Randomized Multicenter Trial for the Validation of an Easy-to-Administer Algorithm to Define Penicillin Allergy Status in Sexually Transmitted Infection Clinic Outpatients.

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).

STI self-testing: ensuring representation and outreach to teens and adolescents in expanded approaches.

In our correspondence, we describe the results from a quality improvement survey in a sexual health clinic in North Carolina regarding attitudes and perceptions among adolescents and providers regarding specimen self-collection. We find that adolescents have high levels of acceptability for self-collection and confidence in their ability to self-collection; however, providers expressed hesitation regarding the ability of adolescents to self-collection. Our study shows that while self-collection may provide a way to expand testing access to difficult-to-reach populations, we must ensure that providers are confident in the corresponding results.

Proctitis: An Approach to the Symptomatic Patient.

Proctitis is an inflammatory condition of the distal rectum that can be associated with common sexually transmitted infections (STIs), such as gonorrhea, chlamydia, and syphilis. For persons presenting with ulcerative findings on examination, in addition to syphilis, Mpox, lymphogranuloma venereum, and herpes simplex virus should be in the differential. Providers should also be aware that there are evolving data to support a role for Mycoplasma genitalium in proctitis. Performing a comprehensive history, clinical evaluation including anoscopy, and rectal nucleic amplification STI testing may be useful in identifying the cause of proctitis and targeting treatment.

Assessing Barriers to Human Papillomavirus (HPV) Vaccination in At-Risk Rural Communities of Western North Carolina, United States.

Human papillomavirus (HPV) vaccination among adolescents in rural, western North Carolina (NC) remains suboptimal. Data are needed to understand the barriers to HPV vaccination in these communities. We conducted a cross-sectional pilot study of parental attitudes and provider practices regarding HPV vaccination in rural western NC counties with lower HPV vaccination rates. Eight health department clinics were enrolled in the study. Further, 29 provider and 32 parent surveys were analyzed along with environmental scans. Median provider comfort regarding knowledge of HPV-associated diseases was 85% (IQR = 75-95), on a scale of 0-100% (100% representing complete comfort). Median parental comfort level regarding knowledge of HPV-associated diseases and the HPV vaccine was 75% (IQR = 50-89) and 75% (IQR = 49-96), respectively. Less than 25% of parents rated the HPV vaccine as 'extremely effective' against genital (16.7%) and anal cancers (17.9%). Parents were more likely to rate the vaccine as 'extremely effective' to 'very effective' if their child was female. There was no significant difference between parental- and provider-reported comfort with knowledge about HPV-associated diseases (p = 0.0725) and the HPV vaccine (p = 0.167). This study identified multiple opportunities to increase HPV vaccine coverage among unvaccinated adolescents at parental, provider, and clinic levels. Health education of rural NC residents and providers in public health settings may identify future interventions to increase HPV vaccine uptake.

Comfort Levels of Outpatient Health Care Professionals When Asking About Substance Use-Related Sexual Activity: A Pilot Survey.

BACKGROUND: Screening, brief intervention, and referral to treatment (SBIRT) is an evidence-based intervention for substance use. Health care professionals may not receive SBIRT training or know of substance use's intersection with sexual activity. This pilot survey inquired about SBIRT training history, attitudes, and comfort among outpatient health care professionals, including assessing sexual activity-related use. METHODS: We conducted a snowball cross-sectional survey of outpatient health care professionals at a large southeastern academic medical center in June 2021 with 4-point Likert questions covering demographics, substance use attitudes, SBIRT training history, and comfort implementing SBIRT. Analysis used descriptive statistics and stratification by demographic and practice characteristics. RESULTS: Seventy-three professionals responded, of whom 82% were White and 66% were female. Forty-seven percent were 30 to 39 years old, 33% were internal medicine professionals, and 59% reported previous SBIRT training. All participants reported believing substance use is a significant health issue. Most reported that they were comfortable or somewhat comfortable assessing patients for substance use (85%), dropping to 60% discussing sexual activity. Advanced practice providers and physicians identified more comfort with rapport building around substance use than other health care respondents. Professionals in infectious diseases and psychiatry reported the greatest comfort assessing substance use with concurrent sexual activity. CONCLUSIONS: There are gaps in SBIRT training and beliefs among health care professionals. Although health care workers report that assessing substance use is important, some professionals endorsed more comfort discussing substance use with patients than others, especially when inquiring about sexual activity. Future work could replicate the pilot to inform increasing comfort through training in the intersection of substance use and sexuality.

Mycoplasma genitalium in the US (MyGeniUS): Surveillance Data From Sexual Health Clinics in 4 US Regions.

BACKGROUND: Mycoplasma genitalium (MG) is on the CDC Watch List of Antimicrobial Resistance Threats, yet there is no systematic surveillance to monitor change. METHODS: We initiated surveillance in sexual health clinics in 6 cities, selecting a quota sample of urogenital specimens tested for gonorrhea and/or chlamydia. We abstracted patient data from medical records and detected MG and macrolide-resistance mutations (MRMs) by nucleic acid amplification testing. We used Poisson regression to estimate adjusted prevalence ratios (aPRs) and 95% CIs, adjusting for sampling criteria (site, birth sex, symptom status). RESULTS: From October-December 2020 we tested 1743 urogenital specimens: 57.0% from males, 46.1% from non-Hispanic Black persons, and 43.8% from symptomatic patients. MG prevalence was 16.6% (95% CI: 14.9-18.5%; site-specific range: 9.9-23.5%) and higher in St Louis (aPR: 1.9; 1.27-2.85), Greensboro (aPR: 1.8; 1.18-2.79), and Denver (aPR: 1.7; 1.12-2.44) than Seattle. Prevalence was highest in persons <18 years (30.4%) and declined 3% per each additional year of age (aPR: .97; .955-.982). MG was detected in 26.8%, 21.1%, 11.8%, and 15.4% of urethritis, vaginitis, cervicitis, and pelvic inflammatory disease (PID), respectively. It was present in 9% of asymptomatic males and 15.4% of asymptomatic females, and associated with male urethritis (aPR: 1.7; 1.22-2.50) and chlamydia (aPR: 1.7; 1.13-2.53). MRM prevalence was 59.1% (95% CI: 53.1-64.8%; site-specific range: 51.3-70.6%). MRMs were associated with vaginitis (aPR: 1.8; 1.14-2.85), cervicitis (aPR: 3.5; 1.69-7.30), and PID cervicitis (aPR: 1.8; 1.09-3.08). CONCLUSIONS: MG infection is common in persons at high risk of sexually transmitted infections; testing symptomatic patients would facilitate appropriate therapy. Macrolide resistance is high and azithromycin should not be used without resistance testing.

Sexually Transmitted Infections in Older Adults: Increasing Tide and How to Stem It.

Sexually transmitted infections (STIs) have been increasing in older adults. Sexual health remains an important part of overall health care at any age. There are several barriers and facilitators to addressing sexual health in this population. Changes attributable to normal physiologic aging as well as sexual dysfunction can affect sexuality in older adults. When it comes to preventing STIs, combination prevention strategies remain applicable in older adults. Addressing sexual health using a tailored approach is critical to stem the tide of increasing STIs rates in older adults.

Successful Treatment of Persistent 5-Nitroimidazole-Resistant Trichomoniasis With an Extended Course of Oral Secnidazole Plus Intravaginal Boric Acid.

ABSTRACT: We describe a case of persistent 5-nitroimidazole-resistant trichomoniasis cured after 14 days of oral secnidazole and intravaginal boric acid. Secnidazole may be an important treatment option for resistant trichomoniasis, particularly in women who fail other regimens, including higher doses of oral metronidazole and tinidazole for longer durations of time.

Global monkeypox case hospitalisation rates: A rapid systematic review and meta-analysis.

Background: Estimates of the case hospitalization rate and case fatality rate when hospital care is available for monkeypox (MPX) infections have not been well defined. This rapid systematic review and meta-analysis aimed to estimate the case hospitalisation rate and case fatality rate where hospital care is available. Methods: We systematically searched PubMed, Embase, the Lancet Preprints, and MedRxiv for studies published between Jan 1, 1950 and Aug 2, 2022. We included documents which contained both the number of cases and associated hospitalisations of MPX infections. From eligible studies we extracted the country, the year of the study, the study design type, the clade of MPX, the participant characteristics, transmission type, any treatments used, number of cases (including suspected, probable, or laboratory confirmed diagnosis), number of hospitalizations, hospitalized patient outcomes, and case definition. Case hospitalization rate (CHR) was defined as the proportion of cases that were admitted to hospital care while case fatality rate (CFR) was defined as the proportion of cases that died. CHR and CFR were analysed in a fully Bayesian meta-analytic framework using random effects models, including sub-group analysis with heterogeneity assessed using I2. Findings: Of the 259 unique documents identified, 19 studies were eligible for inclusion. Included studies represented 7553 reported cases among which there were 555 hospitalizations. Of the 7540 cases for which outcomes were available, there were 15 recorded deaths. The median age of cases was 35 years (interquartile range 28-38, n = 2010) and primarily male (7339/7489, 98%) in studies where age or sex were available. Combined CHR was estimated to be 14.1% (95% credible interval, 7.5-25.0, I2 97.4%), with a high degree of heterogeneity. Further analysis by outbreak period indicates CHRs of 49.8% (28.2-74.0, I2 81.4%), 21.7% (7.2-52.1, I2 57.7%), and 5.8% (3.2-9.4, I2 92.4%) during the pre-2017, 2017-2021, and 2022 outbreaks, respectively, again with high levels of heterogeneity. CFR was estimated to be 0.03% (0.0-0.44, I2 99.9%), with evidence of large heterogeneity between the studies. Interpretation: There is limited data for MPX hospitalization rates in countries where MPX has been traditionally non-endemic until the current outbreak. Due to substantial heterogeneity, caution is needed when interpreting these findings. Health care organizations should be cognizant of the potential increase in healthcare utilization. Rapid identification of infection and use of appropriate therapies such as antivirals play a role reducing the CHR and associated CFR. Funding: None.

Enteric Infections in Men Who Have Sex With Men.

BACKGROUND: Enteric pathogens are often associated with exposure to food, water, animals, and feces from infected individuals. However, in sexual networks of men who have sex with men (MSM), transmission of enteric pathogens may occur during direct or indirect oral-anal contact. METHODS: We performed a scoping review of the literature for studies prior to July 2019 with key terms for gastrointestinal syndromes ("proctitis," "enteritis," "proctocolitis"), enteric pathogens or sexually transmitted infections (STIs), and outbreaks using multiple electronic databases. RESULTS: We identified 5861 records through database searches, bibliography reviews, and keyword searches, of which 117 references were included in the pathogen-specific reviews. CONCLUSIONS: The strength of observational data describing enteric pathogens in MSM and possible sexual transmission of enteric pathogens varies by pathogen; however, a robust body of literature describes the sexual transmission of Campylobacter, Giardia lamblia, and Shigella (particularly antimicrobial-resistant strains) in sexual networks of MSM. Providers are encouraged to consider enteritis or proctocolitis in MSM as possibly having been sexually transmitted and encourage targeted STI testing. Risk/harm reduction and prevention messages should also be incorporated, though there is an acknowledged paucity of evidence with regards to effective strategies. Further research is needed to understand the transmission and prevention of enteric pathogens in MSM.

Coinfection With Chlamydial and Gonorrheal Infection Among US Adults With Early Syphilis.

ABSTRACT: Among 865 adults with early syphilis considered for a multicenter treatment trial, 234 (27%) were excluded before enrollment because of bacterial sexually transmitted infection coinfection. Coinfection with Neisseria gonorrhoeae (29%), Chlamydia trachomatis (22%), or both (23%) was common. Study findings highlight the need for comprehensive bacterial sexually transmitted infection screening in patients with syphilis.

Perceptions, experiences, and preferences for partner services among Black and Latino men who have sex with men and transwomen in North Carolina.

OBJECTIVES: In the United States, sexually transmitted infections (STIs) disproportionately affect men who have sex with men (MSM) and transwomen of color. Partner services can prevent STI transmission by facilitating testing and treatment for partners of individuals diagnosed with an STI. Understanding client perspectives towards partner services is critical to their acceptance and uptake. This study examined perceptions, experiences, and preferences for partner services among Black and Latino MSM and transwomen in North Carolina. DESIGN: We conducted seven audio-recorded focus groups in English (n = 5) and Spanish (n = 2). The audio was transcribed verbatim and we inductively analyzed data using field notes, systematic coding, and thematic comparison. RESULTS: Black MSM reported the most exposure and experiences with partner services, and most perceived partner services negatively. Feeling supported and having flexibility characterized positive experiences with partner services among Black MSM; feeling judged or harassed characterized negative experiences. Black transwomen had less exposure to partner services and had a mix of positive reactions to the approach, along with concerns about client confidentiality. Most Latino participants were unaware of partner services and expressed openness to their potential. All participants preferred self-notifying and wanted flexible, discreet, supportive partner services with linkages to other wellness resources. CONCLUSION: Building off positive partner services experiences and responding to client preferences can enhance trust, acceptability, and service use.

Intersection of Syphilis and Human Immunodeficiency Virus (HIV) Networks to Identify Opportunities to Enhance HIV Prevention.

BACKGROUND: Human immunodeficiency virus (HIV) and syphilis infection continue at disproportionate rates among minority men who have sex with men (MSM) in the United States. The integration of HIV genetic clustering with partner services can provide important insight into local epidemic trends to guide interventions and control efforts. METHODS: We evaluated contact networks of index persons defined as minority men and transgender women diagnosed with early syphilis and/or HIV infection between 2018 and 2020 in 2 North Carolina regions. HIV clusters were constructed from pol sequences collected through statewide surveillance. A combined "HIV-risk" network, which included persons with any links (genetic or sexual contact) to HIV-positive persons, was evaluated by component size, demographic factors, and HIV viral suppression. RESULTS: In total, 1289 index persons were identified and 55% named 1153 contacts. Most index persons were Black (88%) and young (median age 30 years); 70% had early syphilis and 43% had prevalent HIV infection. Most people with HIV (65%) appeared in an HIV cluster. The combined HIV-risk network (1590 contact network and 1500 cluster members) included 287 distinct components; however, 1586 (51%) were in a single component. Fifty-five percent of network members with HIV had no evidence of viral suppression. Overall, fewer index persons needed to be interviewed to identify 1 HIV-positive member without viral suppression (1.3 vs 4.0 for contact tracing). CONCLUSIONS: Integration of HIV clusters and viral loads illuminate networks with high HIV prevalence, indicating recent and ongoing transmission. Interventions intensified toward these networks may efficiently reach persons for HIV prevention and care re-engagement.

High Number of Positive Rapid Plasma Reagin With Low Titers Using the Automated AIX 1000 RPR System.

ABSTRACT: This study evaluated the performance of manual rapid plasma reagin (RPR) and automated AIX1000 RPR tests for the diagnosis of syphilis. Manual RPR showed a 3% reactive result compared with 5.8% for the automated test mainly because of RPR reactive results with low titers not confirmed by Treponema pallidum particle agglutination.

Evaluating the Efficacy of Eradicating Gardnerella vaginalis Vaginal Colonization With Amoxicillin: A Randomized, Double-Blind, Phase 2 Study.

BACKGROUND: Research suggests that Gardnerella vaginalis (GV) is the keystone pathogen in bacterial vaginosis (BV). Knowledge gaps exist regarding the role of GV eradication in the development of BV. This study was designed to test the hypothesis that vaginal colonization with GV could be eradicated by treatment of women without BV with amoxicillin, a drug highly active against GV. If GV is necessary for the development of BV, then eradication of GV may prevent the development of BV. METHODS: We conducted a randomized control trial of amoxicillin 500 mg twice daily versus placebo for 7 days in women aged 18 to 45 years without vaginitis who screened positive for vaginal colonization with GV by quantitative polymerase chain reaction. Test-of-cure visit for GV was conducted at day 21. RESULTS: One hundred seventy-two women met preliminary criteria and were screened for enrollment. Ninety-seven GV-positive women were randomized to receive amoxicillin versus placebo. Eradication of GV occurred in 21% of women randomized to amoxicillin versus 16% on placebo (P = 0.757). In the 4 weeks between screening and test-of-cure visit, 16 of 92 (17%) of participants developed Nugent scores greater than 3 with 8 of 92 (9%) having BV. All of these were in participants in whom GV was not eradicated (P = 0.035). CONCLUSIONS: The study failed to show a benefit of treatment with amoxicillin to eradicate GV. No participants in whom GV was eradicated had progression to abnormal vaginal flora during the study period.

Beyond Disease Intervention: Exploring an Expanded Role for Partner Services in the MATRix-NC Demonstration Project.

BACKGROUND: Disease intervention specialists (DIS) provide partner services for sexually transmitted infections (STIs). 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 4 urban North Carolina 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 preexposure 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 partner services clients allowed DIS to access persons with significant medical and social service needs, demonstrating that DIS can support marginalized communities beyond STI intervention.

Anal cancer incidence in men with HIV who have sex with men: are black men at higher risk?

OBJECTIVE: To assess differences in anal cancer incidence between racial/ethnic groups among a clinical cohort of men with HIV who have sex with men. DESIGN: Clinical cohort study. METHODS: We studied men who have sex with men (MSM) in the Centers for AIDS Research Network of Integrated Clinical Systems (CNICS) who initiated antiretroviral therapy (ART) under HIV care in CNICS. We compared anal cancer incidence between Black and non-Black men and calculated hazard ratios controlling for demographic characteristics (age, CNICS site, year of ART initiation), HIV disease indicators (nadir CD4+, peak HIV RNA), and co-infection/behavioral factors including hepatitis B virus (HBV), hepatitis C virus (HCV), tobacco smoking and alcohol abuse. RESULTS: We studied 7473 MSM with HIV who contributed 41 810 person-years of follow-up after initiating ART between 1996 and 2014 in CNICS. Forty-one individuals had an incident diagnosis of anal cancer under observation. Crude rates of anal cancer were 204 versus 61 per 100 000 person-years among Black versus non-Black MSM. The weighted hazard ratio for anal cancer in Black MSM (adjusting for demographics, HIV disease factors, and co-infection/behavioral factors) was 2.37 (95% confidence interval: 1.17, 4.82) compared to non-Black MSM. CONCLUSIONS: In this large multicenter cohort, Black MSM were at significantly increased risk for anal cancer compared to non-Black MSM. Further detailed studies evaluating factors impacting anal cancer incidence and outcomes in Black men with HIV are necessary. Inclusion of more diverse study cohorts may elucidate modifiable factors associated with increased anal cancer risk experienced by Black MSM.

Enhancing Gonococcal Antimicrobial Resistance Surveillance in Cisgender Women, Strengthening the US Response to Resistant Gonorrhea, 2018 to 2019.

BACKGROUND: Cisgender women have been underrepresented in antibiotic-resistant gonorrhea (ARGC) surveillance systems. Three of 8 project sites (City of Milwaukee [MIL], Guilford County [GRB], Denver County [DEN]), funded under the Centers for Disease Control and Prevention's Strengthening the US Response to Resistant Gonorrhea (SURRG), focused efforts to better include cisgender women in ARGC surveillance. METHODS: MIL, GRB, and DEN partnered with diverse health care settings and developed gonorrhea culture criteria to facilitate urogenital specimen collection in cisgender women and men. Regional laboratories within the Antibiotic Resistance Laboratory Network performed agar dilution antibiotic susceptibility testing (AST) of gonococcal isolates. Data from 2018 and 2019 were analyzed. RESULTS: In SURRG, 90.5% (11,464 of 12,667) of the cisgender women from whom urogenital culture specimens were collected were from MIL, GRB, and DEN. Of women in SURRG whose gonococcal isolates underwent AST, 70% were from these 3 sites. In these 3 sites, a substantial proportion of cisgender women with positive urogenital cultures and AST were from health care settings other than sexually transmitted disease (STD) clinics (non-STD clinics; MIL, 56.0%; GRB, 80.4%; and DEN, 23.5%). Isolates with AST were obtained from 5.1%, 10.2%, and 2.4% of all diagnosed gonorrhea cases among cisgender women in MIL, GRB, and DEN, respectively, and were more often susceptible to all antibiotics than those from cisgender men from each of these sites. CONCLUSIONS: With focused efforts and partnerships with non-STD clinics, 3 SURRG sites were able to include robust ARGC surveillance from cisgender women. These findings may guide further efforts to improve gender equity in ARGC surveillance.