A Conference Designathon to Spark Innovation: Actionable Ideas to Enhance STD Control.

BACKGROUND: Designathons can be used to enhance public health training and spur innovation. A designathon is a three-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. METHODS: For this designathon we created four groups: early career researchers, silver group (people with >10 years of experience), travelers (people from low- and middle-income countries and those who received a conference scholarship) and a community group. Each group developed its own plan to consult members, iteratively develop ideas, and aggregate insights. Each group developed STD control strategies that were presented. Cross-cutting themes across these ideas were identified. RESULTS: Designathon participants included a subset of conference participants. Cross-cutting themes from final ideas included co-creating STD interventions with end-users, using sex-positive framing, enhancing open access digital STD resources, and reducing STD stigma. Early career researchers presented a call for community ideas focusing on ending STD epidemics by increasing accessibility to STD care services among all populations. The silver group proposed digital innovations, including an AI-powered tool for testing and treatment and a social game to promote sex positivity. The traveler group conceptualized an information hub to support implementation of STD programs. Community members underscored the importance of a more human-centered approach to STD control which reduces stigma and normalizes sex and sexual pleasure. CONCLUSION: Sex positive campaigns and open access digital resources should be considered within STD programs. Implementation research studies are needed to evaluate these ideas.

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. Designathon activities occurred during the Congress, and innovative solutions were presented during the closing plenary. Organisers prioritised participant diversity and engagement by creating four distinct groups based on lived experiences (Silver, Early Career, Traveller, and Community). Although competing priorities through the Congress were a challenge, participation from the attendees was high. Dedicated time and space for the event allowed for a successful designathon event, and the lack of restrictions, as might be encountered from funders or other stakeholder agencies, allowed participants to creatively develop innovative solutions for STI control. This designathon serves as an exemplar for successfully hosting a designathon at a large scientific meeting to engage attendees and contribute their intellect and voice to collectively solving significant problems.

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. METHODS: The early performance of the lateral flow assay was evaluated using frozen clinical samples. Limit of detection, inclusivity, and exclusivity studies were performed using well-characterized NG strains, common commensal genital microorganisms, and other Neisseria bacteria. Subsequently, clinical performance was evaluated at 2 sexual health clinics in Birmingham, Alabama. RESULTS: The observed limit of detection with reference NG strains was 5 × 103 CFU/mL. Inclusivity was demonstrated for 31 NG strains. Exclusivity testing showed no cross-reactivity with 28 non-Neisseria and nongonococcal Neisseria species; cross-reactivity was observed with Neisseria meningitidis, Neisseria lactamica, and Neisseria polysaccharea. The lateral flow assay demonstrated clinical sensitivity and specificity of 78.6% and 100% in female vaginal swabs and 100% and 89.7% in male urine, respectively. CONCLUSIONS: FIND has developed a lateral flow assay that aligns with the majority of the World Health Organization Target Product Profile criteria for confirming or excluding NG infection at the point of care. The NG lateral flow assay has now achieved design freeze (final device optimization) and is ready for technology transfer to a manufacturing partner. This test has the potential to support the shift in patient management from a syndromic to an etiological approach.

"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. The state of Alabama is of priority to federal HIV prevention initiatives; therefore, this study conducted focus groups among 47 cis-gender Black women in rural and urban Alabama counties, with the highest statewide HIV incidence rates, to understand perceptions of PrEP and decision-making processes. Deductive coding analysis was conducted and themes were finalized based on consensus among the two coders. Four themes were identified. Findings show stigma undergirds Alabaman Black women's decisions to engage in PrEP care. Moreover, women reported stigma stifled community-level education about PrEP. Despite these experiences, education was regarded as a strategy to decrease stigma and PrEP skepticism, the latter of which emerged as a prominent theme. Medical mistrust and healthcare engagement were the other emergent themes influencing participation in PrEP care. To ensure PrEP efforts meet the needs of Black cisgender women in Alabama counties, interventions must address longstanding stigma, increase educational initiatives, and ensure interventions consider women's experiences with medical mistrust and health care engagement.

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

ABSTRACT: 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. METHODS: We conducted surveys (September 2019-March 2020) and collected information on sociodemographics, HIV/preexposure prophylaxis (PrEP) knowledge, HIV/PrEP stigma, sexual practices, and other factors identified as PrEP barriers among Black CGW (n = 795). This cross-sectional study used logistic regression models to assess intrapersonal, interpersonal, and structural factors among individuals willing to use PrEP versus individuals unwilling or unsure to use PrEP. RESULTS: Our study population had a mean age of 37 years, predominantly lived in urban areas (65%), had stable housing (96.7%), and had private insurance/Medicare (78.2%). Overall, 29.6% reported willingness to use PrEP, 35.6% reported unwillingness to use PrEP, and 34.8% were unsure of PrEP use. The multivariable analysis showed that, compared with individuals reporting unwillingness/unsure to PrEP use, those reporting willingness to PrEP use were younger (adjusted odds ratio [AOR; 95% confidence interval {CI}], 0.97 [0.96-0.99]), had lower odds of intimate partner violence (AOR [95% CI], 0.87 [0.78-0.98), and had higher odds of organizational religiosity (AOR [95% CI], 1.10 [1.01-1.20]), HIV knowledge (AOR [95% CI], 1.08 [1.03-1.13]), and perceived need for PrEP (AOR [95% CI], 6.38 [3.36-12.11]). CONCLUSIONS: Preexposure prophylaxis willingness among Black CGW was impacted by individual-level, interpersonal, and structural factors. Improving PrEP willingness and uptake among Black CGW will require multilevel interventions.

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

ABSTRACT: 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, 6.9%-15.7%), but no macrolide resistance-associated mutations.

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

ABSTRACT: 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. The World Health Organization Special Programme for Research and Training in Tropical Diseases further outlines desirable POC characteristics with the REASSURED criteria.Despite advantages related to immediate test-and-treat care, integrating POC into RLS health care systems can present challenges that preclude reliance on these tests. In 2018, we incorporated molecular near-POC for chlamydia, gonorrhea, and trichomoniasis and SDBioline treponemal immunochromatographic testing confirmed by rapid plasma reagin for syphilis diagnosis at the Mbarara University of Science and Technology Research Laboratory in rural southwestern Uganda. We describe our experiences with STI POC as a case example to guide a narrative review of the field using the Consolidated Framework for Implementation Research as a conceptual framework.Although POC and near-POC are described as easy to use, the challenges of limited person-power, health care processes, limited infrastructure/resources, high costs, and quality control obstacles can impede the impact of these tests. Increased investment in operators, training, and infrastructure, restructuring health care systems to accommodate increased POC access, and optimizing costs are all crucial to the successful implementation of STI POC in RLS. Expanded STI POC in RLS will increase access to accurate diagnoses, appropriate treatment, and engagement in partner notification, treatment, and prevention efforts.

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 Lactobacillus species to an increase in facultative and strict anaerobic bacteria, its exact etiology remains unknown. The purpose of this minireview is to provide an updated overview of the range of tests currently used for the diagnosis of BV in both clinical and research settings. This article is divided into two primary sections: traditional BV diagnostics and molecular diagnostics. Molecular diagnostic assays, particularly 16S rRNA gene sequencing, shotgun metagenomic sequencing, and fluorescence in situ hybridization (FISH), are specifically highlighted, in addition to multiplex nucleic acid amplification tests (NAATs), given their increasing use in clinical practice (NAATs) and research studies (16S rRNA gene sequencing, shotgun metagenomic sequencing, and FISH) regarding the vaginal microbiota and BV pathogenesis. We also provide a discussion of the strengths and weaknesses of current BV diagnostic tests and discuss future challenges in this field of research.

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. Odds ratios were calculated to determine the association with CT/NG screening across vaginitis testing categories. RESULTS: Approximately 48% of 1,359,289 women received a vaginitis diagnosis that involved a laboratory-based test. Of these women, only 34% were co-tested for CT/NG. CT/NG co-testing was highest for those with nucleic acid amplification testing for vaginitis and lowest for those with no vaginitis testing CPT code (71% vs. 23%, respectively; P < 0.0001). CONCLUSIONS: The vaginitis nucleic acid amplification test, indicated by CPT code, was associated with statistically significantly higher CT/NG testing rates. Molecular diagnostics may support vaginitis testing in settings that have limited opportunities for microscopy and clinical examinations and offer greater opportunity to offer comprehensive women's health care that includes testing for chlamydia and/or gonorrhea infections.

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. In contrast, several bacteria associated with vaginal dysbiosis were present only in specimens from men who reported vaginal intercourse. Sexual behavior, but not other evaluated behavioral, demographic, or clinical variables, strongly associated with inter-specimen variance in urethral microbiome composition. Thus, the male urethra supports a simple core microbiome that is established independent of sexual exposures but can be re-shaped by vaginal sex. Overall, the results suggest that urogenital microbiology and sexual behavior are inexorably intertwined, and show that the male urethra harbors female urogenital pathobionts.

Vaginal Swab vs Urine for Detection of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis: A Meta-Analysis.

PURPOSE: Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) are the 2 most frequently reported notifiable sexually transmitted infections (STIs) in the United States, and Trichomonas vaginalis (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. The objective of this meta-analysis was to assess the diagnostic sensitivity of commercially available assays for vaginal swabs vs urine specimens from women. METHODS: A systematic search of multiple databases from 1995 through 2021 identified studies that (1) evaluated commercially available assays, (2) presented data for women, (3) included data obtained from the same assay on both a urine specimen and a vaginal swab from the same patient, (4) used a reference standard, and (5) were published in English. We calculated pooled estimates for sensitivity and the corresponding 95% CIs for each pathogen as well as odds ratios for any difference in performance. RESULTS: We identified 28 eligible articles with 30 comparisons for CT, 16 comparisons for NG, and 9 comparisons for TV. Pooled sensitivity estimates for vaginal swabs and urine, respectively, were 94.1% and 86.9% for CT, 96.5% and 90.7% for NG, and 98.0% and 95.1% for TV (all P values <.001). CONCLUSIONS: Evidence from this analysis supports the Centers for Disease Control and Prevention's recommendation that vaginal swabs are the optimal sample type for women being tested for chlamydia, gonorrhea, and/or trichomoniasis.

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. However, for some infections, serology offers the best insight into infectious status. Clinicians should be aware of the performance characteristics of the available STI diagnostic tests and understand how to use them. Point-of-care tests are helpful to implement rapid and accurate treatment responses, which are particularly helpful in certain at-risk populations.

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. RESULTS: A total of 3081 cases were included. There were statistically significant differences in the proportion of male individuals and populations more burdened by STI tested for STI in the SHC (i.e., persons who identify as Black and younger female individual). We also observed a higher percentage of positive gonorrhea and chlamydia test results and a greater likelihood of extragenital screening in men who have sex with men in the SHC. CONCLUSIONS: The dedicated SHC within the University of Alabama at Birmingham's Student Health and Wellness Center was associated with an increase in STI screenings. There was a significant difference between the demographics of those presenting to the SHC versus primary care clinics, proportionally more diagnoses of gonorrhea and chlamydia, and, for men who have sex with men, more extragenital screenings performed in the SHC. These findings suggest that there may be a benefit of an embedded SHC in college and university health and wellness centers.

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. MVP test results for BV were compared to the BD MAX Vaginal Panel (BDVP). Results for Candida group and Candida glabrata and Candida krusei targets (species not differentiated) were assessed relative to yeast culture followed by mass spectrometry for species identification. Trichomonas vaginalis (TV) results were compared relative to a composite method that included results from the BDVP and InPouch TV culture. The investigational test demonstrated high positive percent agreement ranging from 93.6 to 99.0%, and negative percent agreement ranging from 92.1% to 99.8% for both CVS and SVS specimens, indicating it may be a valuable tool for the diagnosis of vaginitis/vaginosis in laboratory and POC settings.

Testing Technologies as Enhancers of Disease Intervention Specialist Activities: Applying Lessons From COVID-19.

ABSTRACT: Disease intervention specialists are often at the forefront of adoption of new technologies in support of sexually transmitted infection (STI) contact tracing efforts. Newer technology for detection of treatable STI includes point-of-care molecular tests for detection of chlamydia, gonorrhea, and trichomonas and syphilis serology point-of-care tests. Other additions to our case finding toolbox are the use of telemedicine and the proliferation of direct-to-consumer offerings, both of which rely on remote sample collection involving self-collection of specimens in nonclinical settings. Finally, on the near horizon are over-the-counter tests that will support self-testing without the involvement of a medical professional. Each of these new developments is discussed and contextualized in experiences resulting from the COVID-19 pandemic response. Many options are now available, or will be soon, for detection of STIs in nontraditional settings, and we need to consider the processes involved as we move toward adoption of these new tools.

A Review of the Scope of Direct-to-Consumer Sexually Transmitted Infection Testing Services Offered on the Internet.

BACKGROUND: The prevalence of sexually transmitted infections (STIs) is at an all-time high. Direct-to-consumer STI testing services may help alleviate this undue health burden. These products are sold online and rarely require interaction with a health care professional (HCP). Vendors offer STI self-collection kits or prescriptions for HCP specimen collection. The objective was to understand the scope of direct-to-consumer STI testing services offered and provide recommendations for consumers and industry. METHODS: Seven volunteers searched for "STD tests" on Google from February 1 through March 31, 2021 and shared their top 3 results. The study team extracted data from consumer-facing information on each website. Descriptive statistics and thematic qualitative analyses were performed. RESULTS: Twenty vendors were identified. Most vendors (95%) used Clinical Laboratory Improvement Amendments (CLIA)-certified or College of American Pathologists (CAP) accredited laboratories. Analyses distinguished between STI self-collection kits (n = 9) using independent laboratories and HCP specimen collection (n = 10), which used commercial laboratories (n = 1 offered both). The STI self-collection kits were cheaper per test and bundle on average (eg, $79.00 vs. $106.50 for chlamydia/gonorrhea), and more closely aligned with clinical recommendations compared with the HCP specimen collection options. Websites often contained inaccurate or misleading information (n = 13), often promoting testing outside of the recommendations. CONCLUSIONS: Direct-to-consumer STI testing services are part of an emerging market lacking regulation. Consumers should select vendors offering prescriptions for HCP specimen collection at CAP accredited and CLIA-certified laboratories. Vendors should provide a screening tool to assess individual patient risk prior to test purchase.