Comprehensive observational study evaluating the enduring effectiveness of 4CMenB, the meningococcal B vaccine against gonococcal infections in the Northern Territory and South Australia, Australia: study protocol.

INTRODUCTION: The effectiveness of antibiotics for treating gonococcal infections is compromised due to escalating antibiotic resistance; and the development of an effective gonococcal vaccine has been challenging. Emerging evidence suggests that the licensed meningococcal B (MenB) vaccine, 4CMenB is effective against gonococcal infections due to cross-reacting antibodies and 95% genetic homology between the two bacteria, Neisseria meningitidis and Neisseria gonorrhoeae, that cause the diseases. This project aims to undertake epidemiological and genomic surveillance to evaluate the long-term protection of the 4CMenB vaccine against gonococcal infections in the Northern Territory (NT) and South Australia (SA), and to determine the potential benefit of a booster vaccine doses to provide longer-term protection against gonococcal infections. METHODS AND ANALYSES: This observational study will provide long-term evaluation results of the effectiveness of the 4CMenB vaccine against gonococcal infections at 4-7 years post 4CMenB programme implementation. Routine notifiable disease notifications will be the basis for assessing the impact of the vaccine on gonococcal infections. Pathology laboratories will provide data on the number and percentage of N. gonorrhoeae positive tests relative to all tests administered and will coordinate molecular sequencing for isolates. Genome sequencing results will be provided by SA Pathology and Territory Pathology/New South Wales Health Pathology, and linked with notification data by SA Health and NT Health. There are limitations in observational studies including the potential for confounding. Confounders will be analysed separately for each outcome/comparison. ETHICS AND DISSEMINATION: The protocol and all study documents have been reviewed and approved by the SA Department for Health and Well-being Human Research Ethics Committee (HREC/2022/HRE00308), and the evaluation will commence in the NT on receipt of approval from the NT Health and Menzies School of Health Research Human Research Ethics Committee. Results will be published in peer-reviewed journals and presented at scientific meetings and public forums.

Multicentre double-blind randomised placebo-controlled trial evaluating the efficacy of the meningococcal B vaccine, 4CMenB (Bexsero), against Neisseria gonorrhoeae infection in men who have sex with men: the GoGoVax study protocol.

INTRODUCTION: Gonorrhoea, the sexually transmissible infection caused by Neisseria gonorrhoeae, has a substantial impact on sexual and reproductive health globally with an estimated 82 million new infections each year worldwide. N. gonorrhoeae antimicrobial resistance continues to escalate, and disease control is largely reliant on effective therapy as there is no proven effective gonococcal vaccine available. However, there is increasing evidence from observational cohort studies that the serogroup B meningococcal vaccine four-component meningitis B vaccine (4CMenB) (Bexsero), licensed to prevent invasive disease caused by Neisseria meningitidis, may provide cross-protection against the closely related bacterium N. gonorrhoeae. This study will evaluate the efficacy of 4CMenB against N. gonorrhoeae infection in men (cis and trans), transwomen and non-binary people who have sex with men (hereafter referred to as GBM+). METHODS AND ANALYSIS: This is a double-blind, randomised placebo-controlled trial in GBM+, either HIV-negative on pre-exposure prophylaxis against HIV or living with HIV (CD4 count >350 cells/mm3), who have had a diagnosis of gonorrhoea or infectious syphilis in the last 18 months (a key characteristic associated with a high risk of N. gonorrhoeae infection). Participants are randomised 1:1 to receive two doses of 4CMenB or placebo 3 months apart. Participants have 3-monthly visits over 24 months, which include testing for N. gonorrhoeae and other sexually transmissible infections, collection of demographics, sexual behaviour risks and antibiotic use, and collection of research samples for analysis of N. gonorrhoeae-specific systemic and mucosal immune responses. The primary outcome is the incidence of the first episode of N. gonorrhoeae infection, as determined by nucleic acid amplification tests, post month 4. Additional outcomes consider the incidence of symptomatic or asymptomatic N. gonorrhoeae infection at different anatomical sites (ie, urogenital, anorectum or oropharynx), incidence by N. gonorrhoeae genotype and antimicrobial resistance phenotype, and level and functional activity of N. gonorrhoeae-specific antibodies. ETHICS AND DISSEMINATION: Ethical approval was obtained from the St Vincent's Hospital Human Research Ethics Committee, St Vincent's Hospital Sydney, NSW, Australia (ref: 2020/ETH01084). Results will be disseminated in peer-reviewed journals and via presentation at national and international conferences. TRIAL REGISTRATION NUMBER: NCT04415424.

Screening for Chlamydia and Gonorrhea in Youth Correctional Facilities, Utah, USA.

We reviewed data obtained in October 2021-May 2023 from youth who reported a history of sexual activity upon admission to 1 of 12 juvenile justice facilities in Utah, USA, that offered screening for Chlamydia trachomatis and Neisseria gonorrhoeae. Urinalysis revealed C. trachomatis positivity of 10.77%, N. gonorrhoeae positivity of 1.08%, and coinfection C. trachomatis N. gonorrhoeae) of 0.90%. Prevalence of infection was similar for youths in rural and urban facilities. A total of 12.01% of those identifying as male and 14.01% of those identifying as female tested positive for C. trachomatis, N. gonorrhoeae, or coinfection. Of young adults who tested positive, 74.65% received their results while incarcerated, all of whom accepted treatment. Our research underscores the feasibility of providing prompt C. trachomatis/N. gonorrhoeae screening and treatment in juvenile correctional facilities. The pervasiveness of infection emphasizes the urgent need for early identification and treatment for C. trachomatis and N. gonorrhoeae in incarcerated youth nationwide.

45 years of tetracycline post exposure prophylaxis for STIs and the risk of tetracycline resistance: a systematic review and meta-analysis.

There is considerable interest in the use of doxycycline post exposure prophylaxis (PEP) to reduce the incidence of bacterial sexually transmitted infections (STIs). An important concern is that this could select for tetracycline resistance in these STIs and other species. We searched PubMed and Google Scholar, (1948-2023) for randomized controlled trials comparing tetracycline PEP with non-tetracycline controls. The primary outcome was antimicrobial resistance (AMR) to tetracyclines in all bacterial species with available data. Our search yielded 140 studies, of which three met the inclusion criteria. Tetracycline PEP was associated with an increasedprevalence of tetracycline resistance in Neisseria gonorrhoeae, but this effect was not statistically significant (Pooled OR 2.3, 95% CI 0.9-3.4). PEP had a marked effect on the N. gonorrhoeae tetracycline MIC distribution in the one study where this was assessed. Prophylactic efficacy was 100% at low MICs and 0% at high MICs. In the one study where this was assessed, PEP resulted in a significant increase in tetracycline resistance in commensal Neisseria species compared to the control group (OR 2.9, 95% CI 1.5-5.5) but no significant effect on the prevalence of tetracycline resistance in Staphylococcus aureus. The available evidence suggests that PEP with tetracyclines could be associated with selecting tetracycline resistance in N. gonorrhoeae and commensal Neisseria species.

The impact of HIV preexposure prophylaxis on bacterial sexually transmitted infection occurrence in MSM: a systematic review and meta-analysis.

OBJECTIVE: To evaluate the effect of preexposure prophylaxis (PrEP) initiation on bacterial sexually transmitted infection (STI) occurrence (overall; chlamydia; gonorrhea; syphilis), in MSM. DESIGN: Systematic review and meta-analysis. METHODS: Systematic searches were performed in PubMed, Embase, and Scopus without language restrictions until 1 February 2023. We sought studies reporting data for the estimation of incidence rate ratios (IRR), prevalence ratios or cumulative incidence ratios (the latter in equal time periods before and after PrEP initiation) regarding bacterial STI occurrence. Separate analyses were performed overall for any STI, syphilis, chlamydia and gonorrhea (overall; rectal; urethral; pharyngeal for the two latter conditions); ratios greater than unity denoted increase in STI occurrence after PrEP initiation. RESULTS: Twenty-three eligible studies with 11 776 participants (age range: 18-71 years) with a median follow-up of 12 months were included. Overall, PrEP initiation was associated with a significant increase in the occurrence of any STI (pooled effect size: 1.15, 95% confidence interval (CI): 1.04-1.26), any gonorrhea (pooled effect size: 1.17, 95% CI: 1.02-1.34), any chlamydia (pooled effect size: 1.31, 95% CI: 1.09-1.58) and rectal chlamydia (pooled effect size: 1.31, 95% CI: 1.05-1.64), whereas a borderline increase was found in urethral chlamydia (pooled effect size: 1.25, 95% CI: 0.99-1.60, P  = 0.064). Changes in pharyngeal chlamydia and site-specific gonorrhea occurrence did not reach statistical significance. Syphilis showed virtually no change after PrEP initiation (pooled effect size: 0.99, 95% CI: 0.72-1.37). CONCLUSION: These results highlight the need for more comprehensive, accessible STI testing to tackle bacterial STI infections in PrEP users.

Questioning risk compensation: pre-exposure prophylaxis (PrEP) and sexually transmitted infections among men who have sex with men, capital region of Denmark, 2019 to 2022.

BackgroundPre-exposure prophylaxis (PrEP) effectively prevents HIV, but its association with sexually transmitted infections (STIs) has raised concerns about risk compensation, potentially impacting the expansion of PrEP programmes.AimWe examined the relationship between PrEP and the incidence of chlamydia, gonorrhoea and syphilis.MethodsIn this prospective cohort study, we compared STI rates before and after PrEP initiation among users in the capital region of Denmark (2019-2022), calculating incidence rate ratios adjusted for age and testing frequency (aIRR). To pinpoint when increases began, we plotted weekly STI rates, adjusting the timeline to correspond with PrEP initiation.ResultsThe study included 1,326 PrEP users with a median age of 35 years. The STI incidence rate per 100,000 person-years rose from 35.3 before to 81.2 after PrEP start, with an aIRR of 1.35 (95% CI: 1.18-1.56). Notably, this increase preceded PrEP initiation by 10-20 weeks. Specific aIRR for chlamydia, gonorrhoea and syphilis were 1.23 (95% CI: 1.03-1.48), 1.24 (95% CI: 1.04-1.47) and 1.15 (95% CI: 0.76-1.72), respectively. In subanalyses for anatomical sites aIRR was 1.26 (95% CI: 1.01-1.56) for rectal chlamydia and 0.66 (95% CI: 0.45-0.96) for genital gonorrhoea.ConclusionWe found a 35% increase in STI incidence associated with PrEP use. It started before PrEP initiation, challenging the assumption that PrEP leads to risk compensation. Instead, the data suggest that individuals seek PrEP during periods of heightened sexual risk-taking. Consequently, PrEP programmes should include sexual health consultations, STI testing, treatment and prevention strategies to prevent HIV and improve sexual health.

Australian consensus statement on doxycycline post-exposure prophylaxis (doxy-PEP) for the prevention of syphilis, chlamydia and gonorrhoea among gay, bisexual and other men who have sex with men.

INTRODUCTION: Doxycycline post-exposure prophylaxis (doxy-PEP) involves consuming 200 mg of doxycycline up to 72 hours after a condomless sex act to reduce the risk of bacterial sexually transmitted infections (STIs). Recent clinical trials of doxy-PEP have demonstrated significant reductions in syphilis, chlamydia and, to a lesser degree, gonorrhoea among gay, bisexual and other men who have sex with men (GBMSM). There is a high level of interest in doxy-PEP in the GBMSM community and, in response, the Australasian Society for HIV, Viral Hepatitis and Sexual Health Medicine (ASHM) held a national consensus conference with the aim of creating preliminary guidance for clinicians, community, researchers and policy makers. MAIN RECOMMENDATIONS: There was broad agreement that doxy-PEP should be considered primarily for the prevention of syphilis in GBMSM who are at risk of this STI, with a secondary benefit of reductions in other bacterial STIs. At the end of the consensus process, there remained some disagreement, as some stakeholders felt strongly that doxy-PEP should be considered only for the prevention of syphilis in GBMSM, and that the risk of increasing antimicrobial resistance outweighed any potential benefit from reductions in other bacterial STIs in the target population. The national roundtable made several other recommendations for clinicians, community, researchers and policy makers, as detailed in this article. ASHM will support the development of detailed clinical guidelines and education materials on doxy-PEP (www.ashm.org.au/doxy-pep). CHANGES IN MANAGEMENT AS A RESULT OF THIS CONSENSUS STATEMENT: For GBMSM at high risk of syphilis, and perhaps other bacterial STIs, clinicians may consider prescribing doxy-PEP for a limited period of time, followed by a review of ongoing need. Unlike human immunodeficiency virus (HIV) pre-exposure prophylaxis (PrEP), doxy-PEP may not be suitable as a population-level intervention and should instead be used more selectively.

Vaccination May Be Economically and Epidemiologically Advantageous Over Frequent Screening for Gonorrhea Prevention.

BACKGROUND: Gonorrhea's rapid development of antimicrobial resistance underscores the importance of new prevention modalities. Recent evidence suggests that a serogroup B meningococcal vaccine may be partially effective against gonococcal infection. However, the viability of vaccination and the role it should play in gonorrhea prevention are an open question. METHODS: We modeled the transmission of gonorrhea over a 10-year period in a heterosexual population to find optimal patterns of year-over-year investment of a fixed budget in vaccination and screening programs. Each year, resources could be allocated to vaccinating people or enrolling them in a quarterly screening program. Stratifying by mode (vaccination vs. screening), sex (male vs. female), and enrollment venue (background screening vs. symptomatic visit), we consider 8 different ways of controlling gonorrhea. We then found the year-over-year pattern of investment among those 8 controls that most reduced the incidence of gonorrhea under different assumptions. A compartmental transmission model was parameterized from existing literature in the US context. RESULTS: Vaccinating men with recent symptomatic infection, which selected for higher sexual activity, was optimal for population-level gonorrhea control. Given a prevention budget of $3 per capita, 9.5% of infections could be averted ($299 per infection averted), decreasing gonorrhea sequelae and associated antimicrobial use by similar percentages. These results were consistent across sensitivity analyses that increased the budget, prioritized incidence or prevalence reductions in women, or lowered screening costs. Under a scenario where only screening was implemented, just 5.5% of infections were averted. CONCLUSIONS: A currently available vaccine, although only modestly effective, may be superior to frequent testing for population-level gonorrhea control.

Treatment Rates for Chlamydia trachomatis and Neisseria gonorrhoeae in a Metropolitan Area: Observational Cohort Analysis.

BACKGROUND: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (GC) are the 2 most common sexually transmitted infections (STIs) in the United States. The Centers for Disease Control and Prevention regularly publishes and updates STI Treatment Guidelines. The purpose of this study was to measure and compare treatment rates for CT and GC among public and private providers. METHODS: Data from multiple sources, including electronic health records and Medicaid claims, were linked and integrated. Cases observed during 2016-2020 were defined based on positive laboratory results. We calculated descriptive statistics and odd ratios based on characteristics of providers and patients, stratifying by public versus private providers. Univariate logistic regression models were used to examine the factors associated with recommended treatment. RESULTS: Overall, we found that 82.2% and 63.0% of initial CT and GC episodes, respectively, received Centers for Disease Control and Prevention-recommended treatment. The public STI clinic treated more than 90% of CT and GC cases consistently across the 5-year period. Private providers were significantly less likely to treat first episodes for CT (79.6%) and GC (53.3%; P < 0.01). Other factors associated with a higher likelihood of recommended treatment included being male, being HIV positive, and identifying as Black or multiracial. Among GC cases, 10.8% received nonrecommended treatment; all CT cases with treatment occurred per guidelines. CONCLUSIONS: Although these treatment rates are higher than previous studies, there remain significant gaps in STI treatment that require intervention from public health.

Effect of screening for Neisseria gonorrhoeae and Chlamydia trachomatis on incidence of these infections in men who have sex with men and transgender women taking HIV pre-exposure prophylaxis (the Gonoscreen study): results from a randomised, multicentre, controlled trial.

BACKGROUND: Guidelines recommend screening for Neisseria gonorrhoeae and Chlamydia trachomatis at three anatomical sites (urethra, anus, and pharynx) every 3 months (3 × 3) in men who have sex with men (MSM) and transgender women taking HIV pre-exposure prophylaxis (PrEP). We present the first randomised controlled trial to compare the effect of screening versus non-screening for N gonorrhoeae and C trachomatis on the incidence of these infections in MSM and transgender women taking PrEP. METHODS: A multicentre, randomised, controlled trial of 3 × 3 screening for N gonorrhoeae and C trachomatis versus non-screening was done among MSM and transgender women taking PrEP in five HIV reference centers in Belgium. Participants attended the PrEP clinics quarterly for 12 months. N gonorrhoeae and C trachomatis was tested at each visit in both arms, but results were not provided to the non-screening arm, if asymptomatic. The primary outcome was incidence rate of N gonorrhoeae and C trachomatis infections in each arm, assessed in the per-protocol population. Non-inferiority of the non-screening arm was proven if the upper limit of the 95% CI of the incidence rate ratio (IRR) was lower than 1·25. This trial is registered with ClinicalTrials.gov, NCT04269434, and is completed. FINDINGS: Between Sept 21, 2020, and June 4, 2021, 506 participants were randomly assigned to the 3 × 3 screening arm and 508 to the non-screening arm. The overall incidence rate of N gonorrhoeae and C trachomatis was 0·155 cases per 100 person-days (95% CI 0·128-0·186) in the 3 × 3 screening arm and 0·205 (95% CI 0·171-0·246) in the non-screening arm. The incidence rate was significantly higher in the non-screening arm (IRR 1·318, 95% CI 1·068-1·627). Participants in the non-screening arm had a higher incidence of C trachomatis infections and symptomatic C trachomatis infections. There were no significant differences in N gonorrhoeae infections. Participants in the non-screening arm consumed significantly fewer antimicrobial drugs. No serious adverse events were reported. INTERPRETATION: We failed to show that non-screening for N gonorrhoeae and C trachomatis is non-inferior to 3 × 3 screening in MSM and transgender women taking PrEP in Belgium. However, screening was associated with higher antibiotic consumption and had no effect on the incidence of N gonorrhoeae. Further research is needed to assess the benefits and harms of N gonorrhoeae and C trachomatis screening in this population. FUNDING: Belgian Health Care Knowledge Centre.

Patterns of Chlamydia trachomatis and Neisseria gonorrhoeae in different anatomical sites among Pre-Exposure Prophylaxis (PrEP) users in Brazil.

BACKGROUND: The presence of untreated sexually transmitted infections (STIs) significantly increases the chance of acquiring HIV. In Brazil, testing for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) among Pre-Exposure Prophylaxis (PrEP) users is insufficient, and syndromic treatment is a priority in clinical practice. Multi-site testing for CT/NG improves thescreening of asymptomatic cases and ensures timely treatment. Therefore, it is essential for HIV prevention. This study aims to test the importance of two-site testing for better screening of these pathogens and to determine whether the presence of symptoms is an indicator of CT/NG infection. METHODS: This is a cross-sectional study carried out in four public infectious diseases clinics in São Paulo State, Brazil between January of 2022 and March of 2023. All participants had an anal swab and a first-pass or mid-stream urine collected for CT/NG analysis by Polymerase chain reaction (PCR). Data about sociodemographic, sexual behavioural and clinical aspects were collected. Pathway analysis was used to examine the direct and indirect relationships between variables according to the theoretical model. RESULTS: We screened 171 PrEP users which had two samples collected, resulting in 342 samples. Comparing the anatomic sites, the urine samples showed lower sensitivity for CT and NG than anal samples. Gonorrhoea was directly linked to lower age (ß= -0.161, p = 0.001). Time of PrEP use was directly associated with CT infection (ß = 0.202; p = 0.042) and inversely associated with dysuria (ß= -0.121, p = 0.009). Lower occurrence of yellow-green secretion was linked to detection of CT (ß= -0.089, p = 0.005) and NG (ß= -0.048, p = 0.002) infections. Foul-smelling discharge was directly associated with CT (ß = 0.275, p = 0.004) and NG (ß = 0.295, p = 0.037) infection. CONCLUSION: The symptoms are a bad indicator of CT and NG infection, and the screening must be done in more than one site since most of the positive results would be missed if only urines were tested. In the case of testing only one anatomical site, specifically the urethra, the CT/NG incidence and prevalence would be underestimated. The two-sites testing improves detection rates of CT/NG, and PrEP follow-up benefits people offering STI testing.

An Interactive Modeling Tool for Projecting the Health and Direct Medical Cost Impact of Changes in the Sexually Transmitted Diseases Prevention Program Budgets.

CONTEXT: Estimating the return on investment for public health services, tailored to the state level, is critical for demonstrating their value and making resource allocation decisions. However, many health departments have limited staff capacity and expertise to conduct economic analyses in-house. PROGRAM: We developed a user-friendly, interactive Excel-based spreadsheet model that health departments can use to estimate the impact of increases or decreases in sexually transmitted infection (STI) prevention funding on the incidence and direct medical costs of chlamydia, gonorrhea, syphilis, and STI-attributable HIV infections. Users tailor results to their jurisdictions by entering the size of their population served; the number of annual STI diagnoses; their prior annual funding amount; and their anticipated new funding amount. The interface was developed using human-centered design principles, including focus groups with 15 model users to collect feedback on an earlier model version and a usability study on the prototype with 6 model users to finalize the interface. IMPLEMENTATION: The STI Prevention Allocation Consequences Estimator ("SPACE Monkey 2.0") model will be publicly available as a free downloadable tool. EVALUATION: In the usability testing of the prototype, participants provided overall positive feedback. They appreciated the clear interpretations, outcomes expressed as direct medical costs, functionalities to interact with the output and copy charts into external applications, visualization designs, and accessible information about the model's assumptions and limitations. Participants provided positive responses to a 10-item usability evaluation survey regarding their experiences with the prototype. DISCUSSION: Modeling tools that synthesize literature-based estimates and are developed with human-centered design principles have the potential to make evidence-based estimates of budget changes widely accessible to health departments.

Neisseria gonorrhoeae vaccines: a contemporary overview.

Neisseria gonorrhoeae infection is an important public health issue, with an annual global incidence of 87 million. N. gonorrhoeae infection causes significant morbidity and can have serious long-term impacts on reproductive and neonatal health and may rarely cause life-threatening disease. Global rates of N. gonorrhoeae infection have increased over the past 20 years. Importantly, rates of antimicrobial resistance to key antimicrobials also continue to increase, with the United States Centers for Disease Control and Prevention identifying drug-resistant N. gonorrhoeae as an urgent threat to public health. This review summarizes the current evidence for N. gonorrhoeae vaccines, including historical clinical trials, key N. gonorrhoeae vaccine preclinical studies, and studies of the impact of Neisseria meningitidis vaccines on N. gonorrhoeae infection. A comprehensive survey of potential vaccine antigens, including those identified through traditional vaccine immunogenicity approaches, as well as those identified using more contemporary reverse vaccinology approaches, are also described. Finally, the potential epidemiological impacts of a N. gonorrhoeae vaccine and research priorities for further vaccine development are described.

Rebound of Gonorrhea after Lifting of COVID-19 Preventive Measures, England.

After lifting of all COVID-19 preventive measures in England in July 2021, marked, widespread increases in gonorrhea diagnoses, but not testing numbers, were observed, particularly in persons 15-24 years of age. Continued close surveillance and public health messaging to young persons are needed to control and prevent gonorrhea transmission.

Inequities Along the Human Immunodeficiency Virus (HIV) Pre-exposure Prophylaxis Services Continuum for Black Women in the United States, 2015-2020.

OBJECTIVE: To estimate the number of women who received human immunodeficiency virus (HIV) and sexually transmitted infection (STI) testing and HIV pre-exposure prophylaxis (PrEP) services by race and ethnicity in seven THRIVE (Targeted Highly Effective Interventions to Reverse the HIV Epidemic)-funded jurisdictions and to estimate associations of age and syphilis and gonorrhea diagnoses with receipt of HIV PrEP services. METHODS: We analyzed data collected from 2015 to 2020 in Birmingham, Alabama; Baltimore City, Maryland; Washington, DC, New Orleans, Louisiana; Brooklyn, New York; Philadelphia, Pennsylvania; and Hampton Roads, Virginia. We compared Black women and women of additional racial and ethnic groups by age, HIV status at enrollment, receipt of STI testing and test positivity, and steps in the PrEP continuum (screened, eligible, referred, linked, and prescribed). We also examined the association of age, syphilis, or gonorrhea with the following steps in the PrEP continuum: screened, referred, linked, and prescribed. RESULTS: Black women made up 69.2% (8,758/12,647) of women served in THRIVE. Compared with non-Black women, Black women were more likely to have a positive test result for syphilis (3.3% vs 2.1%), gonorrhea (4.9% vs 3.5%), chlamydia (5.1% vs 1.9%), or more than one STI (1.4% vs 0.3%). Among women with negative HIV test results or unknown HIV status, Black women were more likely to be screened for PrEP eligibility (88.4% vs 64.9%). Among Black women, the proportion screened for PrEP was higher among those diagnosed with syphilis (97.3%) or gonorrhea (100%) than among those without an STI (88.1% and 87.8%, respectively). Among 219 Black women who presented with syphilis, only 10 (4.6%) were prescribed PrEP; among 407 with gonorrhea, only 11 (2.7%) were prescribed PrEP. CONCLUSION: Although most Black women seeking services received STI testing, the proportion of Black women who were eligible for PrEP and prescribed PrEP was low. To achieve national HIV-prevention goals, it is imperative that Black women have access to PrEP information and services.

Anorectal gonorrhoea and chlamydia among transgender women in Brazil: prevalence and assessment of performance and cost of anorectal infection detection and management approaches.

OBJECTIVES: We aimed to determine the prevalence of anorectal Neisseria gonorrhoeae (NG) and Chlamydia trachomatis (CT) among transgender women in Brazil, and to assess the performance and costs of various approaches for the diagnosis and management of anorectal NG/CT. METHODS: TransOdara was a multicentric, cross-sectional STI prevalence study among 1317 transgender women conducted in five capital cities representing all Brazilian regions. Participants aged >18 years were recruited using respondent-driven sampling (RDS), completed an interviewer-led questionnaire, offered an optional physical examination and given choice between self-collected or provider-collected samples for NG/CT testing. Performance and cost indicators of predetermined management algorithms based on the WHO recommendations for anorectal symptoms were calculated. RESULTS: Screening uptake was high (94.3%) and the estimated prevalence of anorectal NG, CT and NG and/or CT was 9.1%, 8.9% and 15.2%, respectively. Most detected anorectal NG/CT infections were asymptomatic (NG: 87.6%, CT: 88.9%), with a limited number of participants reporting any anorectal symptoms (9.1%). Of those who permitted anal examination, few had clinical signs of infection (13.6%). Sensitivity of the tested algorithms ranged from 1.4% to 5.1% (highest for treatment based on the reported anorectal discharge or ulcer and receptive anal intercourse (RAI) in the past 6 months) and specificity from 98.0% to 99.3% (highest for treatment based on the reported anorectal discharge with clinical confirmation or report of RAI). The estimated cost-per-true case of anorectal NG/CT infection treated varied from lowest providing treatment for anorectal discharge syndrome based on the reported RAI ($2.70-4.28), with algorithms including clinical examinations decreasing cost-effectiveness. CONCLUSIONS: High prevalence of mostly asymptomatic anorectal NG and CT was observed among Brazilian transgender women. Multi-site NG/CT screening should be offered to transgender women. Where diagnostic testing capacity is limited, syndromic management for those presenting with anorectal symptoms is recommended.

Promising developments in gonococcal vaccines.

PURPOSE OF REVIEW: While effective vaccines to prevent invasive infections by Neisseria meningitidis have been deployed around the world, development of a vaccine to prevent Neisseria gonorrhoeae has lagged. After multiple failed vaccine candidates, vaccine development for N. gonorrhoeae is showing promise for the first time in several decades. This review highlights recent progress in the field. RECENT FINDINGS: Vaccines containing outer-membrane vesicles (OMV) have been used to manage outbreaks of the serogroup B N. meningitidis in a number of countries. Epidemiologic studies indicate these vaccination campaigns were associated with reductions in reported N. gonorrhoeae infections. Recently, a serogroup B N. meningitidis vaccine containing both recombinant antigens and OMV has been licensed through much of the world. Epidemiologic studies also demonstrate associations between 4CMenB immunization and reduced N. gonorrhoeae infections. Additionally, mathematical modeling studies have begun to identify potential strategies for vaccine deployment to maximize reduction of infections. SUMMARY: After several decades with little progress towards an effective gonococcal vaccine, large observational studies have provided evidence that a new generation of group B N. meningitidis vaccines containing OMV have serendipitously restarted the field. Ongoing clinical trials will soon provide definitive evidence regarding the efficacy of these vaccines in preventing N. gonorrhoeae infection.

Expedited Partner Therapy: A Multicomponent Initiative to Boost Provider Counseling.

BACKGROUND: Expedited partner therapy prescription remains low and highly variable throughout the United States, leading to frequent reinfections with Chlamydia trachomatis and Neisseria gonorrhoeae . We examined provider counseling on expedited partner therapy before and after an electronic smart tool-based initiative. METHODS: In this quasi-experimental interrupted time-series study, we implemented an initiative of electronic smart tools and education for expedited partner therapy in March 2020. We reviewed the records of patients with chlamydia and/or gonorrhea at an urban, academic obstetrics and gynecology clinic in the preimplementation (March 2019-February 2020) and postimplementation (March 2020-February 2021) groups. Descriptive statistics and an interrupted time-series model were used to compare the percent of expedited partner therapy offered by clinicians to patients in each group. RESULTS: A total of 287 patient encounters were analyzed, 155 preintervention and 132 postintervention. An increase in expedited partner therapy counseling of 13% (95% confidence interval [CI], 2%-24%) was observed before the intervention (27.1% [42 of 155]) versus after the intervention (40.2% [53 of 132]). Significant increases in provider counseling were seen for patients who were single (15%; 95% CI, 3%-26%), 25 years or older (21%; 95% CI, 6%-37%), receiving public insurance (15%; 95% CI, 3%-27%), seen by a registered nurse (18%; 95% CI, 4%-32%), or seen for an obstetrics indication (21%; 95% CI, 4%-39%). No difference was seen in patients' acceptance of expedited partner therapy ( P = 1.00). CONCLUSIONS: A multicomponent initiative focused on electronic smart tools is effective at increasing provider counseling on expedited partner therapy. Further research to understand patient perceptions and acceptance of expedited partner therapy is critical.

The global burden of sexually transmitted infections.

Understanding the global burden of sexually transmitted infections (STIs) is fundamental to being able to address and control these infections and the health harms they cause. The World Health Organization has renewed its global health sector strategy for the prevention and control of STIs. Reducing STIs remains an integral part of HIV prevention and of sexual and reproductive health programs. Data to measure and describe the global burden continue to improve, with systematic reviews and modeling providing global and regional data for the major STIs. Although substantial gaps remain, as many countries have limited data, the measures available demonstrate the scale of the problem for the main curable STIs, gonorrhea, chlamydia, syphilis, and trichomoniasis; the most common viral STIs, human papillomavirus and genital herpes; the interrelation between STIs and HIV; and the substantially unequal burden of these infections globally and among key populations. Regional and global trends in these infections are affected by population changes; the impact and availability of interventions, such as vaccination; changing behaviors that alter the dynamics of STI transmission; and the role of international travel in promulgating STIs in an increasingly interconnected world.