Patterns of Use and Barriers to STI Point-of-care Tests for Military Obstetrician Gynecologists.

INTRODUCTION: Sexually transmitted infections (STIs) are commonly reported in military populations. Point-of-care tests (POCTs) are commercially available, but their use is variable in the civilian sector. Their use among military providers has not been evaluated. We sought to identify the pattern of use and barriers to using STI POCTs for military obstetrician/gynecologists (OBGYNs). MATERIALS AND METHODS: We adapted a survey of civilian OBGYNs on patterns of use and barriers to STI POCTs for military OBGYNs. We sent an online questionnaire to 479 military OBGYNs via Army, Air Force, and Navy specialty leaders in May 2023. The questionnaire included 14 demographic questions and up to 52 questions regarding availability, use, and barriers to STI POCTs. The USU Institutional Review Board deemed the study exempt from Institutional Review Board review. RESULTS: Of the 479 solicited, 117 participated in the survey (24.4%). Of respondents, 64.1% were women and 79.5% non-Hispanic white. Sexually transmitted infections were detected once to twice weekly by 13.0% of respondents and once or twice monthly by 52.8%. The most available STI-related POCTs were wet mount prep (68.7%), rapid HIV (43.3%), and urine dipstick (38.6%). Gram stain was available for 30.3%, the Affirm VPIII (Becton, Dickinson and Company, Franklin Lakes, NJ) for 24.5%, and stat RPR for 16.3%. Economic barriers to using POCTs included cost of the test from manufacturer/distributor (57.9%) and military funding/stocking decisions (10.3%). The greatest barriers to use were the purchasing of an instrument (60.8%) and the interruption to workflow in clinic (57.8%). CONCLUSIONS: Military OBGYNs rely on several STI-related POCTs. Economic factors and interruption to workflow were cited as the most significant barriers to using POCTs for military OBGYNs. Test cost and impact on workflow should be considered in future development and procurement of POCTs for the Military Health System.

An Evaluation of the Performance, Patient Acceptability and Feasibility of a Point-of-Care HIV-Syphilis Assay in an Urban Emergency Department.

BACKGROUND: Point-of-care (POC) tests for sexually transmitted infections (STIs) permit delivery of results during the patient's emergency department (ED) encounter. We evaluated performance, patient acceptability, and feasibility of a new duplex POC test, Chembio DPP® HIV-Syphilis Assay in an urban ED setting. METHODS: Convenience sampling approach prioritizing those considered at increased risk for an STI and/or with a history of HIV. For the performance evaluation, participants were tested for HIV/syphilis with the Chembio POC assay, and the reference laboratory tests; sensitivity and specificity were determined. For the patient acceptability evaluation, participants completed pre- and post-user surveys. For the feasibility evaluation, ED clinical technicians completed a survey evaluating their perceptions regarding feasibility of use of this POC test. RESULTS: 327 patients were consented and enrolled. The diagnostic sensitivity and specificity of the Chembio POC assay for HIV was 96.5% (95% CI: 90.1%, 99.3%) and 99.6% (95% CI: 97.7%, 100.0%), respectively, and for syphilis was 93.9% (95% CI: 85.0%, 98.3%) and 99.6% (95% CI: 97.9%, 100.0%), respectively. Regarding patient acceptability: 87% trusted the result; and 93% reported they were more likely to seek treatment if they received a positive STI test result in the ED rather than after the ED visit. Regarding feasibility: 90% of the technicians reported they would recommend using the test in EDs. CONCLUSIONS: The Chembio DPP® HIV-Syphilis POC assay had excellent performance characteristics when evaluated in an ED population, as well as high perceived acceptability from patients, and feasibility for ED use from clinical technicians. The test may have utility for HIV-syphilis screening among high-risk ED patients.

A National, County-Level Evaluation of the Association Between COVID-19 and Sexually Transmitted Infections Within the United States in 2020.

BACKGROUND: Shifts in public health infrastructure to respond to one emerging health threat may have unanticipated consequences for preexisting diseases. Previous research evaluating the impact of COVID-19 on sexually transmitted infections (STIs) has been conducted nationally, with little exploration of the impact on a granular geospatial level. This ecological study seeks to quantify the association between COVID-19 cases or deaths and chlamydia, gonorrhea, and syphilis cases for all US counties in 2020. METHODS: Separate, adjusted multivariable quasi-Poisson models with robust standard errors modeled the county-level association between 2020 COVID-19 cases and deaths per 100,000 and 2020 chlamydia, gonorrhea, or syphilis cases per 100,000. Models were adjusted for sociodemographic characteristics. RESULTS: Every 1000 additional COVID-19 cases per 100,000 was associated with a 1.80% increase in the average number of chlamydia cases ( P < 0.001) and a 5.00% increase in the average number of gonorrhea cases ( P < 0.001). Every 1000 additional COVID-19 deaths per 100,000 was associated with a 57.9% increase in the average number gonorrhea cases ( P < 0.001) and a 74.2% decrease in the average number of syphilis cases ( P = 0.004). CONCLUSIONS: Higher rates of COVID-19 cases and deaths were associated with increased rates of some STIs at the US county level. The underlying reasons for these associations could not be established by this study. The emergency response to an emerging threat may have unanticipated influence on preexisting diseases that varies by level of governance.

Identification of shared bacterial strains in the vaginal microbiota of related and unrelated reproductive-age mothers and daughters using genome-resolved metagenomics.

It has been suggested that the human microbiome might be vertically transmitted from mother to offspring and that early colonizers may play a critical role in development of the immune system. Studies have shown limited support for the vertical transmission of the intestinal microbiota but the derivation of the vaginal microbiota remains largely unknown. Although the vaginal microbiota of children and reproductive age women differ in composition, the vaginal microbiota could be vertically transmitted. To determine whether there was any support for this hypothesis, we examined the vaginal microbiota of daughter-mother pairs from the Baltimore metropolitan area (ages 14-27, 32-51; n = 39). We assessed whether the daughter's microbiota was similar in composition to their mother's using metataxonomics. Permutation tests revealed that while some pairs did have similar vaginal microbiota, the degree of similarity did not exceed that expected by chance. Genome-resolved metagenomics was used to identify shared bacterial strains in a subset of the families (n = 22). We found a small number of bacterial strains that were shared between mother-daughter pairs but identified more shared strains between individuals from different families, indicating that vaginal bacteria may display biogeographic patterns. Earlier-in-life studies are needed to demonstrate vertical transmission of the vaginal microbiota.

Building Partnerships and Stakeholder Relationships for HIV Prevention: Longitudinal Cohort Study Focuses on Community Engagement.

BACKGROUND: African American women bear disproportionate human immunodeficiency virus (HIV) burden in the United States, yet are often underrepresented in clinical research. Community engagement may decrease research mistrust and increase participation. We describe strategies used to engage community partners and female participants in a multisite HIV incidence study, HIV Prevention Trials Network (HPTN) 064. OBJECTIVES: HPTN 064 assessed HIV incidence among women in 10 geographic areas chosen for both high prevalence of HIV and poverty. METHODS: Women were recruited using venue-based sampling and followed for six to 12 months. Recruitment and engagement approaches aligned with the National Institutes of Health (NIH) Director's Council of Public Representatives (COPR) Community Engagement Framework's. RESULTS: Results showed engagement activities increased rapport and established new partnerships with community stakeholders. Study sites engaged 56 community organizations with 2,099 women enrolled in 14 months. Final retention was 94%. CONCLUSIONS: The COPR model maximized inclusiveness and participation of African American women impacted by HIV, supported recruitment and retention, and was the cornerstone of community engagement.

The National Network of Sexually Transmitted Disease Clinical Prevention Training Centers Turns 40-A Look Back, a Look Ahead.

Since 1979, the National Network of Sexually Transmitted Disease (STD) Clinical Prevention Training Centers (NNPTC) has provided state-of-the-art clinical and laboratory training for STD prevention across the United States. This article provides an overview of the history and activities of the NNPTC from its inception to present day, and emphasizes the important role the network continues to play in maintaining a high-quality STD clinical workforce. Over time, the NNPTC has responded to changing STD epidemiological patterns, technological advances, and increasing private-sector care-seeking for STDs. Its current structure of integrated regional and national training centers allows NNPTC members to provide dynamic, tailored responses to STD training needs across the country.

Patterns of point-of-care test use among obstetricians and gynaecologists in the US.

Background Point-of-care tests (POCTs) for reproductive health conditions have existed for decades. Newer POCTs for syphilis, HIV and trichomonas are currently available and easy to use. We surveyed practicing obstetricians and gynaecologists to determine current POCT use and perceived obstacles to use. METHODS: Between June and August 2016, 1000 members of the American College of Obstetricians and Gynecologists were randomly selected and invited to complete a Qualtrics (222 West river Park Drive, Provo, Utah 84604, USA) survey; 600 of these were members of the Collaborative Ambulatory Research Network. Respondents who completed at least 60% of the survey were included in the analysis. RESULTS: Of the 1000 selected members, 749 had valid emails and 288 (38%) of these participated in and completed the survey. Of the respondents, 70% were male with a mean of 18 years in practice. Detection of sexually transmissible infections (STIs) once or twice a week was reported by 30%, whereas 45% reported detecting STIs once or twice a month. POCTs used included pregnancy tests (83%), urine dipstick (83%), wet mount tests (79%) and the vagina pH test (54.8%). Few used Gram stain (5%) and stat rapid plasma regain tests (4%). Relatively newer US Food and Drug Administration-approved POCTs were used less frequently, with 25% of respondents reporting using the Affirm VPIII (Becton, Dickinson and Company, 1 Becton Drive, Franklin Lakes, NJ 07471, USA) test use and only 10% using a rapid HIV test. The most common perceived barriers to testing were the amount of reimbursement received for performing the test (61.9%) and the payment coverage from the patient (61.3%). CONCLUSIONS: US obstetricians and gynaecologists rely on laboratory test results and traditional POCTs to diagnosis STIs. Future development and marketing of POCTs should consider not only ease and time of test performance, but also the cost of the tests to the practice and the patient, as well as reimbursement.

A Silent Epidemic: The Prevalence, Incidence and Persistence of Mycoplasma genitalium Among Young, Asymptomatic High-Risk Women in the United States.

Background: Mycoplasma genitalium can result in pelvic inflammatory disease and adverse pregnancy outcomes. We analyzed data collected from a prospective study of asymptomatic bacterial vaginosis (BV) to determine the natural history of M. genitalium. Methods: Women aged 15-25 years, with asymptomatic BV and ≥2 risk factors for sexually transmitted infection were recruited from 10 sites throughout the United States. Vaginal swab samples were collected at enrollment and through home-based testing every 2 months over 12 months. M. genitalium nucleic acid amplification testing was performed for M. genitalium using transcription-mediated assays (Hologic). The prevalence, incidence, and persistence of M. genitalium, defined as all positive specimens during follow-up, were estimated with 95% confidence intervals (CIs). Adjusted odds ratios (AOR) were calculated using logistic and Poisson regression to evaluate participant characteristics associated with M. genitalium infection. Results: Among 1139 women, 233 were M. genitalium positive, for a prevalence of 20.5% (95% CI, 18.2%-22.9%); 42 of 204 had persistent M. genitalium (20.6%). Among 801 M. genitalium-negative women at baseline, the M. genitalium incidence was 36.6 per 100 person-years (95% CI, 32.4-41.3). Black race (AOR, 1.92; 95% CI, 1.09-3.38), age ≤21 years (1.40; 1.03-1.91), and prior pregnancy (1.36; 1.00-1.85) were associated with prevalent M. genitalium; only black race was associated with incident M. genitalium (P = .03). Conclusions: We identified high rates of prevalent, incident, and persistent M. genitalium infections among young, high-risk women with asymptomatic BV, supporting the need for clinical trials to evaluate the impact of M. genitalium screening on female reproductive health outcomes.

National Institute of Biomedical Imaging and Bioengineering Point-of-Care Technology Research Network: Advancing Precision Medicine.

To advance the development of point-of-care technology (POCT), the National Institute of Biomedical Imaging and Bioengineering established the POCT Research Network (POCTRN), comprised of Centers that emphasize multidisciplinary partnerships and close facilitation to move technologies from an early stage of development into clinical testing and patient use. This paper describes the POCTRN and the three currently funded Centers as examples of academic-based organizations that support collaborations across disciplines, institutions, and geographic regions to successfully drive innovative solutions from concept to patient care.

Variations in Clinical Presentation of Ocular Syphilis: Case Series Reported From a Growing Epidemic in the United States.

Ocular syphilis, a form of neurosyphilis, has been increasingly diagnosed in the United States. This case series summarizes the course of 6 patients recently diagnosed with ocular syphilis, emphasizing the varied sociodemographic factors and the wide range of symptoms and outcomes that are seen in patients with this disease.

Correlates of anal sex roles among Malay and Chinese MSM in Kuala Lumpur, Malaysia.

Identifying roles for anal sex is an important issue for populations of MSM. We describe the prevalence of identifying as being 'top', 'bottom', 'versatile', or 'don't know/not applicable' among Malay and Chinese MSM in Kuala Lumpur, Malaysia, and behavioural outcomes according to these labels for sexual role identity. Data analysis was conducted on a survey administered during weekly outreach throughout Kuala Lumpur in 2012. Pearson's Chi square tests were used to compare demographic and behavioural characteristics of MSM who reported roles for anal sex. Binary logistic regression was used to explore the odds of behavioural outcomes among MSM who identified as 'bottom', 'versatile,' and 'don't know' compared to MSM who reported that 'top' was their sexual role. Labels for anal sex roles were significantly associated with condom use for last anal sex. Among MSM who used labels for anal sex roles, MSM who identified as 'bottom' had highest level of not using condoms for last anal sex (24.1%, p = .045). In binary logistic regression model, identifying as 'top' was significantly associated with reporting using a condom during last anal sex and reported consistent condom use for anal sex in the past six months (p = .039 and .017, respectively). With regard to sexual role identity, some MSM may be a part of a special subgroup of at-risk men to be targeted. Future research should evaluate the origins, meanings, and perceptions of these labels, and the developmental process of how these MSM identify with any of these categories. Research should also uncover condom use decision making with regard to these labels for sexual positioning.

Developing Federal Clinical Care Recommendations for Men.

U.S. men experience substantial sexual and reproductive health needs across the life span. A significant barrier for providers in serving men in family planning, primary care, and sexually transmitted disease clinics has been the lack of standards for men's sexual and reproductive health care. The goal of this synthesis paper is to describe the development of clinical recommendations for the delivery of family planning services for men that were developed and published by CDC and the U.S. Office of Population Affairs. This paper is intended to describe the process used from 2011 to 2014 to develop the recommendations for the delivery of comprehensive reproductive healthcare services to men, and the rationale underpinning them.

Prevalence and correlates of knowledge of male partner HIV testing and serostatus among African-American women living in high poverty, high HIV prevalence communities (HPTN 064).

Knowledge of sexual partners' HIV infection can reduce risky sexual behaviors. Yet, there are no published studies to-date examining prevalence and characteristics associated with knowledge among African-American women living in high poverty communities disproportionately affected by HIV. Using the HIV Prevention Trial Network's (HPTN) 064 Study data, multivariable logistic regression was used to examine individual, partner, and partnership-level determinants of women's knowledge (n = 1,768 women). Results showed that women's demographic characteristics alone did not account for the variation in serostatus awareness. Rather, lower knowledge of partner serostatus was associated with having two or more sex partners (OR = 0.49, 95 % CI 0.37-0.65), food insecurity (OR = 0.68, 95 % CI 0.49-0.94), partner age >35 years (OR = 0.68, 95 % CI 0.49-0.94), and partner concurrency (OR = 0.63, 95 % CI 0.49-0.83). Access to financial support (OR = 1.42, 95 % CI 1.05-1.92) and coresidence (OR = 1.43, 95 % CI 1.05-1.95) were associated with higher knowledge of partner serostatus. HIV prevention efforts addressing African-American women's vulnerabilities should employ integrated behavioral, economic, and empowerment approaches.

Awareness and utilization of HIV services of an AIDS community-based organization in Kuala Lumpur, Malaysia.

In Malaysia, homosexuality is illegal; little is known about access to HIV prevention services among Malaysian men who have sex with men (MSM). We analysed PT Foundation outreach data to describe the profiles among MSM who accessed PT Foundation services and to examine factors associated with being aware of PT Foundation and having visited the organization. A survey was administered during weekly outreach throughout Kuala Lumpur from March-December 2012. Pearson's Chi square tests were used to compare demographic and behavioural characteristics of participants who were and were not aware of the PT Foundation. Binary logistic regression was used to identify correlates of MSM visiting the PT Foundation among those who had heard of the organization. Of 614 MSM, this study found significantly higher awareness of the PT Foundation among MSM who perceived they had "good" HIV knowledge (p = .026) and participants who reported always using condoms (p = .009). MSM who reported being paid for sex were 2.81 times as likely to visit the PT Foundation compared to men who did not. A subgroup of MSM known to be at high risk for HIV infection is accessing prevention services. Future studies should uncover motivations and barriers of accessing these services among MSM in Malaysia.

Dense genotyping of immune-related loci identifies variants associated with clearance of HPV among HIV-positive women in the HIV epidemiology research study (HERS).

Persistent high-risk human papillomavirus (HR-HPV) is a necessary and causal factor of cervical cancer. Most women naturally clear HPV infections; however, the biological mechanisms related to HPV pathogenesis have not been clearly elucidated. Host genetic factors that specifically regulate immune response could play an important role. All HIV-positive women in the HIV Epidemiology Research Study (HERS) with a HR-HPV infection and at least one follow-up biannual visit were included in the study. Cervicovaginal lavage samples were tested for HPV using type-specific HPV hybridization assays. Type-specific HPV clearance was defined as two consecutive HPV-negative tests after a positive test. DNA from participants was genotyped for 196,524 variants within 186 known immune related loci using the custom ImmunoChip microarray. To assess the influence of each single-nucleotide polymorphism (SNP) with HR-HPV clearance, the Cox proportional hazards model with the Wei-Lin-Weissfeld approach was used, adjusting for CD4+ count, low risk HPV (LR-HPV) co-infection, and relevant confounders. Three analytical models were performed: race-specific (African Americans (n = 258), European Americans (n = 87), Hispanics (n = 55), race-adjusted combined analysis, and meta-analysis of pooled independent race-specific analyses. Women were followed for a median time of 1,617 days. Overall, three SNPs (rs1112085, rs11102637, and rs12030900) in the MAGI-3 gene and one SNP (rs8031627) in the SMAD3 gene were associated with HR-HPV clearance (p<10(-6)). A variant (rs1633038) in HLA-G were also significantly associated in African American. Results from this study support associations of immune-related genes, having potential biological mechanism, with differential cervical HR-HPV infection outcomes.

Point-of-care tests for sexually transmissible infections: what do 'end users' want?

BACKGROUND: Clinicians and developers identify sensitivity as an important quality in a point-of-care test (POCT) for sexually transmissible infections (STIs). Little information exists regarding what patients want for STI POCTs. METHODS: A qualitative study, encompassing five focus groups among attendees of STI and adolescent health centres in Baltimore, Maryland, and Cincinnati, Ohio, were conducted between March 2008 and April 2009. Discussion topics included advantages and disadvantages of having a POCT, perceived barriers to using POCTs in the clinic setting and at home, priorities for the development of new POCTs for STIs, and envisioned characteristics of an ideal POCT. All discussions were recorded and transcribed. A qualitative content analysis was performed to examine frequencies or patterns of recurring codes, which were regrouped and indexed to identify salient themes. RESULTS: Patients attending STI and adolescent outpatient clinics are in favour of diagnostic tests that are rapid, easy to read and simple to use. Home testing options for POCTs were acceptable and provided better confidentiality, privacy and convenience, but clinic-based POCTs were also acceptable because they offer definitive results and ensure immediate treatment. Barriers to home POCTs centred on cost and the ability to read and perform the test correctly at home. Opinions did not differ by patient ethnicity, except that Hispanic participants questioned the reliability of home test results, wanted high sensitivity and desired bilingual instructions. CONCLUSIONS: Patients attending STI and adolescent medical centres are in favour of STI POCTs if they are affordable, rapid, easy to read and simple to use.

Perceptions on Point-of-Care Tests for Sexually Transmitted Infections - Comparison between Frontline Clinicians and Professionals in Industry.

OBJECTIVES: To determine if a gap exists between sexually transmitted infection (STI) clinicians and industry professionals regarding perceptions of the ideal types and characteristics of STI point-of-care tests (POCTs). METHODS: Our online survey design contained sections on demographics; barriers of use for available STI POCTs; characteristics of an ideal POCT, including prioritizing pathogens for targets; and "building your own POCT". Practicing clinicians and academic experts from two venues, STI-related international conference attendees and U.S. STD clinic clinicians, were invited to participate in the clinician survey. Professionals from industry in the STI diagnostic field were invited to participate in the industry survey. Chi-square test and conditional logistical regression were used for data analysis. RESULTS: Clinician survey participants (n=218) identified "the time frame required" (39.9%), "complexity" (31.2%), and "interruption of work flow" (30.3%) as the top three barriers making it difficult to use STI POCTs, while the industry survey participants (n=107) identified "complexity" (65.4%), "unreliability" (53.3%), and "difficulty in reading results" (34.6%) as the top three barriers (all p values <0.05). Sensitivity was always the most important attribute to be considered for a new STI POCT by both participant groups. Participants of the clinician group chose cost as the second priority attribute, while those of the industry group chose specificity as the second priority. CONCLUSION: We identified differences in the perceptions regarding barriers and ideal attributes for STI POCTs between frontline clinical providers and industry personnel. Tailored training is warranted to inform scientists, biomedical engineers, and other industry experts about characteristics that clinicians desire for STI POCTs.

Association between semen exposure and incident bacterial vaginosis.

OBJECTIVE. To identify correlates of incident bacterial vaginosis (BV) diagnosed with Nugent scoring among high-risk women. STUDY DESIGN. We conducted both cohort and case-crossover analyses, stratified by HIV infection status, based on 871 HIV-infected and 439 HIV-uninfected participants in the HIV Epidemiology Research Study, conducted in 4 US sites in 1993-2000. RESULTS. BV incidence was 21% and 19% among HIV-infected and -uninfected women, respectively. Fewer correlates of BV were found with case-crossover than with cohort design. Reporting frequent coitus (regardless of consistency of condom use) was correlated with BV in cohort analyses but not in case-crossover analyses. The sole correlate of BV in both types of analyses was the detection of spermatozoa on Gram stain, which is a marker of semen exposure. CONCLUSION. The inconsistent association between condom use and BV in prior studies could be from reporting bias. We found evidence of a relationship between semen exposure and incident BV.

Discordance between spermatozoa detection and self-reported semen exposure.

An analysis of data from a prospective study of 1257 high-risk women revealed 7 predictors of discordance between self-reported lack of recent exposure to semen and detection of spermatozoa on Gram stain, suggesting that inaccuracies in the reporting of sexual behaviors cannot be assumed to be distributed randomly.

Bacterial vaginosis and the natural history of human papillomavirus.

OBJECTIVE: To evaluate associations between common vaginal infections and human papillomavirus (HPV). STUDY DESIGN: Data from up to 15 visits on 756 HIV-infected women and 380 high-risk HIV-uninfected women enrolled in the HIV Epidemiology Research Study (HERS) were evaluated for associations of bacterial vaginosis, trichomoniasis, and vaginal Candida colonization with prevalent HPV, incident HPV, and clearance of HPV in multivariate analysis. RESULTS: Bacterial vaginosis (BV) was associated with increased odds for prevalent (aOR = 1.14, 95% CI: 1.04, 1.26) and incident (aOR = 1.24, 95% CI: 1.04, 1.47) HPV and with delayed clearance of infection (aHR = 0.84, 95% CI: 0.72, 0.97). Whereas BV at the preceding or current visit was associated with incident HPV, in an alternate model for the outcome of incident BV, HPV at the current, but not preceding, visit was associated with incident BV. CONCLUSION: These findings underscore the importance of prevention and successful treatment of bacterial vaginosis.