Kenneth H. Fife
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View article: Clinical Performance of the BD CTGCTV2 Assay for the BD MAX System for Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Infections
Clinical Performance of the BD CTGCTV2 Assay for the BD MAX System for Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis Infections Open
Background 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 mo…
View article: Urine Tenofovir Levels Measured Using a Novel Immunoassay Predict Human Immunodeficiency Virus Protection
Urine Tenofovir Levels Measured Using a Novel Immunoassay Predict Human Immunodeficiency Virus Protection Open
New tools are needed to support pre-exposure prophylaxis (PrEP) adherence for human immunodeficiency virus (HIV) prevention, including those that enable real-time feedback. In a large, completed PrEP trial, adequate urine tenofovir levels …
View article: Young Women and Oral Human Papillomavirus—Vaccination Is Associated With Protection
Young Women and Oral Human Papillomavirus—Vaccination Is Associated With Protection Open
Nicolas F. Schlecht, PhD; Martin Masika, MD; Angela Diaz, MD, PhD; Anne Nucci-Sack, MD; Anthony Salandy, PhD; Sarah Pickering, MPH; Howard D. Strickler, MD, MPH; Viswanathan Shankar, DrPH; Robert D. Burk, MD
View article: Impact of Tenofovir-Based Pre-exposure Prophylaxis on Biomarkers of Bone Formation, Bone Resorption, and Bone Mineral Metabolism in HIV-Negative Adults
Impact of Tenofovir-Based Pre-exposure Prophylaxis on Biomarkers of Bone Formation, Bone Resorption, and Bone Mineral Metabolism in HIV-Negative Adults Open
Background Pre-exposure prophylaxis (PrEP) with emtricitabine (FTC)/tenofovir disoproxil fumarate (TDF) reduces the risk of HIV seroconversion but may promote bone mineral density (BMD) decline. The mechanisms of BMD decline with FTC/TDF r…
View article: P049 STI testing and documentation via a phone application (app): experience with the safe app
P049 STI testing and documentation via a phone application (app): experience with the safe app Open
Background The STI epidemic continues to grow among young people. Encouraging screening and careful partner selection are approaches to controlling STI transmission. Methods The SAFE App is a free, phone-based program that encourages users…
View article: Evaluation of the Performance of the Cobas CT/NG Test for Use on the Cobas 6800/8800 Systems for Detection of <i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i> in Male and Female Urogenital Samples
Evaluation of the Performance of the Cobas CT/NG Test for Use on the Cobas 6800/8800 Systems for Detection of <i>Chlamydia trachomatis</i> and <i>Neisseria gonorrhoeae</i> in Male and Female Urogenital Samples Open
The clinical performance of the Cobas CT/NG assay on the Cobas 6800/8800 systems (Cobas) for the detection of Chlamydia trachomatis and Neisseria gonorrhoeae was established in a multisite, prospective collection study using male and femal…
View article: 1491. <i>Mycoplasma genitalium</i>: A Concordance Study in Heterosexual Partnerships at Risk for Chlamydial Infection
1491. <i>Mycoplasma genitalium</i>: A Concordance Study in Heterosexual Partnerships at Risk for Chlamydial Infection Open
BACKGROUND: Mycoplasma genitalium (MG) causes symptomatic nonchlamydial, nongonococcal urethritis in men, and cervicitis, pelvic inflammatory disease and infertility in women. We aimed to determine: prevalence and concordance of MG infecti…
View article: Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital Herpes Simplex Virus-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-Controlled Trial
Effects of Different Doses of GEN-003, a Therapeutic Vaccine for Genital Herpes Simplex Virus-2, on Viral Shedding and Lesions: Results of a Randomized Placebo-Controlled Trial Open
Background GEN-003 is a candidate therapeutic vaccine for genital herpes simplex virus type 2 (HSV-2). We compared virologic and clinical impact of varying GEN-003 doses. Methods Adults with symptomatic HSV-2 received placebo or GEN-003 (3…
View article: Herpes Therapy Enters the Molecular Age
Herpes Therapy Enters the Molecular Age Open
View article: Prevalence, Magnitude, and Correlates of HIV-1 Genital Shedding in Women on Antiretroviral Therapy
Prevalence, Magnitude, and Correlates of HIV-1 Genital Shedding in Women on Antiretroviral Therapy Open
In addition to ART, reducing immune activation through prevention and treatment of HIV-related conditions and genital tract infections may decrease the risk of HIV-1 shedding and potential transmission.
View article: Efficacy of oral pre-exposure prophylaxis (PrEP) for HIV among women with abnormal vaginal microbiota: a post-hoc analysis of the randomised, placebo-controlled Partners PrEP Study
Efficacy of oral pre-exposure prophylaxis (PrEP) for HIV among women with abnormal vaginal microbiota: a post-hoc analysis of the randomised, placebo-controlled Partners PrEP Study Open
View article: The effect of oral preexposure prophylaxis on the progression of HIV-1 seroconversion
The effect of oral preexposure prophylaxis on the progression of HIV-1 seroconversion Open
Ongoing PrEP use in seroconverters may delay detection of infection and elongate seroconversion, although the delay does not increase risk of resistance.
View article: P1.26 Evaluation of two diagnostic systems for the detection of<i>chlamydia trachomatis</i>(CT) and<i>neisseria gonorrhoeae</i>(NG) using male urethral swabs
P1.26 Evaluation of two diagnostic systems for the detection of<i>chlamydia trachomatis</i>(CT) and<i>neisseria gonorrhoeae</i>(NG) using male urethral swabs Open
Introduction Urine is the specimen of choice for CT and NG molecular testing from males and many of the next generation testing platforms are not FDA approved for use with urethral swabs. Urethral swabs remain valuable in research settings…
View article: P3.120 Prevalence of<i>ureaplasma urealyticum</i>in urine of men attending a sexually transmitted disease clinic
P3.120 Prevalence of<i>ureaplasma urealyticum</i>in urine of men attending a sexually transmitted disease clinic Open
Introduction Ureaplasma urealyticum (UU) is probably one of the causes of non-gonococcal, non-chlamydial urethritis in men and post-partum endometritis in women. The epidemiology of UU is currently unclear because culture isolation is diff…
View article: Clinical Validation of a Test for the Diagnosis of Vaginitis
Clinical Validation of a Test for the Diagnosis of Vaginitis Open
OBJECTIVE: Vaginitis may be diagnosed as bacterial vaginosis, vulvovaginal candidiasis, trichomoniasis, or coinfection. A new molecular test assays the vaginal microbiome and organisms that cause three common infections. The objective of t…
View article: Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial
Therapeutic Vaccine for Genital Herpes Simplex Virus-2 Infection: Findings From a Randomized Trial Open
Background. Genital herpes simplex virus type 2 (HSV-2) infection causes recurrent lesions and frequent viral shedding. GEN-003 is a candidate therapeutic vaccine containing HSV-2 gD2∆TMR and ICP4.2, and Matrix-M2 adjuvant. Methods. Person…
View article: Effect of Pritelivir Compared With Valacyclovir on Genital HSV-2 Shedding in Patients With Frequent Recurrences
Effect of Pritelivir Compared With Valacyclovir on Genital HSV-2 Shedding in Patients With Frequent Recurrences Open
clinicaltrials.gov Identifier: NCT01658826.
View article: Human Papillomavirus DNA Detection in Older Women—Implications for Cancer Screening and Prevention
Human Papillomavirus DNA Detection in Older Women—Implications for Cancer Screening and Prevention Open
View article: Transient Increase in Herpes Simplex Virus Type 2 (HSV-2)–Associated Genital Ulcers Following Initiation of Antiretroviral Therapy in HIV/HSV-2–Coinfected Individuals
Transient Increase in Herpes Simplex Virus Type 2 (HSV-2)–Associated Genital Ulcers Following Initiation of Antiretroviral Therapy in HIV/HSV-2–Coinfected Individuals Open
Initiation of ART in HIV/HSV-2-coinfected persons is associated with a transient increase in GUD and HSV-2 GUD. Acyclovir reduces the incidence of GUD but does not prevent an increase in GUD incidence during the first quarter following ini…
View article: Effect of Condom Use on Per-act HSV-2 Transmission Risk in HIV-1, HSV-2-discordant Couples
Effect of Condom Use on Per-act HSV-2 Transmission Risk in HIV-1, HSV-2-discordant Couples Open
Background. The efficacy of condoms for protection against transmission of herpes simplex virus type 2 (HSV-2) has been examined in a variety of populations with different effect measures. Often the efficacy has been assessed as change in …
View article: P248 Sensitivity of the amsel’s criteria compared to the nugent score in absence and in presence of<i>trichomonas vaginalis</i>(TV) and/or<i>candida</i>SPP among women with symptomatic vaginitis/vaginosis
P248 Sensitivity of the amsel’s criteria compared to the nugent score in absence and in presence of<i>trichomonas vaginalis</i>(TV) and/or<i>candida</i>SPP among women with symptomatic vaginitis/vaginosis Open
Background/introduction In a multicenter clinical trial funded by BD, we observed less accurate clinician diagnosis of bacterial vaginosis (BV) based on clinical observations when Trichomonas vaginalis (TV) and/or Candida spp…
View article: Validation of a Real Time PCR Assay for the Detection of Ureaplasma urealyticum
Validation of a Real Time PCR Assay for the Detection of Ureaplasma urealyticum Open
View article: Frequency of False Positive Rapid HIV Serologic Tests in African Men and Women Receiving PrEP for HIV Prevention: Implications for Programmatic Roll-Out of Biomedical Interventions
Frequency of False Positive Rapid HIV Serologic Tests in African Men and Women Receiving PrEP for HIV Prevention: Implications for Programmatic Roll-Out of Biomedical Interventions Open
Rapid HIV assays are the mainstay of HIV testing globally. Delivery of effective biomedical HIV prevention strategies such as antiretroviral pre-exposure prophylaxis (PrEP) requires periodic HIV testing. Because rapid tests have high (>95%…
View article: GEN-003 Phase 2 Interim Results: Therapeutic Vaccine for Genital Herpes Significantly Reduces Viral Shedding and Genital Lesions
GEN-003 Phase 2 Interim Results: Therapeutic Vaccine for Genital Herpes Significantly Reduces Viral Shedding and Genital Lesions Open
RESULTS: Patient Demographics 898 1The University of Alabama at Birmingham, Birmingham, AL, 2Medical Center for Clinical Research, San Diego, CA, 3Tekton Research, Austin, TX, 4Westover Heights Clinic, Portland, OR, 5Center for Clinical St…