Browsing by Author "Van Der Pol, Barbara"
Now showing 1 - 10 of 16
Results Per Page
Sort Options
Item Analytical and Clinical Sample Performance Characteristics of the Onclarity Assay for the Detection of Human Papillomavirus(American Society for Microbiology, 2020-12-17) Young, Stephen; Vaughan, Laurence; Yanson, Karen; Eckert, Karen; Li, Aojun; Harris, James; Ermel, Aaron; Williams, James A.; Al-Ghoul, Mohammad; Cammarata, Catherine L.; Taylor, Stephanie N.; Luff, Ronald; Cooper, Charles K.; Van Der Pol, Barbara; Medicine, School of MedicineThe objective of this study was to determine the result reproducibility and performance of the BD Onclarity human papillomavirus (HPV) assay (Onclarity) on the BD Viper LT platform using both contrived and clinical specimens. Reproducibility was assessed in BD SurePath liquid-based cytology (LBC) medium (SurePath) using contrived panels (HPV genotype 16 [HPV16] positive, HPV18 positive, or HPV45 positive) or clinical specimens (HPV16, -18, -31, -33/58, -45, or -52 positive or HPV negative). In addition, specimens from 3,879 individuals from the Onclarity trial were aliquoted prior to or following cytology processing and tested for HPV. Finally, specimens were collected using either the Cervex-Brush or Cytobrush (or Cytobrush/spatula) for comparison of HPV results. Contrived specimens showed >95% concordance with the expected results, and pooled clinical specimens had standard deviations and coefficients of variation ranging from 0.87 to 1.86 and 2.9% to 5.6%, respectively. For precytology and postcytology aliquot analyses, specimens showed >98.0% overall agreement and mean differences in cycle threshold (CT ) scores for HPV ranging from -0.07 to 0.31. Positivity rates were close between the Cervex-Brush and Cytobrush/spatula for all age groups tested. Onclarity results are reproducible and reliable, regardless of sample collection before or after cytology aliquoting. Onclarity performs well regardless of the method of specimen collection (Cervex-Brush or Cytobrush/spatula) for cervical cancer screening.Item Clinical Performance of the BD CTGCTV2 Assay for the BD MAX System for Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Infections(Wolters Kluwer, 2021) Van Der Pol, Barbara; Torres-Chavolla, Edith; Kodsi, Salma; Cooper, Charles K.; Davis, Thomas E.; Fife, Kenneth H.; Taylor, Stephanie N.; Augenbraun, Michael H.; Gaydos, Charlotte A.; Medicine, School of MedicineBackground: Diagnostic options to combat the increasing rates of sexually transmitted infections recorded throughout the world increasingly include multiplex assays. Here we describe the estimated sensitivity and specificity of a triplex molecular assay that simultaneously detects Chlamydia trachomatis (CT), Neisseria gonorrhoeae (or gonococci [GC]), and Trichomonas vaginalis (TV). Methods: Participants (2547 women and 1159 men) were recruited from 12 clinics in the United States. BD CTGCTV2 for BD MAX System assay (CTGCTV2) results were obtained from vaginal and endocervical swabs, endocervical samples in cytology medium, and female and male urine. Results were compared with infection standards that were sample type and pathogen dependent. Results: Female specimen sensitivity estimates ranged from 92.7% to 98.4%, 92.9% to 100%, and 86.6% to 100% for CT, GC and TV, respectively. Male urine sensitivity estimates were 96.7%, 99.2%, and 97.9% for CT, GC, and TV, respectively. Specificity estimates were >98.7% for all sample types. Conclusions: BD CTGCTV2 performed well using a variety of sample types. As a true triplex assay, performed using a benchtop instrument, BD CTGCTV2 may be useful in settings where no testing is currently performed and in settings, such as reference laboratories, where testing turnaround time may be several days. Use of this assay at local laboratories may result in greater access to testing and a shorter time to result, which are important steps for improving our ability to combat sexually transmitted infections.Item Coping Strategies and Behavioral Changes Following a Genital Herpes Diagnosis Among an Urban Sample of Underserved Midwestern Women(Sage, 2016-03) Davis, Alissa; Roth, Alexis; Brand, Juanita Ebert; Zimet, Gregory D.; Van Der Pol, Barbara; Department of Pediatrics, IU School of MedicineThis study focused on understanding the coping strategies and related behavioural changes of women who were recently diagnosed with herpes simplex virus type 2. In particular, we were interested in how coping strategies, condom use, and acyclovir uptake evolve over time. Twenty-eight women screening positive for herpes simplex virus type 2 were recruited through a public health STD clinic and the Indianapolis Community Court. Participants completed three semi-structured interviews with a woman researcher over a six-month period. The interviews focused on coping strategies for dealing with a diagnosis, frequency of condom use, suppressive and episodic acyclovir use, and the utilisation of herpes simplex virus type 2 support groups. Interview data were analysed using content analysis to identify and interpret concepts and themes that emerged from the interviews. Women employed a variety of coping strategies following an herpes simplex virus type 2 diagnosis. Of the women, 32% reported an increase in religious activities, 20% of women reported an increase in substance use, and 56% of women reported engaging in other coping activities. A total of 80% of women reported abstaining from sex immediately following the diagnosis, but 76% of women reported engaging in sex again by the six-month interview. Condom and medication use did not increase and herpes simplex virus type 2 support groups were not utilised by participants. All participants reported engaging in at least one coping mechanism after receiving their diagnosis. A positive diagnosis did not seem to result in increased use of condoms for the majority of participants and the use of acyclovir was low overall.Item Delay in Seeking Healthcare Services Following Onset of Urethritis Symptoms in Men(Wolters Kluwer, 2019-05) Aaron, Kristal J.; Van Der Pol, Barbara; Jordan, Stephen J.; Schwebke, Jane R.; Hook, Edward W., III; Medicine, School of MedicineBackground: Symptom awareness, behavioral factors, and other barriers associated with timely sexually transmitted infection (STI) health care provision in men is not well studied. Methods: Men attending an STI clinic answered a questionnaire regarding their symptoms, sexual behavior, and sociodemographic and behavioral characteristics. Characteristics of symptomatic men were compared between those who did and did not delay seeking health care services. Delayed care seeking was defined as clinic attendance longer than 7 days after symptoms, whereas early care seeking was defined as clinic attendance of 7 days or less. Results: Over a quarter (n = 43 [27.7%]) of men with urethritis symptoms (urethral discharge or dysuria) delayed seeking care for more than 7 days. Compared with men who sought treatment within 7 days, those that delayed care worried for longer periods that their symptoms were STI-related, were more likely to attempt self-treatment of STI symptoms, were more likely to continue engaging in sexual activity, and were less likely to use a condom during their last sexual encounter. Conversely, men that delayed care seeking were less likely to have urethral discharge on physical examination, to have 5 or more polymorphonuclear leukocytes, and to test positive for Neisseria gonorrhoeae. When compared with men that sought care earlier, men that delayed care seeking had fewer overall and new partners in the past 30 days. Conclusions: Our data suggest that over a quarter of men aware of STI symptoms delay seeking health services. Interventions that promote better patient understanding of the importance of symptom recognition and that facilitate timely access to care may provide new opportunities to reduce STI transmission.Item Differences in risk behaviours, HIV/STI testing and HIV/STI prevalence between men who have sex with men and men who have sex with both men and women in China(SAGE, 2016-09) Davis, Alissa; Best, John; Luo, Juhua; Van Der Pol, Barbara; Dodge, Brian; Meyerson, Beth; Aalsma, Matthew; Wei, Chongyi; Tucker, Joseph D.; Department of Epidemiology, Richard M. Fairbanks School of Public HealthDifferences in risk behaviours between men who have sex with men (MSM) and men who have sex with both men and women (MSMW) have important implications for HIV and sexually transmitted infection (STI) transmission. We examined differences in risk behaviours, HIV/STI testing, self-reported HIV/STI diagnoses, and linkage to HIV care between MSM and MSMW across China. Participants were recruited through three MSM-focused websites in China. An online survey containing items on socio-demographics, risk behaviours, testing history, self-reported HIV/STI diagnosis, and linkage to and retention in HIV care was completed from September to October 2014. Chi square tests and logistic regression analyses were conducted. MSMW were less likely to use a condom during last anal sex (p ≤ 0.01) and more likely to engage in group sex (p ≤ 0.01) and transactional sex (p ≤ 0.01) compared to MSM. Self-reported HIV/STI testing and positivity rates between MSM and MSMW were similar. Among HIV-infected MSM, there was no difference in rates of linkage to or retention in antiretroviral therapy when comparing MSM and MSMW. Chinese MSM and MSMW may benefit from different HIV and STI intervention and prevention strategies. Achieving a successful decrease in HIV/STI epidemics among Chinese MSM and MSMW will depend on the ability of targeted and culturally congruent HIV/STI control programmes to facilitate a reduction in risk behaviours.Item Evaluation of the Performance of a Point-of-Care Test for Chlamydia and Gonorrhea(JAMA Network, 2020-05) Van Der Pol, Barbara; Taylor, Stephanie N.; Mena, Leandro; Lebed, Joel; McNeil, Candice Joy; Crane, LaShonda; Ermel, Aaron; Sukhija-Cohen, Adam; Gaydos, Charlotte A.; Medicine, School of MedicineImportance: Rates of chlamydial and gonococcal infection continue to increase in the United States, as do the associated costs of untreated infections. Improved diagnostic technologies that support testing and treating in 1 clinical visit are critical to advancing efforts to control the rates of chlamydial and gonococcal infection. Objective: To evaluate the clinical performance of a point-of-care (POC) molecular diagnostic assay for the detection of chlamydia and gonorrhea. Design, setting, and participants: A noninterventional, cross-sectional clinical study was conducted from September 18, 2018, through March 13, 2019, at sexually transmitted infection (STI), HIV, family planning, and obstetrics and gynecology clinics where STI screening is routine, using a convenience sample and comparing commercially available assays with a new 30-minute POC assay. Patients included were those eligible for STI screening or diagnostic testing who had not taken antibiotics effective against chlamydia or gonorrhea within the previous 28 days. Four vaginal swab samples were collected from women and a first-catch urine sample was obtained from men. Main outcomes and measures: A composite infection status was used to classify participants as infected if 2 or more comparator results were positive, as not infected if 2 or more comparator samples were negative, and as unevaluable if 1 result was invalid and the other 2 results did not agree with each other. Results: Swab samples from 1523 women (median age, 27 years [interquartile range, 17-37 years]), 817 (53.6%) of whom presented with symptoms, and 922 men (median age, 29 years [interquartile range, 17-41 years]), 308 (33.4%) of whom were symptomatic, were tested. For chlamydia, sensitivity of the new POC assay was 96.1% (95% CI, 91.2%-98.3%) for women and 92.5% (95% CI, 86.4%-96.0%) for men. For gonorrhea, sensitivity estimates were 100.0% (95% CI, 92.1%-100.0%) for women and 97.3% (95% CI, 90.7%-99.3%) for men. For chlamydia, specificity of the new POC assay was 99.1% (95% CI, 98.4%-99.5%) for women and 99.3% (95% CI, 98.4%-99.7%) for men. For gonorrhea, specificity estimates were 99.9% (95% CI, 99.5%-100%) for women and 100% (95% CI, 95.5%-100%) for men. Non-laboratory-trained personnel performed 94.8% of all tests (2318 of 2445) during the study. Conclusions and relevance: This study suggests that self-obtained vaginal swab samples were associated with performance equivalent to laboratory-based molecular diagnostics, which can support use of this POC assay in many settings. The availability of an easy-to-use, rapid (30-minute) molecular test for accurate detection of chlamydia and gonorrhea has the power to facilitate testing and treatment in a single patient visit for these STIs.Item Genotype-specific Concordance of Chlamydia trachomatis Genital Infection within Heterosexual Partnerships(Lippincott, Williams & Wilkins, 2016-12) Schillinger, Julia A.; Katz, Barry P.; Markowitz, Lauri E.; Braslins, Phillip G.; Shrier, Lydia A.; Madico, Guillermo; Van Der Pol, Barbara; Orr, Donald P.; Rice, Peter A.; Batteiger, Byron E.; Biostatistics, School of Public HealthBackground Sexual transmission rates of Chlamydia trachomatis (Ct) cannot be measured directly; however, the study of concordance of Ct infection in sexual partnerships (dyads) can help to illuminate factors influencing Ct transmission. Methods Heterosexual men and women with Ct infection and their sex partners were enrolled and partner-specific coital and behavioral data collected for the prior 30 days. Microbiological data included Ct culture, nucleic acid amplification testing (NAAT), quantitative Ct polymerase chain reaction (qPCR), and ompA genotyping. We measured Ct concordance in dyads, and factors (correlates) associated with concordance. Results 121 women and 125 men formed 128 dyads. Overall, 72.9% of male partners of NAAT-positive women and 68.6% of female partners of NAAT-positive men were Ct-infected. Concordance was more common in dyads with culture-positive members (78.6% of male partners, 77% of female partners). Partners of women and men who were NAAT-positive only had lower concordance (33.3%, 46.4%, respectively). Women in concordant dyads had significantly higher median endocervical qPCR values (3,032) compared with CT-infected women in discordant dyads (1,013 IFU DNA equivalents per ml), p<0.01. Among 54 Ct-concordant dyads with ompA genotype data for both members, 96.2% had identical genotypes. Conclusions Higher organism load appears associated with concordance among women. Same-genotype chlamydial concordance was high in sexual partnerships. No behavioral factors were sufficiently discriminating to guide partner services activities. Findings may help model coitus-specific transmission probabilities.Item Intimate Partner Violence and Correlates With Risk Behaviors and HIV/STI Diagnoses Among Men Who Have Sex With Men and Men Who Have Sex With Men and Women in China: A Hidden Epidemic(Ovid Technologies (Wolters Kluwer) - Lippincott Williams & Wilkins, 2015-07) Davis, Alissa; Best, John; Wei, Chongyi; Luo, Juhua; Van Der Pol, Barbara; Meyerson, Beth; Dodge, Brian; Aalsma, Matthew; Tucker, Joseph; Social Entrepreneurship for Sexual Health Research Group; Department of Pediatrics, IU School of MedicineBACKGROUND: Intimate partner violence (IPV) research has primarily focused on heterosexual couples but has largely ignored IPV among men who have sex with men (MSM). We examined IPV prevalence among MSM and men who have sex with men and women (MSMW) in China. METHODS: Men who have sex with men older than 16 years were recruited through 3 MSM-focused Web sites in China. An online survey containing items on sociodemographics, risk behaviors, IPV, and self-reported HIV or sexually transmitted infection diagnosis was completed. Multivariate regression was used to examine associations between IPV and risk behaviors and an HIV or sexually transmitted infection diagnosis. RESULTS: Among 610 participants, 182 (29.8%) reported experiencing at least 1 type of IPV. Men who have sex with both men and women were at significantly greater risk for IPV (adjusted odds ratio [AOR], 1.65; 95% confidence interval [CI], 1.08-2.53) compared with MSM. Men who had experienced IPV were more likely to have participated in group sex (AOR, 1.86; 95% CI, 1.08-3.21), to have had sex in exchange for gifts or money (AOR, 5.06; 95% CI, 2.47-10.35), and to report a positive HIV diagnosis (AOR, 2.59; 95% CI, 1.22-5.51). CONCLUSIONS: There is a hidden epidemic of IPV among MSM in China, especially among MSMW. The hidden nature of MSM and MSMW suggests the need for a clinical environment more conducive to disclosure. Research is needed to understand the pathways linking IPV and HIV risk among MSM to optimize the design of effective interventions.Item Meatal Swabs Contain Less Cellular Material and Are Associated with a Decrease in Gram Stain Smear Quality Compared to Urethral Swabs in Men(ASM, 2017-07) Jordan, Stephen J.; Schwebke, Jane R.; Aaron, Kristal J.; Van Der Pol, Barbara; Hook, Edward W., III; Medicine, School of MedicineUrethral swabs are the samples of choice for point-of-care Gram stain testing to diagnose Neisseria gonorrhoeae infection and nongonococcal urethritis (NGU) in men. As an alternative to urethral swabs, meatal swabs have been recommended for the collection of urethral discharge to diagnose N. gonorrhoeae and Chlamydia trachomatis infection in certain populations by nucleic acid amplification testing (NAAT), as they involve a less invasive collection method. However, as meatal swabs could be sampling a reduced surface area and result in fewer collected epithelial cells compared to urethral swabs, the adequacy of meatal swab specimens to collect sufficient cellular material for Gram stain testing remains unknown. We enrolled 66 men who underwent either urethral or meatal swabbing and compared the cellular content and Gram stain failure rate. We measured the difference in swab cellular content using the Cepheid Xpert CT/NG sample adequacy control crossing threshold (SACCT) and determined the failure rate of Gram stain smears (GSS) due to insufficient cellular material. In the absence of discharge, meatal smears were associated with a significant reduction in cellular content (P = 0.0118), which corresponded with a GSS failure rate significantly higher than that for urethral swabs (45% versus 3%, respectively; P < 0.0001). When discharge was present, there was no difference among results from urethral and meatal swabs. Therefore, if GSS testing is being considered for point-of-care diagnosis of N. gonorrhoeae infection or NGU in men, meatal swabs should be avoided in the absence of a visible discharge.Item A mixed methods approach to assess the likelihood of testing for STI using self-collected samples among behaviourally bisexual women(BMJ, 2015-08) Schick, Vanessa; Van Der Pol, Barbara; Dodge, Brian; Baldwin, Aleta; Fortenberry, J. Dennis; Department of Pediatrics, IU School of MedicineObjectives Behaviourally bisexual women (women who have sex with women and men (WSWM)) are more likely to report a history of sexually transmitted infections (STI) than women who have sex exclusively with men or exclusively with women. Barriers to care may prohibit WSWM from seeking STI testing. The present study investigated participant willingness to self-collect oral, vaginal and anal samples for STI testing. Methods Eighty WSWM were recruited from two midwestern locations. After completing an online questionnaire, a subset of the participants were interviewed (n=54) and provided the option to self-collect oral, vaginal and/or anal samples to screen for Chlamydia trachomatis, Neisseria gonorrhoeae and Trichomonas vaginalis. Results Over two-thirds (67.5%, n=54) of the participants completed the baseline scheduled and attended the interview. The majority of these participants provided vaginal (87.0%, n=47), oral (85.2%, n=46) and/or anal (61.1%, n=33) samples. Participants with a history of anal play were significantly more likely to provide an anal sample. C. trachomatis infection was identified in the samples of 6.8% (n=3) of the participants including 4.5% (n=2) of the vaginal samples and 3.3% (n=1) of the anal samples. None of the samples were positive for N. gonorrhoeae or T. vaginalis. Participants who reported a recent history of anal sexual behaviour with a male partner were significantly more likely to self-collect an anal sample. Conclusions Given the comparatively high STI rates among WSWM, self-sampling in non-traditional settings may present a unique opportunity to provide needed care to this underserved population of women.