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Competing Interests: Conflict of Interest and Sources of Funding: None declared.

Competing Interests: Conflict of Interest and Sources of Funding: None declared.

Competing Interests: Conflict of Interest and Sources of Funding: None declared.

Gonorrhea remains a major public health challenge, and current recommendations for gonorrhea treatment are threatened by evolving antimicrobial resistance and a diminished pipeline for new antibiotics. Evaluations of potential new treatments for gonorrhea currently make limited use of new understanding of the pharmacokinetic and pharmacodynamic contributors to effective therapy, the prevention of antimicrobial resistance, and newer designs for clinical trials. They are hampered by the requirement to utilize combination ceftriaxone/azithromycin therapy as the comparator regimen in noninferiority trials designed to seek an indication for gonorrhea therapy. Evolving gonococcal epidemiology and clinical trial design constraints hinder the enrollment of those populations at the greatest risk for gonorrhea (adolescents, women, and persons infected with antibiotic-resistant Neisseria gonorrhoeae). This article summarizes a recent meeting on the evaluation process for antimicrobials for urogenital gonorrhea treatment and encourages the consideration of new designs for the evaluation of gonorrhea therapy., (© The Author(s) 2019. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail: journals.permissions@oup.com.)

Background: Dual human immunodeficiency virus (HIV)/syphilis rapid, point-of-care testing may enhance syphilis screening among high-risk populations, increase case finding, reduce time to treatment, and prevent complications. We assessed the laboratory-based performance of a rapid dual HIV/syphilis test using serum collected from patients enrolled in the Zimbabwe Sexually Transmitted Infections (STI) Etiology study., Methods: Blood specimens were collected from patients presenting with STI syndromes in 6, predominantly urban STI clinics in different regions of Zimbabwe. All specimens were tested at a central research laboratory using the Standard Diagnostics Bioline HIV/Syphilis Duo test. The treponemal syphilis component of the dual rapid test was compared with the Treponema pallidum hemagglutination assay (TPHA) as a gold standard comparator, both alone or in combination with a nontreponemal test, the rapid plasma reagin test. The HIV component of the dual test was compared with a combination of HIV rapid tests conducted at the research laboratory following the Zimbabwe national HIV testing algorithm., Results: Of 600 men and women enrolled in the study, 436 consented to serological syphilis and HIV testing and had specimens successfully tested by all assays. The treponemal component of the dual test had a sensitivity of 66.2% (95% confidence interval [CI], 55.2%-77.2%) and a specificity of 96.4% (95% CI, 94.5%-98.3%) when compared with TPHA; the sensitivity increased to 91.7% (95% CI, 82.6%-99.9%) when both TPHA and rapid plasma reagin were positive. The HIV component of the dual test had a sensitivity of 99.4% (95% CI, 98.4%-99.9%) and a specificity of 100% (95% CI, 99.9%-100%) when compared with the HIV testing algorithm., Conclusions: Laboratory performance of the SD Bioline HIV/Syphilis Duo test was high for the HIV component of the test. Sensitivity of the treponemal component was lower than reported from most laboratory-based evaluations in the literature. However, sensitivity of the test increased substantially among patients more likely to have active syphilis for which results of both standard treponemal and nontreponemal tests were positive.

Background: Syphilis prevalence in sub-Saharan Africa appears to be stable or declining but is still the highest globally. Ongoing sentinel surveillance in high-risk populations is necessary to inform management and detect changes in syphilis trends. We assessed serological syphilis markers among persons with sexually transmitted infections in Zimbabwe., Methods: We studied a predominantly urban, regionally diverse group of women and men presenting with genital ulcer disease (GUD), women with vaginal discharge and men with urethral discharge at clinics in Zimbabwe. Syphilis tests included rapid plasma reagin and the Treponema pallidum hemagglutination assay., Results: Among 436 evaluable study participants, 36 (8.3%) tested positive for both rapid plasma reagin and Treponema pallidum hemagglutination assay: women with GUD: 19.2%, men with GUD: 12.6%, women with vaginal discharge: 5.7% and men with urethral discharge: 1.5% (P < 0.0001)., Conclusions: Syphilis rates in Zimbabwe are high in sentinel populations, especially men and women with GUD.

Background: HIV and other sexually transmitted infections (STI) frequently co-occur. We conducted HIV diagnostic testing in an assessment of the etiologies of major STI syndromes in Zimbabwe., Methods: A total of 600 patients were enrolled at six geographically diverse, high-volume STI clinics in Zimbabwe in 2014-15: 200 men with urethral discharge, 200 women with vaginal discharge, and 100 men and 100 women each with genital ulcer disease (GUD). Patients completed a questionnaire, underwent a genital examination, and had specimens taken for etiologic testing. Patients were offered, but not required to accept, HIV testing using a standard HIV algorithm in which two rapid tests defined a positive result., Results: A total of 489 participants (81.5%) accepted HIV testing; 201 (41.1%) tested HIV-1-positive, including 16 (11.9%) of 134 participants who reported an HIV-negative status at study enrollment, and 58 (28.2%) of 206 participants who reported their HIV status as unknown. Of 147 who self-reported being HIV-positive at study enrollment, 21 (14.3%) tested HIV negative. HIV infection prevalence was higher in women (47.3%) than in men (34.8%, p<0.01), and was 28.5% in men with urethral discharge, 40.5% in women with vaginal discharge, 45.2% in men with GUD, and 59.8% in women with GUD (p<0.001)., Conclusions: The high prevalence of HIV infection in STI clinic patients in Zimbabwe underscores the importance of providing HIV testing and referral for indicated prevention and treatment services for this population. The discrepancy between positive self-reported and negative study HIV test results highlights the need for operator training, strict attention to laboratory quality assurance, and clear communication with patients about their HIV infection status., Competing Interests: Dr. Rietmeijer, the sole proprietor of Rietmeijer Consulting, was the lead consultant for the project. Rietmeijer Consulting was not involved in other projects that presented a conflict of interest. This does not alter our adherence to PLOS ONE policies on sharing data and materials. The authors have declared that no other potential competing interests exist.

Introduction: Symptomatic vaginal discharge is a common gynecological condition managed syndromically in most developing countries. In Zimbabwe, women presenting with symptomatic vaginal discharge are treated with empirical regimens that commonly cover both sexually transmitted infections (STIs) and reproductive tract infections, typically including a combination of an intramuscular injection of kanamycin, and oral doxycycline and metronidazole regimens. This study was conducted to determine the current etiology of symptomatic vaginal discharge and assess adequacy of current syndromic management guidelines., Methods: We enrolled 200 women with symptomatic vaginal discharge presenting at 6 STI clinics in Zimbabwe. Microscopy was used to detect bacterial vaginosis and yeast infection. Nucleic acid amplifications tests were used to detect Neisseria gonorrhoeae, Chlamydia trachomatis, Trichomonas vaginalis, and Mycoplasma genitalium. In addition, serologic testing was performed to detect human immunodeficiency virus (HIV) infection., Results: Of the 200 women, 146 (73%) had an etiology detected, including bacterial vaginosis (24.7%); N. gonorrhoeae (24.0%); yeast infection (20.7%); T. vaginalis (19.0%); C. trachomatis (14.0%) and M. genitalium (7.0%). Among women with STIs (N = 90), 62 (68.9%) had a single infection, 18 (20.0%) had a dual infection, and 10 (11.1%) had 3 infections.Of 158 women who consented to HIV testing, 64 (40.5%) were HIV infected.The syndromic management regimen covered 115 (57.5%) of the women in the sample who had gonorrhea, chlamydia, M. genitalium, or bacterial vaginosis, whereas 85 (42.5%) of women were treated without such diagnosis., Conclusions: Among women presenting with symptomatic vaginal discharge, bacterial vaginosis was the most common etiology, and gonorrhea was the most frequently detected STI. The current syndromic management algorithm is suboptimal for coverage of women presenting with symptomatic vaginal discharge; addition of point of care testing could compliment the effectiveness of the syndromic approach.

Background: In many countries, sexually transmitted infections (STIs) are treated syndromically. Thus, patients diagnosed as having genital ulcer disease (GUD) in Zimbabwe receive a combination of antimicrobials to treat syphilis, chancroid, lymphogranuloma venereum (LGV), and genital herpes. Periodic studies are necessary to assess the current etiology of GUD and assure the appropriateness of current treatment guidelines., Materials and Methods: We selected 6 geographically diverse clinics in Zimbabwe serving high numbers of STI cases to enroll men and women with STI syndromes, including GUD. Sexually transmitted infection history and risk behavioral data were collected by questionnaire and uploaded to a Web-based database. Ulcer specimens were obtained for testing using a validated multiplex polymerase chain reaction (M-PCR) assay for Treponema pallidum (TP; primary syphilis), Haemophilus ducreyi (chancroid), LGV-associated strains of Chlamydia trachomatis, and herpes simplex virus (HSV) types 1 and 2. Blood samples were collected for testing with HIV, treponemal, and nontreponemal serologic assays., Results: Among 200 GUD patients, 77 (38.5%) were positive for HSV, 32 (16%) were positive for TP, and 2 (1%) were positive for LGV-associated strains of C trachomatis. No H ducreyi infections were detected. No organism was found in 98 (49.5%) of participants. The overall HIV positivity rate was 52.2% for all GUD patients, with higher rates among women compared with men (59.8% vs 45.2%, P < 0.05) and among patients with HSV (68.6% vs 41.8%, P < 0.0001). Among patients with GUD, 54 (27.3%) had gonorrhea and/or chlamydia infection. However, in this latter group, 66.7% of women and 70.0% of men did not have abnormal vaginal or urethral discharge on examination., Conclusions: Herpes simplex virus is the most common cause of GUD in our survey, followed by T. pallidum. No cases of chancroid were detected. The association of HIV infections with HSV suggests high risk for cotransmission; however, some HSV ulcerations may be due to HSV reactivation among immunocompromised patients. The overall prevalence of gonorrhea and chlamydia was high among patients with GUD and most of them did not meet the criteria for concomitant syndromic management covering these infections.

Introduction: Sexually transmitted infections (STIs) are managed syndromically in most developing countries. In Zimbabwe, men presenting with urethral discharge are treated with a single intramuscular dose of kanamycin or ceftriaxone in combination with a week's course of oral doxycycline. This study was designed to assess the current etiology of urethral discharge and other STIs to inform current syndromic management regimens., Methods: We conducted a study among 200 men with urethral discharge presenting at 6 regionally diverse STI clinics in Zimbabwe. Urethral specimens were tested by multiplex polymerase chain reaction testing for Neisseria gonorrhoeae, Chlamydia trachomatis, Mycoplasma genitalium, and Trichomonas vaginalis. In addition, serologic testing for syphilis and HIV was performed., Results: Among the 200 studied men, one or more pathogens were identified in 163 (81.5%) men, including N. gonorrhoeae in 147 (73.5%), C. trachomatis in 45 (22.5%), T. vaginalis in 8 (4.0%), and M. genitalium in 7 (3.5%). Among all men, 121 (60%) had a single infection, 40 (20%) had dual infections, and 2 (1%) had 3 infections. Among the 45 men with C. trachomatis, 36 (80%) were coinfected with N. gonorrhoeae. Overall, 156 (78%) men had either N. gonorrhoeae or C. trachomatis identified. Of 151 men who consented to HIV testing, 43 (28.5%) tested positive. There were no differences in HIV status by study site or by urethral pathogen detected., Conclusions: Among men presenting at Zimbabwe STI clinics with urethral discharge, N. gonorrhoeae and C. trachomatis are the most commonly associated pathogens. Current syndromic management guidelines seem to be adequate for the treatment for symptomatic men, but future guidelines must be informed by ongoing monitoring of gonococcal resistance.

Potential legal liability for practicing expedited partner therapy is a common concern among providers, although it has been uncertain how these concerns translate into clinical practice. This study suggests that providers are more likely to practice expedited partner therapy in more favorable legal environments.

We assessed trends in behavioral risk for HIV infection among men who have sex with men (MSM). Seattle MSM participated in random digit dial telephone surveys in 2003 (n = 400) and 2006 (n = 400). Fourteen percent in 2003 and 9% in 2006 reported unprotected anal intercourse with a partner of different or unknown HIV status (non-concordant UAI; odds ratio [OR] = 0.7; 95% confidence interval [CI]: 0.5, 1.2). Compared to participants in 2003, participants in 2006 met a greater proportion of their anal sex partners through the Internet (OR = 2.0; 95% CI: 1.2, 3.1). Although the proportion of anal sex partnerships formed online increased between 2003 and 2006, Internet partnerships were not more risky than those initiated elsewhere. While the emergence of the Internet as a venue through which men meet partners demonstrates that sexual risk among MSM remains highly dynamic, our findings suggest that sexual risk behavior among MSM is currently stable.

Background: Expedited partner therapy (EPT) has been shown to reduce the risk of persistent or recurrent gonorrhea and chlamydial infection in heterosexuals, and to increase the proportion of sex partners receiving treatment. The objective of this analysis was to evaluate the consistency of EPT's effect across sociodemographic and behavioral subgroups., Methods: Subset analyses from a randomized controlled trial compared EPT to standard partner referral (SPR) in sociodemographic and behaviorally defined subgroups. Outcomes included persistent or recurrent infection in study participants and participants' report that their partners received treatment., Results: Reinfection risk was lower among EPT recipients than nonrecipients in 21 of 22 subgroups, with relative risks (RRs) varying from 0.4 to 0.94. Compared to persons receiving SPR, persons receiving EPT were more likely to report that their partners were very likely to have been treated in 33 of 34 subgroups (RRs range, 1.03-1.36). Although EPT reduced the risk of persistent or recurrent infection somewhat more in men (RR, 0.56; 95% CI, 0.3-1.08) than in women (RR, 0.81; 95% CI, 0.61-1.07) and more in persons with gonorrhea (RR, 0.32; 95% CI, 0.13-0.78) than those with chlamydial infection (RR, 0.82; 95% CI, 0.63-1.07), the RR of partners being treated associated with EPT was similar in men (RR, 1.21; 95% CI, 1.05-1.39) and women (RR, 1.18; 95% CI, 1.10-1.27), and also in persons with gonorrhea (RR, 1.33; 95% CI, 0.80-2.23) and chlamydial infection (RR, 1.33; 95% CI, 1.07-1.66)., Conclusions: In this study, EPT is shown to be superior to SPR across a wide spectrum of sociodemographic and behaviorally defined subgroups.

This cross-sectional study describes the baseline prevalence and correlates of common bacterial and viral sexually transmitted diseases (STDs) and risk behaviors among individuals at high risk for HIV recruited in five low- and middle-income countries. Correlations of risk behaviors and demographic factors with prevalent STDs and the association of STDs with HIV prevalence are examined. Between 2,212 and 5,543 participants were recruited in each of five countries (China, India, Peru, Russia, and Zimbabwe). Standard protocols were used to collect behavioral risk information and biological samples for STD testing. Risk factors for HIV/STD prevalence were evaluated using logistic regression models. STD prevalence was significantly higher for women than men in all countries, and the most prevalent STD was Herpes simplex virus-type 2 (HSV-2). HIV prevalence was generally low (below 5%) except in Zimbabwe (30% among women, 11.7% among men). Prevalence of bacterial STDs was generally low (below 5% for gonorrhea and under 7% for syphilis in all sites), with the exception of syphilis among female sex workers in India. Behavioral and demographic risks for STDs varied widely across the five study sites. Common risks for STDs included female gender, increasing number of recent sex partners, and in some sites, older age, particularly for chronic STDs (i.e., HSV-2 and HIV). Prevalence of HIV was not associated with STDs except in Zimbabwe, which showed a modest correlation between HIV and HSV-2 prevalence (Pearson coefficient = .55). These findings underscore the heterogeneity of global STD and HIV epidemics and suggest that local, focused interventions are needed to achieve significant declines in these infections.

Objective: To evaluate a partner notification program for gonorrhea and chlamydial infection that involves communitywide access to free patient-delivered partner therapy (PDPT) and use of case-report forms to triage patients to receive partner notification assistance., Methods: We evaluated program components in randomly selected cases and compared outcomes before and after program institution., Results: Following institution of the program, the percentage of cases who received PDPT from their diagnosing clinician increased from 5.6% to 16% (adjusted OR 3.2, 2.5-4.1). Among randomly selected cases, those referred to the health department via the case-report form were significantly more likely than nonreferred cases to have untreated sex partners (76% vs. 35%, OR 6.0, 95% CI 4.5-8.0), to accept PDPT from the health department (36% vs. 14%, 3.3, 95% CI 2.4-4.7), and to request that health department staff notify a partner for them (11% vs. 3%, OR 3.5, 95% CI 1.8-6.7). The percentage of cases classified as having all of their partners treated increased from 39% to 65% concurrent with institution of the program., Conclusions: A public health program that promotes routine use of PDPT and referral of selected patients for partner notification assistance appears to have improved partner notification outcomes.

Background: Suppressive therapy has not been studied during the first year after acquisition of genital herpes, the time of maximum frequency of reactivation, potential for transmission, and impact on quality of life., Objective: The objective of this study was to evaluate the effectiveness of suppressive therapy with valacyclovir initiated within 3 months of infection., Study Design: The authors conducted a double-blind, randomized, controlled trial of 1.0 g valacyclovir daily versus placebo for 6 months in 119 patients., Results: Herpes simplex virus (HSV) type 2 and HSV-1 were documented in 75 and 22 patients, respectively. In intention-to-treat analysis, annualized rates of symptomatic recurrences for valacyclovir and placebo, respectively, were 1.7 +/- 2.7 (mean +/- standard deviation) and 3.4 +/- 4.0 outbreaks per year (P = 0.012). Time to first recurrence was 80 +/- 47 days for valacyclovir and 54 +/- 49 days for placebo (P = 0.001). The differences in favor of valacyclovir were greatest in patients with confirmed HSV-2 infection. The Recurrent Genital Herpes Quality of Life score in HSV-2 infected patients rose 11.9 +/- 11.1 points for valacyclovir and 5.9 +/- 9.1 points for placebo (P = 0.040)., Conclusions: Early suppressive therapy with valacyclovir reduces symptomatic recurrent outbreaks, especially in patients with HSV-2 infection. Valacyclovir therapy was associated with improved herpes-related quality of life.

Objective: The objective of this study was to assess the impact of syphilis control activities in King County, Washington., Study Design: We calculated rates of early syphilis and trends in numbers of persons tested and diagnosed through screening and partner notification from 1998 to 2005., Results: Early syphilis cases increased from 38 in 1998 to 188 in 2005 with 92% occurring among men who have sex with men (MSM). Our health department conducted public awareness campaigns, increased publicly financed syphilis screening among MSM by 179%, and intensified partner notification efforts. Despite these efforts, the prevalence of syphilis among screened populations was only 1.1%, and 71% syphilis cases were diagnosed after seeking care for symptoms. The proportion of cases diagnosed through screening and partner notification did not significantly change during the evaluation period. Early syphilis incidence among MSM more than doubled between 2003 and 2005., Conclusions: New, innovative approaches to syphilis control are needed.

Objective: To evaluate the effectiveness and cost-effectiveness of a health department-based peer referral program for identifying previously undiagnosed cases of HIV among men who have sex with men (MSM)., Design and Methods: Between 2002 and 2005, 283 MSM peer recruiters were enrolled in a public health program in King County, Washington, USA. Peer recruiters were enrolled from a sexually transmitted disease (STD) clinic, an HIV clinic, via media advertisements and through collaboration with community-based organizations (CBO). The peer recruiters underwent a brief training and were then paid US$ 20 for each peer they referred to be tested for HIV, STD and viral hepatitis. Peers were paid US$ 20 for being tested. The main outcome measure was the number of new cases of HIV identified and cost per case of HIV identified., Results: Recruiters referred 498 peers for HIV, STD and hepatitis testing. Among 438 peers not previously diagnosed with HIV, 22 (5%) were HIV positive, of whom 18 received their HIV test results. Other infections were variably prevalent among tested peers: gonorrhea [23/307 (8%)], chlamydia [6/285 (2%)], syphilis [1/445 (0.2%)], hepatitis C [61/198 (31%)], surface antigen positive hepatitis B [8/314 (3%)]. Excluding the costs of testing for viral hepatitis and STDs other than HIV, the cost per new HIV case identified was US$ 4929. During the same period, the cost per new case of HIV detected through bathhouse-based HIV testing and through the county's largest CBO-based HIV testing program were US$ 8250 and US$ 11 481, respectively., Conclusions: Peer referral is an effective means of identifying new cases of HIV among MSM.

These recommendations for human immunodeficiency virus (HIV) testing are intended for all health-care providers in the public and private sectors, including those working in hospital emergency departments, urgent care clinics, inpatient services, substance abuse treatment clinics, public health clinics, community clinics, correctional health-care facilities, and primary care settings. The recommendations address HIV testing in health-care settings only. They do not modify existing guidelines concerning HIV counseling, testing, and referral for persons at high risk for HIV who seek or receive HIV testing in nonclinical settings (e.g., community-based organizations, outreach settings, or mobile vans). The objectives of these recommendations are to increase HIV screening of patients, including pregnant women, in health-care settings; foster earlier detection of HIV infection; identify and counsel persons with unrecognized HIV infection and link them to clinical and prevention services; and further reduce perinatal transmission of HIV in the United States. These revised recommendations update previous recommendations for HIV testing in health-care settings and for screening of pregnant women (CDC. Recommendations for HIV testing services for inpatients and outpatients in acute-care hospital settings. MMWR 1993;42[No. RR-2]:1-10; CDC. Revised guidelines for HIV counseling, testing, and referral. MMWR 2001;50[No. RR-19]:1-62; and CDC. Revised recommendations for HIV screening of pregnant women. MMWR 2001;50[No. RR-19]:63-85). Major revisions from previously published guidelines are as follows: For patients in all health-care settings HIV screening is recommended for patients in all health-care settings after the patient is notified that testing will be performed unless the patient declines (opt-out screening). Persons at high risk for HIV infection should be screened for HIV at least annually. Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing. Prevention counseling should not be required with HIV diagnostic testing or as part of HIV screening programs in health-care settings. For pregnant women HIV screening should be included in the routine panel of prenatal screening tests for all pregnant women. HIV screening is recommended after the patient is notified that testing will be performed unless the patient declines (opt-out screening). Separate written consent for HIV testing should not be required; general consent for medical care should be considered sufficient to encompass consent for HIV testing. Repeat screening in the third trimester is recommended in certain jurisdictions with elevated rates of HIV infection among pregnant women.

Objective: To assess the levels and correlates of potential exposure to and transmission of HIV in a contemporary, community-based probability sample of men who have sex with men (MSM)., Methods: In 2003, 311 sexually active MSM participated in a random-digit dial telephone survey in Seattle neighborhoods with a high prevalence of MSM. The primary outcomes were potential exposure to and transmission of HIV, defined as unprotected anal intercourse with a man of opposite or unknown HIV status in the preceding 12 months., Results: Fourteen percent of respondents reported being HIV-positive, 77% reported being HIV-negative, and 8% had not been tested. Of 241 HIV-negative MSM, 25 (10%; 95% confidence interval [CI], 7-15%) were potentially exposed to HIV; among 45 HIV-positive MSM, 14 (31%; 95% CI, 20-46%) were potential HIV-transmitters. Among HIV-negative men, the strongest bivariate correlates of potential exposure to HIV were recent bacterial sexually transmitted disease (odds ratio [OR], 5.8), number of recent male sexual partners (OR, 1.01 per partner), recent sex at a bathhouse (OR, 9.1), and recent use of sildenafil (OR, 4.4), amyl nitrite (OR, 6.2), and methamphetamine (OR, 8.0). Among HIV-infected men, the strongest correlates of potential HIV transmission were recent use of amyl nitrite (OR, 3.1), number of recent male sex partners (OR, 1.07 per partner), and having a male spouse or domestic partner (OR, 0.3)., Conclusions: Most MSM knew their HIV status and adopted safer sexual behaviors to reduce their risk of HIV acquisition or transmission. However, 10% of HIV-negative MSM and 31% of HIV-positive MSM recently engaged in behaviors that placed them at high risk for acquiring or transmitting HIV.

Objective: The objective of this study was to define the positive predictive value (PPV) of the Focus herpes simplex virus type 2 (HSV-2) enzyme-linked immunosorbent assay (ELISA) in a low HSV-2 prevalence population and to develop a new test interpretation algorithm., Methods: HSV-2 Western blots were performed on sera from male sexually transmitted disease clinic patients testing HSV-2 ELISA-positive and used to define a new class of indeterminate HSV-2 ELISA result. HSV-2 Western blots were then prospectively performed on sequential sera with indeterminate HSV-2 ELISAs., Results: Ninety-one (84%) of 108 HSV-2 ELISA-positive sera tested HSV-2 Western blot-positive. Western blot positivity was more common in men without herpes simplex virus type 1 (HSV-1) antibody than in those with HSV-1 antibody (93% vs 76%, P = 0.02) and in men with a history or clinical evidence of genital lesions (88% vs 80%, P = 0.30). Selectively raising the ELISA index value defining HSV-2 positivity from >1.1 to >or=3.0 either among HSV-1-positive men or among those without a history or clinical evidence of genital lesions increased the PPV to >or=93%. Prospective evaluation of an algorithm incorporating HSV-1 serostatus found that 11 of 70 persons with indeterminate HSV-2 ELISAs were Western blot-positive., Conclusions: Clinicians should consider selectively using a higher index value to define Focus ELISA HSV-2 positivity based on either HSV-1 serostatus or clinical circumstances.

Background: Few studies have evaluated the relationship between condom use and herpes simplex virus type 2 (HSV-2) and HSV type 1 (HSV-1) acquisition., Objective: To assess the relationship between condom use and acquisition of HSV-2 and HSV-1 among men and women., Design: Analysis of data collected as part of a clinical trial of an ineffective candidate vaccine for HSV-2., Setting: Sexually transmitted disease clinics., Participants: Men and women at risk for HSV-2 acquisition, defined as having 4 or more sexual partners or having a sexually transmitted disease in the past year., Measurement: Acquisition of HSV-2 and HSV-1 as measured by viral culture or change to positive HSV serostatus., Results: Of 1843 participants, 118 (6.4%) became infected with HSV-2. In multivariate analyses, participants reporting more frequent use of condoms were at lower risk for acquiring HSV-2 than participants who used condoms less frequently (hazard ratio, 0.74 [95% CI, 0.59 to 0.95]); categories of increasing condom use were 0% to 25%, 25% to 75%, and greater than 75% of sexual acts. Nineteen (2.9%) of 659 participants at risk for infection with HSV-1 became infected. No statistically significant association between condom use and infection with HSV-1 was found (hazard ratio, 0.79 [CI, 0.48 to 1.31])., Limitations: Use of condoms was measured by self-report, and persons who used condoms may have differed from those who did not., Conclusions: Consistent use of condoms is associated with lower rates of infection with HSV-2 and should be routinely recommended.

Sexual transmission accounts for the majority of hepatitis B virus (HBV) infections in industrialized countries. Hepatitis A virus (HAV) can be transmitted by sexual practices that involve fecal-oral exposure. Both infections are disproportionately frequent in men who have sex with men (MSM). Routine immunization against HBV is recommended for MSM and for persons being evaluated or treated for sexually transmitted diseases (STDs), and HAV immunization is advised for MSM and for other persons at risk who are commonly seen in STD care settings, such as users of illegal drugs. However, numerous attitudinal and structural barriers interfere with routine immunization in persons at risk for sexual acquisition of HAV and HBV. Substantial success has been documented in vaccinating persons at risk in public STD clinics and other settings; however, at a national level, efforts to achieve desired immunization rates have largely failed. Until universal childhood immunization produces a largely immune adult population, the universal vaccination of adults-as a supplement to the current risk-based approaches-may be worthwhile to achieve immunization of persons at risk for sexual transmission of HBV.

Neonatal herpes is a devastating disease, the most serious complication of genital herpes, one of the most common serious congenital or perinatal infections, and the most frequent complication of sexually transmitted infections among children. Nevertheless, neonatal herpes is not reportable to health authorities in most states. The potential for prevention has been enhanced by recent diagnostic and therapeutic advances, and the disease meets widely accepted criteria for reporting, including incidence rates that exceed those of comparable conditions, epidemiologic instability, disease severity, direct and indirect socioeconomic costs, concern by persons at risk, the potential for prevention by public health interventions, and the prospect that the resulting data would influence public health policy. The absence of national surveillance contributes to beliefs by healthcare providers and the public health community that genital and neonatal herpes are uncommon conditions that affect small segments of society, beliefs that directly interfere with prevention. Neonatal herpes should be a reportable condition.

HIV-RNA testing may identify individuals with primary HIV infection. Men who have sex with men (MSM) having HIV testing through Public Health, Seattle and King County were screened for primary infection through pooled RNA testing. Eighty-one out of 3525 specimens (2.3%) had detectable antibody and RNA, and seven out of 3439 antibody-negative specimens (0.2%) had HIV RNA. Targeted screening for primary infection through pooled RNA testing in MSM is a useful addition to HIV case finding.

Background: Patient-delivered partner therapy (PDPT) is the practice of providing disease-specific antimicrobial agents to patients for delivery to their sex partners. Some partners who receive PDPT may forgo clinical evaluation, resulting in missed opportunities for the diagnosis and treatment of comorbid conditions., Methods: We conducted a review of electronic charts for 8623 individuals attending 4 sexually transmitted disease clinics who were sex partners of patients with selected sexually transmitted infections (STIs). We evaluated the concordance between STIs diagnosed in partners and their reported exposures for which they might have received PDPT., Results: Among 3503 female and 4647 heterosexual male partners, 19 (0.4%) of 4716 individuals tested were newly diagnosed with human immunodeficiency virus (HIV) infection, and 61 individuals (0.7%) had syphilis. Pelvic inflammatory disease was diagnosed in 133 women (3.8%). Seventy-two (3.2%) of 2226 female and heterosexual male partners reporting exposure to patients with chlamydial infection had gonorrhea diagnosed. Chlamydial infection or gonorrhea was diagnosed in 81 heterosexual male partners (10.3%) who reported contact with women with trichomoniasis. Among 473 men who have sex with men (MSM; including bisexual men), 13 (6.3%) of 207 tested were newly diagnosed with HIV infection, and 8 (1.7%) had syphilis. Six (6.1%) of 98 MSM reporting exposure to patients with chlamydial infection had gonorrhea diagnosed., Conclusions: Infrequent coinfections in female and heterosexual male partners exposed to patients with chlamydial infection or gonorrhea would not preclude use of PDPT. However, PDPT for male partners of women with trichomoniasis and for MSM requires further study.

Background: Many sex partners of persons with gonorrhea or chlamydial infections are not treated, which leads to frequent reinfections and further transmission., Methods: We randomly assigned women and heterosexual men with gonorrhea or chlamydial infection to have their partners receive expedited treatment or standard referral. Patients in the expedited-treatment group were offered medication to give to their sex partners, or if they preferred, study staff members contacted partners and provided them with medication without a clinical examination. Patients assigned to standard partner referral were advised to refer their partners for treatment and were offered assistance notifying partners. The primary outcome was persistent or recurrent gonorrhea or chlamydial infection in patients 3 to 19 weeks after treatment., Results: Persistent or recurrent gonorrhea or chlamydial infection occurred in 121 of 931 patients (13 percent) assigned to standard partner referral and 92 of 929 (10 percent) assigned to expedited treatment of sexual partners (relative risk, 0.76; 95 percent confidence interval, 0.59 to 0.98). Expedited treatment was more effective than standard referral of partners in reducing persistent or recurrent infection among patients with gonorrhea (3 percent vs. 11 percent, P=0.01) than in those with chlamydial infection (11 percent vs. 13 percent, P=0.17) (P=0.05 for the comparison of treatment effects) and remained independently associated with a reduced risk of persistent or recurrent infection after adjustment for other predictors of infection at follow-up (relative risk, 0.75; 95 percent confidence interval, 0.57 to 0.97). Patients assigned to expedited treatment of sexual partners were significantly more likely than those assigned to standard referral of partners to report that all of their partners were treated and significantly less likely to report having sex with an untreated partner., Conclusions: Expedited treatment of sex partners reduces the rates of persistent or recurrent gonorrhea or chlamydial infection., (Copyright 2005 Massachusetts Medical Society.)

Objectives: We measured and compared the concentration of primary and secondary syphilis, gonorrhea, chlamydial infection, and genital herpes in a large county with urban, suburban, and rural settings., Methods: We geocoded sexually transmitted infections reported to King County, Washington health department in 2000-2001 to census tract of residence. We used a model-based approach to measure concentration with Lorenz curves and Gini coefficients., Results: Syphilis exhibited the highest level of concentration (estimated Gini coefficient = 0.68, 95% confidence interval [CI] = 0.64, 0.78), followed by gonorrhea (estimated Gini coefficient=0.57; 95% CI=0.54, 0.60), chlamydial infection (estimated Gini coefficient = 0.45; 95% CI = 0.40, 0.43), and herpes (estimated Gini coefficient=0.26; 95% CI=0.22, 0.29)., Conclusions: Geographically targeted interventions may be most appropriate for syphilis and gonorrhea. For less-concentrated infections, control strategies must reach a wider portion of the population.

Objectives: The objective of this study was to define the legal status of patient-delivered partner therapy (PDPT) in the United States., Study: A survey of directors of state boards of pharmacy and medicine in the 50 United States and the District of Columbia was performed., Results: Completed surveys were returned by 37 (72%) pharmacy boards and 37 (72%) medical boards representing 47 states. PDPT was clearly defined as legal in four states. PDPT was regarded as illegal by 16 (43%) medical boards and 19 (51%) pharmacy boards and as of uncertain legality by 16 (43%) medical boards and 14 (38%) pharmacy boards. Most boards (88%) that regarded PDPT as illegal or of uncertain legality indicated that the issue had never been addressed., Conclusions: The legal status of PDPT is uncertain in much of the U.S., and the practice is often considered illegal. New laws or legal rulings will be needed if PDPT is to be widely promoted.

Objective: The objective of this study was to define the scope and case-finding success of HIV partner notification (PN) in the United States., Study: The authors conducted an analysis of PN data from metropolitan areas >500,000 reporting > or =200AIDS cases in 2001., Results: Data were collected from 28 (72%) of 39 eligible jurisdictions. In 22 jurisdictions with reportable HIV, health departments interviewed 32% of 20,353 persons with newly reported HIV. Among 6394 sex or needle-sharing partners, 19% had been previously HIV-diagnosed; 10% tested HIV-positive; 32% tested HIV-negative; and 39% were not notified, denied previous HIV diagnosis and refused HIV testing, or outcome was unknown. Health departments interviewed 13.8 persons to identify 1 new case of HIV (range, 1.0-196). Areas in which larger proportions of AIDS cases occurred among men who have sex with men reported less success identifying new cases of HIV through PN., Conclusions: HIV PN programs identify new cases of HIV but have variable success and affect a minority of persons reported with HIV.

Objective: The objective of this study was to compare reporting between audio computer-assisted self-interview (ACASI) and clinician-administered sexual histories., Goal: The goal of this study was to explore the usefulness of ACASI in sexually transmitted disease (STD) clinics., Study: The authors conducted a cross-sectional study of ACASI followed by a clinician history (CH) among 609 patients (52% male, 59% white) in an urban, public STD clinic. We assessed completeness of data, item prevalence, and report concordance for sexual history and patient characteristic variables classified as socially neutral (n=5), sensitive (n=11), or rewarded (n=4)., Results: Women more often reported by ACASI than during CH same-sex behavior (19.6% vs. 11.5%), oral sex (67.3% vs. 50.0%), transactional sex (20.7% vs. 9.8%), and amphetamine use (4.9% vs. 0.7%) but were less likely to report STD symptoms (55.4% vs. 63.7%; all McNemar chi-squared P values <0.003). Men's reporting was similar between interviews, except for ever having had sex with another man (36.9% ACASI vs. 28.7% CH, P <0.001). Reporting agreement as measured by kappas and intraclass correlation coefficients was only moderate for socially sensitive and rewarded variables but was substantial or almost perfect for socially neutral variables. ACASI data tended to be more complete. ACASI was acceptable to 89% of participants., Conclusions: ACASI sexual histories may help to identify persons at risk for STDs.

We collected specimens from women who tested positive for Neisseria gonorrhoeae using the Gen-Probe APTIMA Combo 2 (AC2), and we performed confirmatory tests using a nucleic acid amplification test (NAAT) that targets alternate gonococcal nucleic acid sequences. Among 59,664 specimens, 280 (0.47%) had positive results using AC2; 265 of these specimens were tested using the confirmatory NAAT, of which 258 yielded positive results (positive predictive value, 97.4%; 95% confidence interval, 95.1%-98.8%). Routine confirmatory testing of specimens with positive AC2 gonorrhea test results is not indicated.

Clinical HIV risk assessments have not typically integrated questions about sex partners' HIV status with questions about condom use and type of sex. Since 2001, we have asked all men who have sex with men (MSM) evaluated in an urban sexually transmitted disease (STD) clinic how often in the preceding 12 months they used condoms for anal sex with partners who were HIV-positive, HIV-negative, and of unknown HIV status. Overall, MSM displayed a pattern of assortative mixing by HIV status, particularly for unprotected anal intercourse (UAI). Nevertheless, 433 (27%) of 1580 MSM who denied knowing they were HIV-positive and 93 (43%) of 217 HIV-positive MSM reported having UAI with a partner of opposite or unknown HIV status. Among men who denied previously knowing they were HIV-positive, 24 (9.6%) of 251 MSM who reported having UAI with an HIV-positive partner or partner of unknown HIV status compared with 11 (1.7%) of 620 MSM who denied such exposure tested HIV-positive (odds ratio=5.8, 95% confidence interval: 2.8-12.1). UAI with an HIV-positive partner or partner with unknown HIV status was 69% sensitive and 73% specific in identifying men with previously undiagnosed HIV infection; UAI regardless of partner HIV status was 80% sensitive but only 45% specific. The positive predictive value was highest for risk assessments that included partner HIV status. Integrating questions about anal sex partner HIV status and condom use identifies MSM at greatest risk for HIV acquisition and transmission. These risk criteria might be effectively used to triage MSM into more intensive prevention interventions.