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Gonorrhea rates and antibiotic resistance are both increasing. Neisseria gonorrhoeae (Ng) is an exclusively human pathogen and is exquisitely adapted to its natural host. Ng can subvert immune responses and undergoes frequent antigenic variation, resulting in limited immunity and protection from reinfection. Previous gonococcal vaccine efforts have been largely unsuccessful, and the last vaccine to be tested in humans was more than 35 years ago. Advancing technologies and the threat of untreatable gonorrhea have fueled renewed pursuit of a vaccine as a long-term sustainable solution for gonorrhea control. Despite the development of a female mouse model of genital gonococcal infection two decades ago, correlates of immunity or protection remain largely unknown, making the gonococcus a challenging vaccine target. The controlled human urethral infection model of gonorrhea (Ng CHIM) has been used to study gonococcal pathogenesis and the basis of anti-gonococcal immunity. Over 200 participants have been inoculated without serious adverse events. The Ng CHIM replicates the early natural course of urethral infection. We are now at an inflexion point to pivot the use of the model for vaccine testing to address the urgency of improved gonorrhea control. Herein we discuss the need for gonorrhea vaccines, and the advantages and limitations of the Ng CHIM in accelerating the development of gonorrhea vaccines.

Background Gentamicin has been used for the treatment of gonorrhea in Malawi since 1993. However, declining clinical cure rates have been suspected. We evaluated current Neisseria gonorrhoeae susceptibility to gentamicin in vitro and clinically. Methods Men with acute urethritis were recruited at the Bwaila District Hospital STI Clinic in Lilongwe, Malawi, between January 2017 and August 2019. All men provided urethral swabs for etiological testing at enrollment and test of cure (TOC), one week later, using Gram-stained microscopy and culture. We used Etest to determine minimum inhibitory concentrations (MICs) of gentamicin, azithromycin, cefixime, ceftriaxone, ciprofloxacin, and spectinomycin, disc diffusion for tetracycline susceptibility and whole genome sequencing (WGS) to verify/refute treatment failure. Results Among 183 N. gonorrhoeae culture-positive men enrolled, 151 (82.5%) had a swab taken for TOC. Of these 151 men, 16 (10.6%) had a positive culture at TOC. 141 baseline isolates were tested for gentamicin susceptibility using Etest; 2 (1.4%) MIC = 2 μg/mL; 111 (78.7%) MIC = 4 μg/mL; and 28 (19.9%) MIC = 8 μg/mL. All isolates were susceptible to azithromycin, cefixime, ceftriaxone, and spectinomycin while 63.1% had intermediate susceptibility or resistance to ciprofloxacin. Almost all (96.1%) isolates were resistant to tetracycline. All examined isolates cultured at TOC (n = 13) had gentamicin MICs ≤8 μg/mL. Ten men had pre- and post-treatment isolates examined by WGS, 2 (20%) were verified new infections (4119 and 1272 single-nucleotide polymorphisms (SNPs)), while 8 (80%) were confirmed treatment failures (0-1 SNP). Conclusions Gentamicin MICs poorly predict gonorrhea treatment outcome with gentamicin, and treatment failures are verified with gonococcal strains with in vitro susceptibility to gentamicin. The first-line treatment for gonorrhea in Malawi should be reassessed.

We conducted a prospective study of 13 heterosexual couples to understand the impact of recent condomless vaginal sex on vaginal immune marker measurement and potential exposure misclassification due to the presence of semen. All immune markers were detectable in semen and concentrations of vaginal immune markers varied by sex recency.

To evaluate the validity and acceptability of at-home self-collection to test for high-risk human papillomavirus (HPV) and sexually transmitted infections among women overdue for cervical cancer screening by national guidelines.Low-income, infrequently screened women were recruited from the general population in North Carolina to participate in an observational study. Participants provided two self-collected cervicovaginal samples (one at home and one in the clinic) and a clinician-collected cervical sample. Samples were tested for high-risk HPV, Chlamydia trachomatis, Neisseria gonorrhoeae, Trichomonas vaginalis, and Mycoplasma genitalium. Cervical samples were also tested by liquid-based cytology.Overall, 193 women had conclusive high-risk HPV results for all three samples and cytology results. Prevalence of high-risk HPV within self-home samples (12.4%) was not different from that within clinician samples (11.4%; P=.79) and from that within self clinic samples (15.5%; P=.21). Positivity for high-risk HPV in all sample types increased with increasing grades of cervical abnormality (P.001). Self-home samples detected high-risk HPV in all identified cases of high-grade squamous intraepithelial lesions and of cervical intraepithelial neoplasia 2 or worse. Detection was comparable across sample types for T vaginalis (range 10.2-10.8%), M genitalium (3.3-5.5%), C trachomatis (1.1-2.1%), and N gonorrhoeae (0-0.5%). Kappa values between sample types ranged from 0.56 to 0.66 for high-risk HPV, 0.86-0.91 for T vaginalis, and 0.65-0.83 for M genitalium. Most participants reported no difficulty understanding self-collection instructions (93.6%) and were willing to use self-collection in the future (96.3%).Mail-based, at-home self-collection for high-risk HPV and sexually transmitted infection detection was valid and well accepted among infrequently screened women in our study. These findings support the future use of high-risk HPV self-collection to increase cervical cancer screening rates among higher risk women in the United States.

Background Mycoplasma genitalium can result in pelvic inflammatory disease and adverse pregnancy outcomes. We analyzed data collected from a prospective study of asymptomatic bacterial vaginosis (BV) to determine the natural history of M. genitalium. Methods Women aged 15-25 years, with asymptomatic BV and ≥2 risk factors for sexually transmitted infection were recruited from 10 sites throughout the United States. Vaginal swab samples were collected at enrollment and through home-based testing every 2 months over 12 months. M. genitalium nucleic acid amplification testing was performed for M. genitalium using transcription-mediated assays (Hologic). The prevalence, incidence, and persistence of M. genitalium, defined as all positive specimens during follow-up, were estimated with 95% confidence intervals (CIs). Adjusted odds ratios (AOR) were calculated using logistic and Poisson regression to evaluate participant characteristics associated with M. genitalium infection. Results Among 1139 women, 233 were M. genitalium positive, for a prevalence of 20.5% (95% CI, 18.2%-22.9%); 42 of 204 had persistent M. genitalium (20.6%). Among 801 M. genitalium-negative women at baseline, the M. genitalium incidence was 36.6 per 100 person-years (95% CI, 32.4-41.3). Black race (AOR, 1.92; 95% CI, 1.09-3.38), age ≤21 years (1.40; 1.03-1.91), and prior pregnancy (1.36; 1.00-1.85) were associated with prevalent M. genitalium; only black race was associated with incident M. genitalium (P = .03). Conclusions We identified high rates of prevalent, incident, and persistent M. genitalium infections among young, high-risk women with asymptomatic BV, supporting the need for clinical trials to evaluate the impact of M. genitalium screening on female reproductive health outcomes.

Background The Hologic Aptima HIV-1 Quant Assay that is currently available on the Panther system is FDA-cleared for plasma viral load monitoring. We compared to other assays for use with dried blood spots (DBS) and for early infant diagnosis (EID) using plasma and DBS. Methods Spiked dilution panels of plasma and DBS were made using negative donor blood and subtype B and subtype C HIV-1 stocks. Patient samples included plasma from HIV-1-infected adults, plasma from HIV-1-infected infants and exposed uninfected infants, and DBS from infected adults. Samples were run on Aptima Quant and either Abbott RealTime HIV-1 Quant assay or Hologic Aptima HIV-1 Qual assay. Results Aptima Quant and Abbott Quant were comparable: the 95% limit of detection was 42cp/ml for Aptima Quant and 91cp/ml for Abbott Quant. EID comparisons showed that Aptima Quant and Qual had 100% sensitivity and 98.9% specificity with overall agreement between the assays of 98.4%. Aptima Qual had a slightly lower limit of detection (95% limit of detection was 27cp/ml for Aptima Qual and 65 cp/ml for Aptima Quant). With spiked DBS, all 16 DBS with >30cp/ml on Aptima Quant were detected on Aptima Qual, 10/12 (83%) with ‘ Conclusion The Hologic Aptima HIV-1 Quant assay performed similarly for viral load and EID on both plasma and DBS samples. Our data suggest the ‘ Disclosure No significant relationships.

Experimental infection of male volunteers with Neisseria gonorrhoeae is safe and reproduces the clinical features of naturally acquired gonococcal urethritis. The human model is useful for testing the importance of putative gonococcal virulence factors for urethral infection in men and the model presents opportunities to examine host immune responses that may be exploited or improved in development and testing of gonococcal vaccines. In this chapter, we describe methods for production, characterization, and storage of N. gonorrhoeae stocks for experimental human challenge, preparation and delivery of inoculum suspensions, monitoring experimental infection, and statistical considerations for data analysis.

Vaginal dysbiosis has been shown to increase the risk of some adverse birth outcomes. HIV infection may be associated with shifts in the vaginal microbiome. We characterized microbial communities in vaginal swabs collected between 16–20 gestational weeks in the Zambian Preterm Birth Prevention Study to investigate whether HIV and its treatment alter the microbiome in pregnancy. We quantified relative abundance and diversity of bacterial taxa by whole-genome shotgun sequencing and identified community state types (CST) by hierarchical clustering. Associations between exposures—HIV serostatus (HIV+ vs HIV-) and preconceptional ART (ART+ vs ART-)—and microbiome characteristics were tested with rank-sum, and by linear and logistic regression, accounting for sampling by inverse-probability weighting. Of 261 vaginal swabs, 256 (98%) had evaluable sequences; 98 (38%) were from HIV+ participants, 55 (56%) of whom had preconceptional ART exposure. Major CSTs were dominated by: L. crispatus (CST 1; 17%), L.] iners (CST 3; 32%), Gardnerella vaginalis (CST 4-I; 37%), G. vaginalis & Atopobium vaginae (CST 4-II; 5%), and other mixed anaerobes (CST 4-III; 9%). G. vaginalis was present in 95%; mean relative abundance was higher in HIV+ (0.46±0.29) compared to HIV- participants (0.35±0.33; rank-sum p = .01). Shannon diversity was higher in HIV+/ART+ (coeff 0.17; 95%CI (0.01,0.33), p = .04) and HIV+/ART- (coeff 0.37; 95%CI (0.19,0.55), p < .001) participants compared to HIV-. Anaerobe-dominant CSTs were more prevalent in HIV+/ART+ (63%, AOR 3.11; 95%CI: 1.48,6.55, p = .003) and HIV+/ART- (85%, AOR 7.59; 95%CI (2.80,20.6), p < .001) compared to HIV- (45%). Restricting the comparison to 111 women in either CST 3 (L. iners dominance) or CST 1 (L. crispatus dominance), CST 3 frequency was similar in HIV- (63%) and HIV+/ART- participants (67%, AOR 1.31; 95%CI: (0.25,6.90), p = .7), but higher in HIV+/ART+ (89%, AOR 6.44; 95%CI: (1.12,37.0), p = .04). Pregnant women in Zambia, particularly those with HIV, had diverse anaerobe-dominant vaginal microbiota.

Despite evidence that education and poverty act through distinct pathways to influence sexually transmitted infection (STI), few studies have examined the unique, independent associations of these socioeconomic vulnerabilities with sexual risk behaviors and STI among women.From August to October 2013, women at an antenatal clinic in Gressier, Haiti, were interviewed and tested for chlamydial infection, gonorrhea, and trichomoniasis (N = 200). We measured low educational attainment as less than 9 years of schooling and currently living in poverty based on crowding, defined as more than 2 people sleeping in one room. We used logistic regression to estimate independent associations between each socioeconomic indicator and outcomes of sexual behaviors and STI.Approximately 29% of the sample had a current STI (chlamydia, 8.0%; gonorrhea, 3.0%; trichomoniasis, 20.5%), with 2.5% testing positive for more than 1 STI. Forty percent of the sample reported low educational attainment and 40% reported current poverty. Low educational attainment was associated with early risk behaviors, including twice the odds of earlier sexual debut (adjusted odds ratio [AOR], 2.09; 95% confidence interval [CI],: 1.14-3.84). Poverty was associated with reporting the current main sexual partner to be nonmonogamous (AOR, 2.01; 95% CI, 1.00-4.01) and current STI (AOR, 2.50; 95% CI, 1.26-4.98).Education and poverty seem to independently influence STI behaviors and infection, with low education associated with early sexual risk and poverty associated with current risk and infection. Improving women's educational attainment may be important in improving risk awareness, thereby reducing risky sexual behaviors and preventing a trajectory of STI risk.

Objectives Herpes simplex virus type 2 (HSV-2) biomarkers are often used in adolescent sub-Saharan HIV prevention studies, but evaluations of test performance and disclosure outcomes are rare in the published literature. Therefore, we investigated the proportion of ELISA-positive and indeterminate samples confirmed by western blot (WB), the psychosocial response to disclosure and whether reports of sexual behaviour and HSV-2 symptoms are consistent with WB confirmatory results among adolescent orphans in Kenya. Methods In 2011, 837 Kenyan orphan youth in grades 7 and 8 enrolled in an HIV prevention clinical trial with HSV-2 biomarker outcomes. We used a modified algorithm for the Kalon HSV-2 ELISA to improve specificity; positive and indeterminate results were WB tested. We developed culturally sensitive protocols for disclosing positive results, and documented psychosocial responses, reports of sexual contact and HSV-2 symptoms. Results 28 adolescents (3.3%) were identified as HSV-2 seropositive, six as indeterminate. Of these, 22 positive and all indeterminates were WB tested; 20 and 5, respectively, were confirmed positive. Most youth reported moderate brief stress after disclosure; 22% reported longer and more severe distress. Boys were more likely to be in the latter category. Self-reported virginity was highly inconsistent with WB-confirmed positives. Conclusions The higher than manufacturer9s cut-off for Kalon ELISA modestly reduced the rate of false-positive test results, but also increased false negatives. Investigators should consider the risk:benefit ratio in deciding whether or not to disclose HSV-2 results to adolescent participants under specific field conditions. Trial registration number NCT01501864.

INTRODUCTION HIV prevention strategies often include outreach to female sex workers at social venues identified as places where people meet new sexual partners. Patrons and staff at these venues may include female sex workers, their clients, as well as others who have high rates of new sexual partnerships. Few studies have compared HIV/STI among venue-based and general populations, across types of venues, or by sub-group of the venue population. Program planners often assume that the prevalence of infection is highest among female sex workers and considerably lower among other people at these venues, but there are few empiric studies assessing the prevalence of infection by sex worker status and type of venue. METHODS In 2011, we used the PLACE method to identify public venues where people meet new sexual partners across Jamaica. The study team visited all venues with reported sex work as well as a 10% random sample of other venues and subsequently interviewed and tested a probability sample of 991 venue patrons and workers for HIV and other STI. RESULTS Community informants identified 1207 venues. All venues where sex work was reported (735 venues) and a random sample of the remainder (134 of 472) were selected for onsite visits. Of these, 585 were found and operational. At a stratified random sample of venues, survey teams interviewed and tested 717 women and 274 men. 394 women reported recent sex work and 211 of these women reported soliciting clients on the street. Women exchanging sex for money were more likely to be infected with HIV (5.4% vs 1.0%; OR = 5.6, 95% CI = 1.8,17.3) or syphilis (11.7% vs. 5.8%, OR = 2.2, 95% CI = 1.7,4,0) than other women, but not significantly more likely to be infected with gonorrhea (8.4% vs 7.8%; OR = 1.1,95% CI = 0.6,1.9), chlamydia (16.2% vs 21.6%;OR = 0.7,95% CI = 0.5,1.0) or trichomoniasis (23.0% vs 17.0%, OR = 1.5,95% CI = 0.9,2.2). Women at venues were more likely to report sex work and multiple partners than women interviewed in a 2008 national population-based household survey commissioned by the Ministry of Health. CONCLUSIONS In Jamaica, although the highest HIV prevalence was among street-based sex workers, the risk of HIV and STI extends to men and women at high risk venues, even those who do not self-identify as sex workers. Findings confirm the appropriateness of outreach to all men and women at these venues.

Introduction Vaginal prostate-specific antigen (PSA) is a biomarker of recent semen exposure that may overcome potential fallacies of self-reported sexual behaviours, improving sexual exposure assessment in HIV/STI research. Methods We conducted a cohort study to compare PSA detection and self-reported unprotected sex using data from a clinical trial in Malawi that randomised 73 HIV-infected and 24 HIV-uninfected women to depot medroxyprogesterone acetate injectable or levonorgestrel implant. Women were advised to abstain from vaginal intercourse or use a condom the day preceding study visits. We tested 539 vaginal swabs from 97 women for PSA using the ABAcard p30 rapid strip test (Abacus Diagnostics, Inc., West Hills, CA). Self-reported sexual behaviours and vaginal swabs were collected at six study visits. Log-binomial regression with generalised estimating equations were used to estimate associations of PSA detection and reported unprotected sex with demographic and behavioural factors, adjusting for study arm and pre- vs. post-contraception initiation. Results Overall, 55 (57%) women tested positive for PSA and 54 (56%) women reported unprotected sex. Among PSA-positive samples, 62% (65/105) of instances reported no unprotected sex. The following were associated with PSA detection: HIV-negative status (Prevalence Ratio (PR): 1.69, 95% Confidence Interval (CI):1.09, 2.61), younger age (PR: 1.04, CI: 1.00, 1.08), reported unprotected sex (PR: 2.48, CI: 1.70, 3.60), and sex within past 48 hours (PR: 4.68, CI: 3.00, 7.30). The same factors were significantly associated with self-reported unprotected sex, as was PSA detection (PR: 2.45, CI: 1.7, 3.53). Conclusions Self-reported sexual behaviours were significantly associated with PSA detection. However, PSA was detected among women reporting no unprotected sex, suggesting misreporting of condom use or condom failure. HIV-negative status and younger age were associated with unprotected sex, suggesting more frequent biases in research data for these groups based on social desirability and non-adherence to protocols.

The practical feasibility of using prostate specific antigen (PSA) as a biomarker of semen exposure was examined among HIV-infected Ugandan women. Vaginal fluids were obtained with self-collected swabs and a qualitative rapid test (ABAcard®p30) was used to detect PSA. Trained laboratory technicians processed samples on-site and positive PSA tests were compared to self-reported unprotected vaginal sex (UVS) in the last 48h. A total of 77 women submitted 126 samples for PSA testing at up to three study visits. Of these samples, 31% (n=39/126) were PSA positive, and 64% (n=25/39) of the positive PSA samples were accompanied by self-report of no UVS at the study visit the PSA was collected. There were no reported difficulties with specimen collection, storage, or processing. These findings provide preliminary data on high levels of misreported UVS among HIV-infected Ugandan women using practically feasible methods for PSA collection and processing.

Introduction: Mycoplasma genitalium (MG) is an emerging sexually transmitted infection (STI) associated with cervicitis, pelvic inflammatory disease, and adverse pregnancy outcomes in women, yet little is known regarding its natural history. We conducted a secondary analysis of specimens collected from young women enrolled in a multi-centre study of asymptomatic bacterial vaginosis (BV) in order to determine the natural history of MG and associated factors with infection. Methods Sexually active women aged 15–25 years were recruited from 10 US clinical sites. Eligible women had asymptomatic BV at baseline, and >/=2 STI risk factors. Self-collected vaginal swabs were collected at enrollment, and by home-based testing at 2, 4, 6, 8, 10 and 12 months. MG nucleic acid amplification testing was performed using a transcription mediated assay (Hologic Inc, San Diego, California). Prevalent, incident and persistent MG were estimated with 95% confidence intervals (CI). Univariate analyses and logistic regression modelling were performed to assess associations between participants’ baseline demographic, sexual, and clinical characteristics with prevalent MG infection. Results Specimens were tested for MG from 1365 predominantly Black (85.4%) women. At baseline, 233 women were MG+ (prevalence 20.5% [95% CI: 18.2–22.9]); among 204 participants with follow-up specimens, 42 (20.6%) had persistent MG, remaining MG+ on all follow-up testing. Among 801 women who were MG negative at baseline with follow-up testing, 220 had at least one subsequent MG+ test for an incidence of 27.5% (95% CI: 24.4–30.7). Black race (adjusted odds ratio (AOR) 1.92, 95% CI: 1.09–3.38) and younger (15–21 years) age (AOR 1.40, 95% CI: 1.03–1.91) were significantly associated with prevalent MG infection. Conclusions We identified high rates of prevalent, incident, and persistent MG infections among sexually active young women followed over 12 months. As national programs consider the impact of MG as an STI, the implications of asymptomatic infections should be considered among at-risk populations.

We evaluated 2 assays to detect antibodies to herpes simplex virus type 2 in dried blood spots prepared from blood specimens submitted to a reference laboratory in Kenya. Dried blood spots did not perform well with the Kalon herpes simplex virus type 2 assay. Focus HerpeSelect 2 was 98.8% sensitive and 98.9% specific with dried blood spots.

Objective: To estimate the association between a simple measure of sexual partner concurrency and sexually transmitted infection (STI). Design: Cross-sectional surveys STI testing. Methods: A population-based household survey (n=1795) and targeted surveys of people at venues where people meet sexual partners (n=1580) asked about sexual behavior. Persons interviewed at venues were tested for HIV gonorrhea chlamydia gonorrhea and trichomoniasis. We compared the association between STI and reporting a partner had other partners. Results: More women than men reported their main partner had other partners. Thirteen percent of all women in the population-based survey and 14.4% in the targeted survey reported having one partner in the past 12 months and that partner had additional partners. STI prevalence was significantly associated with reporting a partner had other partners (36.8% vs. 30.2%; prevalence ratio [PR] 1.2; 95% confidence interval [CI] 1.1 1.4). Discussion: Construction of complete sexual networks is costly and not routinely feasible. We recommend adding a question to cross-sectional surveys used to monitor sexual behavior about whether the respondent believes his or her partner has other sexual partners. Although subject to bias the question was useful in Jamaica to identify a group of women with only one sexual partner at increased risk of infection.

Self-report of sexual behavior among adolescents is notoriously inconsistent, yet such measures are commonly used as outcomes for human immunodeficiency virus (HIV) prevention intervention trials. There has been a growing interest in the use of HIV and other sexually transmitted disease biomarkers as more valid measures of intervention impact in high HIV prevalence areas, particularly in sub-Saharan Africa. We examine the challenges, benefits, and feasibility of including HIV and herpes simplex virus type 2 (HSV-2) biomarker data, with details about different data collection and disclosure methods from two adolescent prevention trials in Kenya and Zimbabwe. In Kenya, whole blood samples were collected using venipuncture; adult guardians were present during biomarker procedures and test results were disclosed to participants and their guardians. In contrast, in Zimbabwe, samples were collected using finger pricks for dried blood spots (DBS); guardians were not present during biomarker procedures, and results were not disclosed to participants and/or their guardians. In both countries, prevalence in the study samples was low. Although the standard of care for testing for HIV and other sexually transmitted infections includes disclosure in the presence of a guardian for adolescents under age 18, we conclude that more research about the risks and benefits of disclosure to adolescents in the context of a clinical trial is needed. Notably, current serological diagnosis for HSV-2 has a low positive predictive value when prevalence is low, resulting in an unacceptable proportion of false positives and serious concerns about disclosing test results to adolescents within a trial. We also conclude that the DBS approach is more convenient and efficient than venipuncture for field research, although both approaches are feasible. Manufacturer validation studies using DBS for HSV-2, however, are needed for widespread use.

A possible solution to assessment of professionalism and communication skills is peer evaluation. To determine if non-anonymous feedback could improve student perception of the peer-feedback process and result in better feedback, we implemented a face-to-face feedback approach in a large, preclinical course. Student pairs were asked to meet in person to discuss their contributions in small group activities. A post-course survey suggested that this approach was well received by students and that a majority of the students felt the feedback they received was more useful than feedback they had previously received when using an online, anonymous approach.

Recent advances in tests for the sexually transmitted protozoan parasite Trichomonas vaginalis have increased opportunities for diagnosis and treatment of this important sexually transmitted infection. This review summarises currently available tests, highlighting their performance characteristics, advantages and limitations. The recent development of molecular tests for the detection of T vaginalis, including rapid antigen detection and nucleic acid amplification tests, has significantly improved the quality of diagnostics for trichomoniasis, particularly in women. In light of the expanded menu of testing options now available, improved recognition and better control of trichomoniasis are in sight, which should enable the eventual reduction of adverse reproductive consequences associated with T vaginalis infection.

The World Health Organization estimates 340 million new cases of sexually transmitted infections (STIs) occur annually worldwide, with the rate of new infections in Latin America and the Caribbean second only to that of sub-Saharan Africa.1 Because STIs increase risk for adverse health outcomes such as HIV,2,3 preventing patients with newly diagnosed, curable STIs from infecting their partners is crucial. The main strategy for preventing secondary infections involves counseling index patients either to abstain from sex while they remain infectious or to use condoms consistently and correctly to protect against the transmission of STIs spread primarily through skin-to-skin contact or, to a lesser degree, those spread by contact with mucosal surfaces.4 The effectiveness of abstinence-only interventions, in general, has not been demonstrated.5 although abstinence-based interventions combined with safer-sex strategies such as condom use may reduce self-reported behaviors, data on their effectiveness against biological outcomes is limited.6 Furthermore, evidence from the few trials conducted, which involve long-term behavior changes, might not be applicable in the context of preventing transmission from patients with curable infections during their short-term course of treatment. Guidelines from the Centers for Disease Control and Prevention and other bodies recommend complete abstinence but do not recommend or mention the use of condoms in this situation.4,7 Conversely, the Jamaican Ministry of Health recommends both abstinence and condom use interventions in their written guidance, which has resulted in patients receiving either of 2 counseling messages for the treatment period: abstinence or abstinence backed up by condom use in case sex was to occur.8 Given their unknown relative effectiveness, we conducted a pilot randomized controlled trial using a biological marker of recent semen exposure detected in vaginal fluid as a proxy of recent unprotected vaginal intercourse in addition to self-reported sexual behavior to compare these 2 counseling messages.

Purpose Using a clustered randomized controlled trial design, we evaluated whether support to keep Kenyan orphaned adolescents in school reduces the risk of HIV infection. Methods Participants included 835 orphaned boys and girls in grades 7 and 8 (mean age at the baseline = 15 years) in western Kenya. Primary schools (N = 26) were randomized to the study condition. Intervention participants received school uniforms, payment of tuition when they transitioned into high school, and nurse visits to monitor school absenteeism and provide assistance to stay in school. Annual surveys were conducted from 2011 through 2014, and HIV and herpes simplex virus 2 (HSV-2) biomarker data were collected at the baseline and the end line. Data were analyzed using survey logistic regression or generalized estimating equations controlling for age, gender, and socioeconomic status. Results Intervention and control groups were equivalent at the baseline and did not differ on new HIV or HSV-2 incidence at the end line. The school support intervention increased school retention but had few HIV-related effects, except increased circumcision among male participants and reduced likelihood of transactional sex. Conclusions Despite a strong study design, we found no relative reduction in HIV or HSV-2 infection after 3 years of intervention implementation. New incidence of HIV was lower than expected in this region among youth whose average age at end line was 18 years (range = 14–23). Although support for secondary school promises many benefits for vulnerable youth, our study adds to the growing body of research showing weak evidence for its effectiveness as an HIV prevention.

Female mice were immunized intravaginally with gonococcal outer membrane vesicles (OMVs) plus microencapsulated interleukin-12 (IL-12), and challenged using an established model of genital infection with Neisseria gonorrhoeae. Whereas sham-immunized and control animals cleared the infection in 10-13 days, those immunized with OMV plus IL-12 cleared infection with homologous gonococcal strains in 6-9 days. Significant protection was also seen after challenge with antigenically distinct strains of N. gonorrhoeae, and protective anamnestic immunity persisted for at least 6 months after immunization. Serum and vaginal immunoglobulin G (IgG) and IgA antibodies were generated against antigens expressed by homologous and heterologous strains. Iliac lymph node CD4+ T cells secreted interferon-γ (IFNγ), but not IL-4, in response to immunization, and produced IL-17 in response to challenge regardless of immunization. Antigens recognized by immunized mouse serum included several shared between gonococcal strains, including two identified by immunoproteomics approaches as elongation factor-Tu (EF-Tu) and PotF3. Experiments with immunodeficient mice showed that protective immunity depended upon IFNγ and B cells, presumably to generate antibodies. The results demonstrated that immunity to gonococcal infection can be induced by immunization with a nonliving gonococcal antigen, and suggest that efforts to develop a human vaccine should focus on strategies to generate type 1 T helper cell (Th1)-driven immune responses in the genital tract.

The AmpliVue Trichomonas Assay (Quidel) is a new Federal Drug Administration-cleared rapid test for qualitative detection of Trichomonas vaginalis (TV) DNA in female vaginal specimens. The assay is based on BioHelix's helicase-dependent amplification isothermal technology in conjunction with a disposable lateral-flow detection device, with a total turnaround time of approximately 45 minutes.The objective of this study was to compare the performance of this new assay to wet preparation and culture as well as to another Federal Drug Administration-cleared nucleic acid amplification assay.Four clinician collected vaginal swabs were obtained from women attending sexually transmitted disease, family planning, and OB/GYN clinics and tested by AmpliVue Trichomonas Assay and comparator tests: saline microscopy, TV culture (InPouch), and Aptima TV. AmpliVue Trichomonas Assay results were compared with a composite positive comparator (CPC) as determined by the results from culture and/or wet mount microscopic examination. At least one of either the wet preparation or culture reference test results was required to be positive to establish CPC.A total of 992 patients, 342 symptomatic and 650 asymptomatic patients, were included in the study. Results for AmpliVue for all women combined compared with saline microscopy and culture as a CPC yielded a sensitivity of 100%. Specificity for all women was 98.2%. Overall percent agreement versus Aptima TV was 97.8%. Sensitivity for AmpliVue compared with Aptima was 90.7% %, whereas specificity was 98.9%.The rapid AmpliVue Trichomonas Assay performed as well as microscopy and culture, and had comparable sensitivity and specificity to another nucleic acid amplification test for the detection of TV. This study provided evidence of new diagnostic options and indicated very good performance of amplified testing for detection of TV in symptomatic and asymptomatic women.

Background Sexually transmitted infections (STI)/HIV rates are disproportionately high among men involved in the criminal justice system. Mental health disorders, including personality disorders, are also elevated among inmates. Borderline personality disorder (BPD) may be an important risk factor for STI/HIV, yet remains relatively understudied, particularly among inmates. Methods We used baseline data from Project DISRUPT, a cohort study of African American men being released from prison in North Carolina who were in heterosexual relationships at prison entry (n=189), to assess their STI/HIV risk in the 6 months before incarceration and BPD symptoms focused on emotional lability and relationship dysfunction. We created a continuous BPD symptom severity score and a dichotomous BPD indicator split at the top quartile of the score (BPD-TQ) to examine associations between BPD and STI/HIV outcomes using logistic regression. We also examined associations between individual symptoms and outcomes. Results After adjustment for sociodemographics and antisocial personality disorder, BPD-TQ was associated with sexual risk behaviors including multiple partnerships (adjusted odds ratio, 2.58; 95% confidence interval, 1.24-5.36) and sex with nonmonogamous partners (adjusted odds ratio, 2.54; 95% confidence interval, 1.17-5.51). Prevalence of previous STI (47.5% vs. 29.6%) and prevalent chlamydial infection (6.9% vs. 3.1%) seemed higher in those in BPD-TQ, although the associations were not statistically significant. Associations were similar to those with the continuous score. Borderline personality disorder symptoms most associated with STI/HIV risk were abandonment worry, mood swings, and shifts in opinions. Conclusions Borderline personality disorder is strongly associated with STI/HIV risk in this sample. Researchers should further evaluate the relationship between STI/HIV and BPD, in addition to mood disorders.

BACKGROUND To assess factors associated with having a Trichomonas vaginalis (TV) infection among persons receiving care for human immunodeficiency virus (HIV) and estimate the number of transmitted HIV infections attributable to TV. METHODS HIV clinic patients were recruited from 2 secondary prevention studies, screened by urine nucleic-acid amplification tests for sexually transmitted infections, and interviewed about risk factors (baseline, 6, and 12 months). We conducted mathematical modeling of the results to estimate the number of transmitted HIV infections attributable to TV among a cohort of HIV-infected patients receiving medical care in North Carolina. RESULTS TV was prevalent in 7.4%, and incident in 2% to 3% of subjects at follow-up. Individuals with HIV RNA

In female sexually transmitted infection clinic attendees, Mycoplasma genitalium was more frequently detected using vaginal (53/73) versus endocervical (43/73) specimens. In women without other sexually transmitted infections, M. genitalium detection (N = 44) was associated with age ≤22 years (odds ratio, 2.53; P = 0.006) and clinical evidence of cervicitis (odds ratio, 2.11; P = 0.03).

Chlamydia trachomatis (Ct) is the most frequently reported infectious disease in the United States. This article reports population and subpopulation prevalence estimates of Ct and correlates of infection among 15- to 35-year-olds in Baltimore, MD.The Monitoring STIs Survey Program (MSSP) monitored sexually transmitted infection (STI) prevalence among probability samples of residents of Baltimore, a city with high STI rates. MSSP respondents completed telephone audio computer-assisted self-interviews and provided biospecimens for STI testing.Among 2120 Baltimore residents aged 15 to 35 years, the estimated prevalence of chlamydia was 3.9% (95% confidence interval [CI]: 2.8, 5.0). Prevalence was 5.8% (95% CI: 4.1, 7.6) among black MSSP respondents versus 0.7% (95% CI: 0.0, 1.4) among nonblack respondents; all but 4 infections detected were among black respondents. Sexual behaviors and other factors associated with infection were far more prevalent among black than nonblack Baltimore residents. Racial disparities persisted after adjustment for sociodemographic, behavioral, and health factors.The MSSP highlights a higher Ct prevalence among young people in Baltimore than in the United States overall, with notable racial disparities in infection and associated risk behaviors. Public health efforts are needed to improve the diagnosis and treatment of asymptomatic infections in this population.

Haemophilus ducreyi , the etiological agent of chancroid, has a strict requirement for heme, which it acquires from its only natural host, humans. Previously, we showed that a vaccine preparation containing the native hemoglobin receptor HgbA purified from H. ducreyi class I strain 35000HP (nHgbA I ) and administered with Freund's adjuvant provided complete protection against a homologous challenge. In the current study, we investigated whether nHgbA I dispensed with monophosphoryl lipid A (MPL), an adjuvant approved for use in humans, offered protection against a challenge with H. ducreyi strain 35000HP expressing either class I or class II HgbA (35000HP hgbA I and 35000HP hgbA II , respectively). Pigs immunized with the nHgbA I /MPL vaccine were protected against a challenge from homologous H. ducreyi strain 35000HP hgbA I but not heterologous strain 35000HP hgbA II , as evidenced by the isolation of only strain 35000HP hgbA II from nHgbA I -immunized pigs. Furthermore, histological analysis of the lesions showed striking differences between mock-immunized and nHgbA I -immunized animals challenged with strains 35000HP hgbA I but not those challenged with strain 35000HP hgbA II . Mock-immunized pigs were not protected from a challenge by either strain. The enzyme-linked immunosorbent assay (ELISA) activity of the nHgbA I /MPL antiserum was lower than the activity of antiserum from animals immunized with the nHgbA I /Freund's vaccine; however, anti-nHgbA I from both studies bound whole cells of 35000HP hgbA I better than 35000HP hgbA II and partially blocked hemoglobin binding to nHgbA I . In conclusion, despite eliciting lower antibody ELISA activity than the nHgbA I /Freund's, the nHgbA I /MPL vaccine provided protection against a challenge with homologous but not heterologous H. ducreyi , suggesting that a bivalent HgbA vaccine may be needed.

Research on the determinants of condom use and condom non-use generally has relied on self-reported data with questionable validity. We identified predictors of recent, unprotected sex among 331 female sex workers in Madagascar using two outcome measures: self-reports of unprotected sex within the past 48 h and detection of prostate-specific antigen (PSA), a biological marker of recent semen exposure. Multivariable logistic regression revealed that self-reported unprotected sex was associated with three factors: younger age, having a sipa (emotional partner) in the prior seven days, and no current use of hormonal contraception. The sole factor related to having PSA detected was prevalent chlamydial infection (adjusted odds ratio, 4.5; 95% confidence interval, 2.0–10.1). Differences in predictors identified suggest that determinants of unprotected sex, based on self-reported behaviors, might not correlate well with risk of semen exposure. Caution must be taken when interpreting self-reported sexual behavior measures or when adjusting for them in analyses evaluating interventions for the prevention of HIV/STIs.

Malawi adopted syndromic management of sexually transmitted infections in 1993. Based on clinical efficacy and cost, gentamicin 240 mg intramuscularly, and doxycycline 100 mg twice daily x 7 days was selected as the first line regimen to treat urethritis. We sought to establish current laboratory-based Neisseria gonorrhoeae antibiotic susceptibility patterns for Malawi and describe the pattern of susceptibility since syndromic management began.Between May 15 and August 10, 2007, 126 men with urethritis attending the STD clinic at Kamuzu Central Hospital in Lilongwe had history, genital exam, and urethral swabs taken. All were treated with gentamicin and doxycycline in accordance with Malawi guidelines. Gonorrhea was diagnosed by Gram stain and culture. Antimicrobial susceptibility patterns in gonococcal isolates were determined by disk diffusion and E-test minimum inhibitory concentration (MIC) determination and agar dilution MIC determination.One hundred six isolates were cultured, and MICs were determined for 100. High levels of resistance to tetracycline and penicillin were observed, but isolates were uniformly susceptible to both gentamicin and ciprofloxacin. Susceptibility patterns identified by the agar dilution MIC and E-test MIC agreed.The most recent study continues the trend of high susceptibility of gonococcal isolates to gentamicin in Malawi after 14 years of use and suggests agar dilution MICs may be substituted with the simpler E-test methods in future susceptibility testing. However because of the lack of susceptibility criteria for aminoglycosides for N. gonorrhoeae and the difficulty obtaining clinical/in vitro correlates in this setting, caution should be exercised in using these data for modifying treatment regimens.

Objectives: The enhanced sensitivity of nucleic acid amplification tests (NAAT) provides an opportunity for estimating the prevalence of untreated Chlamydia trachomatis infections. The transmissibility and public health significance of some NAAT-identified infections are, however, not known. Methods: Adults attending an urban emergency department provided specimens for C trachomatis screening using NAAT. Participants testing positive were offered follow-up including re-testing for C trachomatis using NAAT and traditional methods, eg culture and direct fluorescent antibody, and were treated. Partners were offered identical evaluation and treatment. Overall, 90 C trachomatis -positive participants had one or more sexual partners enrolled. Results: Evidence of transmission, as defined by infection concordance between partnerships, was observed among 75% of partners of index cases testing positive by both NAAT and traditional assay but only 45% of partners of index cases testing positive by NAAT only (prevalence ratio 1.7, 95% CI 1.1 to 2.5). Among index participants returning for follow-up, 17% had no evidence of C trachomatis infection by NAAT or traditional assay (median follow-up three weeks). Conclusions: A substantial proportion of positive NAAT results for chlamydial infection may be of lower transmissibility and may not persist after a short follow-up. The long-term health effects of some positive NAAT are uncertain.

SUMMARYThis study examined the prevalence of HIV and other sexually transmitted infections (STIs) in pregnant women in Kinshasa, the Democratic Republic of the Congo (DRC). Between April and July 2004, antenatal attendees at two of the largest maternity clinics in Kinshasa were tested to identify HIV status, syphilis, Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG). HIV seroprevalence was 1·9% in 2082 women. With PCR techniques, CT and NG infections were also uncommon in the first 529 women (1·7% and 0·4%, respectively). No active syphilis infection case was identified by Treponema pallidum haemagglutination assay (TPHA) and rapid plasma reagin test (RPR). A woman's risk of HIV infection was significantly associated with her reporting a male partner having had other female sexual partners (OR 2·7, 95% CI 1·2–6·2). The continuing low seroprevalence of HIV in pregnant women from Kinshasa was confirmed. Understanding factors associated with this phenomenon could help prevent a future HIV epidemic in low HIV transmission areas in Africa.

Background. Diagnosis of Trichomonas vaginalis (TV) infection is limited by imperfect testing methods. Newer tests, such as rapid antigen and nucleic acid amplification tests, are often compared with culture, which is not widely used but is more sensitive than wet mount. We assessed the sensitivity and specificity of 4 tests for the identification of TV using 3 statistical approaches. Methods. Sexually active adolescent women aged 14-21 years (n = 330) were recruited from a teen health center and emergency department. Vaginal swabs were tested for TV using wet mount, culture (InPouch TV; Biomed Diagnostics), rapid antigen testing (OSOM TV; Genzyme Diagnostics), and transcription-mediated amplification testing (TMA; APTIMA TV analyte specific reagents; Gen-Probe). Results. TV was detected in 61 participants (18.5%). Compared with a composite reference standard (i.e., any TV test with positive results), the sensitivities of wet mount, culture, rapid antigen testing, and TMA were 50.8%, 75.4%, 82%, and 98.4%, respectively. Using latent class analysis, the sensitivity of wet mount (56%) was significantly lower than that of other tests, and the sensitivities of culture and rapid antigen testing were similar (83% and 90%, respectively); specificity was 100% for each of these 3 methods. TMA had a sensitivity of 98.2% and a specificity of 98%. Tests performed equally well regardless of whether the participant had bleeding or other infections. The sensitivities of the rapid antigen test and TMA were comparable (92.5% and 97.5%, respectively) in women who had vaginal symptoms. Conclusions. Wet mount alone is insufficient for the reliable diagnosis of TV infection in women. TMA and rapid antigen tests are highly sensitive and specific, and both are superior to wet mount. Rapid antigen testing is equivalent to culture, and it compares favorably with the sensitivity of TMA for the detection of TV.

Our objective was to evaluate condom failure (breakage and slippage) rates before and those during a trial that provided instructions on correct condom use.Our analysis was based on 314 men who presented with urethral discharge at Jamaica's largest sexually transmitted infection clinic and were enrolled into our 6-month trial.Participants reported breaking 18.5% (95% confidence interval=12.8-24.1%) of their condoms during the 7 days prior to the screening visit and having 3.5% (95% confidence interval=1.2-5.7%) of their condoms slip off completely. After the condom counseling provided during the screening visit, breakage rates decreased (p.05) and remained below 10% throughout the trial. During in-depth interviews, the men who reported frequent condom failures cited (1) improper storage/exposure to heat, (2) improper handling while putting on condoms and (3) use of lubricants/improper lubricants as the possible reasons for their high failure rates.Although the rates of reported condom breakage and slippage decreased significantly after counseling, we need to improve the quality of condom counseling to further reduce failure rates.

Background Trichomonas vaginalis causes a common sexually transmitted infection (STI) in women, yet trichomoniasis in male sexual partners is not well recognized. Nucleic acid amplification tests can increase detection of T. vaginalis in men compared with culture. Methods We conducted a prospective, multicenter study to evaluate T. vaginalis infection among male partners of women with trichomoniasis and factors associated with infection by recruiting patients from 3 public clinics in the United States. Male partners were tested for concordant T. vaginalis infection, defined as a positive urethral culture, urine culture, or urine polymerase chain reaction (PCR) result. A subset of men also provided a semen sample for T. vaginalis culture and PCR. Factors associated with concordant infection were determined from bivariable and multivariable analyses. Results We enrolled 540 women with trichomoniasis (diagnosed using wet mount microscopy and/or culture) and 261 (48.4%) of their male partners. T. vaginalis infection was detected in 177 (71.7%) of 256 male partners (95% confidence interval [CI], 66.0%-77.3%), of whom 136 (77.3%) were asymptomatic. A vaginal pH of >4.5 in a woman was independently associated with infection in the male partner (adjusted odds ratio, 2.5; 95% CI, 1.0-6.3). Younger male age (20-29 and 30-39 years) was also found to be an independent risk factor for concordant trichomoniasis. Conclusions The majority of male partners of women with trichomoniasis were infected; however, few factors predicted infection. T. vaginalis causes a highly prevalent STI, necessitating vastly improved partner management, application of sensitive nucleic-acid based testing, and better clinical recognition.

We assessed the validity of self-reported sex and condom use by comparing self-reports with prostate-specific antigen (PSA) detection in a prospective study of 210 female sex workers in Mombasa, Kenya. Participants were interviewed on recent sexual behaviours at baseline and 12-month follow-up visits. At both visits, a trained nurse instructed participants to self-swab to collect vaginal fluid specimens, which were tested for PSA using enzyme-linked immunosorbent assay (ELISA). Eleven percent of samples ( n = 329) from women reporting no unprotected sex for the prior 48 hours tested positive for PSA. The proportions of women with this type of discordant self-reported and biological data did not differ between the enrolment and 12-month visit (odds ratio [OR] 1.1; 95% confidence interval [CI] 0.99, 1.2). The study found evidence that participants failed to report recent unprotected sex. Furthermore, because PSA begins to clear immediately after exposure, our measures of misreported semen exposure likely are underestimations.

Trichomonas vaginalis is the most prevalent nonviral sexually transmitted infection, affecting an estimated 3.7 million women and men in the United States. Health disparities are prominent in the epidemiology of this infection, which affects 11% of women aged ≥40 years and a disproportionately high percentage of black women. Particularly high prevalences have been identified among sexually transmitted disease (STD) clinic patients and incarcerated individuals. This article reviews and updates scientific evidence in key topic areas used for the development of the 2015 STD Treatment Guidelines published by the Centers for Disease Control and Prevention. Current evidence is presented regarding conditions associated with Trichomonas vaginalis infection, including human immunodeficiency virus (HIV) and pregnancy complications such as preterm birth. Nucleic acid amplification tests and point-of-care tests are newly available diagnostic methods that can be conducted on a variety of specimens, potentially allowing highly sensitive testing and screening of both women and men at risk for infection. Usually, trichomoniasis can be cured with single-dose therapy of an appropriate nitroimidazole antibiotic, but women who are also infected with HIV should receive therapy for 7 days. Antimicrobial resistance is an emerging concern.

Objectives This study estimates HIV prevalence among men who have sex with men (MSM) in Jamaica and explores social determinants of HIV infection among MSM. Design An island-wide cross-sectional survey of MSM recruited by peer referral and outreach was conducted in 2011. A structured questionnaire was administered and HIV/STI tests done. We compared three groups: MSM who accepted cash for sex within the past 3 months (MSM SW), MSM who did not accept cash for sex (MSM non-SW), and MSM with adverse life events (ever raped, jailed, homeless, victim of violence or low literacy). Results HIV prevalence among 449 MSM was 31.4%, MSM SW 41.1%, MSM with adverse life events 38.5%, 17 transgender MSM (52.9%), and MSM non-SW without adverse events 21.0%. HIV prevalence increased with age and number of adverse life events (test for trend P < 0.001), as did STI prevalence (P = 0.03). HIV incidence was 6.7 cases/100 person-years (95% CI: 3.74, 12.19). HIV prevalence was highest among MSM reporting high-risk sex; MSM SW who had been raped (65.0%), had a STI (61.2%) and who self identified as female (55.6%). Significant risk factors for HIV infection common to all 3 subgroups were participation in both receptive and insertive anal intercourse, high-risk sex, and history of a STI. Perception of no or little risk, always using a condom, and being bisexual were protective. Conclusion HIV prevalence was high among MSM SW and MSM with adverse life events. Given the characteristics of the sample, HIV prevalence among MSM in Jamaica is probably in the range of 20%. The study illustrates the importance of social vulnerability in driving the HIV epidemic. Programs to empower young MSM, reduce social vulnerability and other structural barriers including stigma and discrimination against MSM are critical to reduce HIV transmission.

ffective diagnosis and treatment of infected persons is a critical component of sexually transmitted diseases (STDs) prevention and control. STD diagnostic methods that are sensitive, rapid and inexpensive are ideal for testing of individuals presenting with genitourinary symptoms and screening of asymptomatic individuals in high risk populations. Fortunately, recent advances in STD diagnostics have provided nucleic acid amplification tests (NAATs) with increased sensitivity compared to older tests and rapid “pointof-care” (POC) tests, with quick turn-around time for results. However, despite their ability to improve best practices for STD management, NAATs and POC tests have not been widely adopted into public and privately funded practices. This may in part be due to barriers ranging from the cost and complexity of some of these methods to unfamiliarity with application of these new technologies for the testing and screening of at-risk patients. Although federal resources for the control and prevention of STDs are primarily distributed to state and local health departments, the National Health and Social Life Survey reported that STDs are frequently treated in private practice settings. 1 Therefore, consideration of the ideal STD testing methods to use in the apparently low prevalence populations evaluated in private clinics is as crucial as application of these technologies in high prevalence populations presenting to STD clinics and emergency rooms.

Objective The objective of this study was to assess the validity of women's reports of recent unprotected sex by testing for prostate-specific antigen (PSA) in vaginal samples. Study design The authors conducted prospective research with 332 female sex workers attending 2 public dispensaries in Madagascar. Results Among women who reported no sex or protected sex only within the past 48 hours, 21% and 39%, respectively, tested positive for PSA. Among those testing positive for PSA, no differences in PSA concentrations were found among those reporting no sex, protected sex only, or at least one unprotected act. Conclusions The substantial disagreement between self-reports and measurement of a biologic marker of semen exposure in vaginal specimens substantiates that self-reports of sexual behavior cannot be assumed to be valid measures. Future sexually transmitted infection/HIV and pregnancy prevention studies should confirm the validity of self-reports or use end points that do not rely on self-reported data.

Objectives. We estimated HIV prevalence rates among young adults in the United States. Methods. We used survey data from the third wave of the National Longitudinal Study of Adolescent Health, a random sample of nearly 19000 young adults initiated in 1994–1995. Consenting respondents were screened for the presence of antibodies to HIV-1 in oral mucosal transudate specimens. We calculated prevalence rates, accounting for survey design, response rates, and test performance. Results. Among the 13184 participants, the HIV prevalence rate was 1.0 per 1000 (95% confidence interval [CI] = 0.4, 1.7). Gender-specific prevalence rates were similar, but rates differed markedly between non-Hispanic Blacks (4.9 per 1000; 95% CI=1.8, 8.7) and members of other racial/ethnic groups (0.22 per 1000; 95% CI=0.00, 0.64). Conclusions. Racial disparities in HIV in the United States are established early in the life span, and our data suggest that 15% to 30% of all cases of HIV occur among individuals younger than 25 years.

The objective of this study was to assess whether providing a choice of condoms would increase condom acceptability increase self-reported use and decrease incident sexually transmitted infection. We randomized 414 men presenting with urethral discharge in Jamaica to receive either the "standard" clinic condom or a choice of 4 different types of condoms. Men were treated presumptively at enrollment and followed up at 1 2 4 and 6 months. Participants in the choice group had a strong preference (P < 0.01) for the most popular condom available in Jamaica. This preference did not translate into higher condom use (P = 0.16). The 6-month cumulative probability of first incidence of gonorrhea chlamydia or trichomoniasis was slightly higher in the choice group (21%; 95% confidence interval [CI] 15-28%) versus the control group (17%; 95% CI 11-23%); the difference in the survival curves was not significant (P = 0.35). A choice of condoms may increase perceived acceptability but not lead to increased condom use and subsequently lower sexually transmitted infection rates. (authors)

Women's power in sexual relationships is thought to be an important predictor of condom use. However, research on correlates of condom use often relies on participant reporting of behavior, which has questionable validity. We evaluated the association between scores from the modified Sexual Relationship Power Scale (SRPS-M) and biological detection of semen exposure in a prospective study of adult women attending a sexually transmitted infection clinic in Kingston, Jamaica with cervicitis or abnormal vaginal discharge in 2010-2011. At enrollment, women were counseled to avoid sex while on treatment and were asked to return in six days for a follow-up visit. At both study visits, women were administered a questionnaire and had vaginal swabs collected to test for prostate-specific antigen (PSA), a biological marker of recent semen exposure. We found no association at enrollment or follow up between SRPS-M scores and semen exposure, as measured with either self-reported data (p=0.63 and p=0.82, respectively) or PSA positivity. Semen biomarkers could be used to develop and validate new scales on relationship power and self-efficacy related to condom use.

Objectives/Goal: Most resource-poor settings rely on syndromic criteria to diagnose genital ulcer disease (GUD). However, the etiologic pathogens of GUD vary temporally and geographically, and current criteria may not reflect changes in the prevalence of specific pathogens. Study: In 1999, we estimated the prevalence of Treponema pallidum (Tp), herpes simplex virus (HSV), and Haemophilus ducreyi (Hd) in Malawi. We then used regression coefficients of independent correlates of HSV and Hd to develop weighted diagnostic algorithms, in which weights were β-coefficients corresponding to each factor. Results: Overall, a decrease in the proportion of sexually transmitted disease attributable to GUD was noted in 7 years. Thirty-five percent were attributable to HSV, 30% to H. ducreyi, and 4% to T. pallidum. Areas under the receiver operating characteristic curves for weighted and unweighted HSV diagnostic algorithms were 67.6% and 66.5%, respectively. There was no significant difference in the explanatory performance of the weighted and unweighted algorithms. Conclusions: Unweighted algorithms can therefore be used to improve diagnostic accuracy of GUD.

Trichomonas vaginalis infection is estimated to be the most widely prevalent nonviral sexually transmitted infection in the world. Wet-mount microscopy is the most common diagnostic method, although it is less sensitive than culture. The OSOM Trichomonas Rapid Test (Genzyme Diagnostics, Cambridge, Mass.) (referred to here as OSOM) is a new point-of-care diagnostic assay for T. vaginalis that uses an immunochromatographic capillary flow (dipstick) assay and provides results in 10 min. The purpose of this study was to determine the test characteristics of OSOM compared to those of a composite reference standard (CRS) comprised of wet-mount microscopy and T. vaginalis culture. This multicenter cross-sectional study enrolled sexually active women ≥18 years of age who presented with symptoms of vaginitis, exposure to T. vaginalis , or multiple sexual partners. Vaginal-swab specimens were obtained for T. vaginalis culture, wet mount, and rapid testing. The prevalence of T. vaginalis in this sample was 23.4% (105 of 449) by the CRS. The sensitivity and specificity of OSOM vaginal-swab specimens were 83.3 and 98.8%, respectively, while wet mount had a sensitivity and specificity of 71.4 and 100%, respectively, compared to the CRS. OSOM performed significantly better than wet mount ( P = 0.004) and detected T. vaginalis in samples that required 48 to 72 h of incubation prior to becoming culture positive. The performance of the rapid test was not affected by the presence of coinfections with chlamydia and gonorrhea. The OSOM Trichomonas Rapid Test is a simple, objective test that can be expected to improve the diagnosis of T. vaginalis , especially where microscopy and culture are unavailable.