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Network approaches can be used to study sociosexual partnerships and identify individuals at high risk of infection. Little is known about the cost structure of these services and their association with STD diagnoses.We collected costs associated with using a peer network strategy to recruit men who have sex with men and transwomen of color in 4 counties in North Carolina: Guilford, Forsyth, Durham, and Wake from February through October 2019. We used a comprehensive costing approach to gather detailed retrospective information on the intervention cost, broken down by category and programmatic activity.The sociosexual networks collected consisted of 31 initial seeds (index cases) and 49 peers of those seeds. In peers, 5 cases of human immunodeficiency virus (HIV) and 10 cases of syphilis were identified. The cost per case (HIV or syphilis) identified was $7325. Personnel costs accounted for 80% of total expenditures, followed by laboratory expenses (12%). Personnel cost was distributed between disease intervention specialist patient navigators (51%), nonclinical (37%), and management (12%) staff. General administration was the costliest programmatic activity (37%), followed by case management and field services (37%), and study activities (11%). The estimated average cost per patient tested was $2242.Finding positive peer cases in nonclinical settings is costly but may be crucial for limiting the spread of sexually transmitted diseases. The cost of staff was the major driver. This study demonstrates that using a network strategy can be a cost-effective way to identify, test, and refer patients at high risk of syphilis and HIV infections to care.

The American Sexually Transmitted Diseases Association has, for several years, been conducting a cross-sector workshop to bring together a variety of stakeholders to develop ideas for collaboratively improving the sexually transmitted infection control efforts in the United States. In this summary, we share the content of discussions and ideas of the fourth annual workshop for future research and potential changes to practice with a focus on diagnostic capacity.

Trichomonas vaginalis is likely 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 trichomoniasis, as African Americans are >4 times more likely to be infected than persons of other races. Since publication of the 2015 Centers for Disease Control and Prevention sexually transmitted diseases treatment guidelines, additional data have bolstered the importance of T. vaginalis infection sequelae in women, including increased risk of human immunodeficiency virus (HIV) acquisition, cervical cancer, preterm birth, and other adverse pregnancy outcomes. Less is known about the clinical significance of infection in men. Newly available diagnostic methods, including point-of-care assays and multiple nucleic acid amplification tests, can be performed on a variety of genital specimens in women and men, including urine, allowing more accurate and convenient testing and screening of those at risk for infection. Repeat and persistent infections are common in women; thus, rescreening at 3 months after treatment is recommended. In vitro antibiotic resistance to 5-nitroimidazole in T. vaginalis remains low (4.3%) but should be monitored. High rates of T. vaginalis among sexual partners of infected persons suggest a role for expedited partner treatment. A randomized controlled trial in HIV-uninfected women demonstrated that multidose metronidazole 500 mg twice daily for 7 days reduced the proportion of women with Trichomonas infection at 1 month test of cure compared with women receiving single-dose therapy (2 g). The 2-g single-dose oral metronidazole regimen remains the preferred treatment in men.

Improving adherence to antiretroviral therapy (ART) is essential for limiting HIV disease progression among young sexual minority men living with HIV. Daily diaries allow for a detailed examination of how fluctuations in psychosocial factors are associated with adherence over time. Across three cities in the United States, this study collected 60 days of quantitative data from 44 young men (between 16 and 24 years of age) living with HIV who have sex with men. Lagged transition models explored the associations of mood, stress, social support, substance use, and condomless intercourse with daily ART adherence. Baseline levels of illicit substance use and condomless intercourse, and a higher proportion of days with stress or marijuana use, were associated with lower ART adherence. Lapses in adherence predicted non-adherence the following day. Findings suggest prospective data collection may identify different predictors of adherence compared to retrospective recall. Lapse-management strategies are needed to improve adherence following a missed dose.

This systematic review and meta-analysis provide support for a nearly 2-fold higher risk for acquiring Trichomonas vaginalis among women with bacterial vaginosis compared with women without bacterial vaginosis. Supplemental digital content is available in the text., Background Bacterial vaginosis (BV) has been associated with an increased risk for acquisition of human immunodeficiency virus and sexually transmitted infections. We evaluated the association between BV and incident Trichomonas vaginalis (TV) infection in women. Methods MEDLINE and ClinicalTrials.gov were searched for articles published between January 1, 1980, and May 7, 2021. Observational studies in women that evaluated the relationship between having/not having BV and the risk for acquiring TV were included. Results Fourteen studies were included in the systematic review; 12 studies were included in meta-analyses involving 18,424 participants. Most studies used Nugent scoring to diagnose BV. For TV diagnosis, 12 studies used wet mount microscopy or culture, and 2 used nucleic acid amplification tests. There was diversity in the measures of association used, so an overall effect size could not be calculated. The majority of studies reported odds ratios, which showed an increased risk of incident TV among women with BV versus without BV (adjusted odds ratio, 1.87; 95% confidence interval, 1.45–2.40; P = 0.007). However, there were heterogeneity and potential confounding factors (eg, age, sexual partners) reported among studies. Conclusions This systematic review and meta-analysis provide evidence for a nearly 2-fold higher risk for acquiring TV among women with BV compared with women without BV.

BACKGROUND We conducted an observational study to determine whether patients with syphilis who do not demonstrate serological cure or lack of seroreversion in nontreponemal (NT) antibody titers after initial therapy benefit from re-treatment and cerebrospinal fluid (CSF) analysis. METHODS We enrolled patients with syphilis from sexually transmitted disease clinics in Guangzhou, China, who had persistent NT titers after therapy. Serological nonresponse was defined as a

Background Few studies have examined long-term outcomes among persons who initiate preexposure prophylaxis (PrEP) in the South, including PrEP discontinuation and sexually transmitted infection (STI) rates. Methods Care discontinuation (>6 months without a PrEP appointment) and incident STIs were evaluated for patients at 2 PrEP clinics in Durham, NC. We tested for predictors of discontinuation as a binary variable using logistic regression. Model covariates included age, race/ethnicity, sex, known HIV-positive partner, commercial sex work, men who have sex with men (MSM) versus not MSM, type of insurance, and clinic site. A similar analysis was completed for STI incidence, controlling for days in the study. Results Among 271 patients, mean age was 33.2 years, 46.9% were Black and 11.1% were Latino, 81.2% were MSM, and 32% were uninsured. Preexposure prophylaxis was discontinued in 47%, and another 11% had intermittent care. Sexually transmitted infection incidence was 45.4/100 person-years, and 5 patients were diagnosed with HIV at baseline or in follow-up. Men who have sex with men were less likely to discontinue PrEP relative to non-MSM (odds ratio [OR], 0.26; 95% confidence interval [CI], 0.10-0.64). Baseline STI was associated with a higher likelihood of incident STI (OR, 8.19; 95% CI, 3.69-19.21), whereas care discontinuation was associated with a lower likelihood of STI (OR, 0.28; 95% CI, 0.11-0.65). Conclusions Preexposure prophylaxis programs in the Southern United States are reaching uninsured and predominantly Black and Latino MSM, but discontinuation rates are high despite elevated rates of incident STI and HIV. Further work is required to elucidate causes of PrEP discontinuation and encourage persistence in care.

Progressive antimicrobial resistance in Neisseria gonorrhoeae, Mycoplasma genitalium, and Trichomonas vaginalis has created a pressing need for treatment optimisations for sexually transmitted infections (STIs). In this Review, we aim to highlight urgent needs in global STI management, including: (1) improved surveillance to monitor antimicrobial resistance and clinical outcomes; (2) systematic pharmacokinetic and pharmacodynamic evaluations to ensure resistance suppression and bacterial eradication at all sites of infection; (3) development of novel, affordable antimicrobials; and (4) advancements in new molecular and point-of-care tests to detect antimicrobial resistance determinants. Antimicrobial resistance among STIs is a global public health crisis. Continuous efforts to develop novel antimicrobials will be essential, in addition to other public health interventions to reduce the global STI burden. Apart from prevention through safer sexual practices, the development of STI vaccines to prevent transmission is a crucial research priority.

Background Antimicrobial resistance in Mycoplasma genitalium (MG), a cause of urethritis, is a growing concern. Yet little is known about the geographic distribution of MG resistance in the United States or about its associated clinical outcomes. We evaluated the frequency of MG among men with urethritis, resistance mutations, and posttreatment symptom persistence. Methods We enrolled men presenting with urethritis symptoms to 6 US sexually transmitted disease (STD) clinics during June 2017–July 2018; men with urethritis were eligible for follow-up contact and, if they had persistent symptoms or MG, a chart review. Urethral specimens were tested for MG and other bacterial STDs. Mutations in 23S ribosomal ribonucleic acid (rRNA) loci (macrolide resistance–associated mutations [MRMs]) and in parC and gyrA (quinolone-associated mutations) were detected by targeted amplification/Sanger sequencing. Results Among 914 evaluable participants, 28.7% (95% confidence interval [CI], 23.8–33.6) had MG. Men with MG were more often Black (79.8% vs 66%, respectively), Conclusions MG infection was common among men with urethritis; the MRM prevalence was high among men with MG. Persistent symptoms following treatment were frequent among men both with and without MG.

Background Disease intervention specialists (DIS) provide partner services (PS) for sexually transmitted infections (STI). We assessed an expansion of DIS services for clients with HIV and/or syphilis, and contacts within their social and sexual networks. Methods Black and Latinx cisgender men and transgender women who have sex with men diagnosed with HIV and/or syphilis in four urban North Carolina (NC) counties were referred to designated DIS, who were trained to recruit clients as "seeds" for chain-referral sampling of sociosexual network "peers." All received HIV/STI testing and care; referrals for pre-exposure prophylaxis (PrEP) and social, behavioral, and non-STI medical services were offered. Participants completed baseline, 1 month, and 3 month computerized surveys. Results Of 213 cases referred to DIS from May 2018 to February 2020, 42 seeds (25 with syphilis, 17 with HIV) and 50 peers participated. Median age was 27 years; 93% were Black and 86% were cisgender men. Most peers came from seeds' social networks: 66% were friends, 20% were relatives, and 38% were cisgender women. Incomes were low, 41% were uninsured, and 10% experienced recent homelessness. More seeds than peers had baseline PrEP awareness; attitudes were favorable but utilization was poor. Thirty-seven participants were referred for PrEP 50 times; 17 (46%) accessed PrEP by month 3. Thirty-nine participants received 129 non-PrEP referrals, most commonly for housing assistance, primary care, Medicaid navigation, and food insecurity. Conclusions Chain-referral sampling from PS clients allowed DIS to access persons with significant medical and social service needs, demonstrating that DIS can support marginalized communities beyond STI intervention.

Background Whole-genome sequencing (WGS) of Treponema pallidum subspecies pallidum (TPA) has been constrained by the lack of in vitro cultivation methods for isolating spirochetes from patient samples. Methods We built upon recently developed enrichment methods to sequence TPA directly from primary syphilis chancre swabs collected in Guangzhou, China. Results By combining parallel, pooled whole-genome amplification with hybrid selection, we generated high-quality genomes from 4 of 8 chancre-swab samples and 2 of 2 rabbit-passaged isolates, all subjected to challenging storage conditions. Conclusions This approach enabled the first WGS of Chinese samples without rabbit passage and provided insights into TPA genetic diversity in China.

The syndromic management of genital ulcer disease (GUD) misses asymptomatic syphilis cases but is widely utilized in resource-limited settings without diagnostic capabilities to ensure treatment for the most common etiologies of GUD. We used rapid serology tests for syphilis screening at a Malawian sexually transmitted infections clinic. The estimated seroprevalence was 9% and was highest among patients with genital ulcers (26%) and newly diagnosed HIV infection (19%). Rapid syphilis screening has the potential to increase syphilis detection, but accurate patient histories regarding syphilis diagnosis and prior treatment are needed.

Guidance about integration of comprehensive hepatitis C virus (HCV)-related services in sexually transmitted disease (STD) clinics is limited. We evaluated a federally funded HCV testing and linkage-to-care program at an STD clinic in Durham County, North Carolina. During December 10, 2012, to March 31, 2015, the program tested 733 patients for HCV who reported 1 or more HCV risk factor; 81 (11%) were HCV-infected (ie, HCV antibody-positive and HCV ribonucleic acid-positive). Fifty-one infected patients (63%) were linked to care. We concluded that essential program resources include reflex HCV ribonucleic acid testing; a dedicated bridge counselor to provide test results, health education, and linkage-to-care assistance; and referral relationships for local HCV management and treatment.

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.

Expanding access to HIV preexposure prophylaxis (PrEP) could help reduce rates of HIV infection in the United States. This study characterizes activities and barriers to PrEP implementation at local health departments (LHDs) in North Carolina (NC), which contains a large rural population.In May 2016, a web-based survey was distributed to health directors of all county and district health departments in NC to assess PrEP-related activities, perceived barriers to PrEP implementation, and desired PrEP-related resources.Of 85 LHDs in NC, 56 (66%) responded to the survey. Of these, 2 (4%) reported PrEP prescribing and 7 (13%) externally referred for PrEP services. Among the 54 departments not prescribing PrEP, the most frequently cited reasons were cost concerns (n = 25, 46%), lack of formal prescribing protocols (n = 21, 39%), and belief that PrEP would be better managed at primary care or specialty clinics (n = 19, 35%). Among the 47 departments not prescribing or referring clients for PrEP, the most frequently cited reasons for the lack of PrEP referral were the absence of local PrEP providers (n = 29, 62%), lack of PrEP knowledge among staff (n = 13, 28%), and perceived lack of PrEP candidates (n = 12, 26%). The most frequently requested PrEP-related resources included training to help identify PrEP candidates (n = 39, 70%) and training on PrEP prescribing and management (n = 38, 68%).PrEP prescribing and referral among LHDs in NC remains extremely limited. Increased PrEP-related training and support for LHD-based providers could enhance PrEP access, especially in rural and underserved areas.

Uptake of pre-exposure prophylaxis (PrEP) has been limited among black and Latino men who have sex with men (MSM), especially in the southern United States. Public health departments and federally qualified health centers (FQHCs) serving predominantly uninsured populations are uniquely positioned to improve access. We evaluated a novel PrEP collaboration between a public health department and an FQHC in North Carolina (NC). In May 2015, a PrEP program was initiated that included no-cost HIV/sexually transmitted infection screening at a public health department, followed by referral to a colocated FQHC for PrEP services. We profiled the PrEP continuum for patients entering the program until February 2018. PrEP initiators and noninitiators were compared using Wilcoxon rank-sum test for continuous variables and chi-square or Fisher's exact tests for categorical variables. Of 196 patients referred to the FQHC, 60% attended an initial appointment, 43% filled a prescription, 38% persisted in care for >3 months, and 30% reported >90% adherence at follow-up. Among those presenting for initial appointments (n = 117), most were MSM (n = 95, 81%) and black (n = 62, 53%); 21 (18%) were Latinx and 9 (8%) were trans persons. Almost half (n = 55) were uninsured. We found statistically significant differences between PrEP initiators versus noninitiators based on race/ethnicity (p = 0.02), insurance status (p = 0.05), and history of sex work (p = 0.05). In conclusion, this collaborative model of PrEP care was able to reach predominantly black and Latino MSM in the southern United States. Although sustainable, program strategies to improve steps along the PrEP care continuum are vital in this population.

BACKGROUND Syphilis management is complex and demonstration of treatment response requires monitoring of nontreponemal antibody titers for a ≥ 4-fold decline and/or seroreversion to nonreactive titers. METHODS We evaluated data from a multicenter clinical trial of syphilis treatment conducted from 2000 to 2009 involving human immunodeficiency virus (HIV)-negative patients 18 years or older with early syphilis. To assess the rate of titer decline and seroreversion after effective therapy, rapid plasma reagin (RPR) titers were analyzed at 1, 3, 6, 9, and 12 months among patients with an appropriate treatment response. We plotted the rate of RPR titer decline after treatment, estimated the frequency of seroreversion, and conducted multivariate analyses to assess characteristics associated with seroreversion. RESULTS Among 369 (79.4%) of 465 HIV-negative patients with early syphilis who had an appropriate treatment response, 333 participants had complete RPR data over 12 months. Although the decline in RPR titers was ≥ 4-fold among 88.0% (293/333) of participants at 3 months and ≥ 8-fold among 77.8% at 6 months, only 9.6% achieved complete RPR seroreversion at 6 months and 17.1% at 12 months after therapy. Male sex (adjusted odds ratio, 4.3; 95% confidence interval, 1.8-10.5) and baseline RPR titers ≤ 1:32 (adjusted odds ratio, 14.5; 95% confidence interval, 6.8-31.2) were associated with higher odds of seroreversion compared with females and titers > 1:32, respectively. CONCLUSIONS Despite a ≥ 4-fold RPR titer decline after treatment, the majority of HIV-negative patients with early syphilis failed to have seroreversion at 12 months. Nontreponemal antibody titers often persist despite an appropriate treatment response.

Background Despite advances in antivirals, disparities in hepatitis C (HCV) treatment remain. We evaluated persons diagnosed with HCV in 4 safety net sites in a large Southeastern county, using care cascades to conceptualize milestones in treatment. Methods Persons diagnosed with HCV in 4 screening sites across Durham County, North Carolina, from December 2015 to May 2018 were included, allowing for 9 months of follow-up. Sites included the county health department (CHD), a federally qualified health center (FQHC) where providers trained in HCV care, jail and community outreach. Persons with HCV were eligible for a bridge counselor intervention to enhance linkage to care with an HCV-treating provider (either primary care or specialist). Outcomes were monitored by chart review. Persons linked to care in the prison (n = 36) were censored from subsequent cascade steps due to inability to obtain records. Cascades were compared by the site of diagnosis. Multivariable logistic regression was used to evaluate predictors of being prescribed antivirals. Results 505 persons were diagnosed with HCV: 216 in the FQHC, 158 in the jail, 72 in the CHD, and 59 in community outreach. Overall, 89% were counseled on their diagnosis, 65% were linked to care, 41% prescribed antivirals, 38% started medications, 34% completed medications and 24% achieved sustained viral response at 12 weeks (SVR-12). Progression through the cascade was highest for those diagnosed at the FQHC (figure). In analyses adjusted for demographics and risk factors, diagnosis in a community outreach setting had lower odds of antiviral prescription, compared with diagnosis in the FQHC (OR 0.33, 95% CI 0.12–0.89). Linkage to care at a specialist clinic (vs. primary care) was associated with antiviral prescription (OR 3.82, CI 1.95–7.46). Sex, race/ethnicity, insurance status and HCV risk factors were not associated with antiviral prescription. Conclusion Among persons diagnosed with HCV across four safety net sites, a quarter achieved SVR-12. Those diagnosed in community outreach had lower odds of antiviral prescription, and those who were linked to a specialist were more likely to receive antiviral prescription. Improving progression through cascade milestones across safety-net settings is integral to improving population-based HCV outcomes. Disclosures All authors: No reported disclosures.

Neisseria gonorrhoeae and Chlamydia trachomatis are well-documented urethral pathogens, and the literature supporting Mycoplasma genitalium as an etiology of urethritis is growing. Trichomonas vaginalis and viral pathogens (herpes simplex virus types 1 and 2 and adenovirus) can cause urethritis, particularly in specific subpopulations. New data are emerging regarding the potential role of bacterial vaginosis-associated bacteria in urethritis, although results are inconsistent regarding the pathogenic role of Ureaplasma urealyticum in men. Mycoplasma hominis and Ureaplasma parvum do not appear to be pathogens. Men with suspected urethritis should undergo evaluation to confirm urethral inflammation and etiologic cause. Although nucleic acid amplification testing would detect N. gonorrhoeae and C. trachomatis (or T. vaginalis if utilized), there is no US Food and Drug Administration-approved clinical test for M. genitalium available in the United States at this time. The varied etiologies of urethritis and lack of diagnostic options for some organisms present treatment challenges in the clinical setting.

We evaluated the syphilis reverse sequence algorithm (RSA) in a Veteran Affairs facility, finding 5.5% reactive Treponema pallidum enzyme immunoassay (EIA) tests. In a subset of EIA+/VDRL-/TP-PA+ cases, 48% were previously treated. Of veterans with unknown/no prior therapy, only 45% had documentation of subsequent treatment, suggesting suboptimal interpretation of RSA results.

Background To improve the HIV continuum of care, a team of field service interventionists (State Bridge Counselors, SBC) was developed through a state public health system and provided brief (1-2) contacts for linkage of newly diagnosed persons with HIV and reengagement of persons living with HIV (PLWH) who were not in care. Setting North Carolina, United States. Methods Service data from January 2013 to June 2015 were analyzed to determine characteristics of clients referred to SBCs, proportions linked or reengaged in care, and/or achieved viral load suppression (VLs). We evaluated associations between client characteristics and outcomes using multivariable analyses and estimated odds ratios (OR) with 95% confidence intervals (CI). Results SBCs provided linkage services to 299 newly diagnosed individuals and reengagement services to 606 PLWH throughout North Carolina. Among persons who received linkage services, 189 (63%) had evidence of care within 90 days of referral and 205 (69%) had VLs within a year. Among PLWH who received reengagement services, 278 (46%) had care within 90 days and 308 (51%) had VLs within a year. Persons aged 30-39 years (OR, 2.1; 95% CI, 1.1 to 3.9) and 40-49 years had an increased likelihood (OR, 2.4; 95% CI, 1.1 to 5.2) of linkage within 90 days compared with persons aged 18-29 years. Non-white PLWH had an increased OR of 1.7; (95% CI, 1.2 to 2.5) of reengagement compared with whites. Conclusions Our SBC program successfully implemented a "low-touch" approach to provision of linkage and reengagement services, demonstrating that public health resources can be used to address the HIV care continuum on a statewide level.

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.

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).

Background Nongonococcal urethritis (NGU) is a common chlamydia-associated syndrome in men; however, Trichomonas vaginalis and Mycoplasma genitalium are associated with its etiology and should be considered in approaches to therapy. We sought to determine whether the addition of tinidazole, an anti-trichomonal agent, to the treatment regimen would result in higher cure rates than those achieved with treatment with doxycycline or azithromycin alone. A secondary aim was to compare the efficacy of doxycycline therapy and with that of azithromycin therapy. Methods Randomized, controlled, double-blinded phase IIB trial of men with NGU. Participants were randomized to receive doxycycline plus or minus tinidazole or azithromycin plus or minus tinidazole and were observed for up to 45 days. Results The prevalences of Chlamydia trachomatis, M. genitalium, and T. vaginalis were 43%, 31%, and 13%, respectively. No pathogens were identified in 29% of participants. Clinical cure rates at the first follow-up visit were 74.5% (111 of 149 patients) for doxycycline-containing regimens and 68.6% (107 of 156 patients) for azithromycin-containing regimens. By the final visit, cure rates were 49% (73 of 149 patients) for doxycycline-containing regimens and 43.6% (68 of 156 patients) for azithromycin-containing regimens. There were no significant differences in clinical response rates among the treatment arms. However, the chlamydia clearance rate was 94.8% (55 of 58 patients) for the doxycycline arm and 77.4% (41 of 53 patients) for the azithromycin arm (P = .011), and the M. genitalium clearance rate was 30.8% (12 of 39 patients) for the doxycycline arm and 66.7% (30 of 45 patients) for the azithromycin arm (P = .002). Conclusions Addition of tinidazole to the treatment regimen did not result in higher cure rates but effectively eradicated trichomonas. Clinical cure rates were not significantly different between patients treated with doxycycline and those treated with azithromycin; however, doxycycline had significantly better efficacy against Chlamydia, whereas azithromycin was superior to doxycycline for the treatment of M. genitalium.

Background Despite national recommendations in the United States to conduct hepatitis C virus (HCV) screening among the birth cohort and high-risk populations, persons seeking public health services have limited access to care. We developed a HCV screening and linkage-to-care program at a public health facility in North Carolina (NC), and evaluated the HCV prevalence and care continuum. Methods We collaborated with the Durham County Department of Public Health in Durham, NC to integrate routine HCV testing at the human services facility. Targeted screening with HCV antibody and reflex RNA was conducted based on U.S. guidelines (e.g., birth cohort, intravenous drug use [IVDU]) in clinical areas and the department of social services. To support linkage to care, a “bridge counselor” or social worker assisted chronic HCV-infected persons with transportation, initial appointments with HCV specialists, and access to other services. We analyzed the HCV prevalence, risk factors, and the care continuum among this population. Results From March 2016 to February 2018, targeted HCV screening was conducted among 2,775 persons, of which 84 (3%) were HCV antibody positive and RNA positive. Among persons identified with chronic HCV infection, the median age was 48.5 (interquartile range (IQR): 23–76), 48 (57%) were male, and 53 (63%) were African-American. HCV-infected persons had multiple risk factors including past or current IVDU use (n = 38, 45%), history of unlicensed tattoo/ear piercings (n = 35, 42%), and prior incarceration (n = 31, 38%); no HIV co-infections were identified. An assessment of the care continuum demonstrated that the majority with chronic HCV infection received post-test counseling (96%), met with the bridge counselor (70%) and attended their first medical appointment (74%). However, only 49% were prescribed HCV treatment and 24% achieved sustained virologic response. Conclusion Implementation of targeted screening with HCV antibody and reflex RNA in a public health setting, coupled with bridge counseling, can identify persons with chronic HCV infections and link them to care. However, only half received HCV treatment and a fourth achieved HCV cure, highlighting the gaps in the care continuum where future interventions should be directed. Disclosures A. Sena, Gilead Sciences: Grant Investigator, Grant recipient. C. Givens, Gilead Sciences: Grant support for salary, Grant recipient. G. McKnight, Gilead Sciences: Grant Investigator, Grant recipient. J. Thayer, Gilead Sciences: Grant Investigator, Grant recipient. A. Hilton, Gilead Sciences: Grant Investigator, Grant recipient.

Objective: An investigation was conducted to determine factors associated with a syphilis outbreak in a rural North Carolina county. Study Design: A retrospective chart review was performed on 61 primary (PS), secondary (SS), and early latent (ELS) syphilis case patients reported in Columbus County between January 2001 and February 2002. Sociosexual network analysis was conducted using electronic contact tracing information. Results: We identified 20 PS, 25 SS, and 16 ELS case patients who were predominantly black. Seventy-two percent had reported ≥1 sexual partner with early syphilis, 51% used crack cocaine and/or had sex with a crack-using partner, and 31% exchanged sex for drugs or money. The sexual network exhibited predominantly linear connections between case patients and sexual partners. Adding social connections to the network further demonstrated dense cyclic interactions characteristic of core groups. Conclusions: The syphilis outbreak in this rural community was associated with crack cocaine and exchange of sex for drugs in a densely interconnected sociosexual network.

Survivors of sexual assault are at risk for acquiring sexually transmitted infections (STIs). We conducted literature reviews and invited experts to assist in updating the sexual assault section for the 2015 Centers for Disease Control and Prevention sexually transmitted diseases (STD) treatment guidelines. New recommendations for STI management among adult and adolescent sexual assault survivors include use of nucleic acid amplification tests (NAATs) for detection of Trichomonas vaginalis by vaginal swabs; NAATs for detection of Neisseria gonorrhoeae and Chlamydia trachomatis from pharyngeal and rectal specimens among patients with a history of exposure or suspected extragenital contact after sexual assault; empiric therapy for gonorrhea, chlamydia, and trichomoniasis based on updated treatment regimens; vaccinations for human papillomavirus (HPV) among previously unvaccinated patients aged 9-26 years; and consideration for human immunodeficiency virus (HIV) nonoccupational postexposure prophylaxis using an algorithm to assess the timing and characteristics of the exposure. For child sexual assault (CSA) survivors, recommendations include targeted diagnostic testing with increased use of NAATs when appropriate; routine follow-up visits within 6 months after the last known sexual abuse; and use of HPV vaccination in accordance with national immunization guidelines as a preventive measure in the post-sexual assault care setting. For CSA patients, NAATs are considered to be acceptable for identification of gonococcal and chlamydial infections from urine samples, but are not recommended for extragenital testing due to the potential detection of nongonococcal Neisseria species. Several research questions were identified regarding the prevalence, detection, and management of STI/HIV infections among adult, adolescent, and pediatric sexual assault survivors.

Background Syphilis remains a global public health threat and can lead to severe complications. In addition to resolution of clinical manifestations, a reduction in nontreponemal antibody titers after treatment is regarded as “proof of cure.” However, some patients manifest

The Xpert(®) MTB/RIF assay has demonstrated robust capability for diagnosing tuberculosis (TB) and rifampin (RMP) resistance. Optimal use of Xpert in diverse settings will require knowledge of challenges when interpreting the results. We present three selected cases from the United States, a low-burden TB setting, to highlight important clinical scenarios encountered with Xpert testing: rapid RMP resistance detection in a patient with pre-extensively drug-resistant TB who immigrated from the Philippines, false-positive RMP resistance detection, and Mycobacterium tuberculosis detection in a culture-negative patient. These cases demonstrate that a low pre-test probability of TB or drug-resistant TB can complicate the interpretation of the Xpert assay.

The impact of syphilis reverse sequence screening has not been evaluated in community outreach. Using reverse sequence screening in neighborhoods identified with geographic information systems, we found that among 239 participants, 45 (19%) were seropositive. Of these, 3 (7%) had untreated syphilis, 33 (73%) had previously treated syphilis infection, and 9 (20%) had negative nontreponemal test results.

Objectives: Trichomonas vaginalis is the most common nonviral sexually transmitted pathogen. Wet mount microscopy performs poorly compared with culture; however, universal screening using culture would be cost-prohibitive. Goal: The goal of this study was to develop a predictive model for wet mount-negative women who may benefit from targeted use of culture for T. vaginalis detection. Study: Women presenting for sexually transmitted disease evaluation were prospectively screened for trichomoniasis using wet mount and culture. Multivariate logistic regression was used to identify predictors of culture-proven trichomoniasis among wet mount-negative women. Results: A total of 2194 women were screened for trichomoniasis; overall, the prevalence of T. vaginalis was 17.5%. Three predictors (any drug use, contact to trichomoniasis, and African-American race) provided the most specific model (100%); any 1 predictor, the most sensitive model (97.8%). Conclusions: Given the public health impact of trichomoniasis, we recommend using any 1 of 3 predictors to identify women who would benefit from targeted culture for T. vaginalis.

Trichomonas vaginalis was originally considered a commensal organism until the 1950s when the understanding of its role as a sexually transmitted infection (STI) began to evolve. Trichomoniasis has been associated with vaginitis, cervicitis, urethritis, pelvic inflammatory disease (PID), and adverse birth outcomes. Infection with T vaginalis could have an important role in transmission and acquisition of HIV. T vaginalis is site specific for the genitourinary tract and has been isolated from virtually all genitourinary structures. Asymptomatic disease is common in both men and women, thus screening for disease is important. Various sociodemographic factors have been correlated with presence of T vaginalis, and may be used to predict infection. Diagnosis is usually made from wet mount microscopy and direct visualisation, which are insensitive. DNA amplification techniques perform with good sensitivity, but are not yet approved for diagnostic purposes. In areas where diagnostic methods are limited, management of trichomoniasis is usually as part of a clinical syndrome; vaginal discharge for women and urethral discharge for men. A single dose of metronidazole is effective in the majority of cases. Outside of the United States, other nitroimidazoles may be used and are as effective as metronidazole. Metronidazole resistance is an emerging problem, but its clinical importance is not yet clear. Concomitant treatment of sexual partners is recommended.

Persistent nontreponemal titers after treatment are common among patients with early syphilis. We retreated 82 human immunodeficiency virus–negative early syphilis participants who were serofast at 6 months using benzathine penicillin. Only 27% exhibited serological response after retreatment and after an additional 6 months of follow-up.

Background Serologic tests for syphilis results at the time of diagnosis are the basis for evaluating response to syphilis therapy. After treatment, however, serologic tests for syphilis titers may continue to increase for several weeks. We evaluated rapid plasma reagin (RPR) titer variation during the 14 days after therapy using data from a recent large, prospective randomized controlled trial. Methods Prospectively enrolled participants in North America and Madagascar with primary, secondary, or early latent syphilis were randomly assigned to penicillin, doxycycline (in the case of penicillin allergy), or azithromycin treatment. Blood for RPR analysis was drawn at days 0, 7, and 14 posttreatment. All RPR titers were determined simultaneously at a central laboratory. Results Four hundred and seventy patients had data available for at least 2 of 3 RPR measurements. Overall, 20% of patients showed a titer increase of at least 1 dilution in the 14 days after therapy. The greatest proportion of titer increases following therapy was observed in patients with primary syphilis. Comparing outcome of therapy using the initial (day 0) RPR titer versus the maximal RPR titer (during 14 days) resulted in outcome reclassification in 2.98% of participants. Conclusions Despite the fact that about 20% of early syphilis patients had increases in RPR titers immediately after treatment, these changes rarely influenced assessment of therapeutic outcome. Only 3% of patients treated would have been reclassified.

In a randomized trial among African women with recurrent genital herpes, episodic acyclovir therapy resulted in modestly greater likelihood of lesion healing (HR=1.48, p=0.098; mean 5.1 vs. 6.0 days) and cessation of HSV shedding (HR=1.88, p=0.008; mean 3.0 vs. 5.0 days) compared with placebo, similar to results from high-income countries. (ClinicalTrials.gov registration NCT00808405).

Background While pre-exposure prophylaxis (PrEP) is a promising strategy for reducing HIV transmission, persons at highest risk for infection are not being adequately reached, particularly Black Men who have Sex with Men (MSM). Methods In December 2015, a dedicated PrEP clinic was established at Duke University Medical Center in Durham, North Carolina (NC). We performed a retrospective review of patients evaluated at the PrEP clinic, abstracting the following routinely collected variables: age, race, ethnicity, sex at birth, self-identified gender, HIV risk factors and source of referral. Descriptive statistics are presented as medians and frequencies. Results Over 18 months, 91 patients were evaluated. Most were male (90%, n = 82), approximately half were non-Hispanic Black (46%, n = 42), and median age was 31 years (range 19–66). Most patients identified as MSM (78%, n = 71) and 3 (3%) were transgender women who have sex with men (TGW). Specifically, 30% (n = 27) were Black MSM or TGW. Risk factors for all patients included multiple sexual partners (65%), known HIV+ partner (19%), or a recent sexually transmitted infection (16%). One-quarter of patients (n = 23) were uninsured. Among all Black patients, the most common source of referral was a community-based organization (CBO) (40%, n = 17), and specifically, Black MSM and TGW were most commonly referred by a CBO (44%, n = 12). Among White patients, most were self-referrals (47%, n = 18). Demographic characteristics of our patient population relative to those newly diagnosed with HIV in NC in 2015 are shown in Table 1. Conclusion Although further efforts are needed to improve PrEP uptake in underserved populations in NC, the racial breakdown of our PrEP clinic is more representative of the national HIV epidemic as compared with all PrEP users in the US. Our study demonstrates that community partnerships can be a valuable avenue for patient recruitment and achieve success in reaching Black MSM with messages about PrEP. Disclosures All authors: No reported disclosures.

Trichomonas vaginalis (TV) is a common sexually transmitted infection that can cause vaginitis, cervicitis and urethritis. Persistent and recurrent TV infections are frequent in women, potentially due to the lack of routine screening recommendations for this pathogen, the chronic nature of some infections, and drug resistance. Metronidazole and tinidazole are two oral drugs that are effective against trichomoniasis. There are few alternative treatment options for persons with a metronidazole allergy or treatment failure. Most TV isolates from women with treatment failures that have been analyzed for susceptibility testing in the United States have exhibited low-level metronidazole resistance, supporting the initial use of tinidazole for patients who fail metronidazole therapy. Several non-nitroimidazole drugs and other agents have demonstrated acceptable in vitro activity or cure rates in case reports for metronidazole-resistant trichomoniasis; however, clinical trials are imperative to evaluate their efficacy as alternative therapeutic regimens for this highly prevalent infection.

Nongonococcal urethritis (NGU) is a frequent diagnosis worldwide among adolescent and adult men presenting with urethral discharge or dysuria. There are no recent estimates of the prevalence of NGU in the United States; however, data from the 1970s indicate that 19%–78% of urethritis cases among men in sexually transmitted infection (STI) clinics and 85% of urethritis cases on college campuses in the United States were due to NGU [1, 2]. Chlamydia trachomatis (CT), Mycoplasma genitalium (MG), and Trichomonas vaginalis (TV) are the most recognized pathogens contributing to NGU. However, recent studies have demonstrated the contribution of Ureaplasma urealyticum, herpes simplex virus, and adenovirus to the etiology of NGU, owing in part to advancements in nucleic acid amplification tests (NAATs) for detection [3–5]. Empiric therapy is directed primarily at chlamydial infection, yet the clinical manifestations of these pathogens are usually indistinguishable and may require different treatment considerations. Persistent NGU can occur in a significant proportion of men after treatment; whether this is due to a slow resolution of the primary inflammatory response or due to persistent pathogens causing infection is uncertain. Treatment recommendations for NGU include azithromycin or doxycycline therapy [6]. A randomized controlled trial conducted by Schwebke et al [7] found that microbiological cure differed between CT and MG, with CT having the highest clearance rate (94.8%) after doxycycline therapy, and MG having the highest clearance rate (66.7%) after treatment with azithromycin. This finding raises concern about the different response rates of each pathogen to recommended therapy and their contribution to persistent NGU. Although a test-of-cure for NGU (ie, repeat testing at 3–4 weeks after therapy) is not recommended unless symptoms persist or reinfection is suspected, the proportion of cases with persistent infection after treatment should be further delineated. We conducted an analysis of the data collected by Schwebke et al [7] to ascertain characteristics associated with CT, MG, and TV infection at baseline and persistence after therapy in symptomatic heterosexual men with NGU. In the absence of point-of-care tests for these organisms in men, recognition of factors that predict specific infections at baseline could direct optimal therapy and management of sexual partners. We also assessed factors associated with microbiological persistence of CT or MG after standard treatment with azithromycin or doxycycline, and their correlation with persistent NGU.

SETTING Pulmonary tuberculosis (TB) patients reported in North Carolina (NC), USA, from 1996 to 2008 (inclusive). OBJECTIVE To compare prevalence of cavitary TB as a surrogate marker for advanced disease in low-caseload counties with high-caseload counties. DESIGN A multivariate log binomial regression model was used to estimate prevalence ratios (PRs) for cavitary TB. RESULTS The proportion of TB cases in low-caseload counties vs. the total number of TB cases in NC over the study period increased from 10% in 1996 to 20% in 2008. After adjusting for human immunodeficiency virus (HIV) status, excess alcohol use and report year, patients in rural areas of low-caseload counties had greater prevalence (PR 1.40, 95%CI 1.19-1.64) of cavitary disease compared with patients from rural areas of high-caseload counties. The prevalence of cavitary TB did not differ between urban residents of high- or low-caseload counties (PR 1.00, 95%CI 0.86-1.16) after adjusting for HIV status, excess alcohol use and report year. DISCUSSION TB patients in rural areas of low-caseload counties presented with more advanced TB disease compared with patients from urban and/or high-caseload counties. Barriers to timely recognition of TB in rural low-caseload settings must be considered in TB control programs.

Trichomonas vaginalis (TV) infection is the most prevalent curable sexually transmitted infection in the United States and worldwide. Most TV infections are asymptomatic, and the accurate diagnosis of this infection has been limited by lack of sufficiently sensitive and specific diagnostic tests, particularly for men. To provide updates for the 2010 Centers for Disease Control and Prevention’s Sexually Transmitted Diseases Treatment Guidelines, a PubMed search was conducted of all TV literature published from 9 January 2004 through 24 September 2008. Approximately 175 pertinent abstracts and articles were reviewed and discussed with national experts. This article describes advances in TV diagnostics which have led to an improved understanding of the epidemiology of this pathogen, as well as potential biologic and epidemiological interactions between TV and human immunodeficiency virus (HIV). New data on treatment outcomes, metronidazole-resistant TV, management of nitroimidazole-allergic patients, frequency of recurrent TV infection following treatment, and screening considerations for TV in certain populations are also presented.

The mainstay of diagnosis for Treponema pallidum infections is based on nontreponemal and treponemal serologic tests. Many new diagnostic methods for syphilis have been developed, using specific treponemal antigens and novel formats, including rapid point-of-care tests, enzyme immunoassays, and chemiluminescence assays. Although most of these newer tests are not yet cleared for use in the United States by the Food and Drug Administration, their performance and ease of automation have promoted their application for syphilis screening. Both sensitive and specific, new screening tests detect antitreponemal IgM and IgG antibodies by use of wild-type or recombinant T. pallidum antigens. However, these tests cannot distinguish between recent and remote or treated versus untreated infections. In addition, the screening tests require confirmation with nontreponemal tests. This use of treponemal tests for screening and nontreponemal serologic tests as confirmatory tests is a reversal of long-held practice. Clinicians need to understand the science behind these tests to use them properly in syphilis management.

Background Syphilis remains an important source of morbidity worldwide. Long-acting penicillin is the only therapy currently recommended for syphilis in much of the world. Because of hesitation to use penicillin for fear of anaphylaxis, there is a need for an effective, well-tolerated alternative to penicillin for syphilis therapy. Methods This multicenter, randomized clinical trial was conducted in clinics for the treatment of persons with sexually transmitted diseases. We compared serological cure rates for human immunodeficiency virus (HIV)-negative persons with early syphilis treated with azithromycin at a dosage of 2.0 g administered orally as a single dose with cure rates for those treated with benzathine penicillin G at a dosage of 2.4 million units administered intramuscularly. Results A total of 517 participants were enrolled in the trial. In the intention-to-treat analysis, after 6 months of follow-up, serological cure was observed in 180 (77.6%) of 232 azithromycin recipients and 186 (78.5%) of 237 penicillin recipients (1-sided lower bound 95% confidence interval, 7.2%). Nonserious adverse events were more common among azithromycin recipients than they were among penicillin recipients (61.5% vs 46.3%), and such adverse events were accounted for, in large part, by self-limited gastrointestinal complaints. Conclusions In this trial, the efficacy of azithromycin at a dosage of 2.0 g administered orally was equivalent to that of benzathine penicillin G for the treatment of early syphilis in persons without HIV infection.

Latino immigrants in the United States are disproportionally impacted by the HIV epidemic but face barriers to clinic-based testing. We assessed a community-based strategy for rapid HIV testing by conducting “door-to-door” outreaches in apartments with predominately Latino immigrants in Durham, North Carolina, that has experienced an exponential growth in its Latino population. Eligible persons were 18 years or older, not pregnant, and reported no HIV test in the previous month. Participants were asked to complete a survey and offered rapid HIV testing. Of the 228 Latino participants, 75.4% consented to HIV testing. There was a high prevalence of sexual risk behaviors among participants, with 42.5% acknowledging ever having sex with a commercial sex worker (CSW). Most (66.5%) had no history of prior HIV testing. In bivariate analysis, perceived HIV risk, no history of HIV testing, sex with a CSW, sex in exchange for drugs or money, living with a partner, and alcohol use were significantly associated with test acceptance. In the multivariate analysis, participants who had never been tested for HIV were more likely to consent to rapid HIV testing than those who had tested in the past (adjusted odds ratio 2.5; 95% confidence interval [CI], 1.1, 5.6). Most participants supported rapid HIV testing in the community (97%). Door-to-door rapid HIV testing is a feasible and acceptable strategy for screening high-risk Latino immigrants in the community. Factors associated with HIV risk among Latino migrants and immigrants in the United States should be considered along with novel testing strategies in HIV prevention programs.

Individualized risk assessments during HIV testing are an integral component of prevention counseling, a currently recommended behavioral intervention for patients in high-risk settings. Additionally, aggregate risk assessment data are the source of aggregate behavioral statistics that inform prevention programs and allocation of resources. Consequently, inaccurate or incomplete risk behavior disclosure during test counseling may impact the efficacy of the counseling intervention, as well as bias aggregate behavioral statistics. To quantify client-reported accuracy during the risk assessment and identify barriers and facilitators to risk behavior disclosure, we interviewed young men accessing HIV testing services in a southeastern United States city using mixed methodology. Data were collected from August 2007 to April 2008. Based on data collected via an audio and computer-assisted self-interview (n = 203), over 30% of men reported that they were not accurate during the risk assessment. Participants reported numerous interpersonal facilitators to complete disclosure. During qualitative interviews (n = 25), participants revealed that many did not understand the purpose of the risk assessment. Findings suggest that risk assessments completed during HIV test counseling may be incomplete. Modifications to the risk assessment process, including better explaining the role of the risk assessment in prevention counseling, may increase the validity of the data.

Kingella kingae can cause invasive pediatric infections and outbreaks of osteomyelitis/septic arthritis in daycare facilities have been described. This is the first reported public health investigation prompted by a case of K. kingae endocarditis in an infant attending a daycare facility. A concurrent case of osteomyelitis was identified. Screening of daycare contacts revealed a low rate of colonization before antibiotic prophylaxis.

BACKGROUND:: Hormonal contraception use by women may increase the risk of acquiring certain sexually transmitted infections. We explored the effect of hormonal contraceptive use specifically oral contraception (OC) and depot-medroxyprogesterone acetate (DMPA) on Trichomonas vaginalis infections in women. METHODS:: We examined data from a prospective case-control study of women with trichomoniasis and noninfected female patients recruited from 3 public sexually transmitted disease clinics. Women with positive wet mount microscopy or T. vaginalis culture results were classified as having trichomoniasis. Participants underwent physical examinations sexually transmitted infections testing and completed questionnaires which included information about demographics sexual behavior douching and contraceptive use. We assessed the association between hormonal contraceptives and trichomoniasis using bivariable and multivariable analysis and estimated exposure odds ratios (ORs) and adjusted odds ratios (aORs) with 95% confidence intervals (CIs). RESULTS:: We identified 427 women with trichomoniasis and 144 uninfected women who had information reported about contraception use. Compared with nonhormonal contraceptive use OC use was negatively associated with trichomoniasis in bivariable analysis (OR: 0.5; 95% CI: 0.3-0.8). This association was no longer statistically significant after adjusting for demographic variables douching and condom use (aOR: 0.9; 95% CI: 0.5-1.6). Use of DMPA compared with nonhormonal contraceptive use was not associated with trichomoniasis in bivariable or multivariable analyses (OR: 1.0 95% CI: 0.5-2.1; aOR = 1.4 95% CI: 0.6-3.4 respectively). CONCLUSIONS:: Although OC use appeared to have a protective effect in the bivariable analysis the hormonal contraceptives OC and DMPA were not associated with T. vaginalis infection after adjustment for other factors.