Multicenter Clinical Performance Evaluation of the NeuMoDx™ CT/NG Assay 2.0.

Background: Given the continued increases in rates of both Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) infection, additional diagnostic assays may be useful in increasing access to testing for these sexually transmitted infections. We evaluated the performance of the NeuMoDx™ CT/NG Assay 2.0 on the NeuMoDx-96 and NeuMoDx-288 Molecular Systems.

Comprehensive assessment of vaginal infections using a single swab.

Background: The decision to use a particular test to diagnose patients presenting with symptoms of vaginitis and/or STI is based primarily on the prevailing standards of care in the clinic at which the patient evaluation takes place. As a result, laboratory testing of vaginal samples for these patients often involves either an STI or a vaginitis test, but rarely both options simultaneously, which complicates the diagnosis and management of concurrent infections.

Methods: Using de-identified remnant vaginal specimens from symptomatic patients previously tested for STI ( (CT), (GC) and (TV)) with the Becton Dickinson (BD) CTGCTV2 assay for BD MAX System, positivity for bacterial vaginosis (BV) and spp (associated with vulvovaginal candidiasis (VVC)) were evaluated using the molecular-based BD MAX Vaginal Panel.

Clinical Performance of the BD Respiratory Viral Panel for BD MAX™ System in Detecting SARS-CoV-2, Influenza A and B, and Respiratory Syncytial Virus.

Using a nasopharyngeal (NP) or anterior nasal (NS) swab from prospectively collected or retrospective specimens, we assessed the clinical performance of the BD Respiratory Viral Panel (BD RVP) for BD MAX System against FDA-cleared or authorized comparators. Across prospective and retrospective specimens, positive percent agreement (PPA) was ≥ 98.4% for SARS-CoV-2, ≥ 96.

Chlamydia and Gonorrhea Testing in Pregnancy: Time to Improve Adherence and Update Recommendations.

Objective: The aim of the study is to evaluate adherence to national recommendations for Chlamydia trachomatis (chlamydia) and Neisseria gonorrhoeae (gonorrhea) testing during pregnancy including tests for cure/clearance and for persistence/potential reinfection at time of delivery.

Materials And Method: We evaluated results of chlamydia and gonorrhea nucleic acid amplification tests (NAAT) performed by major national reference laboratory from January 2010 through July 2022.

Results: Of 3,519,781 uniquely identified pregnant individuals, we identified 4,077,212 pregnancies.

Trimethoprim-Sulfamethoxazole Plus Azithromycin to Prevent Malaria and Sexually Transmitted Infections in Pregnant Women With HIV (PREMISE): A Randomized, Double-Masked, Placebo-Controlled, Phase IIB Clinical Trial.

Background: This trial tested the effectiveness of a novel regimen to prevent malaria and sexually transmitted infections (STIs) among pregnant women with HIV in Cameroon. Our hypothesis was that the addition of azithromycin (AZ) to standard daily trimethoprim-sulfamethoxazole (TMP-SMX) prophylaxis would reduce malaria and STI infection rates at delivery.

Methods: Pregnant women with HIV at gestational age <28 weeks were randomized to adjunctive monthly oral AZ 1 g daily or placebo for 3 days and both groups received daily standard oral TMP-SMX through delivery.

Ultra-Early and Short-Term Tranexamic Acid Treatment in Patients With Good- and Poor-Grade Aneurysmal Subarachnoid Hemorrhage.

Background And Objectives: The results of the ULTRA trial showed that ultra-early and short-term treatment with tranexamic acid (TXA) does not improve clinical outcome after aneurysmal subarachnoid hemorrhage (aSAH). Possibly, the lack of a beneficial effect in all patients with aSAH is masked by antagonistic effects of TXA in certain subgroups. In this post hoc subgroup analysis, we investigated the effect of TXA on clinical outcome in patients with good-grade and poor-grade aSAH.

Catching lightning in a bottle: the STI and HIV 2023 World Congress Participatory Designathon.

The International Society for STD Research (ISSTDR) STI/HIV 2023 World Congress convened a participatory designathon to engage attendees in a problem-solving crowdsourcing event with the mission to design innovative solutions for improving sexually transmitted infection (STI) control. Designathons are three-phase crowdsourcing events consisting of a pre-planning phase, an active and intensive collaborative phase, and denouement phase for implementation and dissemination. Given escalating STI concerns, the Congress organisers recognised the opportunity to harness the collective expertise of the attendees by actively engaging them to generate innovative solutions for STI control by hosting a designathon during the scientific meeting.

A Conference Designathon to Spark Innovation: Actionable Ideas to Enhance Sexually Transmitted Disease Control.

Background: Designathons can be used to enhance public health training and spur innovation. A designathon is a 3-stage participatory activity that includes preparation, intensive collaboration, and follow-up activities. We organized a designathon focused on developing actionable sexually transmitted disease (STD) control strategies and examined the content of ideas resulting from an STD designathon.

Development of a Novel Fluorescent-Based Lateral Flow Assay for the Detection of Neisseria gonorrhoeae at the Point of Care.

Background: Neisseria gonorrhoeae (NG) has acquired significant resistance, primarily due to extensive and unwarranted antibiotic utilization over several decades. This resistance has largely been associated with the syndromic management of sexually transmitted infections, particularly in low- and middle-income countries where affordable point of care tests are unavailable. To address this diagnostic gap, FIND has developed a low-cost lateral flow assay for the detection of NG at the point of care.

"Just the Stigma Associated with PrEP Makes You Feel Like It's HIV Itself": Exploring PrEP Stigma, Skepticism, and Medical Mistrust Among Black Cisgender Women in Urban and Rural Counties in the U.S. Deep South.

Despite its effectiveness in HIV prevention, PrEP use among Black women is suboptimal. Notably in the Deep South, Black women have the lowest PrEP uptake rates among all US regions. To increase PrEP engagement, research suggests the implementation of structural and social interventions particular to the needs of Black women.

Chlamydia trachomatis -Specific Antibody Responses in Women in Cameroon With Secondary Infertility.

The contribution of chlamydia to secondary infertility in women is poorly understood. Among 404 female participants enrolled in a previous study in Cameroon, 142 had secondary infertility (cases) and 262 were pregnant with no history of infertility (controls) , Chlamydia trachomatis seropositivity was 92%. Seropositivity did not significantly differ by case/control status.

Factors Associated With Willingness to Use Preexposure Prophylaxis Among Black Cisgender Women Residing in Rural and Urban Areas: A Cross-Sectional Study.

Background: Black cisgender women (CGW) are disproportionately impacted by the human immunodeficiency virus (HIV) epidemic in the United States. Black women account for 57% of the total new diagnoses among CGW. In addition, Black CGW women are 9 times more likely to be diagnosed with HIV than their White counterparts.

Sexually Transmitted Infection Point-of-Care Testing in Resource-Limited Settings: A Narrative Review Guided by an Implementation Framework.

Most sexually transmitted infections (STIs) are acquired in resource-limited settings (RLSs) where laboratory diagnostic access is limited. Advancements in point-of-care testing (POC) technology have the potential to bring STI testing to many RLSs. We define POC as performed near the patient and with results readily available to inform clinical practice.

Retrospective Evaluation of Mycoplasma genitalium Prevalence and Macrolide Resistance in a Study Cohort of Pregnant Women in Birmingham, AL, From 1997 to 2001.

In a prospective study conducted in 2020 to 2021, macrolide resistance-associated mutations were found in 41% of pregnant persons in Birmingham, AL, with Mycoplasma genitalium detected. We retrospectively evaluated M. genitalium in 203 pregnant persons participating in a study conducted in 1997 to 2001 in Birmingham and adjacent areas and found a prevalence of 11% (95% confidence interval, 6.

The SOS-SAH questionnaire in clinical practice: a multi-method evaluation study.

Background: In patients with mild disabilities after aneurysmal subarachnoid hemorrhage (aSAH), invisible symptoms might be easily overlooked during consultations in the outpatient clinic. We hypothesize that the Questionnaire for the Screening of Symptoms in aneurysmal Subarachnoid Hemorrhage (SOS-SAH), a disease-specific patient-reported outcome measure, might aid in screening for symptoms after aSAH. The objective of this explorative study is to evaluate the perceived impact of using the SOS-SAH in daily clinical practice for patients after aSAH, as well as to explore potential barriers to further implementation.

State of the Art for Diagnosis of Bacterial Vaginosis.

Bacterial vaginosis (BV) is the most common cause of vaginal discharge among reproductive-age women. It is associated with multiple adverse health outcomes, including increased risk of acquisition of HIV and other sexually transmitted infections (STIs), in addition to adverse birth outcomes. While it is known that BV is a vaginal dysbiosis characterized by a shift in the vaginal microbiota from protective species to an increase in facultative and strict anaerobic bacteria, its exact etiology remains unknown.

Differential Screening for Nonviral Sexually Transmitted Infections by Type of Vaginitis Testing.

Background: Data are lacking on adherence to Centers for Disease Control and Prevention testing guidelines among insured US women presenting with vaginal health complaints; thus, we quantified vaginitis testing frequency and assessed the co-testing rate for causes of vaginitis and Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG).

Methods: This was a retrospective analysis of deidentified data from a medical database. Information from women aged 18 to 50 years was obtained from the Truven MarketScan Commercial Database (2012-2017) using Current Procedural Terminology ( CPT ) codes; χ2 testing was applied to determine co-testing differences for CT/NG based on vaginitis test type.

Vaginal Swab vs Urine for Detection of , and A Meta-Analysis.

Purpose: (CT) and (NG) are the 2 most frequently reported notifiable sexually transmitted infections (STIs) in the United States, and (TV), although not a notifiable disease, is the most common curable non-viral STI worldwide. Women bear a disproportionate burden of these infections and testing is necessary to identify infections. Although vaginal swabs are the recommended sample type, the specimen most often used among women is urine.

Sexual behavior shapes male genitourinary microbiome composition.

The origin, composition, and significance of the distal male urethral microbiome are unclear, but vaginal microbiome dysbiosis is linked to new sex partners and several urogynecological syndromes. We characterized 110 urethral specimens from men without urethral symptoms, infections, or inflammation using shotgun metagenomics. Most urethral specimens contain characteristic lactic acid bacteria and Corynebacterium spp.

Embedding a Dedicated Sexual Health Clinic in a University's Health Services Expands Sexually Transmitted Infection Screening Options.

Background: The primary objectives of this study were to assess utilization of sexual health services at a university's student health and wellness center and to determine whether the presence of a dedicated sexual health clinic (SHC) was associated with different utilization patterns for sexual health services when compared with primary care clinics.

Methods: This was a retrospective chart review of patients presenting to the University of Alabama at Birmingham's Student Health and Wellness Center for sexual health services between January 2015 and June 2019. Utilization of sexual health services, specifically sexually transmitted infection (STI) testing, was compared between the dedicated SHC and primary care clinics.

Advances in Diagnostics of Sexually Transmitted Infections.

Sexually transmitted infections (STIs) are caused by various pathogens, many of which have common symptoms. Diagnostic tests are critical to supporting clinical evaluations in making patient management decisions. Molecular diagnostics are the preferred test type when available, especially in asymptomatic patients for many STIs.

Clinical Evaluation of a New Molecular Test for the Detection of Organisms Causing Vaginitis and Vaginosis.

In this prospective, observational, method comparison clinical study, the Xpert Xpress MVP test (MVP) was evaluated using both clinician-collected (CVS) and self-collected vaginal swabs (SVS) collected in a clinical setting. The study was conducted at 12 sites, including point-of-care (POC) settings, from geographically diverse locations in the United States. Participants were biologically female patients ≥ 14 years old with signs and/or symptoms of vaginitis/vaginosis.