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Biomedical subjects

William C Miller

Publications and source records attributed to William C Miller.

At least 19 recordsLinked to original sources

Barriers to asymptomatic screening and other STD services for adolescents and young adults: focus group discussions.

BACKGROUND: Sexually transmitted diseases (STDs) are a major public health problem among young people and can lead to the spread of HIV. Previous studies have primarily addressed barriers to STD care for symptomatic patients. The purpose of our study was to identify perceptions about existing barriers to and ideal services for STDs, especially asymptomatic screening, among young people in a southeastern community. METHODS: Eight focus group discussions including 53 White, African American, and Latino youth (age 14-24) were conducted. RESULTS: Perceived barriers to care included lack of knowledge of STDs and available services, cost, shame associated with seeking services, long clinic waiting times, discrimination, and urethral specimen collection methods. Perceived features of ideal STD services included locations close to familiar places, extended hours, and urine-based screening. Television was perceived as the most effective route of disseminating STD information. CONCLUSIONS: Further research is warranted to evaluate improving convenience, efficiency, and privacy of existing services; adding urine-based screening and new services closer to neighborhoods; and using mass media to disseminate STD information as strategies to increase STD screening.

Adolescent↗

Prevalence of chlamydial and gonococcal infections among young adults in the United States.

CONTEXT: Chlamydial and gonococcal infections are important causes of pelvic inflammatory disease, ectopic pregnancy, and infertility. Although screening for Chlamydia trachomatis is widely recommended among young adult women, little information is available regarding the prevalence of chlamydial and gonococcal infections in the general young adult population. OBJECTIVE: To determine the prevalence of chlamydial and gonococcal infections in a nationally representative sample of young adults living in the United States. DESIGN, SETTING, AND PARTICIPANTS: Cross-sectional analyses of a prospective cohort study of a nationally representative sample of 14,322 young adults aged 18 to 26 years. In-home interviews were conducted across the United States for Wave III of The National Longitudinal Study of Adolescent Health (Add Health) from April 2, 2001, to May 9, 2002. This study sample represented 66.3% of the original 18,924 participants in Wave I of Add Health. First-void urine specimens using ligase chain reaction assay were available for 12,548 (87.6%) of the Wave III participants. MAIN OUTCOME MEASURES: Prevalences of chlamydial and gonococcal infections in the general young adult population, and by age, self-reported race/ethnicity, and geographic region of current residence. RESULTS: Overall prevalence of chlamydial infection was 4.19% (95% confidence interval [CI], 3.48%-4.90%). Women (4.74%; 95% CI, 3.93%-5.71%) were more likely to be infected than men (3.67%; 95% CI, 2.93%-4.58%; prevalence ratio, 1.29; 95% CI, 1.03-1.63). The prevalence of chlamydial infection was highest among black women (13.95%; 95% CI, 11.25%-17.18%) and black men (11.12%; 95% CI, 8.51%-14.42%); lowest prevalences were among Asian men (1.14%; 95% CI, 0.40%-3.21%), white men (1.38%; 95% CI, 0.93%-2.03%), and white women (2.52%; 95% CI, 1.90%-3.34%). Prevalence of chlamydial infection was highest in the south (5.39%; 95% CI, 4.24%-6.83%) and lowest in the northeast (2.39%; 95% CI, 1.56%-3.65%). Overall prevalence of gonorrhea was 0.43% (95% CI, 0.29%-0.63%). Among black men and women, the prevalence was 2.13% (95% CI, 1.46%-3.10%) and among white young adults, 0.10% (95% CI, 0.03%-0.27%). Prevalence of coinfection with both chlamydial and gonococcal infections was 0.030% (95% CI, 0.18%-0.49%). CONCLUSIONS: The prevalence of chlamydial infection is high among young adults in the United States. Substantial racial/ethnic disparities are present in the prevalence of both chlamydial and gonococcal infections.

Adult↗

The use of specimens from various genitourinary sites in men, to detect Trichomonas vaginalis infection.

Variations in estimates of prevalence of trichomoniasis in men may reflect true differences in the burden of disease but are also affected by the performance of diagnostic methods and the type of specimen tested. In this study, men were evaluated at baseline and at follow-up, to evaluate syndromic management of urethritis and the effects of human immunodeficiency virus and trichomoniasis, in Lilongwe, Malawi. First-void urine specimens and urethral swabs were obtained at enrollment, for Trichomonas vaginalis culture; semen specimens were also obtained at follow-up. The sensitivities of testing methods using urine specimens and urethral swabs were equal; 67% of cases were identified by use of either specimen, and, in 47% of cases, both specimens tested positive. When semen specimens were included, all 3 specimens tested positive in only 19% of cases. Semen was the most sensitive single specimen, and, in 25.6% of cases, only semen specimens tested positive. Thus, prevalence of T. vaginalis infection in men is underestimated if only 1 specimen is tested.

Adolescent↗

Frequent detection of acute primary HIV infection in men in Malawi.

BACKGROUND: Acute (antibody-negative) HIV infection is associated with high transmission potential but is rarely recognized. DESIGN: Cross-sectional study. METHODS: We examined the prevalence and predictors of acute HIV infection among 1361 consecutive male outpatients attending sexually transmitted disease (STD; n = 929) and dermatology (n = 432) clinics in Lilongwe, Malawi. Serum specimens negative for HIV antibodies were screened by HIV RNA PCR using a highly specific pooling/resolution testing algorithm. RESULTS: Five-hundred and fifty-three men (40.6%) were HIV antibody positive and 24 (1.8%) had acute HIV infection; 23 of 24 acutely infected men were from the STD clinic, where they represented 4.5% of all HIV antibody-negative men and 5.0% of all HIV infections. HIV RNA levels for acutely infected men were significantly higher [median (interquartile range), 6.10 (5.19-6.54) log10 HIV RNA copies/ml] than for 58 HIV antibody-positive men [4.42 (3.91-4.95) log10 copies/ml; P < 0.0001]. The factor most strongly associated with acute HIV infection was STD clinic attendance: (odds ratio, 15.2; 95% confidence interval, 2.04-113.0). In multivariate analysis considering only STD patients, factors associated with acute HIV infection included inguinal adenopathy, genital ulceration and age 24-26 years, the age stratum associated with peak incidence of HIV infection among Malawian men. CONCLUSIONS: Traditional HIV antibody tests alone are not sufficient to exclude HIV infection among men with acute STD in Malawi due to a surprising proportion of acute HIV infections in this population. Alternative screening methods are required for diagnosis of acute HIV infection; such screening could be important for research and for prevention of the sexual transmission of HIV in select populations.

Acute Disease↗

Interpretations of 'appropriate' minority inclusion in clinical research.

The range of possible interpretations of the phrase "appropriate representation" has left investigators struggling with the practical application of the National Institutes of Health guidelines on the inclusion of minorities in research. At least three goals might be reached by including minorities in clinical research: to test specific hypotheses about differences by race and ethnicity; to generate hypotheses about possible differences by race and ethnicity; and to ensure the just distribution of the benefits and burdens of participation in research, regardless of whether there are expected differences in outcome by race or ethnicity. In this paper, we describe possible interpretations of "appropriate representation," as well as provide a general approach that investigators might use to address this issue. To expand scientific knowledge about the health of minority populations, investigators should be expected to state which goal they have selected and why that goal is appropriate as compared with other possible goals.

Clinical Trials as Topic↗

Does group A beta-hemolytic streptococcal infection increase risk for behavioral and neuropsychiatric symptoms in children?

OBJECTIVE: To determine whether group A beta-hemolytic streptococcal infections increase the risk of developing symptoms characteristic of the diagnosis pediatric autoimmune neuropsychiatric disorders associated with streptococcal infections (PANDAS). DESIGN: Prospective cohort study. METHODS: Children (N = 814) aged 4 to 11 years seen for sore throat or well-child care in a large pediatric practice in Rochester, NY, were enrolled from October 2001 to June 2002 (group A beta-hemolytic streptococcal [GAS] infected, n = 411; GAS uninfected, n = 403, of whom 207 had a sore throat of presumed viral etiology and 196 were well children). Symptomatic children with GAS infection (n = 399) were treated with antibiotics. At baseline and 2 and 12 weeks following baseline, all parents completed a 20-item questionnaire about the presence/absence of recent PANDAS symptoms in their children, and capable children answered 10 items about worries, obsessions, and compulsions. The relative risk of developing a "mild PANDAS variant" (> or = 2 new PANDAS symptoms) by illness type (GAS positive, presumed viral, or well child) and by parent and child report was determined and adjusted for potential covariates. RESULTS: By parent report, ill children more frequently manifested several PANDAS symptoms at baseline than well children. However, neither new symptoms nor the risk of developing a mild PANDAS variant developed during the subsequent 12 weeks more commonly in children with GAS infection than in those with presumed viral illness or in well children by parent or child report. CONCLUSIONS: Ill children with GAS infection, treated for their GAS infection, were not at increased risk for developing PANDAS symptoms or a mild PANDAS variant compared with children with presumed viral illness or well children. The role of antibiotics in the prevention or treatment of PANDAS as well as the investigation of PANDAS in the asymptomatic, infectious host deserves future research.

Autoimmune Diseases of the Nervous System↗

Young adults' attitudes, beliefs, and feelings about testing for curable STDs outside of clinic settings.

The purpose of this paper was to elicit attitudes, beliefs, and feelings about testing for curable STDs outside of clinic settings. Telephone interviews were conducted with 120 black, Latino, and white young adults aged 18 to 25 years. Data were analyzed with descriptive frequencies and content analyses. Most (73%) reported people their age would use self-test urine STD kits if available. Perceived advantages were privacy and convenience. Disadvantages included not having an immediate "face-to-face" discussion with a medical professional about positive tests. Young adults report a range of attitudes, beliefs, and feelings that may influence the success of efforts to screen for curable STDs in nonclinic settings.

Adult↗

Prevalence and characteristics of irritable bowel syndrome among women with chronic pelvic pain.

OBJECTIVE: We sought to evaluate whether there are unique characteristics associated with irritable bowel syndrome (IBS) within a population that has chronic pelvic pain. METHODS: This cross-sectional study of new referral patients attending a pelvic pain clinic between 1993 and 2000 (N = 987) evaluated characteristics associated with IBS at entry to the clinic. The characteristics that we evaluated included demographic characteristics, clinical diagnoses, history of abuse, depression, pain, and prior abdominal surgeries. RESULTS: Thirty-five percent of chronic pelvic pain patients had IBS defined by Rome I criteria. Age 40 years or older (odds ratio [OR] = 1.98, 95% confidence interval [CI]: 1.27, 3.11), muscular back pain (OR = 5.37, 95% CI: 0.98, 29.29), Symptom Checklist-90 global index score in top quartile (OR = 1.77, 95% CI: 1.09, 2.86), depression (OR = 1.93, 95% CI: 1.24, 3.01), 6 or more pain sites (OR = 1.67, 95% CI: 1.01, 2.78), and history of adult physical abuse (OR = 1.51, 95% CI: 1.01, 2.26) were associated with IBS in the final reduced multivariable model. CONCLUSION: Specific characteristics distinguish women with IBS suggesting that IBS and chronic pelvic pain are not simply manifestations of the same disorder. Our findings could help physicians attempt to effectively treat women with IBS and chronic pelvic pain. Physicians could diagnose and treat IBS in conjunction with treatment for chronic pelvic pain.

Adult↗

Quantifying delay in access to new medical treatment: an application of risk advancement period methodology.

BACKGROUND: We present a novel application of the concept of risk or rate advancement to compute the extent of delay in adoption of an effective new drug in 2 German health insurance systems. METHODS: We identified individuals with migraines, age 18 to 65 years, in 371 primary care practices in Germany in 1994 (MediPlus, IMS Health database). These included 8173 persons covered under the statutory health insurance system and 503 persons covered by private health insurance. We derived risk and population risk advancement periods for sumatriptan compared with nonserotoninergic acute migraine therapy using multiplicative risk regression and generalized estimating equations, adjusted for patient, physician, and practice cofactors. RESULTS: For patients at the mean age of the cohort, 43 years of age, sumatriptan was prescribed 1.2 (95% confidence interval [CI] = 0.3-2.0) years later among those in the statutory health insurance system compared with those who had private insurance. The lag increased by 0.6 (-0.1 to 1.3) years for every 10 years of patient age. In the age-mix of our sample, access to the health benefits of sumatriptan therapy lagged nearly 1.5 years behind in the statutory health insurance system and for Germany as a whole. CONCLUSIONS: Migraine patients' access to sumatriptan therapy lagged substantially in the statutory health insurance system and in the country as a whole. Risk advancement periods provide a useful methodology for communicating major healthcare issues in a meaningful way to society and policymakers.

Adult↗

The disparity in access to new medication by type of health insurance: lessons from Germany.

BACKGROUND: Drug provision within the German statutory health insurance system has undergone several reforms, including the introduction of drug macrobudgets in 1993. OBJECTIVE: The objective of this study was to investigate the extent to which statutorily (SHI) and fully privately (PHI) health-insured patients were provided with new medication recommended by professional bodies in an equitable fashion using the example of migraine patients. RESEARCH DESIGN: We conducted a retrospective cohort study. SETTING: A total of 367 primary-care practices (MediPlus, IMS Health) in Germany in the second year of the HealthCare Structural Reform Act were studied. SUBJECTS: Subjected consisted of 7703 SHI and 470 PHI migraineurs (International Classification of Diseases, 10th edition G43) aged 18 to 65 years at their first migraine prescription visit in 1994. OUTCOME MEASURE: We compared prescription of oral or subcutaneous serotonin 5HT1B/1D receptor agonist sumatriptan with nonserotoninergic migraine therapy. RESULTS: In multiplicative risk regression with variance estimation accounting for clustering of patients within practices, PHI patients were 2.3 times (95% confidence interval [CI], 1.6-3.3) more likely to receive sumatriptan than their SHI counterparts at the mean age of the cohorts (43 years) adjusted for incident versus prevalent migraine treatment, the gender of the patient, the age, gender, and primary care specialist group of the physician, and the type and the community size class of the practice. This disparity widened by 38% (95% CI, 1-88%) every 10 years of patient age. CONCLUSION: Even though virtually everyone in Germany has health insurance and drug coverage, use of new and recommended migraine medicines was less common among those with SHI compared with their privately insured counterparts. Systematic studies of access to health care recommended by professional bodies will be critically important to ensure delivery of high-quality health care for all patients.

Adolescent↗

Testing for chlamydial and gonorrheal infections outside of clinic settings: a summary of the literature.

BACKGROUND: Nucleic acid amplification tests (NAATs) provide new technology that makes it feasible to initiate testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) infection outside of clinic settings. METHODS: We summarized the English-language literature describing chlamydial or gonorrheal testing with self-collection of urine or vaginal specimens outside of clinic settings in developed countries published between January 1995 and August 2002. RESULTS: Testing for CT or GC infection has been initiated in school, community, and home settings. Purposes include screening of asymptomatic populations, improving quality of clinic-based health care, and research. Challenges include defining and reaching target populations, overcoming logistic issues, developing communication and counseling strategies, and determining whether alternative testing strategies are effectively reducing infection rates. CONCLUSIONS: The use of NAATs to detect CT and GC infection outside of clinic settings will undoubtedly continue. Future research should focus on how to best use this technology to reduce rates of infection.

Ambulatory Care Facilities↗

Predictors of repeat testing and HIV seroconversion in a sexually transmitted disease clinic population.

OBJECTIVE: This study assessed the extent of and characteristics associated with repeat HIV testing in persons presenting to a sexually transmitted disease (STD) clinic. METHODS: The study population included all 101 newly diagnosed HIV-infected subjects and 411 matched HIV-uninfected subjects identified over a 5-year period in a publicly funded STD clinic in the southeastern United States. RESULTS: Of the 508 subjects (99%) with available records, 160 (32%) had tested previously. Age, race, return for posttest counseling, and the client's stated reason for coming to the clinic were associated with repeat testing. Among the 160 subjects who had tested previously, self-identifying as a man who has sex with men or having a history of incarceration was strongly associated with HIV seroconversion (adjusted odds ratio [OR], 51.82; 95% confidence interval [CI], 9.10-295.13; adjusted OR, 83.98, 95% CI, 17.26-408.69, respectively). Presenting for STD-related reasons (STD symptoms or requesting an STD check) had a negative association with HIV seroconversion (adjusted OR, 0.07; 95% CI, 0.01-0.90) compared with presenting for the sole purpose of requesting an HIV test. CONCLUSIONS: Repeat HIV testing is common among patients receiving services at an STD clinic. The role of repeat testing in HIV prevention efforts is complex and poorly understood. Results from this study could be used to identify and target those testing previously at highest risk for contracting HIV for risk-reduction interventions.

AIDS Serodiagnosis↗

Practical evaluation of methods for detection and specificity of autoantibodies to extractable nuclear antigens.

Detection and specificity of autoantibodies against extractable nuclear antigens (ENA) play a critical role in the diagnosis and management of autoimmune disease. Historically, the detection of these antibodies has employed double immunodiffusion (DID). Autoantibody specificity was correlated with diagnoses by this technique. Enzyme immunoassays have been developed by multiple manufacturers to detect and identify the specificity ENA autoantibodies. To address the relationship of ENA detection by DID and enzyme immunoassay, the performances of five immunoassays were compared. These included two DID and three enzyme-linked immunoassays (ELISA) (both screening and individual antigen profile kits). The sample set included 83 ENA-positive, antinuclear-antibody (ANA)-positive specimens, 77 ENA-negative, ANA-positive specimens, and 20 ENA- and ANA-negative specimens. Sensitivity and specificity were calculated by two methods: first, by using the in-house DID result as the reference standard, and second, by using latent class analysis, which evaluates each kit result independently. Overall, the results showed that the ELISA methods were more sensitive for detection of ENA autoantibodies than DID techniques, but presence and/or specific type of ENA autoantibody did not always correlate with the patient's clinical presentation. Regardless of the testing strategy an individual laboratory uses, clear communication with the clinical staff regarding the significance of a positive result is imperative. The laboratory and the clinician must both be aware of the sensitivity and specificity of each testing method in use in the clinical laboratory.

Antibody Specificity↗

Development and preliminary assessment of the measurement properties of the Seating Identification Tool (SIT).

OBJECTIVE: To present and discuss the development and measurement properties of the Seating Identification Tool (SIT), a screening tool designed to identify the need for formal seating and wheelchair intervention among institutionalized elderly. Specifically, investigation of the inter-rater and test-retest reliability, sensitivity, specificity, the positive and negative predictive values of the SIT was conducted. DESIGN: A two-week retest design. SETTING: A long-term care facility in London, Ontario, Canada. SUBJECTS: Forty-two randomly selected residents with an average age of 83 years who had a disability and required the use of a wheelchair as their main mode of mobility. INTERVENTION: Two health care assistants from a long-term facility collected data using the SIT. One rater assessed all subjects two weeks later to evaluate test-retest reliability. Diagnostic properties (validity) were determined by having all subjects assessed by a seating therapist. MAIN MEASUREMENT: The SIT and formal evaluation by a therapist experienced in seating. RESULTS: The ICC for both test-retest and inter-rater reliability was 0.83. A cut-off score of 2 maximized the sensitivity (100%) and specificity (64% and 57% for raters 1 and 2 respectively) and the area under the receiver operating characteristics curve (0.855 and 0.862 for raters 1 and 2). The positive and negative predictive values ranged from 82 to 100%. CONCLUSION: The SIT is a quick, easy to use, reliable and valid screening tool that can be used to facilitate clinical referral for formal intervention. Other potential uses include population-based surveys to estimate the need for including seating intervention in strategic planning for the institutionalized elderly.

Aged↗

Psychometric properties of the Activities-specific Balance Confidence Scale among individuals with a lower-limb amputation.

OBJECTIVE: To evaluate the internal consistency, test-retest reliability, and construct validity of the Activities-specific Balance Confidence (ABC) Scale among people who have a lower-limb amputation. DESIGN: Retest design. SETTING: A university-affiliated outpatient amputee clinic in Ontario. PARTICIPANTS: Two samples of individuals who have unilateral transtibial and transfemoral amputation. Sample 1 (n=54) was a consecutive and sample 2 (n=329) a convenience sample of all members of the clinic population. INTERVENTIONS: Not applicable. MAIN OUTCOME MEASURES: Repeated application of the ABC Scale, a 16-item questionnaire that assesses confidence in performing various mobility-related tasks. Correlation to test hypothesized relationships between the ABC Scale and the 2-minute walk (2MWT) and the timed up-and-go (TUG) tests; and assessment of the ability of the ABC Scale to discriminate among groups based on amputation cause, amputation level, mobility device use, automatic stepping ability, wearing time, stair climbing ability, and walking distance. RESULTS: Test-retest reliability (intraclass correlation coefficient) of the ABC Scale was .91 (95% confidence interval [CI], .84-.95) with individual item test-retest coefficients ranging from .53 to .87. Internal consistency, measured by Cronbach alpha, was .95. Hypothesized associations with the 2MWT and TUG test were observed with correlations of .72 (95% CI, .56-.84) and -.70 (95% CI, -.82 to -.53), respectively. The ABC Scale discriminated between all groups except those based on amputation level. CONCLUSIONS: Balance confidence, as measured by the ABC Scale, is a construct that provides unique information potentially useful to clinicians who provide amputee rehabilitation. The ABC Scale is reliable, with strong support for validity. Study of the scale's responsiveness is recommended.

Accidental Falls↗

Bacterial vaginosis, vaginal fluid neutrophil defensins, and preterm birth.

OBJECTIVE: To examine the association between bacterial vaginosis, vaginal fluid neutrophil defensins, and preterm birth. METHODS: Vaginal fluid specimens were obtained at 24-29 weeks' gestation from 242 cases with preterm birth and 507 noncases sampled using a case-cohort study design. We tested for bacterial vaginosis by Gram staining and Nugent scores and assayed for neutrophil defensins by enzyme-linked immunosorbent assay. Bacterial vaginosis was studied as a categoric variable (negative, intermediate, and positive), whereas defensins were studied as a continuous, categoric (based on percentiles), and dichotomous measure (presence versus absence). Three gestational age cut points were used to define preterm birth. Modified Cox proportional hazard models were used to evaluate the associations between bacterial vaginosis, defensins, and degree (less than 32, less than 34, and less than 37 weeks) and type (premature rupture of membranes, preterm labor) of preterm birth. RESULTS: Elevated vaginal fluid neutrophil defensins were not associated with birth before 37 weeks. Compared with women who did not have measurable vaginal fluid defensins, women with higher defensin levels (0-2.8 micro g/mL, 2.8-8.2 micro g/mL, and greater than 8.2 micro g/mL) had a greater risk of delivering before 32 weeks. Hazard ratios adjusted for maternal race and vaginal bleeding during pregnancy and 95% confidence intervals for these defensin levels were 1.7 (0.4, 6.9), 2.4 (0.7, 7.9), and 3.1 (1.0, 9.8), respectively. Bacterial vaginosis status did not influence the association between defensins and preterm birth. CONCLUSION: Elevated concentrations of vaginal fluid neutrophil defensins at 24-29 weeks' gestation might predict preterm birth before 32 weeks.

Adult↗

Addition of treatment for trichomoniasis to syndromic management of urethritis in Malawi: a randomized clinical trial.

BACKGROUND: Male urethritis is generally treated syndromically, but failure of empirical treatment is common. GOAL: The study goal was to evaluate the addition of metronidazole to the syndromic management of urethritis in Malawi in a randomized clinical trial. STUDY DESIGN: Men with urethritis were randomized to receive either 2 g of metronidazole by mouth or placebo, in addition to standard care for urethritis (i.e., a single intramuscular dose of 240 mg gentamicin and 100 mg doxycycline twice daily for 7 days). The primary endpoints of the study included measurement of the effects of treatment on Trichomonas vaginalis, signs and symptoms of urethritis, and the concentration of HIV RNA in semen in dually infected subjects. RESULTS: The overall prevalence of T vaginalis was 17.3% (71/411), and treatment with metronidazole cleared 95% of culture-positive infections, compared with 54% clearance among men receiving placebo (P = 0.006). Prevalence of persistent urethritis was observed in approximately 16% of both groups at the end of 1 week (29/179 of those receiving metronidazole versus 29/187 in the placebo group; P = 0.86). For a subset of HIV-infected men with trichomoniasis, the seminal plasma HIV RNA concentration was higher than in a group of HIV-positive control subjects (median copies/mL:35,000 vs. 1800 P = 0.06) [correction]. CONCLUSION: In areas with a high prevalence of trichomoniasis, the addition of metronidazole to the syndromic management of male urethritis can eliminate infection with T vaginalis and may help to reduce the transmission of HIV. Such treatment should be strongly considered as part of empirical therapy for urethritis in men in Malawi and places where T vaginalis infection in men is common.

Administration, Oral↗

Validation of a urine-based PCR-enzyme-linked immunosorbent assay for use in clinical research settings to detect Trichomonas vaginalis in men.

Trichomonas vaginalis infection is highly prevalent worldwide and is associated with urethritis, prostatitis, and urethral strictures in men. However, the natural history and importance of T. vaginalis in men are poorly understood, in part because of difficulties in diagnosing infection. Traditional detection methods rely on culture and wet-mount microscopy, which can be insensitive and time consuming. Urethral swabs are commonly used to detect T. vaginalis in men, but discomfort from specimen collection is a barrier to large studies. One thousand two hundred twenty-five Malawian men attending sexually transmitted disease and dermatology clinics were enrolled in this cross-sectional study to validate detection by urine-based PCR-enzyme-linked immunosorbent assay (ELISA) with urine and urethral swab culture as the reference standard. This assay for detection of amplified T. vaginalis DNA in first-catch urine (< or = 30 ml) performed with a sensitivity of 92.7%, a specificity of 88.6%, and an adjusted specificity of 95.2% compared to culture of urethral swabs or urine sediment. For clinical research settings in which urethral swabs are not available and culture is not feasible, the urine-based PCR-ELISA may be useful for detection of trichomoniasis in men.

Adolescent↗