended-spectrum cephalosporins. Four isolates had high azithromycin MICs ranging from 32mg/L to >256mg/L and grouped into two novel NG-MAST and NG-STAR groups. Two isolates from Group 1 (NG-MAST ST20366, NG-STAR ST4322) contained mutated mtrR (G45D) and 23S rRNA (A2059G) alleles, while the two isolates from Group 2 (NG-MAST ST20367, NG-STAR ST4323) had different mutations in mtrR (A39T) and 23S rRNA (C2611T). CONCLUSIONS: We report the first cases of high-level azithromycin resistance in N. gonorrhoeae from South Africa. Continued AMR surveillance is critical to detect increasing azithromycin resistance prevalence in N. gonorrhoeae , which may justify future modifications to the STI syndromic management guidelines.
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Gonorreia , Uretrite , Masculino , Humanos , Feminino , Azitromicina/farmacologia , Azitromicina/uso terapêutico , Neisseria gonorrhoeae/genética , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Ceftriaxona/farmacologia , Ceftriaxona/uso terapêutico , Gonorreia/tratamento farmacológico , Gonorreia/epidemiologia , África do Sul , RNA Ribossômico 23S/genética , Uretrite/tratamento farmacológico , Farmacorresistência Bacteriana/genéticaRESUMO
OBJECTIVES: Global antimicrobial resistance (AMR) surveillance in Neisseria gonorrhoeae is essential. In 2017-18, only five (10.6%) countries in the WHO African Region reported to the WHO Global Gonococcal Antimicrobial Surveillance Programme (WHO GASP). Genomics enhances our understanding of gonococcal populations nationally and internationally, including AMR strain transmission; however, genomic studies from Africa are extremely scarce. We describe the gonococcal genomic lineages/sublineages, including AMR determinants, and baseline genomic diversity among strains in Uganda, Malawi and South Africa, 2015-20, and compare with sequences from Kenya and Burkina Faso. METHODS: Gonococcal isolates cultured in Uganda (nâ=â433), Malawi (nâ=â154) and South Africa (nâ=â99) in 2015-20 were genome-sequenced. MICs were determined using ETEST. Sequences of isolates from Kenya (nâ=â159), Burkina Faso (nâ=â52) and the 2016 WHO reference strains (nâ=â14) were included in the analysis. RESULTS: Resistance to ciprofloxacin was high in all countries (57.1%-100%). All isolates were susceptible to ceftriaxone, cefixime and spectinomycin, and 99.9% were susceptible to azithromycin. AMR determinants for ciprofloxacin, benzylpenicillin and tetracycline were common, but rare for cephalosporins and azithromycin. Most isolates belonged to the more antimicrobial-susceptible lineage B (nâ=â780) compared with the AMR lineage A (nâ=â141), and limited geographical phylogenomic signal was observed. CONCLUSIONS: We report the first multi-country gonococcal genomic comparison from Africa, which will support the WHO GASP and WHO enhanced GASP (EGASP). The high prevalence of resistance to ciprofloxacin (and empirical use continues), tetracycline and benzylpenicillin, and the emerging resistance determinants for azithromycin show it is imperative to strengthen the gonococcal AMR surveillance, ideally including genomics, in African countries.
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Antibacterianos , Gonorreia , Humanos , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Neisseria gonorrhoeae , Azitromicina/farmacologia , Malaui , África do Sul , Uganda/epidemiologia , Farmacorresistência Bacteriana , Gonorreia/epidemiologia , Gonorreia/tratamento farmacológico , Ciprofloxacina/farmacologia , Testes de Sensibilidade Microbiana , Tetraciclina/farmacologia , GenômicaRESUMO
Bacterial vaginosis (BV) is a dysbiosis of vaginal microbiota characterized by a shift from Lactobacillus species predomination to a heterogeneous mixture of anaerobes. We compared the performance characteristics of the Allplex ™ BV molecular assay with the reference test, Nugent score microscopy, for vaginal swab specimens from symptomatic South African women. A total of 213 patients were enrolled, of whom 99 (46.5%) and 132 (62.0%) were diagnosed with BV by Nugent and Allplex™, respectively. The Allplex™ BV assay displayed a sensitivity of 94.9% (95% CI, 88.7%-97.8%) and a specificity of 66.7% (95% CI, 57.6%-74.6%), with an agreement of 79.8% (95% CI, 73.9%-84.7%) (κ = 0.60). Assay design may be enhanced for improved specificity by accounting for differences in healthy and BV-associated vaginal microbiomes among women of different ethnicities.
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Vaginose Bacteriana , Feminino , Humanos , Vaginose Bacteriana/diagnóstico , Vaginose Bacteriana/microbiologia , África do Sul , Vagina/microbiologia , LactobacillusRESUMO
We describe coverage of maternal syphilis screening, syphilis positivity, coverage of treatment and their association with maternal HIV infection and antiretroviral treatment (ART) status among pregnant women attending South African antenatal clinics. The 2019 antenatal care sentinel survey was a cross-sectional survey conducted from 1 October to 15 November 2019 at 1589 sentinel sites in all nine provinces of the country and aimed to enrol 36,000 pregnant women ages 15-49 years regardless of HIV, ART or syphilis status. Data collection procedures included obtaining written informed consent, a brief interview, medical record review and blood specimen collection. Completed data collection forms and specimens were sent to designated regional laboratories for data capture and HIV serology testing. Data analysis determined four outcomes i) syphilis screening coverage ii) syphilis positivity iii) coverage of any treatment and iv) with Benzathine penicillin G (BPG). Multivariable logistic regression models with or without interaction between HIV infection and ART status with province were used to determine factors associated with syphilis positivity. Of the 41 598 women enrolled, 35 900 were included in the analysis for syphilis screening coverage. The weighted syphilis screening coverage was 96.4% [95% Confidence Interval (CI) 95.9-96.7%] nationally and was lowest among HIV positive women not on ART at 93.5% (95% CI 92.2-94.5%). Syphilis positivity was 2.6% (95% CI 2.4-2.9%) nationally. Among those who were syphilis positive, 91.9% (95% CI 89.8-93.7%) had documentation of syphilis treatment status, of whom 92.0% (95% CI 89.8-93.9%) were treated, with the majority treated with one or more doses of BPG [92.2% (95% CI 89.8-94.3%)]. HIV-positive women, not on ART [adjusted odd ratio (aOR) 2.24 (95% 1.71-2.93)] and those on ART [aOR 2.25 (95% CI 1.91-2.64)] were more likely to be syphilis positive compared to those who were HIV negative. The national syphilis screening coverage met the global screening target of 95%. Syphilis positivity was higher among HIV positive women compared to negative women. Introduction of rapid syphilis testing and ensuring a universal supply of appropriate treatment for syphilis will reduce the likelihood of mother-to-child transmission of syphilis.
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Infecções por HIV , Complicações Infecciosas na Gravidez , Sífilis , Feminino , Gravidez , Humanos , Adolescente , Adulto Jovem , Adulto , Pessoa de Meia-Idade , Sífilis/diagnóstico , Sífilis/tratamento farmacológico , Sífilis/epidemiologia , Infecções por HIV/complicações , Infecções por HIV/tratamento farmacológico , Infecções por HIV/epidemiologia , Gestantes , Complicações Infecciosas na Gravidez/diagnóstico , Complicações Infecciosas na Gravidez/tratamento farmacológico , Complicações Infecciosas na Gravidez/epidemiologia , Estudos Transversais , África do Sul/epidemiologia , Transmissão Vertical de Doenças Infecciosas , Penicilina G Benzatina/uso terapêutico , Antirretrovirais/uso terapêuticoRESUMO
The prevalence of Mycoplasma genitalium (MG) and MG antimicrobial resistance (AMR) appear to be high internationally, however, prevalence data remain lacking globally. We evaluated the prevalence of MG and MG AMR-associated mutations in men who have sex with men (MSM) in Malta and Peru and women at-risk for sexually transmitted infections in Guatemala, South Africa, and Morocco; five countries in four WHO regions mostly lacking MG prevalence and AMR data, and estimated MG coinfections with Chlamydia trachomatis (CT), Neisseria gonorrhoeae (NG), and Trichomonas vaginalis (TV). Male urine and anorectal samples, and vaginal samples were tested for MG, CT, NG, and TV (only vaginal samples) using Aptima assays (Hologic). AMR-associated mutations in the MG 23S rRNA gene and parC gene were identified using ResistancePlus MG kit (SpeeDx) or Sanger sequencing. In total, 1,425 MSM and 1,398 women at-risk were recruited. MG was detected in 14.7% of MSM (10.0% in Malta and 20.0% Peru) and in 19.1% of women at-risk (12.4% in Guatemala, 16.0% Morocco, 22.1% South Africa). The prevalence of 23S rRNA and parC mutations among MSM was 68.1 and 29.0% (Malta), and 65.9 and 5.6% (Peru), respectively. Among women at-risk, 23S rRNA and parC mutations were revealed in 4.8 and 0% (Guatemala), 11.6 and 6.7% (Morocco), and 2.4 and 3.7% (South Africa), respectively. CT was the most frequent single coinfection with MG (in 2.6% of MSM and 4.5% of women at-risk), compared to NG + MG found in 1.3 and 1.0%, respectively, and TV + MG detected in 2.8% of women at-risk. In conclusion, MG is prevalent worldwide and enhanced aetiological MG diagnosis, linked to clinical routine detection of 23S rRNA mutations, in symptomatic patients should be implemented, where feasible. Surveillance of MG AMR and treatment outcome would be exceedingly valuable, nationally and internationally. High levels of AMR in MSM support avoiding screening for and treatment of MG in asymptomatic MSM and general population. Ultimately, novel therapeutic antimicrobials and/or strategies, such as resistance-guided sequential therapy, and ideally an effective MG vaccine are essential.
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[This corrects the article DOI: 10.4102/sajhivmed.v23i1.1450.].
RESUMO
BACKGROUND: The syndromic management of vaginal discharge syndrome (VDS) is challenging because of the prevalence of mixed infection with sexually transmitted infection (STI) pathogens and non-STI causes, such as bacterial vaginosis and candidiasis (CA). We aimed to determine the relative prevalence of VDS etiologies in women presenting to sentinel primary health care clinics in South Africa. Secondary objectives were to ascertain the predictive value of speculum findings for the presence of STI pathogens and the proportion of women presenting with clinical features of CA who had identifiable yeast on vaginal smear microscopy. METHODS: Consecutive, consenting women with complaints of abnormal vaginal discharge were enrolled between January 1, 2019, and December 31, 2020. Genital discharge swab and blood specimens were collected and transported to a central STI reference laboratory in Johannesburg. RESULTS: A total of 364 women were enrolled at 3 sentinel sites. Bacterial vaginosis was the most common cause of VDS (163 of 361 [45.2%]; 95% confidence interval [CI], 40.1%-50.3%); however, a significant proportion had STI coinfection (71 of 163 [43.6%]; 95% CI, 35.8%-51.5%). The predominant STI etiology was Chlamydia trachomatis (73 [20.2%]; 95% CI, 16.4%-24.7%). An abnormal speculum finding had poor predictive value for STIs, and Gram stain microscopy showed yeast in only 37.2% of vaginal smears from women with CA symptoms. CONCLUSIONS: Bacterial vaginosis is the predominant cause of VDS in South Africa; however, STI coinfection is common. Clinical findings are poorly predictive of STI etiologies or candidiasis; therefore, a rapid and accurate STI point-of-care test would be useful in optimizing VDS management.
Assuntos
Candidíase , Coinfecção , Infecções Sexualmente Transmissíveis , Descarga Vaginal , Vaginose Bacteriana , Candidíase/complicações , Coinfecção/epidemiologia , Feminino , Humanos , Prevalência , Saccharomyces cerevisiae , Infecções Sexualmente Transmissíveis/complicações , Infecções Sexualmente Transmissíveis/diagnóstico , Infecções Sexualmente Transmissíveis/epidemiologia , África do Sul/epidemiologia , Descarga Vaginal/diagnóstico , Descarga Vaginal/epidemiologia , Descarga Vaginal/etiologia , Vaginose Bacteriana/complicações , Vaginose Bacteriana/diagnóstico , Vaginose Bacteriana/epidemiologiaRESUMO
BACKGROUND: In South Africa, male urethritis syndrome (MUS) is the most common sexually transmitted infection (STI) syndrome in men. We determined the distribution of STI etiologies and the susceptibility profiles of Neisseria gonorrhoeae isolates from men presenting with MUS to 3 sentinel surveillance health care facilities. Secondary objectives were to determine the seroprevalence of coinfections (HIV, syphilis, herpes simplex virus 2). METHODS: Consecutive, consenting men with symptomatic urethral discharge were enrolled between January 1, 2019, and December 31, 2020. Genital discharge swab and blood specimens were collected and transported to a central STI reference laboratory in Johannesburg, South Africa. RESULTS: Among 769 men enrolled, N. gonorrhoeae was the commonest cause of MUS (674 [87.8%]; 95% confidence interval [CI], 85.2%-89.9%), followed by Chlamydia trachomatis (161 [21.0%]; 95% CI, 18.2%-24.0%). Of 542 cultivable N. gonorrhoeae isolates, all were susceptible to ceftriaxone (modal minimum inhibitory concentration, 0.004 mg/L) and azithromycin (modal minimum inhibitory concentration, 0.128 mg/L). Seroprevalence rates of HIV, syphilis, and HSV-2 were 21.4% (95% CI, 18.5%-24.5%), 2.3%, and 50.1%, respectively. Condom use at last sexual encounter was reported by only 7%, less than 50% had been medically circumcised, and only 66.7% (58 of 87) who self-reported an HIV-positive status were adherent on antiretroviral drugs. CONCLUSIONS: Neisseria gonorrhoeae and C. trachomatis were the predominant causes of MUS. Currently recommended dual ceftriaxone and azithromycin therapy are appropriate for MUS syndromic management; however, surveillance must be maintained to timeously detect emerging and increasing gonococcal resistance. Clinic-based interventions must be intensified in men seeing sexual health care to reduce the community transmission and burden of STI and HIV.
Assuntos
Gonorreia , Infecções por HIV , Infecções Sexualmente Transmissíveis , Sífilis , Uretrite , Azitromicina/uso terapêutico , Ceftriaxona/uso terapêutico , Chlamydia trachomatis , Gonorreia/tratamento farmacológico , Infecções por HIV/complicações , Herpesvirus Humano 2 , Humanos , Masculino , Neisseria gonorrhoeae , Estudos Soroepidemiológicos , Infecções Sexualmente Transmissíveis/tratamento farmacológico , África do Sul/epidemiologia , Sífilis/epidemiologia , Uretrite/diagnósticoRESUMO
BACKGROUND: Herpes simplex virus (HSV) has been the leading cause of genital ulcer syndrome (GUS) in South Africa for more than a decade, and acyclovir therapy is incorporated into syndromic management guidelines. We conducted surveillance at 3 sentinel sites to define the common sexually transmitted etiologies of GUS and to determine whether current syndromic management is appropriate. Secondary objectives of surveillance were to determine the seroprevalence of coinfections (HIV, syphilis, HSV-2) in persons presenting with GUS. METHODS: Consecutive, consenting adult men and women presenting with visible genital ulceration were enrolled between January 1, 2019, and December 31, 2020. Genital ulcer swab and blood specimens were collected and transported to a central sexually transmitted infection reference laboratory in Johannesburg. RESULTS: Among 190 participants with GUS, HSV-2 was the most frequently detected ulcer pathogen (49.0%; 95% confidence interval [CI], 41.9%-56.1%). The relative prevalence of the second most common ulcer-derived pathogen, Treponema pallidum, was 26.3% (95% CI, 20.5%-33.1%), with 90% of primary syphilis cases having a positive rapid plasma reagin (RPR) titer. Male sex was independently associated with primary syphilis compared with herpetic ulcers, after adjusting for the effect of casual sex partners and other exposures (adjusted odds ratio, 3.53; 95% CI, 1.35-9.21; P = 0.010). The overall HIV prevalence among participants was 41.3% (78 of 189; 95% CI, 34.2%-48.6%). CONCLUSIONS: Herpes simplex virus 2 remains the predominant cause of GUS, justifying the continued use of acyclovir in syndromic guidelines. Adequate supplies of benzathine penicillin G for syphilis treatment are essential at primary health care level, in addition to the provision of syphilis and HIV risk reduction services.
Assuntos
Infecções por HIV , Herpes Genital , Herpes Simples , Infecções Sexualmente Transmissíveis , Sífilis , Aciclovir/uso terapêutico , Adulto , Feminino , Genitália , Infecções por HIV/complicações , Infecções por HIV/epidemiologia , Herpes Genital/complicações , Herpes Genital/tratamento farmacológico , Herpes Genital/epidemiologia , Herpesvirus Humano 2 , Humanos , Masculino , Estudos Soroepidemiológicos , Infecções Sexualmente Transmissíveis/complicações , África do Sul/epidemiologia , Sífilis/complicações , Sífilis/tratamento farmacológico , Sífilis/epidemiologia , Úlcera/tratamento farmacológico , Úlcera/epidemiologia , Úlcera/etiologiaRESUMO
BACKGROUND: Antimicrobial resistance in Mycoplasma genitalium is a global concern, as therapeutic options are limited. We aimed to determine the prevalence of macrolide and fluoroquinolone resistance-associated genetic determinants and strain diversity in M. genitalium-positive surveillance specimens from symptomatic primary health care center attendees in South Africa (2015-2018). A secondary objective was to investigate for an association between M. genitalium strain type, HIV serostatus, and antimicrobial resistance. METHODS: A total of 196 M. genitalium-positive specimens from adult males and females presenting with genital discharge to primary health care centers were tested for resistance-associated mutations in 23S rRNA, parC and gyrA. A dual-locus sequence type (DLST) was assigned to M. genitalium strains based on the detection of single nucleotide polymorphisms in the semiconserved 5' region of the mgpB gene (MG191-sequence typing) as well as the enumeration of short tandem repeats within the lipoprotein gene (MG309 short tandem repeat typing). RESULTS: The A2059G mutation in 23S rRNA, associated with macrolide resistance, was detected in 3 of 182 specimens (1.7%; 95% confidence interval, 0.3-4.7). We did not detect gyrA or parC mutations associated with fluoroquinolone resistance in specimens that could be sequenced. Molecular typing with DLST revealed genetic heterogeneity, with DLST 4-11 being the most common M. genitalium strain type detected. There were no associations between DLST and macrolide resistance or HIV infection. CONCLUSIONS: We found a low prevalence of M. genitalium strains with macrolide resistance-associated mutations over a 4-year surveillance period. Ongoing antimicrobial resistance surveillance is essential for informing genital discharge syndromic treatment guidelines.
Assuntos
Infecções por HIV , Infecções por Mycoplasma , Mycoplasma genitalium , Adulto , Antibacterianos/farmacologia , Antibacterianos/uso terapêutico , Farmacorresistência Bacteriana/genética , Feminino , Fluoroquinolonas/farmacologia , Fluoroquinolonas/uso terapêutico , Infecções por HIV/tratamento farmacológico , Humanos , Macrolídeos/farmacologia , Macrolídeos/uso terapêutico , Masculino , Mutação , Infecções por Mycoplasma/tratamento farmacológico , Infecções por Mycoplasma/epidemiologia , Mycoplasma genitalium/genética , RNA Ribossômico 23S/genética , África do Sul/epidemiologiaRESUMO
Acyclovir (ACV) is currently included in the syndromic management algorithm for genital ulcer disease in South Africa, and is the recommended first-line treatment for herpes simplex virus 2 (HSV-2). In the majority of cases, HSV-2 resistance to ACV is due to amino acid changes within the viral thymidine kinase (TK). Phenotypic and genotypic ACV resistance surveillance of HSV-2 derived from genital ulcer disease swab specimens was conducted at a primary healthcare facility in Johannesburg between 2018 and 2020. The objectives of this surveillance were to identify ACV resistance-associated mutations and polymorphisms in HSV-2 TK, and to determine the phenotypic ACV resistance profiles of the corresponding clinical HSV-2 isolates. Genotypic analysis of TK from 67 HSV-2 positive genital ulcer swabs revealed 48 specimens with TK mutations, conferring 113 nucleotide changes. No resistance-associated mutations were found, however, we identified nine known natural polymorphisms (R26H, A27T, S29A, G39E, N78D, L140F, T159I, R220K and R284S) and five amino acid changes of unknown significance (R18C, G39K, M70R, P75S and L263P). Phenotypic susceptibility testing of 52 cultivable HSV-2 isolates revealed all to be susceptible to ACV with IC50 values of <2 µg/ml. The five amino acid changes of unknown significance identified by genotypic testing were not correlated to phenotypic ACV resistance, and therefore grouped as natural polymorphisms. We did not detect any unknown or resistance-associated mutations in specimens that could not be phenotypically tested for ACV resistance. Our findings will supplement existing databases of HSV antiviral resistance-associated mutations and polymorphisms that could be used for genotypic ACV resistance screening.
Assuntos
Herpes Genital , Herpes Simples , Herpesvirus Humano 1 , Aciclovir/farmacologia , Aciclovir/uso terapêutico , Aminoácidos , Antivirais/farmacologia , Antivirais/uso terapêutico , Farmacorresistência Viral/genética , Feminino , Genitália/metabolismo , Herpes Genital/tratamento farmacológico , Herpes Simples/tratamento farmacológico , Herpesvirus Humano 1/genética , Herpesvirus Humano 2 , Humanos , Masculino , África do Sul , Timidina Quinase/genética , Úlcera/tratamento farmacológicoRESUMO
PURPOSE: To develop and trial a dried tube specimen (DTS) panel for proficiency testing of dual HIV/syphilis rapid diagnostic tests (RDTs) at clinical sites. RESULTS: DTS panels were prepared using plasma samples with known HIV and syphilis results, to give varying reactivity for syphilis and HIV test lines on RDTs. Laboratory DTS panels were stable for a minimum 4-week period at ambient temperatures with no inter-reader variability of results. Field testing of panels with Standard Diagnostics Bioline HIV/Syphilis duo showed 100% correlation with laboratory results, and excellent mean pair agreement between the two clinical sites (k = 1.0). With Chembio Dual Path Platform HIV-Syphilis, there were two false negative results for HIV and syphilis, respectively, at one site; and good mean pair agreement between the two sites (k = 0.9). CONCLUSION: It is feasible and practicable to incorporate DTS panels into a field proficiency testing scheme for dual HIV/syphilis RDTs.