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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 settingsHIV 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 womenHIV 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. [ABSTRACT FROM AUTHOR]

Context: In the last 3 decades, herpes simplex virus type 2 (HSV-2) infection seroprevalence and neonatal herpes have increased substantially. An effective vaccine for the prevention of genital herpes could help control this epidemic.Objective: To evaluate the efficacy of a vaccine for prevention of HSV-2 infection.Design: Two randomized, double-blind, placebo-controlled multicenter trials of a recombinant subunit vaccine containing 30 microg each of 2 major HSV-2 surface glycoproteins (gB2 and gD2) against which neutralizing antibodies are directed, administered at months 0, 1, and 6. Control subjects were given a citrate buffer vehicle. Participants were followed up for 1 year after the third immunization.Setting and Participants: We enrolled 2393 persons from December 10, 1993, to April 4, 1995, who were HSV-2 and human immunodeficiency virus seronegative. One trial with 18 centers enrolled 531 HSV-2-seronegative partners of HSV-2-infected persons; the other, with 22 centers, enrolled 1862 persons attending sexually transmitted disease clinics. A total of 2268 (94.8%) met inclusion criteria and were included in the analysis with 1135 randomized to placebo and 2012 to vaccine.Main Outcome Measure: Time to acquisition of HSV-2 infection, defined by seroconversion or isolation of HSV-2 in culture during the study period by randomization group.Results: Time-to-event curves indicated a 50% lower acquisition rate among vaccine vs placebo recipients during the initial 5 months of the trial; however, overall vaccine efficacy was 9% (95% confidence interval, -29% to 36%). Acquisition rates of HSV-2 were 4.6 and 4.2 per 100 patient-years in the placebo and vaccine recipients, respectively (P =.58). Follow-up of vaccine recipients acquiring HSV-2 infection showed vaccination had no significant influence on duration of clinical first genital HSV-2 episodes (vaccine, median of 7.1 days; placebo, 6.5 days; P>.10) or subsequent frequency of reactivation (median monthly recurrence rate with vaccine, 0.2; with placebo, 0.3; P>.10). The vaccine induced high levels of HSV-2-specific neutralizing antibodies in vaccinated persons who did and did not develop genital herpes.Conclusions: Efficient and sustained protection from sexual acquisition of HSV-2 infection will require more than high titers of specific neutralizing antibodies. Protection against sexually transmitted viruses involving exposure over a prolonged period will require a higher degree of vaccine efficacy than that achieved in this study. [ABSTRACT FROM AUTHOR]

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.

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.