scholarly journals Role of IgM testing in the diagnosis and post-treatment follow-up of syphilis: a prospective cohort study

BMJ Open ◽  
2020 ◽  
Vol 10 (9) ◽  
pp. e035838
Author(s):  
Kara K Osbak ◽  
Achilleas Tsoumanis ◽  
Irith De Baetselier ◽  
Marjan Van Esbroek ◽  
Hilde Smet ◽  
...  

ObjectivesThe diagnosis of repeat syphilis and its follow-up remains challenging. We aimed to investigate if IgM testing may assist in the diagnosis of syphilis reinfection/relapse and its treatment follow-up.MethodsThis substudy was conducted in the context of a syphilis biomarker discovery study (ClinicalTrials.gov Nr: NCT02059525). Sera were collected from 120 individuals with a new diagnosis of syphilis (72 with repeat infections) and 30 syphilis negative controls during a cohort study investigating syphilis biomarkers conducted at a sexually transmitted infection/HIV clinic in Antwerp, Belgium. Syphilis was diagnosed based on a simultaneous positive treponemal and non-treponemal assay result and/or positive serum PCR targeting polA. Specimens collected at visit of diagnosis, and 3 and 6 months post-treatment were tested by two enzyme immunoassays (EIAs), recomWell (Mikrogen; MI) and Euroimmun (EU), to detect anti-treponemal IgM. Baseline specimens were also tested for anti-treponemal IgM using a line immunoassay (LIA) recomLine (MI). Quantitative kinetic decay curves were constructed from the longitudinal quantitative EIA results.ResultsAn overall sensitivity for the diagnosis of syphilis of 59.8% (95% CI: 50.3%–68.7%), 75.0% (95% CI: 66.1%–82.3%) and 63.3% (95% CI: 54.8%–72.6%) was obtained for the EU, MI EIAs and MI LIA, respectively. When only considering repeat syphilis, the diagnostic sensitivity decreased to 45.7% (95% CI: 33.9%–58.0%), 63.9% (95% CI: 51.7%–74.6%) and 47.2% (95% CI: 35.5%–59.3%), respectively. IgM seroreverted in most cases 6 months after treatment. Post-treatment IgM concentrations decreased almost 30% faster for initial syphilis compared with repeat infection. The IgM EIAs and IgM LIA agreed from fairly to moderately (Cohen’s kappa (κ): 0.36 (EU EIA); κ: 0.53 (MI EIA); κ: 0.40 (MI LIA)) with the diagnosis of syphilis.ConclusionsIgM detection was not a sensitive method to diagnose syphilis and was even poorer in the diagnosis of syphilis repeat infections.

2019 ◽  
Author(s):  
Kara K. Osbak ◽  
Achilleas Tsoumanis ◽  
Irith De Baetselier ◽  
Marjan Van Esbroek ◽  
Hilde Smet ◽  
...  

ABSTRACTObjectivesThe diagnosis of repeat syphilis and its follow-up remains challenging. We aimed to investigate if IgM testing may assist in the diagnosis of syphilis reinfection/relapse and its treatment follow-up.MethodsSera were collected from 120 individuals with a new diagnosis of syphilis (72 with repeat infections) and 30 syphilis negative controls during a cohort study investigating syphilis biomarkers conducted at a STI/HIV clinic in Antwerp, Belgium. Syphilis was diagnosed based on a simultaneous positive treponemal and non-treponemal assay result and/or positive serum PCR targeting polA. Specimens collected at visit of diagnosis, and 3 and 6 months post-treatment were tested by two enzyme immuno assays (EIAs), recomWell (Mikrogen; MI) and Euroimmun (EU), to detect anti-treponemal IgM. Baseline specimens were also tested for anti-treponemal IgM using a line immuno assay (LIA) recomLine (Mikrogen). Quantitative kinetic decay curves were constructed from the longitudinal quantitative EIA results.ResultsAn overall sensitivity for the diagnosis of syphilis of 59.8 % (95 % confidence interval (CI): 50.3-68.7), 75.0 % (95 %(CI): 66.1-82.3) and 64.2 % (95 %(CI): 54.8-72.6) was obtained for the EU, MI EIAs, and MI LIA, respectively. When only considering repeat syphilis, the diagnostic sensitivity decreased to 45.7 % (95 %(CI): 33.9-58.0), 63.9 % (95 %(CI): 51.7-74.6) and 47.2 % (95 %(CI): 35.5-59.3), respectively. IgM seroreverted in most cases 6 months after treatment. Post-treatment IgM concentrations decreased 30 % faster for initial syphilis compared to repeat infection. The IgM EIAs and IgM LIA agreed from fairly to moderately (Cohen’s kappa (κ): 0.36 [EU EIA]; κ: 0.53 [MI EIA]; κ: 0.40 [MI LIA]) with the diagnosis of syphilis.ConclusionsIgM detection was not a sensitive method to diagnose syphilis and was even poorer in the diagnosis of syphilis repeat infections, but might play a role in treatment follow-up.KEY MESSAGE BOX-IgM detection was not a sensitive method to diagnose syphilis and was even poorer in the diagnosis of syphilis repeat infections-IgM serorevert in most cases 6 months after treatment-In repeat episodes of syphilis, IgM concentrations decline faster post-treatment


2019 ◽  
Vol 31 (2) ◽  
pp. 166-173
Author(s):  
Eleanor P Bergquist ◽  
Anne Trolard ◽  
Anne S Kuhlmann ◽  
Travis Loux ◽  
Stephen Y Liang ◽  
...  

The objective of this study is to evaluate whether pregnant women receive appropriate treatment, undertreatment, or overtreatment in the emergency department (ED) when they are tested for chlamydia and gonorrhea as compared to non-pregnant women. In a retrospective cohort study, we analyzed visits made to an urban ED from 1 July 2012 to 30 June 2014, with testing for chlamydia and gonorrhea (n = 3908). Using multiple logistic regression, we compared undertreatment and overtreatment in women controlling for pregnancy, age, race, and sexually transmitted infection International Statistical Classifications of Diseases (ICD)-9 coded diagnosis. Pregnant women were significantly more likely to be undertreated when positive for infection as compared to non-pregnant women (OR 2.94; 95% CI, 1.47–5.95) and significantly less likely to be overtreated when negative for infection (OR 0.40; 95% CI, 0.31–0.53) as compared to non-pregnant women. Pregnant women may not be receiving appropriate treatment when they present to the ED with chlamydia or gonorrhea. Attention should be paid to this group when administering chlamydia and gonorrhea treatment to ensure appropriate care and follow-up.


Author(s):  
Zixin Wang ◽  
Yuan Fang ◽  
Natthakhet Yaemim ◽  
Kai J. Jonas ◽  
Andrew Chidgey ◽  
...  

The term “Pre-exposure prophylaxis (PrEP) tourists” refers to individuals who obtain PrEP in other countries and use it in their home countries. A prospective observational cohort study was conducted among a group of men who have sex with men (MSM) who obtained PrEP in private clinics in Thailand and used it in Hong Kong. Participants completed two web-based self-administered surveys when obtaining PrEP in Thailand and three months afterwards. Out of 110 participants at baseline, 67 completed the follow-up. The prevalence of sexually transmitted infection (STI) testing was 47.8% during the follow-up period. Eleven participants received an STI diagnosis, and seven of them were incident infections in the past three months. Participants who perceived a higher chance for STI infection (adjusted odds ratios (AOR): 1.90, 95% CI: 1.00, 3.75) and reported higher intention to take up STI testing at baseline (AOR: 1.62, 95% CI: 1.05, 2.50) were more likely to receive STI testing during the follow-up period. Baseline perceptions that service providers would think they were having risky behaviors because of PrEP use was negatively associated with the dependent variable (AOR: 0.51, 95% CI: 0.31, 0.86). Service planning and health promotion related to STI testing is needed for MSM “PrEP tourists”.


BMJ Open ◽  
2021 ◽  
Vol 11 (1) ◽  
pp. e040817
Author(s):  
Patrick O'Byrne ◽  
Amanda Vandyk ◽  
Lauren Orser ◽  
Marlene Haines

ObjectiveTo report the results of a nurse-led pre-exposure prophylaxis (PrEP) delivery service.DesignThis was a prospective cohort study conducted from 5 August 2018 to 4 March 2020. It involved manual chart review to collect data. Variables were described using frequencies and percentages and analysed using χ2 testing. Those significant in bivariate analysis were retained and entered into a binary multiple logistic regression. Hierarchical modelling was used, and only significant factors were retained.SettingThis study occurred in an urban public health unit and community-based sexually transmitted infection (STI) clinic in Ottawa, Canada.ParticipantsOf all persons who were diagnosed with a bacterial STI in Ottawa and everyone who presented to our STI clinic during the study period, there were 347 patients who met our high-risk criteria for PrEP; these criteria included patients who newly presented with any of the following: HIV contacts, diagnosed with a bacterial STI or single use of HIV PEP. Further, eligibility could be determined based on clinical judgement. Patients who met the foregoing criteria were appropriate for PrEP-RN, while lower-risk patients were referred to elsewhere. Of the 347 patients who met our high-risk criteria, 47% accepted and 53% declined. Of those who accepted, 80% selected PrEP-registered nurse (RN).Primary and secondary outcome measuresUptake, acceptance, engagement and attrition factors of participants who obtained PrEP through PrEP-RN.Findings69% of participants who were eligible attended their intake PrEP-RN visit. 66% were retained in care. Half of participants continued PrEP and half were lost to follow-up. We found no significant differences in the uptake, acceptance, engagement and attrition factors of participants who accessed PrEP-RN regarding reason for referral, age, ethnicity, sexual orientation, annual income, education attainted, insurance status, if they have a primary care provider, presence or absence of depression or anxiety and evidence of newly acquired STI during the study period.ConclusionsNurse-led PrEP is an appropriate strategy for PrEP delivery.


2021 ◽  
pp. 095646242110474
Author(s):  
Roy Zucker ◽  
Michael Gaisa ◽  
Keith Sigel ◽  
Ilan Singer ◽  
Amos Adler ◽  
...  

Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infections are common among men who have sex with men (MSM). Many oropharyngeal and anorectal infections remain asymptomatic. We aimed to evaluate triple-site screening following PrEP introduction. We enrolled a prospective cohort study including 210 asymptomatic MSM during 2019–2020, analyzed by groups: HIV positive (HIV+), HIV−uninfected using PrEP (HIV−/PrEP+), or HIV-uninfected not using PrEP (HIV−/PrEP−). A self-administered questionnaire captured demographic information and sexual risk-taking behaviors. CT/NG testing results were compared between study groups and predictors of infection were evaluated. We included 59 HIV+, 70 HIV−/PrEP+, and 81 HIV−/PrEP− subjects. 30% ( n = 62) of participants tested positive for CT/NG. HIV−/PrEP+ group had highest proportion of infections ( n = 33, 47%) followed by HIV−/PrEP− ( n = 16, 22%) and HIV+ ( n=13, 20%; p < .001). Importantly, 98% (80/82) of pharyngeal/anorectal CT/NG infections were missed in genitourinary tract screening alone. PrEP use and previous syphilis infection were the strongest risk factor for CT/NG. Extra-genital asymptomatic CT/NG infections were prevalent among MSM. These data highlight the importance of routine extra-genital CT/NG testing in asymptomatic sexually active MSM. The study describes the consequences for three-site testing lack of implementation in the PrEP era.


Author(s):  
Patrick O’Byrne ◽  
Lauren Orser ◽  
Amanda Vandyk

Patients who use post-exposure prophylaxis (PEP) are at ongoing risk for HIV acquisition after completing PEP. While the Centers for Disease Control and Prevention recommends pre-exposure prophylaxis (PrEP) use immediately after PEP, some practitioners are hesitant to offer PEP-to-PrEP (PEP2PrEP). We began offering PEP2PrEP in the sexually transmitted infection clinic in Ottawa, Canada on August 5, 2018. During the first 16 months of PEP2PrEP, 61 patients requested PEP and 46 were initiated; 30 of these patients agreed to PEP2PrEP and 26 followed through. None of our PEP patients had confirmed HIV exposures; all fulfilled the initiation criterion of condomless anal sex with a male partner of unknown HIV-status. During the study, the number of PEP requests and initiations was statistical unchanged, yet the seroconversion rate among patients who used PEP decreased from 1.7% pre-PEP2PrEP to 0% post-PEP2PrEP. Regarding follow-up, most discontinuations occurred between the PrEP intake and 1-month follow-up visit.


2018 ◽  
Vol 5 (suppl_1) ◽  
pp. S397-S397 ◽  
Author(s):  
Angela Hoth ◽  
Cody Shafer ◽  
Dena Dillon ◽  
Constanza Scheetz ◽  
Seth Owens ◽  
...  

Abstract Background Access to HIV pre-exposure prophylaxis (PrEP) is often poor in small urban and rural areas due to long distances to PrEP providers and stigma. In 2017, the Iowa Department of Public Health (IDPH), University of Iowa (UI), and community representatives collaborated to develop a public health-partnered telemedical PrEP delivery model to overcome these barriers (TelePrEP). IDPH personnel working in five sexually transmitted infection (STI) clinics and partner services (PS) programs in Eastern Iowa screened clients for PrEP indications and referred those with need to TelePrEP pharmacist providers at UI. Via collaborative practice, pharmacists completed initial and follow-up PrEP home video visits with clients on smart phones and laptops. Clients obtained laboratory monitoring and STI screening in public health-affiliated and local laboratories in accordance with USPHS/CDC guidelines, and received PrEP medication by mail. PS personnel linked TelePrEP clients with newly-identified STIs to local treatment. Methods Using the PrEP continuum as framework, we used IDPH databases and UI medical records to conduct a retrospective process evaluation of the TelePrEP model (February 2017–April 2018). Results TelePrEP received 44 referrals from public health and 59 self-referrals via advertising. Pharmacists completed 84 initial visits (81% of referrals), including 37 visits (84%) with clients referred by public health. Most (94%) started emtricitabine/tenofovir after initial visits. Retention in TelePrEP at 6 months was 87%. 96% of guideline-indicated laboratory tests (HIV, creatinine, STI, hepatitis) were completed at baseline and follow-up. Rates of extragenital chlamydia and gonorrhea screening were lower (74 of 104 completed screens) due to variable availability of swabs at local laboratories. 15 clients were diagnosed with 20 STIs on screening (6 syphilis, four gonorrhea, 10 chlamydia) and one unrecognized pregnancy was identified. PS linked all clients with STIs on screens to treatment within 14 days (80% in 3 days). Conclusion Using telemedicine, healthcare systems can partner with public health administered STI clinics and PS programs to create virtual PrEP delivery models in rural settings. Public health partnerships enhance client identification and ensure linkage to care for new STI diagnoses in telemedicine programs. Disclosures A. Hoth, Gilead Sciences, Inc.: Research team member, Research support. M. Ohl, Gilead Sciences, Inc.: Grant Investigator, Research grant.


2021 ◽  
pp. 095646242110486
Author(s):  
Stephanie E Mclaughlin ◽  
Farzana Kapadia ◽  
Richard E Greene ◽  
Robert Pitts

The United States Centers for Disease Control and Prevention (CDC) recommends HIV pre-exposure prophylaxis (PrEP) be considered for all patients diagnosed with a sexually transmitted infection (STI). Emergency departments (EDs) are an important site for diagnosis and treatment of STIs for under-served populations. Consequently, we identified 377 patients diagnosed with a bacterial sexually transmitted infection (gonorrhea, chlamydia, and/or syphilis) at a major New York City emergency department between 1/1/2014 and 7/30/2017 to examine associations between key sociodemographic characteristics and missed opportunities for PrEP provision. In this sample, 299 (79%) emergency department patients missed their medical follow-up 90 days after STI diagnosis, as recommended. Results from adjusted generalized estimating equation regression models indicate that patients >45 yo (aOR = 2.2, 95% CI 1.2–3.9) and those with a primary care provider in the hospital system (aOR = 6.8, 95% CI 3.8–12.0) were more likely to return for follow-up visits, whereas Black patients (aOR = 0.44, 95% CI 0.25–0.77) were less likely to return for follow-up visits. These findings indicate that lack of STI treatment follow-up visits are significantly missed opportunities for PrEP provision and comprehensive human immunodeficiency virus prevention care.


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