Search

Background Approximately 15% of patients in sexually transmitted infection (STI) clinics report penicillin allergies, complicating treatment for syphilis and gonorrhea. Nonetheless, >90% do not have a penicillin allergy when evaluated. We developed and validated an algorithm to define which patients reporting penicillin allergy can be safely treated at STI clinics with these drugs. Methods Randomized controlled trial to assess feasibility and safety of penicillin allergy evaluations in STI clinics. Participants with reported penicillin allergy answered an expert-developed questionnaire to stratify risk. Low-risk participants underwent penicillin skin testing (PST) followed by amoxicillin 250 mg challenge or a graded oral challenge (GOC)—amoxicillin 25 mg followed by 250 mg. Reactions were recorded, and participant/provider surveys were conducted. Results Of 284 participants, 72 (25.3%) were deemed high risk and were excluded. Of 206 low-risk participants, 102 (49.5%) underwent PST without reactions and 3 (3%) had mild reactions during the oral challenge. Of 104 (50.5%) participants in the GOC, 95 (91.3%) completed challenges without reaction, 4 (4.2%) had mild symptoms after 25 mg, and 4 (4.2%) after 250-mg doses. Overall, 195 participants (94.7%) successfully completed the study and 11 (5.3%) experienced mild symptoms. Of 14 providers, 12 (85.7%) completed surveys and 11 (93%) agreed on the safety/effectiveness of penicillin allergy assessment in STI clinics. Conclusions An easy-to-administer risk-assessment questionnaire can safely identify patients for penicillin allergy evaluation in STI clinics by PST or GOC, with GOC showing operational feasibility. Using this approach, 67% of participants with reported penicillin allergy could safely receive first-line treatments for gonorrhea or syphilis. Clinical Trials Registration.  Clinicaltrials.gov (NCT04620746). [ABSTRACT FROM AUTHOR]

Background In 2018, the municipal Sexual Health Clinic in Seattle, implemented trans-inclusive questions about sexual behavior, anatomy, gender-affirming surgeries, and sexually transmitted infection (STI) symptoms in the clinic's computer-assisted self-interview (CASI) to improve care for transgender and nonbinary (TNB) patients. Methods We calculated test positivity, the proportion of TNB patient visits that received testing for human immunodeficiency virus (HIV); syphilis; pharyngeal, rectal, and urogenital gonorrhea (GC); and chlamydia (CT) before (5/2016–12/2018) and after (12/2018–2/2020) implementation of new CASI questions, and the proportion of asymptomatic patients who received anatomic site–specific screening based on reported exposures. Results There were 434 TNB patients with 489 and 337 clinic visits during each period, respectively. Nonbinary patients assigned male at birth (AMAB) had the highest prevalence of GC (10% pharyngeal, 14% rectal, 12% urogenital). Transgender women, transgender men, and nonbinary people AMAB had a high prevalence of rectal CT (10%, 9%, and 13%, respectively) and syphilis (9%, 5%, and 8%). Asymptomatic transgender women, transgender men, and nonbinary patients AMAB were more likely to receive extragenital GC/CT screening compared with nonbinary patients assigned female at birth. After implementation of trans-inclusive questions, there was a 33% increase in the number of annual TNB patient visits but no statistically significant increase in HIV/STI testing among TNB patients. Conclusions TNB people had a high prevalence of extragenital STIs and syphilis. Implementation of trans-inclusive medical history questions at a clinic that serves cisgender and transgender patients was feasible and important for improving the quality of affirming and inclusive sexual healthcare. [ABSTRACT FROM AUTHOR]

Background The prevalence of pharyngeal chlamydia is low, but its incidence and duration are unknown. A high incidence or duration may support the role of pharyngeal chlamydia in sustaining chlamydia transmission. Methods From March 2016 to December 2018, we enrolled men who have sex with men (MSM) in a 48-week cohort study in Seattle, Washington. Participants self-collected pharyngeal specimens weekly. We tested specimens using nucleic acid amplification testing at the conclusion of the study. In primary analyses, we defined incident pharyngeal chlamydia as >2 consecutive weeks of a positive pharyngeal specimen. In sensitivity analyses, we defined incident chlamydia as >1 week of a positive specimen. We estimated duration of pharyngeal chlamydia, censoring at loss to follow-up, receipt of antibiotics, or end of study. Results A total of 140 participants contributed 70.5 person-years (PY); 1.4% had pharyngeal chlamydia at enrollment. In primary analyses, there were 8 pharyngeal chlamydia cases among 6 MSM (incidence = 11.4 per 100 PY; 95% confidence interval [CI]: 6.0–21.9). In sensitivity analysis, there were 19 cases among 16 MSM (incidence = 27.1 per 100 PY; 95% CI: 18.5–39.8). The median duration was 6.0 weeks (95% CI: 2.0–undefined) in primary analysis and 2.0 weeks (95% CI: 1.1–6.0) in sensitivity analysis. Duration was shorter for those with a history of chlamydia compared with those without (3.6 vs 8.7 weeks; P =.02). Conclusions Pharyngeal chlamydia has a low incidence and duration relative to other extragenital sexually transmitted infections. Its contribution to population-level transmission remains unclear. [ABSTRACT FROM AUTHOR]

Background The duration of rectal gonococcal and chlamydial infection remains unknown. This basic epidemiologic parameter is needed to understand transmission dynamics. Methods We conducted a prospective, longitudinal, observational cohort study of 140 men who have sex with men (MSM) at risk of gonorrhea and chlamydia acquisition. For 48 weeks, enrolled men collected rectal swabs (Aptima multi-test kit) at home and responded to an electronic survey about sexual behavior and health conditions weekly. Swabs remained untested until participants completed the study. We used Kaplan-Meier estimates to determine the median duration of infection, censoring infections for treatment, loss to follow-up, and end-of-study. We used log-rank test to compare duration of infection by human immunodeficiency virus (HIV) status, history of infection with gonorrhea or chlamydia, and coinfection with the other pathogen. Results 140 enrolled MSM contributed 70.5 person-years of follow-up. Eighteen men had 20 incident rectal gonococcal infections, which persisted for 2–23 weeks; 30% were censored for treatment. The estimated median duration of rectal gonorrhea was 9 weeks (95% confidence interval [CI]: 3–12 weeks). Twenty-four men experienced 32 rectal chlamydial infections, persisting between 2 and 42 weeks; 60% were censored. The estimated duration of rectal chlamydia was 13 weeks (95% CI: 6 weeks–undefined). There were no differences in the duration of rectal gonorrhea or chlamydia by HIV status, history of chlamydia/gonorrhea, or coinfection. Conclusions On average, rectal gonorrhea and chlamydial infections last 2–3 months, although some infections persisted for 6–11 months. Further understanding into predictors of persistence is needed. [ABSTRACT FROM AUTHOR]

Introduction Neisseria gonorrhoeae has developed resistance to all first-line recommended therapies, making gonococcal antimicrobial resistance a major public health concern given limited antibiotic options currently and an even smaller antimicrobial development pipeline. Since the release of the Centers for Disease Control and Prevention (CDC) 2015 STD Treatment Guidelines, azithromycin, part of the 2015 dual-drug treatment regimen, has had a rapid rise in resistance. The 2020 CDC Gonorrhea Treatment Recommendations and the 2021 Sexually Transmitted Infections (STI) Treatment Guidelines were developed weighing the priorities of treating the individual, protecting the population, and preventing antimicrobial resistance. Methods Gonorrhea subject matter experts (SME) generated 8 key questions and conducted a literature review of updated data from 2013 to 2019 on gonorrhea antimicrobial resistance, treatment failures, clinical trials, and other key topics. More than 2200 abstracts were assessed, and 248 clinically relevant articles were thoroughly reviewed. SMEs also evaluated N gonorrhoeae antimicrobial resistance data from the Gonococcal Isolate Surveillance Project (GISP). Evidence Although there have been reports of ceftriaxone treatment failures internationally, GISP data suggest that ceftriaxone minimal inhibitory concentrations (MICs) have remained stable in the United States, with < 0.1% exhibiting an "alert value" MIC (> 0.25 mcg/mL). However, GISP documented a rapid rise in the proportion of isolates with an elevated MIC (≥ 2.0 mcg/mL) to azithromycin—nearly 5% in 2018. At the same time, new pharmacokinetic/pharmacodynamic data are available, and there is greater recognition of the need for antimicrobial stewardship. Summary The 2021 CDC STI Treatment Guidelines now recommend 500mg ceftriaxone intramuscularly once for the treatment of uncomplicated gonorrhea at all anatomic sites. If coinfection with chlamydia has not been excluded, cotreatment with doxycycline 100mg twice daily for 7 days should be added. Few alternative therapies exist for persons with cephalosporin allergies; there are no recommended alternative therapies for N gonorrhoeae infection of the throat. [ABSTRACT FROM AUTHOR]

Background Neisseria gonorrhoeae culture is necessary to determine antimicrobial resistance, but typically requires specimen collection by clinicians. We sought to determine the sensitivity of patient-collected specimens for N. gonorrhoeae culture. Methods We performed N. gonorrhoeae cultures on paired clinician- and patient-collected specimens from the pharynx (n = 93), rectum (n = 88), endocervix/vagina (n = 89), and urethra/urine (n = 46). We calculated the percent concordance and the kappa statistics for paired-specimen results, and determined the test sensitivity for each specimen type using positivity of either specimen in a pair as a gold standard defining the presence of true infection. Results At least 1 specimen was positive in 26%, 31%, 61%, and 3% of paired samples in the pharynx, rectum, urethra/urine, and endocervix/vagina, respectively. Patient- and clinician-collected results were highly concordant at the pharynx (95%; kappa = 0.85), rectum (99%; kappa = 0.97), urethra/urine (83%; kappa = 0.87), and endocervix/vagina (100%; kappa = 1.0; P  ≤ .005 for all comparisons). Patient-collected pharyngeal and rectal swabs and urine were 92%, 96%, and 96% sensitive, while clinician-collected specimens at these anatomic sites were 87.5%, 100%, and 94% sensitive (P  > .05 for all comparisons). Among 24 urine specimens held for 4–22 hours after collection, 100% yielded concordant N. gonorrhoeae culture results, compared to immediate processing. Conclusions Patient- and clinician-collected specimens are comparably sensitive for N. gonorrhoeae culture. These findings suggest that patient-collected specimens could be used to expand the availability of gonococcal antimicrobial resistance testing for both clinical and surveillance purposes. [ABSTRACT FROM AUTHOR]

Background Pharyngeal gonorrhea is relatively common. However, the duration of untreated pharyngeal gonorrhea is unknown. Methods From March 2016 to December 2018, we enrolled 140 men who have sex with men in a 48-week cohort study. Participants self-collected pharyngeal specimens and completed a survey weekly. Specimens were tested using a nucleic acid amplification test at the conclusion of the study. We estimated the incidence and duration of infection. We defined incident infections as 2 consecutive positive tests, and clearance as 2 consecutive negative tests; and, after visual inspection of the data, we reclassified up to 2 weeks of missing or negative tests as positive if they occurred between 2 episodes of infections. We used Kaplan-Meier estimates to define duration of infection. Finally, we report on the frequency of single-positive tests and the time between the last negative test and the positive test. Results Nineteen (13.6%) of 140 participants experienced 21 pharyngeal infections (incidence, 31.7/100 person-years; 95% confidence interval, 20.7–48.6/100 person-years). The estimated median duration of pharyngeal gonorrhea was 16.3 weeks (95% confidence interval, 5.1–19.7 weeks). Twenty-two men had 25 single-positive specimens, a median of 7 days (interquartile range, 7–10 days) after their last negative test. Conclusions The median duration of untreated pharyngeal gonorrhea is 16 weeks, more than double previous estimates. This long duration of infection likely contributes to high levels of gonorrhea transmission. [ABSTRACT FROM AUTHOR]

Background Centers for Disease Control and Prevention (CDC) guidelines recommend 240 mg gentamicin plus 2 g azithromycin for the treatment of gonorrhea in cephalosporin-allergic patients. The efficacy of gentamicin alone in the treatment of pharyngeal gonorrhea is uncertain. Methods Between September 2018 and March 2019, we enrolled men who have sex with men with nucleic acid amplification test–diagnosed pharyngeal gonorrhea in a single-arm, unblinded clinical trial. Men received a single 360-mg intramuscular dose of gentamicin and underwent test of cure by culture 4–7 days later. The study measured creatinine at enrollment and test of cure, serum gentamicin concentration postdose to establish peak concentration (Cmax), and standard antimicrobial minimum inhibitory concentrations (MICs) by agar dilution. The trial was designed to establish a point estimate for gentamicin's efficacy for pharyngeal gonorrhea. We planned to enroll 50 evaluable participants; assuming gentamicin was 80% efficacious, the trial would establish a 95% confidence interval (CI) of 66%–90%. We planned interim analyses at n = 10 and n = 25. Results The study was stopped early due to poor efficacy. Of 13 enrolled men, 10 were evaluable, and only 2 (20% [95% CI, 2.5%–55.6%]) were cured. Efficacy was not associated with gentamicin Cmax or MIC. No participants experienced renal insufficiency. The mean creatinine percentage change was +5.2% (range, −6.7% to 21.3%). Six (46%) participants experienced headache, all deemed unrelated to treatment. Conclusions Gentamicin alone failed to eradicate Neisseria gonorrhoeae from the pharynx. Clinicians should use caution when treating gonorrhea with the CDC's current alternative regimen (gentamicin 240 mg plus azithromycin 2 g) given increases in azithromycin resistance and gentamicin's poor efficacy at the pharynx. Clinical Trials Registration NCT03632109. [ABSTRACT FROM AUTHOR]

We examined changes in sexual behavior and sexually transmitted infection (STI) prevalence among 183 men who have sex with men (MSM) initiating pre-exposure prophylaxis (PrEP) at an STD Clinic in Seattle, WA. We used generalized estimating equations to measure changes in sexual behavior during PrEP use, and linked PrEP patient data with STI surveillance data to compare the prevalence of chlamydia, gonorrhea, and early syphilis in the periods prior to and during PrEP use. Reporting never using condoms in the prior 30 days increased (adjusted relative risk = 1.46; 95% confidence interval 1.13, 1.88) at 12 months after PrEP initiation compared to the initial PrEP visit. Reporting unknown status partners in the prior 30 days decreased at 12 months compared to the initial PrEP visit, but there was no change in number of sexual partners or reporting HIV-positive or HIV-negative partners. The percentage of patients diagnosed with any STI while using PrEP (49.2%) was higher than the percentage diagnosed in the 12 months prior to PrEP use (35.0%), likely driven in part by increased STI screening during PrEP use. Among MSM on PrEP, we observed decreases in condom use, and a higher prevalence of STIs during PrEP use compared to prior to PrEP initiation. [ABSTRACT FROM AUTHOR]

Little is known about the frequency of ongoing HIV transmission within U.S. African immigrant communities. We used HIV surveillance and partner services data to describe African-born persons newly reported with HIV infection in King County (KC), WA from 1/1/2010 to 12/31/2013. We performed phylogenetic clustering analysis of HIV-1 pol to identify putative transmission events within this population. From 2010 to 2013, 1148 KC adults were reported with HIV, including 102 (9 %) born in Africa. Forty-one African-born cases were interviewed and reported diagnosis after arrival in the U.S. Fourteen (34 %) reported ≥1 negative test prior to diagnosis, and 9 (26 %) reported ≥1 negative test after U.S. arrival. Pol genotypes were available for seven of these nine. For two of these seven, a KC case was the nearest phylogenetic neighbor; two others were infected with subtype B virus. We found substantial evidence of ongoing HIV transmission in the African community of KC. [ABSTRACT FROM AUTHOR]