Maurizio Macaluso

University of Cincinnati, Cincinnati, Ohio, United States

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Publications (172)596.27 Total impact

  • [Show abstract] [Hide abstract]
    ABSTRACT: Most children diagnosed with community-acquired pneumonia (CAP) are treated in the outpatient setting. The objective of this study was to determine the comparative clinical effectiveness of beta-lactam monotherapy and macrolide monotherapy in this population. Children, 1-18 years old, with a clinical diagnosis of CAP at an outpatient practice affiliated (n=71) with Geisinger Health System during January 1, 2008 to January 31, 2010 were eligible. The primary exposure was receipt of beta-lactam or macrolide monotherapy. The primary outcome was treatment failure defined as change in antibiotic prescription within 14 days of the initial pneumonia diagnosis. Propensity scores were used to determine the likelihood of receiving macrolide monotherapy. Treatment groups were matched 1:1, based on propensity score, age group and asthma status. Multivariable conditional logistic regression models estimated the association between macrolide monotherapy and treatment failures. Of 1,999 children with CAP, 1,164 were matched. In the matched cohorts, 24% of children had asthma. Patients who received macrolide monotherapy had no statistical difference in treatment failure regardless of age when compared with patients who received beta-lactam monotherapy. Our findings suggest that children diagnosed with CAP in the outpatient setting and treated with beta-lactam or macrolide monotherapy have the same likelihood to fail treatment regardless of age.
    The Pediatric Infectious Disease Journal 04/2015; DOI:10.1097/INF.0000000000000740 · 3.14 Impact Factor
  • Resmi Gupta, Rhonda D. Szczesniak, Maurizio Macaluso
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    ABSTRACT: Highly skewed count data with excess zeros challenge the application of conventional statistical methods. Additional problems arise from repeated zero-inflated measures. Longitudinal zero-inflated Poisson (ZIP-mixed) models are mixtures of logistic and Poisson models that accommodate excess zeros and repeated counts. We compared a ZIP-mixed model with traditional Poisson and negative binomial models using data on problems with female condom use reported by women at high risk of sexually transmitted diseases. The follow-up experience of this cohort represents a mixture of "perfect use" (no opportunity to report problems), represented by the structural zeros, and use experience that bears the risk of condom use problems, represented by a Poisson distribution. The ZIP-mixed model provided better fit and richer results than other models. The odds of being in the zero problem category increased with age (odds ratio [OR] = 1.1 per additional year, 95% confidence interval [CI]: 1.0-1.3) and with follow-up (OR = 3.0 per additional month, 95% CI: 1.4-6.0).The nonzero problem rate was lower among women who believed in the benefits of condom use (rate ratio [RR] = 0.9, 95% CI: 0.7-1.0) and had no sexually transmitted diseases at baseline (RR = 0.7, 95% CI: 0.6-0.9), and it decreased during follow-up (RR = 0.8 per additional month, 95% CI: 0.7-0.9). Using ZIP-mixed model provided further insights into the determinants of condom failure. Copyright © 2015 Elsevier Inc. All rights reserved.
    Annals of epidemiology 03/2015; 25(8). DOI:10.1016/j.annepidem.2015.03.011 · 2.15 Impact Factor
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    ABSTRACT: Background Studies in populations unexposed to folic acid (FA) fortification have demonstrated that MTHFR C677T polymorphism is associated with increased risk of higher grades of cervical intraepithelial neoplasia (CIN 2+). However, it is unknown whether exposure to higher folate as a result of the FA fortification program has altered the association between MTHFR C677T and risk of CIN, or the mechanisms involved with such alterations. The current study investigated the following in a FA fortified population: 1) The association between MTHFR C677T polymorphism and risk of CIN 2+; 2) The modifying effects of plasma folate concentrations on this association; and 3) The modifying effects of plasma folate on the association between the polymorphism and degree of methylation of long interspersed nucleotide elements (L1s), in peripheral blood mononuclear cell (PBMC) DNA, a documented biomarker of CIN risk. Methods The study included 457 US women diagnosed with either CIN 2+ (cases) or ≤ CIN 1 (non-cases). Unconditional logistic regression models were used to test the associations after adjusting for relevant risk factors for CIN. Results The 677CT/TT MTHFR genotypes were not associated with the risk of CIN 2+. Women with CT/TT genotype with lower folate, however, were more likely to be diagnosed with CIN 2+ compared to women with CT/TT genotype with higher folate (OR = 2.41, P = 0.030). Women with CT/TT genotype with lower folate were less likely to have a higher degree of PBMC L1 methylation compared to women with CT/TT genotype with higher folate (OR = 0.28, P = 0.017). Conclusions This study provides the first evidence that the MTHFR 677CT/TT genotype-associated lower degree of PBMC L1 methylation increases the risk of CIN 2+ in women in the US post-FA fortification era. Thus, even in the post-FA fortification era, not all women have adequate folate status to overcome MTHFR 677CT/TT genotype-associated lower degree of L1 methylation.
    PLoS ONE 10/2014; 9(10):e110093. DOI:10.1371/journal.pone.0110093 · 3.53 Impact Factor
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    ABSTRACT: Objective We evaluated time to clearance of high risk (HR) HPV infection in relation to functional variants in three genes (CYP1A1, GSTT1, and GSTM1). Methods The study group consisted of 450 HR-HPV infected women from the Atypical squamous cells of undetermined significance-low-grade squamous intraepithelial Lesion Triage Study (ALTS) cohort followed up at the clinical center at Birmingham, Alabama. The Cox proportional hazard model with the Wei-Lin-Weisfeld (WLW) approach was used, controlling for relevant covariates. Results Women who were polymorphic for CYP1A1 experienced an HR-HPV clearance rate that was 20% (HR = 0.80, p = 0.04) lower than women without the polymorphism for CYP1A1, adjusting for all other cofactors. The GSTM1 null genotype was associated with higher HR-HPV clearance rate (HR = 1.39, p = 0.006). The polymorphism in GSTT1 was not significantly associated with time to clearance of HR-HPV. Conclusions Xenobiotic metabolism genes may influence the natural history of HR-HPV infection and its progression to cervical cancer.
    Gynecologic Oncology 10/2014; 135(3). DOI:10.1016/j.ygyno.2014.09.015 · 3.69 Impact Factor
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    ABSTRACT: Implantation and live birth rates resulting from IVF cycles using gonadotropin-releasing hormone (GnRH) agonist and (GnRH) antagonist IVF protocols were compared among good-prognosis patients using the Centers for Disease Control and Prevention's National Assisted Reproductive Technology Surveillance System 2009–2010 data (n = 203,302 fresh, autologous cycles). Bivariable and multivariable analyses were conducted between cycles to compare outcomes. Cycles were restricted as follows: age younger than 35 years, maximum FSH less than 10 mIU/mL, first assisted reproduction technology cycle and FSH dose less than 3601 IU. A subgroup analysis including only elective single embryo transfer was also carried out. Among good-prognosis patients, the GnRH-agonist protocol was associated with a lower risk of cancellation before retrieval (4.3 versus 5.2%; P < 0.05) or transfer (5.5 versus 6.8%; P < 0.05), and a higher live birth rate per transfer (adjusted odds ratio [OR] 1.13, confidence interval [CI] 1.03 to 1.25) than the GnRH-antagonist group. Among the elective single embryo transfer group, the GnRH-agonist protocol was associated with a higher implantation rate (adjusted odds ratio [OR] 1.36, CI 1.08 to 1.73) and a higher live birth rate (adjusted OR 1.33, CI 1.07 to 1.66) compared with the GnRH-antagonist protocol. The GnRH-antagonist group had lower rates of ovarian hyperstimulation syndrome. Among good-prognosis patients, agonist protocols decreased cancellation risk and increased odds of implantation and live birth. Antagonist protocols may confer decreased risk of hyperstimulation.
    Reproductive biomedicine online 09/2014; 29(3). DOI:10.1016/j.rbmo.2014.05.007 · 2.98 Impact Factor
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    ABSTRACT: We previously reported that a higher degree of methylation of CpG sites in the promoter (positions 31, 37, 43, 52 and 58) and enhancer site 7862 of HPV 16 was associated with a lower likelihood of being diagnosed with HPV 16-associated CIN 2+. The purpose of the current study was to replicate our previous findings and in addition to evaluate the influence of plasma concentrations of folate and vitamin B12 on the degree of HPV 16 methylation (HPV 16m). The study included 315 HPV 16 positive women diagnosed with either CIN 2+ or ≤ CIN 1. Pyrosequencing technology was used to quantify the degree of HPV 16m. We reproduced the previously reported inverse association between HPV 16m and risk of being diagnosed with CIN 2+. In addition, we observed that women with higher plasma folate and higher HPV 16m or those with higher plasma vitamin B12 and higher HPV 16m were 75% (P<0.01) and 60% (P=0.02) less likely to be diagnosed with CIN 2+, respectively. With a tertile increase in the plasma folate or vitamin B12, there was a 50% (P=0.03) and 40% (P=0.07) increase in the odds of having a higher degree of HPV 16m, respectively. The present study provides initial evidence that methyl donor micronutrients, folate and vitamin B12, may play an important role in maintaining a desirably high degree of methylation at specific CpG sites in the HPV E6 promoter and enhancer that are associated with the likelihood of being diagnosed with CIN 2+.
    Cancer Prevention Research 08/2014; 7(11). DOI:10.1158/1940-6207.CAPR-14-0143 · 5.27 Impact Factor
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    ABSTRACT: Objectives There is currently no information on whether products evaluated in HIV microbicide trials affect the detection of the semen biomarkers PSA or Y chromosome DNA. Study Design We tested (in vitro) dilutions of tenofovir (TFV), UC781, and the hydroxyethylcellulose (HEC) placebo gels using the Abacus ABAcard and the quantitative (Abbott Architect total PSA) assays for PSA and Y chromosome DNA by real-time polymerase chain reaction (real-time PCR). Results TFV gel and the HEC placebo adversely affected PSA detection using the ABAcard, but not the Abbott Architect total PSA assay. UC781 adversely affected both the ABAcard and Abbott Architect total PSA assays. While there were some quantitative changes in the magnitude of the signal, none of the products affected positivity of the Y chromosome assay. Conclusions The presence of TFV or HEC gels did not affect quantitative PSA or Y chromosome detection in vitro. Confirmation of these findings is recommended using specimens obtained following use of these gels in vivo. Implications Researchers should consider the potential for specific microbicides or any products to affect the particular assay used for semen biomarker detection. The ABAcard assay for PSA detection should not be used with TFV and HEC.
    Contraception 08/2014; 90(2). DOI:10.1016/j.contraception.2014.03.009 · 2.93 Impact Factor
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    ABSTRACT: Mixed-method designs are increasingly used in sexually transmitted infection (STI) and HIV prevention research. The authors designed a mixedmethod approach and applied it to estimate and evaluate a predictor of continued female condom use (6+ uses, among those who used it at least once) in a 6-month prospective cohort study. The analysis included 402 women who received an intervention promoting use of female and male condoms for STI prevention and completed monthly quantitative surveys; 33 also completed a semistructured qualitative interview. The authors identified a qualitative theme (couples' female condom enjoyment [CFCE]), applied discriminant analysis techniques to estimate CFCE for all participants, and added CFCE to a multivariable logistic regression model of continued female condom use. CFCE related to comfort, naturalness, pleasure, feeling protected, playfulness, ease of use, intimacy, and feeling in control of protection. CFCE was associated with continued female condom use (adjusted odds ratio: 2.8, 95% confidence interval: 1.4-5.6) and significantly improved model fit (p < .001). CFCE predicted continued female condom use. Mixed-method approaches for "scaling up" qualitative findings from small samples to larger numbers of participants can benefit HIV and STI prevention research.
    AIDS education and prevention: official publication of the International Society for AIDS Education 04/2014; 26(2):95-108. DOI:10.1521/aeap.2014.26.2.95 · 1.51 Impact Factor
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    ABSTRACT: Assisted Reproductive Technology (ART) includes fertility procedures where both egg and sperm are handled in the lab. ART use has increased considerably in recent years, accounting for 47 090 livebirths in the US in 2010. ART increases the probability of multiple gestation births, which are at higher risks than singletons for adverse outcomes. Additionally, ART is associated with a greater risk of complications during pregnancy, labour, and delivery, and increased risk of adverse perinatal outcomes in singleton births. We merged Florida and Massachusetts birth records from 2004-06 with the National ART Surveillance System (NASS) and using NASS as the gold standard, calculated sensitivity, specificity, and positive predictive value (PPV) of ART reporting on the birth certificates by maternal, infant, and hospital characteristics. We fit random-effects logistic regression models to evaluate simultaneously the association of ART reporting with these predictors while accounting for correlation among births occurring in the same hospital. Sensitivity of ART reporting on the birth certificate was 28.9% in Florida and 41.4% in Massachusetts. Specificity was >99% in both states. PPV was 45.5% in Florida and 54.6% in Massachusetts. The odds of ART reporting varied by state and by several maternal and delivery characteristics including age, parity, history of fetal loss, plurality, race/Hispanic ethnicity, delivery payment source, pre-existing conditions, and complications during pregnancy or labour and delivery. There was significant under-reporting of ART procedures on the birth certificates. Using data on ART births identified only from birth certificates yields a biased sample of the population of ART births.
    Paediatric and Perinatal Epidemiology 02/2014; DOI:10.1111/ppe.12110 · 2.81 Impact Factor
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    ABSTRACT: Background The role of adjunct systemic corticosteroid therapy in children with community-acquired pneumonia (CAP) is not known. The objective was to determine the association between adjunct systemic corticosteroid therapy and treatment failure in children who received antibiotics for treatment of CAP in the outpatient setting.
    02/2014; 4(1):21-27. DOI:10.1093/jpids/piu017
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    ABSTRACT: The advent of fertility treatments has led to an increase in the rate of multiple births in the United States. However, the trends in and magnitude of the contribution of fertility treatments to the increase are uncertain. We derived the rates of multiple births after natural conception from data on distributions of all births from 1962 through 1966 (before fertility treatments were available). Publicly available data on births from 1971 through 2011 were used to determine national multiple birth rates, and data on in vitro fertilization (IVF) from 1997 through 2011 were used to estimate the annual proportion of multiple births that were attributable to IVF and to non-IVF fertility treatments, after adjustment for maternal age. Trends in multiple births were examined starting from 1998, the year when clinical practice guidelines for IVF were developed with an aim toward reducing the incidence of multiple births. We estimated that by 2011, a total of 36% of twin births and 77% of triplet and higher-order births resulted from conception assisted by fertility treatments. The observed incidence of twin births increased by a factor of 1.9 from 1971 to 2009. The incidence of triplet and higher-order births increased by a factor of 6.7 from 1971 to 1998 and decreased by 29% from 1998 to 2011. This decrease coincided with a 70% reduction in the transfer of three or more embryos during IVF (P<0.001) and a 33% decrease in the proportion of triplet and higher-order births attributable to IVF (P<0.001). Over the past four decades, the increased use of fertility treatments in the United States has been associated with a substantial rise in the rate of multiple births. The rate of triplet and higher-order births has declined over the past decade in the context of a reduction in the transfer of three or more embryos during IVF. (Funded by the Centers for Disease Control and Prevention.).
    New England Journal of Medicine 12/2013; 369(23):2218-25. DOI:10.1056/NEJMoa1301467 · 54.42 Impact Factor
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    ABSTRACT: Detecting the onset of rapid lung function decline is important to reduce mortality rates in cystic fibrosis (CF) and other lung diseases. The most common approach is conventional linear mixed modeling-estimating a population-level slope of lung function decline and using random effects to address serial correlation-but this ignores nonlinear features of disease progression and distinct sources of variability. The purpose of this article was to estimate patient-specific timing and degree of rapid decline while appropriately characterizing natural progression and variation in CF. We propose longitudinal semiparametric mixed modeling and contrast it with the conventional approach, which restricts lung function (measured as forced expiratory volume in 1 second as a percentage of predicted, FEV1%) to linear decline. Each approach is applied to clinical encounter data from the United States CF Foundation Patient Registry. Timing and degree of rapid FEV1% decline vary across patients and as a function of key covariates. Patients experience maximal FEV1% loss by early adulthood more severe than indicated by conventional slope analysis. Semiparametric mixed modeling provides a means to estimate patient-specific changes in CF disease progression and may be used to inform prognostic decisions in chronic care settings and clinical studies.
    Annals of epidemiology 10/2013; 23(12). DOI:10.1016/j.annepidem.2013.08.009 · 2.15 Impact Factor
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    ABSTRACT: Background: Lung ultrasonography (LUS) is increasingly being used to detect pneumonia in children. Using chest radiograph as a reference standard, studies have found LUS to have >85% sensitivity and specificity in detecting pneumonia. However, the interpreting sonologists have rarely been blinded to clinical information. The objective of this study was to determine the inter-rater reliability among pediatric radiologists blinded to the clinical information, with and without a standardized ultrasound protocol. Methods: LUS performed between January 2011-March 2013 on children 3 months-18 years were included. Five pediatric radiologists were trained on LUS interpretation for signs indicative of pneumonia. Two sets of LUS were read. The first set consisted of 40 LUS that were performed for clinical reasons. These LUS were performed without a standardized protocol to ensure coverage of all portions of the lung. The second set consisted of 15 ultrasounds that were performed using a standardized, evidence-based protocol. Inter-rater reliability was calculated using a kappa statistic. Results: The inter-rater reliability for lung consolidation was fair for standardized LUS (0.40) and for unstandardized LUS (0.36). Interstitial disease had slight to poor agreement regardless of protocol. Pleural effusion had fair inter-rater reliability in the unstandardized set (0.29) but almost perfect reliability in the standardized set (0.82) (Table 1). Conclusion: These preliminary data suggest that standardization of sonogram readings leads to higher inter-rater reliability in detecting pleural effusions in children using LUS. However, reliability, while improved, remained low to moderate for other findings of pneumonia. This may indicate a need for clearer definitions in this relatively new application of LUS. Table 1: Inter-rater reliability of lung ultrasounds using unstandardized and standardized ultrasound protocols* Overall Conclusion Unstandardized LUS Standardized LUS Lobar or Patchy Consolidation 0.36 0.40 Interstitial Disease 0.06 0.16 Pleural Effusion 0.29 0.82 * Classification of the strength of agreement: poor (<0.0); slight (0-0.20); fair (0.21-0.40); moderate (0.41-0.60); substantial (0.61-0.80); almost perfect (0.81-1.0)
    IDWeek 2013 Meeting of the Infectious Diseases Society of America; 10/2013
  • Pediatric Pulmonology 10/2013; 48:368-368. · 2.30 Impact Factor
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    ABSTRACT: Although biological markers of women's exposure to semen from vaginal intercourse have been developed as surrogates for risk of infection or probability of pregnancy, data on their persistence time and clearance are limited. During 2006-2008, 52 couples were enrolled for three 14-day cycles of abstinence from vaginal sex during which women were exposed in the clinic to a specific quantity (10, 100 or 1000 μL) of their partner's semen. Vaginal swabs were collected before and at 1, 6, 12, 24, 48, 72 and 144 h after exposure for testing for prostate-specific antigen (PSA) and Y-chromosome DNA (Yc DNA). Immediately after exposure to 1000 μL of semen, the predicted sensitivity of being PSA positive was 0.96; this decreased to 0.65, 0.44, 0.21 and 0.07 at 6, 12, 24 and 48 h, respectively. Corresponding predicted sensitivity of being Yc DNA positive was 0.72 immediately postexposure; this increased to 0.76 at 1 h postexposure and then decreased to 0.60 (at 6 h), 0.63 (at 12 h), 0.49 (at 24 h), 0.21 (at 48 h), 0.17 (at 72 h) and 0.12 (at 144 h). Overall findings suggest that PSA may be more consistent as a marker of very recent exposure and that Yc DNA is more likely to be detected in the vagina after 12 h postexposure compared to PSA.
    Contraception 08/2013; 88(6). DOI:10.1016/j.contraception.2013.08.003 · 2.93 Impact Factor
  • Maurizio Macaluso
    Annals of epidemiology 07/2013; DOI:10.1016/j.annepidem.2013.06.004 · 2.15 Impact Factor
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    ABSTRACT: Research on interventions to prevent HIV and other sexually transmitted infections (STIs) is heavily influenced by participant reporting of sexual behavior, despite uncertainty about its validity. Exclusive reliance on participant self-report often is based, overtly or by implication, on 4 assumptions: (1) no feasible alternatives exist; (2) misreporting can be minimized to levels that can be disregarded; (3) misreporting tends to underreport sensitive behaviors; and (4) misreporting tends to be nondifferential with respect to the groups being compared. The objective of this review are to evaluate these assumptions, including a review of studies using semen biomarkers to evaluate the validity of self-reported data, and to make recommendations for applying biological markers of semen exposure detectable in women to further strengthen research on HIV/STI prevention. Increasing evidence shows that semen biomarkers provide an important means of assessing and augmenting the validity of studies on HIV/STI prevention. Additional biomarkers are needed to assess male exposure to vaginal sex and both male and female exposure to anal sex. Methods and study designs that incorporate biomarkers into studies collecting self-reported behavioral data should be considered where possible.
    Sexually transmitted diseases 06/2013; 40(6):447-52. DOI:10.1097/OLQ.0b013e31828b2f77 · 2.75 Impact Factor
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    ABSTRACT: OBJECTIVE: To evaluate the safety of semen washing with intrauterine insemination (SW-IUI) for achieving pregnancy when the man is HIV-infected and the woman is HIV-negative. STUDY DESIGN: We conducted a retrospective analysis of 635 HIV-discordant couples enrolled in a SW-IUI program, and followed back 367 Italian women. We computed pregnancy, live birth, and multiple delivery rates, and assessed the women's post-insemination HIV status. RESULTS: The retrospective analysis included 635 couples (2,113 SW-IUI cycles): 41% of the women (95% confidence interval (CI): 37%-45%) had a live birth (per-cycle live birth rate: 13%, CI: 11%-14%). HIV status after SW-IUI was negative when available but unknown for 26% of the women: missing HIV status was not associated with correlates of HIV risk. The follow-back study included 367 couples (1,365 cycles): 47% of the women (CI: 42%-52%) had a live birth (per-cycle rate: 14%, CI: 12%-16%). Ascertainment of post-insemination HIV status was complete and confirmed no HIV transmission attributable to SW-IUI. The upper 95% confidence limit of the HIV transmission rate was 1.8 per 1,000 cycles in the retrospective analysis and 2.7 per 1,000 cycles in the follow-back study. CONCLUSIONS: SW-IUI appears to be a safe and effective method for achieving pregnancy in HIV-discordant couples where the man is HIV-infected.
    American journal of obstetrics and gynecology 02/2013; 208(5). DOI:10.1016/j.ajog.2013.02.009 · 3.97 Impact Factor
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    ABSTRACT: BACKGROUND: The effectiveness of counseling messages to avoid unprotected sex during short-term treatment for curable sexually transmitted infections is unknown. METHODS: We randomized 300 female STI clinic patients 18 years or older with cervicitis and/or vaginal discharge in Kingston, Jamaica, in 2010 to 2011, to 1 of 2 counseling messages for their course of syndromic treatment: abstinence only or abstinence backed up by condom use. At a follow-up visit 6 days afterward, we collected vaginal swabs to test for prostate-specific antigen (PSA), a biological marker of recent semen exposure, and administered a questionnaire assessing sexual behavior. RESULTS: No differences were found in the proportions of women testing positive for PSA at follow-up in the abstinence-plus-condom group (11.9%) and abstinence-only group (8.4%) (risk difference, 3.5; 95% confidence interval, -3.5 to10.5). There also was no significant difference in reporting of unprotected sex between groups. Reporting a history of condom use before enrollment significantly modified the effect of counseling arm on PSA positivity (P = 0.03). Among those reporting recent condom use, 10.3% in the abstinence-only arm and 4.8% in the abstinence-plus-condom arm tested positive for PSA. Conversely, among those not reporting recent condom use, 6.5% in the abstinence-only arm and 17.3% in the abstinence-plus-condom arm had PSA detected. CONCLUSIONS: We found no evidence to support the superiority of either counseling message. Post hoc analyses suggest that women with recent condom experience may benefit significantly more from abstinence-plus-condom messages, whereas women without such experience may benefit significantly more from abstinence-only messages. Providers should weigh individual condom use history when determining the most appropriate counseling message.
    Sexually transmitted diseases 02/2013; 40(2):105-110. DOI:10.1097/OLQ.0b013e31827938a1 · 2.75 Impact Factor
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    ABSTRACT: Objectives Little is known about the effects of commonly used lubricants on detection of biomarkers of semen exposure. We investigated the in vitro effect of Gynol®, K-Y Jelly®, Replens®, Astroglide®, Carbopol, and Silicorel on quantitative detection of Prostate Specific Antigen (PSA). Study Design A predetermined concentration of each of the gels was added to serially diluted semen samples. Additionally, serial dilutions of each of the gels were added to three different semen dilutions (high, medium, or low). The resulting samples were tested for PSA on the Abbott ARCHITECT System. Results When using the Abbott Architect system, the only products that inhibited PSA detection were Gynol® and Replens®. The inhibition caused by Gynol® was dose-dependent, but that of Replens was dose-independent. K-Y Jelly®-spiked samples had higher PSA values than controls. Conclusions Caution is warranted when using the Abbott quantitative assay for PSA detection as a biomarker of semen exposure in settings where Gynol®, Replens® or K-Y Jelly® might also have been used. Neither Astroglide® nor Silicorel inhibited PSA detection. Additional studies evaluating other vaginal products, including microbicides, and their effects on other assays, are needed. In vivo studies will be especially important to optimize PSA detection from clinical samples. Implications Researchers should consider the potential for specific lubricants or any vaginal products to affect the particular assay used for semen biomarker detection. The Abbott Architect’s Total PSA assay should not be used with the product Replens. Caution is warranted when using the assay in settings where Gynol or K–Y jelly may have been used.
    Contraception 01/2013; 89(2). DOI:10.1016/j.contraception.2013.09.016 · 2.93 Impact Factor

Publication Stats

4k Citations
596.27 Total Impact Points

Institutions

  • 2011–2014
    • University of Cincinnati
      Cincinnati, Ohio, United States
    • Cincinnati Children's Hospital Medical Center
      • Division of Biostatistics and Epidemiology
      Cincinnati, Ohio, United States
  • 2001–2014
    • Centers for Disease Control and Prevention
      • Division of Reproductive Health
      Atlanta, Michigan, United States
  • 2009–2013
    • University of North Carolina at Chapel Hill
      • Department of Medicine
      North Carolina, United States
    • Università degli Studi di Palermo
      Palermo, Sicily, Italy
  • 1999–2012
    • Emory University
      • • Department of Gynecology and Obstetrics
      • • Department of Epidemiology
      Atlanta, Georgia, United States
  • 1991–2011
    • University of Alabama at Birmingham
      • • Department of Epidemiology
      • • Department of Nutrition Sciences
      • • School of Public Health
      Birmingham, Alabama, United States
  • 1993–2008
    • University of Alabama
      Tuscaloosa, Alabama, United States
  • 2007
    • University of Texas MD Anderson Cancer Center
      Houston, Texas, United States
  • 2005
    • Epidemiology International, Inc.
      Maryland, United States
    • Wayne State University
      Detroit, Michigan, United States