Last data update: Jun 03, 2024. (Total: 46935 publications since 2009)
Records 1-22 (of 22 Records) |
Query Trace: Park IU [original query] |
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U.S. women with invasive cervical cancer: Characteristics and potential barriers to prevention
Rosenblum HG , Gargano JW , Cleveland AA , Dahl RM , Park IU , Whitney E , Castilho JL , Sackey E , Niccolai LM , Brackney M , Debess E , Ehlers S , Bennett NM , Kurtz R , Unger ER , Markowitz LE . J Womens Health (Larchmt) 2024 Objectives: Although invasive cervical cancer (ICC) rates have declined since the advent of screening, the annual age-adjusted ICC rate in the United States remains 7.5 per 100,000 women. Failure of recommended screening and management often precedes ICC diagnoses. The study aimed to evaluate characteristics of women with incident ICC, including potential barriers to accessing preventive care. Materials and Methods: We abstracted medical records for patients with ICC identified during 2008-2020 in five U.S. population-based surveillance sites covering 1.5 million women. We identified evidence of adverse social and medical conditions, including uninsured/underinsured, language barrier, substance use disorder, incarceration, serious mental illness, severe obesity, or pregnancy at diagnosis. We calculated descriptive frequencies and compared potential barriers by race/ethnicity, and among women with and without symptoms at diagnosis using chi-square tests. Results: Among 1,606 women with ICC (median age: 49 years; non-White: 47.4%; stage I: 54.7%), the majority (68.8%) presented with symptoms. Forty-six percent of women had at least one identified potential barrier; 15% had multiple barriers. The most common potential barriers among all women were being underinsured/uninsured (17.3%), and language (17.1%). Presence of any potential barrier was more frequent among non-White women and women with than without symptoms (p < 0.05). Conclusions: In this population-based descriptive study of women with ICC, we identified adverse circumstances that might have prevented women from seeking screening and treatment to prevent cancer. Interventions to increase appropriate cervical cancer screening and management are critical for reducing cervical cancer rates. |
CDC laboratory recommendations for syphilis testing, United States, 2024
Papp JR , Park IU , Fakile Y , Pereira L , Pillay A , Bolan GA . MMWR Recomm Rep 2024 73 (1) 1-32 This report provides new CDC recommendations for tests that can support a diagnosis of syphilis, including serologic testing and methods for the identification of the causative agent Treponema pallidum. These comprehensive recommendations are the first published by CDC on laboratory testing for syphilis, which has traditionally been based on serologic algorithms to detect a humoral immune response to T. pallidum. These tests can be divided into nontreponemal and treponemal tests depending on whether they detect antibodies that are broadly reactive to lipoidal antigens shared by both host and T. pallidum or antibodies specific to T. pallidum, respectively. Both types of tests must be used in conjunction to help distinguish between an untreated infection or a past infection that has been successfully treated. Newer serologic tests allow for laboratory automation but must be used in an algorithm, which also can involve older manual serologic tests. Direct detection of T. pallidum continues to evolve from microscopic examination of material from lesions for visualization of T. pallidum to molecular detection of the organism. Limited point-of-care tests for syphilis are available in the United States; increased availability of point-of-care tests that are sensitive and specific could facilitate expansion of screening programs and reduce the time from test result to treatment. These recommendations are intended for use by clinical laboratory directors, laboratory staff, clinicians, and disease control personnel who must choose among the multiple available testing methods, establish standard operating procedures for collecting and processing specimens, interpret test results for laboratory reporting, and counsel and treat patients. Future revisions to these recommendations will be based on new research or technologic advancements for syphilis clinical laboratory science. |
Evaluation of three automated nontreponemal rapid plasma reagin (RPR) tests for the laboratory diagnosis of syphilis
Shukla MR , Pereira L , Gaynor AM , Sun Y , Edwards D , Simmons T , Andrews CW , Park IU , Hong J , Cao W , Kersh EN , Fakile Y . J Clin Microbiol 2023 61 (6) e0016823 Automated nontreponemal rapid plasma reagin (RPR) tests were recently introduced in the United States for syphilis testing and limited performance data are available. In collaboration with the Association of Public Health Laboratories, three public health laboratories (PHL) were chosen through a competitive selection process to evaluate the performance of three FDA-cleared automated RPR test systems: BioPlex 2200 Syphilis Total & RPR assay (Bio-Rad Laboratories), AIX 1000 (Gold Standard Diagnostics), and ASI Evolution (Arlington Scientific). Panels prepared at the CDC included: a qualitative panel comprised of 734 syphilis reactive/nonreactive sera; a quantitative panel of 50 syphilis reactive sera (RPR titer 1:64 to 1:1,024); and a reproducibility panel of 15 nonreactive and reactive sera (RPR titer 1:1 to 1:64). Panels were shipped frozen to the PHL and tested on the automated RPR systems following manufacturers' instructions. Prior test results were blinded to all laboratories. When compared to manual RPR (Arlington Scientific) performed at the CDC as a reference test, the qualitative panel results demonstrated an overall concordance of 95.9% for AIX 1000, 94.6% for ASI Evolution, and 92.6% for Bioplex RPR; quantitative panel showed within range titer of 2-fold for 94% of specimens for AIX 1000, 68% for ASI Evolution, and 64% for BioPlex RPR, and the reproducibility testing panel demonstrated point estimates ranging from 69 to 95%. Automated RPR instruments could reduce turnaround time and minimize interpretation errors. However, additional evaluations with more specimens could assist laboratories with implementing automated RPR tests and understanding their limitations. |
HPV type-specific trends in cervical precancers in the United States, 2008-2016
Gargano JW , McClung N , Lewis RM , Park IU , Whitney E , Castilho JL , Pemmaraju M , Niccolai LM , Brackney M , Debess E , Ehlers S , Bennett NM , Scahill M , Cleveland AA , Querec TD , Unger ER , Markowitz LE . Int J Cancer 2022 152 (2) 137-150 Declines in cervical intraepithelial neoplasia grades 2-3 and adenocarcinoma in situ (CIN2+) observed among young women suggest impact from human papillomavirus (HPV) vaccination. To further evaluate vaccine impact including cross-protection and type replacement, we described high-risk (HR)-HPV type-specific cervical precancer incidence rates among women aged 20-39 years, 2008-2016. We analyzed cross-sectional population-based data on 18,344 cases of CIN2+ from a 5-site surveillance system. Diagnostic specimens were tested for individual HPV types, including 14 HR-HPV types (HPV16/18/31/33/35/39/45/51/52/56/58/59/66/68). We estimated age-specific annual HR-HPV type-specific CIN2+ incidence per 100,000 screened women for individual types, vaccine HR-HPV types (HPV16/18) and non-vaccine HR-HPV types (non-HPV16/18). We evaluated trends using average annual percent changes (AAPC) and 95% confidence intervals (CI), and estimated total declines by comparing 2015-2016 to 2008-2009 using incidence rate ratios. Among 20-24-year-olds, HPV16/18-CIN2+ declined from 2008 through 2016 (AAPC: -21.3%, 95% CI: -28.1%, -13.8%), whereas no trend was observed for non-HPV16/18-CIN2+ (AAPC: -1.8%, 95% CI: -8.1%, 4.9%). After 2010, CIN2+ among 20-24-year-olds was more often caused by non-vaccine versus vaccine HR-HPV types. No significant declining trends were observed in older age groups. In 2015-2016 compared to 2008-2009, HPV16-CIN2+ declined 78%, HPV18-CIN2+ 72%, and HPV31-CIN2+ 51% among 20-24-year-olds; no increases were observed in type-specific CIN2+ incidence. Among 25-29-year-olds, HPV16-CIN2+ declined 18%; CIN2+ attributed to seven nonvaccine types increased significantly. No significant declines were observed in older groups. Significant declines in HPV16/18-CIN2+ in 20-24-year-olds and HPV16-CIN2+ in 25-29-year-olds corroborate impact of HPV vaccination. A declining trend in HPV31-CIN2+ is consistent with cross-protection from vaccination. |
Characteristics of the audience reached by the National Network of Sexually Transmitted Disease Clinical Prevention Training Centers and correlation with sexually transmitted infection rates, 2015 to 2020
Hauschild BC , Burnside HC , Gray BA , Johnston C , Neu N , Park IU , Reno HEL , Rompalo A , VanWagoner N , Wendel KA , Coor A , Tromble E , Rietmeijer CA . Sex Transm Dis 2022 49 (4) 313-317 BACKGROUND: The National Network of Sexually Transmitted Disease Clinical Prevention Training Centers (NNPTC) trains clinical providers to diagnose and treat sexually transmitted infections (STIs) in the United States. The purpose of this study was to examine the demographics of clinical providers and to correlate the number of training episodes with STI rates at the county level. METHODS: Registration data were collected between April 1, 2015, and March 31, 2020, in a custom Learning Management System from clinical providers taking NNPTC training. Using the 2018 STI surveillance data, counties were divided into quartiles based on reportable STI case rates and the number of county-level training events was compared per quartile. Univariate and multivariate analyses were conducted in IBM SPSS Statistics 23 (Armonk, NY) and SAS Enterprise Guide 7.1 (Cary, NC). RESULTS: From 2015 to 2020, the NNPTC trained 21,327 individuals, predominantly in the nursing professions and working in a public health environment. In multivariate analysis, the number of training events was significantly associated with higher STI rates at the county level (P < 0.0001) and the state where a prevention training center is located (P < 0001). CONCLUSIONS: The analysis suggests that NNPTC trainings are reaching the clinical providers working in geographic areas with higher STI rates. |
Increases in Human Papillomavirus Testing Preceding Diagnosis of Cervical Precancer in 5 US States, 2008-2016
Cleveland AA , Gargano JW , Griffin MR , Park IU , Niccolai LM , Bennett NM , Pemmaraju M , Fink D , Brackney M , Scahill M , Ehlers SJ , Unger ER , Markowitz LE . J Low Genit Tract Dis 2021 25 (3) 192-198 OBJECTIVE: The aim of the study was to describe trends in human papillomavirus (HPV) testing preceding diagnosis of cervical precancer during a time of changing screening recommendations. MATERIALS AND METHODS: We conducted a cross-sectional analysis of data from active, population-based, laboratory surveillance among 1.5 million residents of 5 areas in the United States. We included women aged 21-39 years diagnosed with cervical intraepithelial neoplasia grades 2, 2/3, or 3 or adenocarcinoma in situ (collectively, CIN2+) during 2008-2016, who had a cytology and/or HPV test before diagnosis (n = 16,359). RESULTS: The proportion of women with an HPV test preceding CIN2+ increased from 42.9% in 2008 to 73.3% in 2016 (p < .01); testing increased in all age groups (21-24 y: 35.3% to 47.6%, 25-29 y: 40.9% to 64.1%, 30-39 y: 51.7% to 85.9%, all p < .01). The HPV testing varied by cytology result and was highest among women with atypical squamous cells of unknown significance (n = 4,310/4,629, 93.1%), negative for intraepithelial lesion or malignancy (n = 446/517, 86.3%), and atypical glandular cells (n = 145/257, 56.4%). By 2016, at least half of all cases in every surveillance area had an HPV test before diagnosis. CONCLUSIONS: During 2008-2016, the proportion of women with an HPV test preceding CIN2+ increased significantly for all age groups, cytology results, and surveillance areas. By 2016, most (85.9%) women aged 30-39 years had an HPV test, consistent with recommendations. Increasing utilization of HPV tests, which have demonstrated improved sensitivity for detecting cervical disease, may in part explain increasing rates of cervical precancer among women 30 years and older. |
Sensitivity and specificity of treponemal-specific tests for the diagnosis of syphilis
Park IU , Tran A , Pereira L , Fakile Y . Clin Infect Dis 2020 71 S13-s20 We conducted a systematic review of relevant syphilis diagnostic literature to address the question, "What is the sensitivity and specificity of the treponemal tests currently approved by the Food and Drug Administration (FDA) for the diagnosis of syphilis (by stage)?" There were 16 treponemal assays evaluated: 13 immunoassays and 3 manual assays (fluorescent treponemal antibody absorbed test [FTA-ABS], microhemagglutination assay for Treponema pallidum antibodies [MHA-TP], Treponema pallidum particle agglutination assay [TP-PA]). MHA-TP and FTA-ABS were less sensitive in primary and secondary syphilis than TP-PA; TP-PA is the most specific manual treponemal assay. There is insufficient evidence to recommend one particular treponemal immunoassay (eg, enzyme immunoassays, chemiluminescence immunoassays, microbead immunoassays) over another based on published performance data. For diagnosis of neurosyphilis, cerebrospinal fluid (CSF) TP-PA has similar performance to CSF FTA-ABS in studies with patients with definitive or presumptive neurosyphilis. However, CSF treponemal testing has limitations in its sensitivity and specificity and should be interpreted within the context of the clinical scenario, additional CSF test results and syphilis prevalence. |
Effectiveness of 1, 2, AND 3 human papillomavirus vaccine doses against HPV-16/18 positive high-grade cervical lesions
Johnson Jones ML , Gargano JW , Powell M , Park IU , Niccolai LM , Bennett NM , Griffin MR , Querec T , Unger ER , Markowitz LE . Am J Epidemiol 2019 189 (4) 265-276 Before 2016, human papillomavirus (HPV) vaccination was recommended in a three-dose schedule; however, many vaccine-eligible U.S. females received <3 doses, providing an opportunity to evaluate real-world vaccine effectiveness (VE) of 1, 2, and 3 doses. We analyzed data on cervical intraepithelial neoplasia grades 2-3 and adenocarcinoma in situ (CIN2+) from the HPV Vaccine Impact Monitoring Project (HPV-IMPACT), 2008-2014. Archived tissue from CIN2+ lesions was tested for 37 HPV types. Women were classified by number of doses received >/=24 months before CIN2+ detection. Using a test-negative design, VE was estimated as 1-adjusted odds ratio from a logistic regression model that compared vaccination history for women whose lesions tested positive for HPV-16/18 (vaccine-type cases) with all other CIN2+ (controls). Among 3,300 women with CIN2+, typing results, and vaccine history available, 1,561 (47%) were HPV-16/18 positive, 136 received (4%) 1 dose, 108 (3%) 2 doses, and 325 (10%) 3 doses. Adjusted odds ratios for vaccination with 1, 2, and 3 doses were 0.53 (95% confidence interval: 0.37, 0.76; VE=47%), 0.45 (95% confidence interval: 0.30, 0.69; VE=55%), and 0.26 (95% confidence interval 0.20, 0.35; VE=74%). We found significant VE against vaccine-type CIN2+ after 3 doses of HPV vaccine and lower but significant VE with 1 or 2 doses. |
Trends in high-grade cervical lesions and cervical cancer screening in 5 states, 2008-2015
Gargano JW , Park IU , Griffin MR , Niccolai LM , Powell M , Bennett NM , Johnson Jones ML , Whitney E , Pemmaraju M , Brackney M , Abdullah N , Scahill M , Dahl RM , Cleveland AA , Unger ER , Markowitz LE . Clin Infect Dis 2019 68 (8) 1282-1291 BACKGROUND: We describe changes in rates of cervical intraepithelial neoplasia grades 2, 3 and adenocarcinoma in situ (CIN2+) during a period of human papillomavirus (HPV) vaccine uptake and changing cervical cancer screening recommendations. METHODS: We conducted population-based laboratory surveillance for CIN2+ in catchment areas in 5 states, 2008-2015. We calculated age-specific CIN2+ rates per 100000 women by age groups. We estimated incidence rate ratios (IRR) of CIN2+ for 2-year periods among all women and among screened women to evaluate changes over time. RESULTS: A total of 16572 CIN2+ cases were reported. Among women aged 18-20 and 21-24 years, CIN2+ rates declined in all sites, whereas in women aged 25-29, 30-34, and 35-39 years, trends differed across sites. The percent of women screened annually declined in all sites and age groups. Compared to 2008-2009, rates among screened women were significantly lower for all 3 periods in women aged 18-20 years (2010-2011: IRR 0.82, 95% confidence interval [CI] 0.67-0.99; 2012-2013: IRR 0.63, 95% CI 0.47-0.85; 2014-2015: IRR 0.44, 95% CI 0.28-0.68) and lower for the latter 2 time periods in women aged 21-24 years (2012-2013: IRR 0.86, 95% CI 0.79-0.94; 2014-2015: IRR 0.61, 95% CI 0.55-0.67). CONCLUSIONS: From 2008-2015, both CIN2+ rates and cervical cancer screening declined in women aged 18-24 years. The significant decreases in CIN2+ rates among screened women aged 18-24 years are consistent with a population-level impact of HPV vaccination. |
Cervical determinants of anal HPV infection and high-grade anal lesions in women: a collaborative pooled analysis
Lin C , Slama J , Gonzalez P , Goodman MT , Xia N , Kreimer AR , Wu T , Hessol NA , Shvetsov Y , Ortiz AP , Grinsztejn B , Moscicki AB , Heard I , Del Refugio Gonzalez Losa M , Kojic EM , Schim van der Loeff MF , Wei F , Longatto-Filho A , Mbulawa ZA , Palefsky JM , Sohn AH , Hernandez BY , Robison K , Simpson SJr , Conley LJ , de Pokomandy A , van der Sande MAB , Dube Mandishora RS , Volpini LPB , Pierangeli A , Romero B , Wilkin T , Franceschi S , Hidalgo-Tenorio C , Ramautarsing RA , Park IU , Tso FK , Godbole S , D'Hauwers KWM , Sehnal B , Menezes LJ , Heraclio SA , Clifford GM . Lancet Infect Dis 2019 19 (8) 880-891 BACKGROUND: Cervical cancer screening might contribute to the prevention of anal cancer in women. We aimed to investigate if routine cervical cancer screening results-namely high-risk human papillomavirus (HPV) infection and cytohistopathology-predict anal HPV16 infection, anal high-grade squamous intraepithelial lesions (HSIL) and, hence, anal cancer. METHODS: We did a systematic review of MEDLINE, Embase, and the Cochrane library for studies of cervical determinants of anal HPV and HSIL published up to Aug 31, 2018. We centrally reanalysed individual-level data from 13 427 women with paired cervical and anal samples from 36 studies. We compared anal high-risk HPV prevalence by HIV status, cervical high-risk HPV, cervical cytohistopathology, age, and their combinations, using prevalence ratios (PR) and 95% CIs. Among 3255 women with anal cytohistopathology results, PRs were similarly calculated for all anal HSIL and HPV16-positive anal HSIL. FINDINGS: Cervical and anal HPV infections were highly correlated. In HIV-negative women, anal HPV16 prevalence was 41% (447/1097) in cervical HPV16-positive versus 2% (214/8663) in cervical HPV16-negative women (PR 16.5, 95% CI 14.2-19.2, p<0.0001); these values were 46% (125/273) versus 11% (272/2588) in HIV-positive women (4.4, 3.7-5.3, p<0.0001). Anal HPV16 was also associated with cervical cytohistopathology, with a prevalence of 44% [101/228] for cervical cancer in HIV-negative women (PR vs normal cytology 14.1, 11.1-17.9, p<0.0001). Anal HSIL was associated with cervical high-risk HPV, both in HIV-negative women (from 2% [11/527] in cervical high-risk HPV-negative women up to 24% [33/138] in cervical HPV16-positive women; PR 12.9, 95% CI 6.7-24.8, p<0.0001) and HIV-positive women (from 8% [84/1094] to 17% [31/186]; 2.3, 1.6-3.4, p<0.0001). Anal HSIL was also associated with cervical cytohistopathology, both in HIV-negative women (from 1% [5/498] in normal cytology up to 22% [59/273] in cervical HSIL; PR 23.1, 9.4-57.0, p<0.0001) and HIV-positive women (from 7% [105/1421] to 25% [25/101]; 3.6, 2.5-5.3, p<0.0001). Prevalence of HPV16-positive anal HSIL was 23-25% in cervical HPV16-positive women older than 45 years (5/20 in HIV-negative women, 12/52 in HIV-positive women). INTERPRETATION: HPV-based cervical cancer screening programmes might help to stratify anal cancer risk, irrespective of HIV status. For targeted secondary anal cancer prevention in high-risk groups, HIV-negative women with cervical HPV16, especially those older than 45 years, have a similar anal cancer risk profile to that of HIV-positive women. FUNDING: International Agency for Research on Cancer. |
Trends in human papillomavirus vaccine types 16 and 18 in cervical precancers, 2008-2014
McClung NM , Gargano JW , Bennett NM , Niccolai LM , Abdullah N , Griffin MR , Park IU , Cleveland AA , Querec TD , Unger ER , Markowitz LE . Cancer Epidemiol Biomarkers Prev 2019 28 (3) 602-609 Background: The impact of human papillomavirus (HPV) vaccination has been observed in the United States through declining cervical precancer incidence in young women. To further evaluate vaccine impact, we described trends in HPV vaccine types 16/18 in cervical precancers, 2008-2014.Methods: We analyzed data from a 5-site, population-based surveillance system. Archived specimens from women age 18-39 years diagnosed with cervical intraepithelial neoplasia grades 2-3 or adenocarcinoma in situ (CIN2+) were tested for 37 HPV types. We described the proportion and estimated number of cases of CIN2+ by HPV-type groups over time. Trends in HPV16/18-positive CIN2+ were examined, overall and by vaccination status, age, histologic grade, and race/ethnicity, using Cochrane-Armitage tests.Results: In 10,206 cases, the proportion and estimated number of cases of HPV16/18-positive CIN2+ declined from 52.7% (1,235 cases) in 2008 to 44.1% (819 cases) in 2014 (P < 0.001). Declining trends in the proportion of HPV16/18-positive CIN2+ were observed among vaccinated (55.2%-33.3%, P < 0.001) and unvaccinated (51.0%-47.3%, P = 0.03) women; ages 18-20 (48.7%-18.8%, P = 0.02), 21-24 (53.8%-44.0%, P < 0.001), 25-29 (56.9%-42.4%, P < 0.001), and 30-34 (49.8%-45.8%, P = 0.04) years; CIN2 (40.8%-29.9%, P < 0.001) and CIN2/3 (61.8%-46.2%, P < 0.001); non-Hispanic white (59.5%-47.9%, P < 0.001) and non-Hispanic black (40.7%-26.5%, P < 0.001).Conclusions: From 2008-2014, the proportion of HPV16/18-positive CIN2+ declined, with the greatest declines in vaccinated women; declines in unvaccinated women suggest herd protection.Impact: The declining proportion of HPV16/18-positive CIN2+ provides additional evidence of vaccine impact in the United States. |
Performance of the Syphilis Health Check in clinic and laboratory-based settings
Fakile YF , Brinson M , Mobley V , Park IU , Gaynor AM . Sex Transm Dis 2019 46 (4) 250-253 BACKGROUND: In this study, we evaluate the performance of the Syphilis Health Check (SHC) in clinical and laboratory settings using fingerstick whole-blood and serum. METHODS: Fingerstick whole-blood and serum specimens from adult patients (n=562) without prior syphilis history presenting at two county health department STD clinics in North Carolina were tested. Fingerstick specimens were tested with the SHC in clinic, and serum specimens were tested at the North Carolina State Laboratory of Public Health with: 1) qualitative rapid plasma reagin (RPR), 2) treponemal EIA and 3) SHC. Sensitivity and specificity were calculated with 95% confidence intervals. RESULTS: The fingerstick whole-blood had a sensitivity of 100% (7/7) and specificity of 95.7% (531/555), compared to consensus reference testing - CRT (RPR and EIA reactive), but a sensitivity of 50% (8/16), and specificity of 95.9% (523/546), when compared to the treponemal EIA. Both laboratory-based SHC on serum and whole-blood SHC performed similarly, compared to CRT, and the treponemal EIA alone. Twenty-four specimens SHC reactive on whole-blood were nonreactive by CRT. In 8/24 of these cases STD clinic staff reported difficulty reading the test line for the SHC. Of the fingerstick whole-blood SHC reactive specimens, only 14/31 were also serum SHC reactive. CONCLUSION: The SHC on whole-blood appears to be sensitive at detecting patients likely to have syphilis, and could be an option for testing among high-risk populations. However, given challenges in interpreting SHC test results, adequate training of persons performing testing and ongoing quality assurance measures are key. |
Cervical adenocarcinoma in situ: Human papillomavirus types and incidence trends in five states, 2008-2015
Cleveland AA , Gargano JW , Park IU , Griffin MR , Niccolai LM , Powell M , Bennett NM , Saadeh K , Pemmaraju M , Higgins K , Ehlers S , Scahill M , Johnson Jones ML , Querec T , Markowitz LE , Unger ER . Int J Cancer 2019 146 (3) 810-818 Primary prevention through the use of human papillomavirus (HPV) vaccination is expected to impact both cervical intraepithelial neoplasia (CIN) and adenocarcinoma in situ (AIS). While CIN is well described, less is known about the epidemiology of AIS, a rare cervical precancer. We identified AIS and CIN grade 3 (CIN3) cases through population-based surveillance, and analyzed data on HPV types and incidence trends overall, and among women screened for cervical cancer. From 2008-2015, 470 AIS and 6,587 CIN3 cases were identified. The median age of women with AIS was older than those with CIN3 (35 vs 31 years; p<0.01). HPV16 was the most frequently detected type in both AIS and CIN3 (57% in AIS; 58% in CIN3), whereas HPV18 was the second most common type in AIS and less common in CIN3 (38% vs. 5%; p<0.01). AIS lesions were more likely than CIN3 lesions to be positive for high-risk types targeted by the bivalent and quadrivalent vaccines (HPV16/18, 92% vs. 63%; p<0.01), and nonavalent vaccine (HPV16/18/31/33/45/52/58, 95% vs. 87%; p<0.01). AIS incidence rates decreased significantly in the 21-24 year age group (annual percent change [APC] overall: -22.1%, 95% CI: -33.9 to -8.2; APC among screened: -16.1%, 95% CI: -28.8 to -1.2), but did not decrease significantly in any older age group. This report on the largest number of genotyped AIS cases to date suggests an important opportunity for vaccine prevention of AIS, and is the first to document a decline in AIS incidence rates among young women during the vaccine era. This article is protected by copyright. All rights reserved. |
Trends in anogenital wart incidence among Tennessee Medicaid enrollees, 2006-2014: The impact of human papillomavirus vaccination
Shing JZ , Hull PC , Zhu Y , Gargano JW , Markowitz LE , Cleveland AA , Pemmaraju M , Park IU , Whitney E , Mitchel EF , Griffin MR . Papillomavirus Res 2019 7 141-149 INTRODUCTION: Evidence of human papillomavirus (HPV) vaccine impact on anogenital warts (AGWs) by race or urbanicity in the US is lacking. We evaluated HPV vaccine impact in Tennessee by assessing AGW trends among Tennessee Medicaid (TennCare) enrollees aged 15-39 years from 2006-2014. METHODS: Persons with incident AGWs were identified using diagnosis/pharmacy codes from TennCare billing claims. We calculated sex-specific annual AGW incidence by age group, race, and urbanicity; estimated annual percent changes (APCs) using log-linear models; and performed pairwise comparisons by race and urbanicity. RESULTS: AGW incidence decreased among females aged 15-19 (APC=-10.6; P<0.01) and 20-24 years (APC=-3.9; P=0.02). Overall trends were similar between Whites and Blacks, and between those living in metropolitan statistical areas (MSAs) and non-MSAs. Rates among males aged 15-19 years began decreasing after 2010. Among enrollees aged 25-39 years, rates increased or were stable. CONCLUSIONS: Following introduction of the HPV vaccine in 2006, AGWs decreased among age groups most likely to be vaccinated. The change in trend among young males after 2010 suggests early herd effects. Our findings indicate vaccine effects and support the importance of improving adherence to current vaccination recommendations for preventing AGWs and other HPV-related diseases. |
Performance of treponemal tests for the diagnosis of syphilis
Park IU , Fakile YF , Chow JM , Gustafson KJ , Jost H , Schapiro JM , Novak-Weekley S , Tran A , Nomura JH , Chen V , Beheshti M , Tsai T , Hoover K , Bolan G . Clin Infect Dis 2018 68 (6) 913-918 Background: Treponemal immunoassays are increasingly used for syphilis screening with the reverse sequence algorithm. There are little data describing performance of treponemal immunoassays compared to traditional treponemal tests in patients with and without syphilis. Methods: We calculated sensitivity and specificity of seven treponemal assays: 1) ADVIA Centaur (chemiluminescence immunoassay-CIA), 2) Bioplex 2200 (microbead immunoassay-MBIA), 3) fluorescent treponemal antibody absorption test (FTA-ABS), 4) INNO-LIA (line immunoassay), 5) LIAISON CIA, 6) TP-PA (Treponema pallidum particle agglutination assay), and 7) Trep-Sure (enzyme immunoassay-EIA), using a reference standard combining clinical diagnosis and serology results. Sera were collected between May 2012-January 2013. Cases were characterized as: 1) current clinical diagnosis of syphilis: primary, secondary, early latent, late latent 2) prior treated syphilis only, 3) no evidence of current syphilis, no prior history of syphilis and at least 4/7 treponemal tests negative. Results: Among 959 participants, 262 had current syphilis, 294 had prior syphilis, and 403 did not have syphilis. FTA-ABS was less sensitive for primary syphilis [78.2% (65.0-88.2%)], than the immunoassays or TP-PA (94.5-96.4%) (all p</=0.01). All immunoassays were 100% sensitive for secondary syphilis, 95.2-100% sensitive for early latent disease, and 86.8-98.5% sensitive in late latent disease. TP-PA had 100% specificity (99.0-100%). Conclusion: Treponemal immunoassays demonstrated excellent sensitivity for secondary, early latent, and seropositive primary syphilis. Sensitivity of FTA-ABS in primary syphilis was poor compared to the immunoassays and TP-PA. Given its high specificity and superior sensitivity, TP-PA is a better test to adjudicate discordant results with the reverse sequence algorithm than the FTA-ABS. |
Correlation of treponemal immunoassay signal strength values with reactivity of confirmatory treponemal testing
Fakile YF , Jost H , Hoover KW , Gustafson KJ , Novak-Weekley SM , Schapiro JM , Tran A , Chow JM , Park IU . J Clin Microbiol 2017 56 (1) Automated treponemal immunoassays are used for syphilis screening with the reverse sequence algorithm; discordant results (e.g., enzyme immunoassay [EIA]-reactive, reactive plasma reagin [RPR]-non-reactive) are resolved with a second treponemal test. We conducted a study to determine automated immunoassay signal strength values consistently correlating with reactive confirmatory treponemal testing.We conducted a cross-sectional analysis of four automated immunoassays: BioPlex 2200 microbead immunoassay (MBIA), LIAISON chemiluminesence immunoassay (CIA), ADVIA-Centaur CIA, and TrepSure EIA, and three manual assays: Treponema Pallidum Particle Agglutination (TP-PA), Fluorescent Treponemal Antibody-Absorption (FTA-ABS) test, INNO-LIA line immunoassay. We compared signal strength values of automated immunoassays and positive and negative agreement. Among 1995 specimens, 908 (45.5%) were true positives (≥4/7 tests reactive) and 1087 (54.5%) were true negatives (≥4/7 tests non-reactive). Positive agreement ranged from 86.1% (83.7-88.2%) for FTA-ABS to 99.7% (99.0-99.9%) for ADVIA-Centaur CIA; negative agreement ranged from 86.3% (84.1-88.2%) for TrepSure EIA to 100% for TP-PA (99.6-100%). Increasing signal strength values correlated with increasing reactivity of confirmatory testing (ptrend <0.0001 for all automated immunoassay). All automated immunoassays had signal strength cutoffs corresponding to ≥4/7 reactive treponemal tests. Bioplex MBIA and LIAISON CIA had signal strength cutoffs correlating with ≥99% and 100% TP-PA reactivity, respectively. ADVIA-Centaur CIA and TrepSure EIA had signal strength cutoffs correlating with at least 95%TP-PA reactivity. All automated immunoassays had signal strength cutoffs correlating with at least 95% FTA-ABS reactivity. Assuming that a 95% level of confirmation is adequate, these signal strength values can be used in lieu of confirmatory testing with TP-PA and FTA-ABS. |
Interventions to improve sexually transmitted disease screening in clinic-based settings
Taylor MM , Frasure-Williams J , Burnett P , Park IU . Sex Transm Dis 2016 43 S28-41 BACKGROUND: The asymptomatic nature and suboptimal screening rates of sexually transmitted diseases (STD) call for implementation of successful interventions to improve screening in community-based clinic settings with attention to cost and resources. METHODS: We used MEDLINE to systematically review comparative analyses of interventions to improve STD (chlamydia, gonorrhea, or syphilis) screening or rescreening in clinic-based settings that were published between January 2000 and January 2014. Absolute differences in the percent of the target population screened between comparison groups or relative percent increase in the number of tests or patients tested were used to score the interventions as highly effective (>20% increase) or moderately effective (5%-19% increase) in improving screening. Published cost of the interventions was described where available and, when not available, was estimated. RESULTS: Of the 4566 citations reviewed, 38 articles describing 42 interventions met the inclusion criteria. Of the 42 interventions, 16 (38.1%) were categorized as highly effective and 14 (33.3%) as moderately effective. Effective low-cost interventions (<$1000) included the strategic placement of specimen collection materials or automatic collection of STD specimens as part of a routine visit (7 highly effective and 1 moderately effective) and the use of electronic health records (EHRs; 3 highly effective and 4 moderately effective). Patient reminders for screening or rescreening (via text, telephone, and postcards) were highly effective (3) or moderately effective (2) and low or moderate cost (<$1001-10,000). Interventions with dedicated clinic staff to improve STD screening were highly effective (2) or moderately effective in improving STD screening (1) but high-cost ($10,001-$100,000). CONCLUSIONS: Successful interventions include changing clinic flow to routinely collect specimens for testing, using EHR screening reminders, and reminding patients to get screened or rescreened. These strategies can be tailored to different clinic settings to improve screening at a low cost. |
Human papillomavirus and genital warts: A review of the evidence for the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines
Park IU , Introcaso C , Dunne EF . Clin Infect Dis 2015 61 Suppl 8 S849-55 To provide updates for the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines on human papillomavirus (HPV) and anogenital warts (AGWs), a review of the literature was conducted in key topic areas: (1) epidemiology and burden of disease; (2) transmission and natural history; (3) diagnosis and management of AGWs; (4) occupational exposure of healthcare workers; (5) anal cancer screening among men who have sex with men (MSM); and (6) HPV vaccine recommendations. Most sexually active persons will have detectable HPV at least once in their lifetime; 14 million persons are infected annually, and 79 million persons have prevalent infection. HPV is transmitted frequently between partners; more frequent transmission has been reported from females to males than from males to females. A new formulation of imiquimod (3.75% cream) is recommended for AGW treatment. Appropriate infection control, including performing laser or electrocautery in ventilated rooms using standard precautions, is recommended to prevent possible transmission to healthcare workers who treat anogenital warts, oral warts, and anogenital intraepithelial neoplasias (eg, cervical intraepithelial neoplasia). Data are insufficient to recommend routine anal cancer screening with anal cytology in persons living with human immunodeficiency virus (HIV)/AIDS or HIV-negative MSM. An annual digital anorectal examination may be useful for early detection of anal cancer in these populations. HPV vaccine is recommended routinely for 11- or 12-year-olds, as well as for young men through age 21 years and young women through age 26 years who have not previously been vaccinated. HPV vaccine is also recommended for MSM, people living with HIV/AIDS, and immunocompromised persons through age 26 years. |
Monitoring effect of human papillomavirus vaccines in US population, Emerging Infections Program, 2008-2012
Hariri S , Markowitz LE , Bennett NM , Niccolai LM , Schafer S , Bloch K , Park IU , Scahill MW , Julian P , Abdullah N , Levine D , Whitney E , Unger ER , Steinau M , Bauer HM , Meek J , Hadler J , Sosa L , Powell SE , Johnson ML , Hpv-Impact Working Group . Emerg Infect Dis 2015 21 (9) 1557-61 In 2007, five Emerging Infections Program (EIP) sites were funded to determine the feasibility of establishing a population-based surveillance system for monitoring the effect of human papillomavirus (HPV) vaccine on pre-invasive cervical lesions. The project involved active population-based surveillance of cervical intraepithelial neoplasia grades 2 and 3 and adenocarcinoma in situ as well as associated HPV types in women >18 years of age residing in defined catchment areas; collecting relevant clinical information and detailed HPV vaccination histories for women 18-39 years of age; and estimating the annual rate of cervical cancer screening among the catchment area population. The first few years of the project provided key information, including data on HPV type distribution, before expected effect of vaccine introduction. The project's success exemplifies the flexibility of EIP's network to expand core activities to include emerging surveillance needs beyond acute infectious diseases. Project results contribute key information regarding the impact of HPV vaccination in the United States. |
Population-based trends in high-grade cervical lesions in the early human papillomavirus vaccine era in the United States
Hariri S , Johnson ML , Bennett NM , Bauer HM , Park IU , Schafer S , Niccolai LM , Unger ER , Markowitz LE . Cancer 2015 121 (16) 2775-81 BACKGROUND: Cervical intraepithelial neoplasia grade 2, 3, and adenocarcinoma in situ (CIN2+) lesions can be monitored as early indicators of human papillomavirus (HPV) vaccine impact. Changes to screening utilization will affect observed reductions in CIN2+ rates and complicate the interpretation of vaccine impact. METHODS: From 2008 to 2012, 9119 cases of CIN2+ among 18- to 39-year-old residents of catchment areas in California, Connecticut, New York, and Oregon were reported to the HPV-IMPACT Project, a sentinel system for monitoring the population impact of HPV vaccine. Age-stratified CIN2+ incidence rates were calculated for each catchment. Annual cervical screening was estimated for California, New York, and Oregon catchments with administrative and survey data. The Cochran-Armitage test was used to examine trends. RESULTS: From 2008 to 2012, the incidence of CIN2+ significantly decreased among 18- to 20-year-olds (California, from 94 to 5 per 100,000 women; Connecticut, from 450 to 57 per 100,000 women; New York, from 299 to 43 per 100,000 women; and Oregon, from 202 to 37 per 100,000 women; Ptrend < .0001) and among 21- to 29-year-olds in Connecticut (from 762 to 589 per 100,000 women) and New York (from 770 to 465 per 100,000 women; Ptrend < .001); rates did not differ among 30- to 39-year-olds. During the same period, screening rates also declined, with the largest decreases among 18- to 20-year-olds (from 67% in Oregon to 88% in California) and with smaller declines among 21- to 29-year-olds (13%-27%) and 30- to 39-year-olds (3%-21%). CONCLUSIONS: The declines in CIN2+ detection in young women were likely due to reduced screening but could also reflect the impact of vaccination. These data illustrate challenges in interpreting CIN2+ ecologic trends in the new era of cervical cancer prevention and emphasize the importance of information such as HPV types detected in lesions to assess the impact of HPV vaccine on cervical precancers. |
Reduction in HPV 16/18-associated high grade cervical lesions following HPV vaccine introduction in the United States - 2008-2012
Hariri S , Bennett NM , Niccolai LM , Schafer S , Park IU , Bloch KC , Unger ER , Whitney E , Julian P , Scahill MW , Abdullah N , Levine D , Johnson ML , Steinau M , Markowitz LE . Vaccine 2015 33 (13) 1608-13 BACKGROUND: Prevention of pre-invasive cervical lesions is an important benefit of HPV vaccines, but demonstrating impact on these lesions is impeded by changes in cervical cancer screening. Monitoring vaccine-types associated with lesions can help distinguish vaccine impact from screening effects. We examined trends in prevalence of HPV 16/18 types detected in cervical intraepithelial neoplasia 2, 3, and adenocarcinoma in situ (CIN2+) among women diagnosed with CIN2+ from 2008 to 2012 by vaccination status. We estimated vaccine effectiveness against HPV 16/18-attributable CIN2+ among women who received ≥1 dose by increasing time intervals between date of first vaccination and the screening test that led to detection of CIN2+ lesion. METHODS: Data are from a population-based sentinel surveillance system to monitor HPV vaccine impact on type-specific CIN2+ among adult female residents of five catchment areas in California, Connecticut, New York, Oregon, and Tennessee. Vaccination and cervical cancer screening information was retrieved. Archived diagnostic specimens were obtained from reporting laboratories for HPV DNA typing. RESULTS: From 2008 to 2012, prevalence of HPV 16/18 in CIN2+ lesions statistically significantly decreased from 53.6% to 28.4% among women who received at least one dose (Ptrend<.001) but not among unvaccinated women (57.1% vs 52.5%; Ptrend=.08) or women with unknown vaccination status (55.0% vs 50.5%; Ptrend=.71). Estimated vaccine effectiveness for prevention of HPV 16/18-attributable CIN2+ was 21% (95% CI: 1-37), 49% (95% CI: 28-64), and 72% (95% CI: 45-86) in women who initiated vaccination 25-36 months, 37-48 months, and >48 months prior to the screening test that led to CIN2+ diagnosis. CONCLUSIONS: Population-based data from the United States indicate significant reductions in CIN2+ lesions attributable to types targeted by the vaccines and increasing HPV vaccine effectiveness with increasing interval between first vaccination and earliest detection of cervical disease. |
HPV and HPV-associated diseases
Dunne EF , Park IU . Infect Dis Clin North Am 2013 27 (4) 765-78 Human papillomavirus (HPV) is the most common sexually transmitted infection. HPV is associated with a significant burden of disease and cancer, including anogenital warts and recurrent respiratory papillomatosis, and anogenital and oropharyngeal cancers. Effective prevention is available, including primary prevention of cancers and anogenital warts through HPV vaccination, and secondary prevention of cervical cancer through screening and treatment of precancer. This article focuses on HPV infection and the clinical consequences of infection, with attention to cervical and anogenital squamous intraepithelial neoplasia and anogenital warts. |
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