Rapid analysis of local data to inform off-label tocilizumab use early in the COVID-19 pandemic.

The interleukin-6 receptor antagonist tocilizumab became widely used early in the coronavirus disease 2019 (COVID-19) pandemic based on small observational studies that suggested clinical benefit in COVID-19 patients with a hyperinflammatory state. To inform our local treatment algorithms in the absence of randomized clinical trial results, we performed a rapid analysis of the first 11 hospitalized COVID-19 patients treated with tocilizumab at our academic medical center. We report their early clinical outcomes and describe the process by which we assembled a team of diverse trainees and stakeholders to extract, analyze, and disseminate data during a time of clinical uncertainty.

HIV Preexposure Prophylaxis Implementation at Local Health Departments: A Statewide Assessment of Activities and Barriers.

BACKGROUND: Expanding access to HIV preexposure prophylaxis (PrEP) could help reduce rates of HIV infection in the United States. This study characterizes activities and barriers to PrEP implementation at local health departments (LHDs) in North Carolina (NC), which contains a large rural population. METHODS: In May 2016, a web-based survey was distributed to health directors of all county and district health departments in NC to assess PrEP-related activities, perceived barriers to PrEP implementation, and desired PrEP-related resources. RESULTS: Of 85 LHDs in NC, 56 (66%) responded to the survey. Of these, 2 (4%) reported PrEP prescribing and 7 (13%) externally referred for PrEP services. Among the 54 departments not prescribing PrEP, the most frequently cited reasons were cost concerns (n = 25, 46%), lack of formal prescribing protocols (n = 21, 39%), and belief that PrEP would be better managed at primary care or specialty clinics (n = 19, 35%). Among the 47 departments not prescribing or referring clients for PrEP, the most frequently cited reasons for the lack of PrEP referral were the absence of local PrEP providers (n = 29, 62%), lack of PrEP knowledge among staff (n = 13, 28%), and perceived lack of PrEP candidates (n = 12, 26%). The most frequently requested PrEP-related resources included training to help identify PrEP candidates (n = 39, 70%) and training on PrEP prescribing and management (n = 38, 68%). CONCLUSIONS: PrEP prescribing and referral among LHDs in NC remains extremely limited. Increased PrEP-related training and support for LHD-based providers could enhance PrEP access, especially in rural and underserved areas.

The North Carolina HIV Bridge Counselor Program: Outcomes From a Statewide Level Intervention to Link and Reengage HIV-Infected Persons in Care in the South.

BACKGROUND: To improve the HIV continuum of care, a team of field service interventionists (State Bridge Counselors, SBC) was developed through a state public health system and provided brief (1-2) contacts for linkage of newly diagnosed persons with HIV and reengagement of persons living with HIV (PLWH) who were not in care. SETTING: North Carolina, United States. METHODS: Service data from January 2013 to June 2015 were analyzed to determine characteristics of clients referred to SBCs, proportions linked or reengaged in care, and/or achieved viral load suppression (VLs). We evaluated associations between client characteristics and outcomes using multivariable analyses and estimated odds ratios (OR) with 95% confidence intervals (CI). RESULTS: SBCs provided linkage services to 299 newly diagnosed individuals and reengagement services to 606 PLWH throughout North Carolina. Among persons who received linkage services, 189 (63%) had evidence of care within 90 days of referral and 205 (69%) had VLs within a year. Among PLWH who received reengagement services, 278 (46%) had care within 90 days and 308 (51%) had VLs within a year. Persons aged 30-39 years (OR, 2.1; 95% CI, 1.1 to 3.9) and 40-49 years had an increased likelihood (OR, 2.4; 95% CI, 1.1 to 5.2) of linkage within 90 days compared with persons aged 18-29 years. Non-white PLWH had an increased OR of 1.7; (95% CI, 1.2 to 2.5) of reengagement compared with whites. CONCLUSIONS: Our SBC program successfully implemented a "low-touch" approach to provision of linkage and reengagement services, demonstrating that public health resources can be used to address the HIV care continuum on a statewide level.

Longitudinal HIV Care Trajectories in North Carolina.

BACKGROUND: Long-term HIV care and treatment engagement is required for maximal clinical and prevention benefits, but longitudinal care patterns are poorly understood. We used the last 10 years' worth of HIV surveillance data from North Carolina to describe longitudinal HIV care trajectories from diagnosis. METHODS: We conducted a retrospective, population-based cohort study of all persons newly diagnosed with HIV in North Carolina between March 31, 2006 and March 31, 2015 (N = 16,207). We defined HIV care attendance in each 3-month and 6-month interval after diagnosis as the presence of viral load and/or CD4 records (care visit proxies) in the interval. We used group-based trajectory modeling to identify common care trajectories and baseline predictors thereof. RESULTS: A predicted 26% of newly HIV-diagnosed persons showed consistently high care attendance over time; ∼16% exhibited steadily declining attendance; ∼26% showed consistently low attendance; ∼17% had initially weak attendance with an increase starting ∼1.5 year later; and ∼15% showed initially weak attendance with an increase starting ∼3 years later. Older age at diagnosis was protective against all suboptimal trajectories (with the "consistently high" pattern as referent), and being a man who has sex with men was protective against 3 of the 4 suboptimal patterns. CONCLUSIONS: As measured by surveillance-based laboratory proxies, most newly HIV-diagnosed persons exhibited suboptimal care trajectories, but there was wide variation in the particular pathways followed. The insights provided by this analytical approach can help to inform the design of epidemic models and tailored interventions, with the ultimate goal of improving HIV care engagement and transmission prevention.

Measuring the HIV Care Continuum Using Public Health Surveillance Data in the United States.

The HIV care continuum is a critical framework for situational awareness of the HIV epidemic; yet challenges to accurate enumeration of continuum components hamper continuum estimation in practice. We describe local surveillance-based estimation of the HIV continuum in the United States, reviewing common practices as recommended by the Centers for Disease Control and Prevention. Furthermore, we review some challenges and biases likely to threaten existing continuum estimates. Current estimates rely heavily on the use of CD4 cell count and HIV viral load laboratory results reported to surveillance programs as a proxy for receipt of HIV-related outpatient care. As such, continuum estimates are susceptible to bias because of incomplete laboratory reporting and imperfect sensitivity and specificity of laboratory tests as a proxy for routine HIV care. Migration of HIV-infected persons between jurisdictions also threatens the validity of continuum estimates. Data triangulation may improve but not fully alleviate biases.

HIV risk behaviors and sociodemographic features of HIV-infected Latinos residing in a new Latino settlement area in the Southeastern United States.

The Southeastern United States (US) has a rapidly growing Latino population, yet little is known about HIV-infected Latinos in the region. To help inform future prevention studies, we compared sociodemographic, clinical, and behavioral characteristics between immigrant and US-born HIV-infected Latinos using face-to-face interviews conducted at three clinics in North Carolina. Questions encompassed HIV testing, acculturation, sexual- and substance-related behaviors, and migration history. Behavioral data were compared with 451 black and white clinic patients. Differences were tested using Pearson's and Kruskal-Wallis tests. Participants (n = 127) were primarily male (74%) and immigrants (82%). Most immigrants were Mexican (67%), had low acculturation scores (92%), and were diagnosed a median of 8 years (IQR 0-12) following immigration. Compared with US-born Latinos, immigrants had lower CD4 counts at clinic entry (median 187 vs. 371 cells/mm(3)) and were less likely to have graduated high school (49% vs. 78%) or have insurance (9% vs. 52%; all P <0.05). Most immigrants identified as heterosexual (60%) and reported fewer lifetime partners than US-born Latinos (median 6 vs. 20; P = 0.001). Immigrant men were less likely to report sex with men than US-born men (43% vs. 81%; P = 0.005). Immigrant men also had similar risk behaviors to black men, and US-born Latino men exhibited behaviors that were more similar to white men in our clinic. At the time of survey, >90% of participants were receiving antiretroviral therapy (ART) and most had achieved HIV RNA <50 copies/mL (62% immigrants vs. 76% US-born; P = 0.32). In conclusion, Latino immigrants were more likely to present with advanced disease, identify as heterosexual, and report different risk behaviors than US-born Latinos, yet receipt and response to ART were similar between the two groups. Prevention strategies should prioritize finding innovative methods to reach Latino immigrants for routine early testing regardless of risk stratification and include programs targeted toward the different needs of immigrant and US-born Latinos.

Longitudinal effects of SafeTalk, a motivational interviewing-based program to improve safer sex practices among people living with HIV/AIDS.

Programs to help people living with HIV/AIDS practice safer sex are needed to prevent transmission of HIV and other sexually transmitted infections. We sought to assess the impact of SafeTalk, a multicomponent motivational interviewing-based safer sex program, on HIV-infected patients' risky sexual behavior. We enrolled sexually active adult HIV-infected patients from one of three clinical sites in North Carolina and randomized them to receive the 4-session SafeTalk intervention versus a hearthealthy attention-control. There was no significant difference in the proportion of people having unprotected sex between the two arms at enrollment. SafeTalk significantly reduced the number of unprotected sex acts with at-risk partners from baseline, while in controls the number of unprotected sex acts increased. Motivational interviewing can provide an effective, flexible prevention intervention for a heterogeneous group of people living with HIV.

Effects on health of volunteers deployed during a disaster.

Little is known about the risks, hazards, and health outcomes for health care personnel and volunteers working in disaster relief. We sought to characterize risks and outcomes in volunteers deployed to provide relief for victims of Hurricane Katrina. We performed a longitudinal e-mail survey that assessed preventive measures taken before and during deployment, exposures to hazards while deployed, and health outcomes at 1, 3, and 6 months postdeployment. Overall response rate was 36.1 per cent and one-third of those who responded did so for all three surveys. Exposures to different types of hazards changed over time with exposures to contaminated water being common. Despite predeployment and on-site education, use of preventive measures such as vaccination, appropriate clothing, hydration, sunscreen, and insect repellant was variable. Few injuries were sustained. Insect bites were common despite the use of insect repellants. Skin lesions, diarrhea, and other gastrointestinal complaints occurred most commonly early on during or after deployment. Psychological complaints were common at 3 and 6 months. In conclusion, identification of at risk volunteer cohorts with longitudinal surveillance is critical for future disaster planning to provide training for volunteers and workers and to allow for deployment of appropriate resources pre, during, and postdeployment.

Trichomonas vaginalis infection in male sexual partners: implications for diagnosis, treatment, and prevention.

BACKGROUND: Trichomonas vaginalis causes a common sexually transmitted infection (STI) in women, yet trichomoniasis in male sexual partners is not well recognized. Nucleic acid amplification tests can increase detection of T. vaginalis in men compared with culture. METHODS: We conducted a prospective, multicenter study to evaluate T. vaginalis infection among male partners of women with trichomoniasis and factors associated with infection by recruiting patients from 3 public clinics in the United States. Male partners were tested for concordant T. vaginalis infection, defined as a positive urethral culture, urine culture, or urine polymerase chain reaction (PCR) result. A subset of men also provided a semen sample for T. vaginalis culture and PCR. Factors associated with concordant infection were determined from bivariable and multivariable analyses. RESULTS: We enrolled 540 women with trichomoniasis (diagnosed using wet mount microscopy and/or culture) and 261 (48.4%) of their male partners. T. vaginalis infection was detected in 177 (71.7%) of 256 male partners (95% confidence interval [CI], 66.0%-77.3%), of whom 136 (77.3%) were asymptomatic. A vaginal pH of >4.5 in a woman was independently associated with infection in the male partner (adjusted odds ratio, 2.5; 95% CI, 1.0-6.3). Younger male age (20-29 and 30-39 years) was also found to be an independent risk factor for concordant trichomoniasis. CONCLUSIONS: The majority of male partners of women with trichomoniasis were infected; however, few factors predicted infection. T. vaginalis causes a highly prevalent STI, necessitating vastly improved partner management, application of sensitive nucleic-acid based testing, and better clinical recognition.

Methods for detection of Trichomonas vaginalis in the male partners of infected women: implications for control of trichomoniasis.

Trichomonas vaginalis infection in men is an important cause of nongonococcal urethritis. Effective detection of the parasite in men using culture requires examination of multiple specimens. We compared culture and PCR-enzyme-linked immunosorbent assay in urethral swabs, urine, and semen for T. vaginalis detection in male sexual partners of women with trichomoniasis identified by wet mount and culture. Trichomonads were detected by at least one positive test in 205/280 men (73.2%) who submitted at least one specimen for culture and PCR. Whereas InPouch TV culture detected only 46/205 cases (22.5%), PCR detected 201/205 (98.0%). Urethral swab cultures from men with urethritis were more likely to be positive with shorter incubation than specimens from men without urethritis. T. vaginalis was detected more often in men with wet-mount-positive partners. Even with a sensitive PCR assay, reliable detection of T. vaginalis in male partners required multiple specimens. The majority of male sexual partners in this study were infected, emphasizing the importance of partner evaluation and treatment.

The prevalence of trichomoniasis in young adults in the United States.

BACKGROUND AND OBJECTIVES: The prevalence of trichomoniasis in the general population of the United States is unknown. This study provides the first population-based prevalence estimates of trichomoniasis among young adults in the United States. METHODS: The National Longitudinal Study of Adolescent Health (Add Health) is an ongoing prospective cohort study. In a cross-sectional analysis of Wave III of Add Health (N = 12,449), we determined the prevalence of trichomoniasis using a polymerase chain reaction assay. RESULTS: The estimated overall prevalence of trichomoniasis in U.S. young adults was 2.3% (95% confidence interval [CI], 1.8-2.7%). The prevalence was slightly higher among women (2.8%; 95% CI, 2.2-3.6%) than men (1.7%; 95% CI, 1.3-2.2%). The prevalence increased with age and varied by region, with the south having the highest prevalence (2.8%; 95% CI, 2.2-3.5%). The prevalence was highest among black women (10.5%; 95% CI, 8.3-13.3%) and lowest among white women (1.1%; 95% CI, 0.8-1.6%). Among men, the prevalence was highest among Native Americans (4.1%; 95% CI, 0.4-29.3%) and blacks (3.3%; 95% CI, 2.2-4.9%), and lowest among white men (1.3%; 95% CI, 0.9-1.8%). CONCLUSIONS: Trichomoniasis is moderately prevalent among the general U.S. population of young adults and disturbingly high among certain racial/ethnic groups.

Targeted screening for Trichomonas vaginalis with culture using a two-step method in women presenting for STD evaluation.

OBJECTIVES: Trichomonas vaginalis is the most common nonviral sexually transmitted pathogen. Wet mount microscopy performs poorly compared with culture; however, universal screening using culture would be cost-prohibitive. GOAL: The goal of this study was to develop a predictive model for wet mount-negative women who may benefit from targeted use of culture for T. vaginalis detection. STUDY: Women presenting for sexually transmitted disease evaluation were prospectively screened for trichomoniasis using wet mount and culture. Multivariate logistic regression was used to identify predictors of culture-proven trichomoniasis among wet mount-negative women. RESULTS: A total of 2194 women were screened for trichomoniasis; overall, the prevalence of T. vaginalis was 17.5%. Three predictors (any drug use, contact to trichomoniasis, and African-American race) provided the most specific model (100%); any 1 predictor, the most sensitive model (97.8%). CONCLUSIONS: Given the public health impact of trichomoniasis, we recommend using any 1 of 3 predictors to identify women who would benefit from targeted culture for T. vaginalis.

Development and validation of a PCR-based enzyme-linked immunosorbent assay with urine for use in clinical research settings to detect Trichomonas vaginalis in women.

Trichomonas vaginalis infection is highly prevalent worldwide and is associated with poor birth outcomes and enhanced human immunodeficiency virus transmission. Traditional detection methods rely on microscopic examination of vaginal specimens (wet mount) and culture, which can be insensitive and time-consuming. More than 3,000 women attending two sexually transmitted disease clinics were enrolled in this cross-sectional study to evaluate urine-based PCR for detection of T. vaginalis using a combined reference standard of wet mount and culture from vaginal swab. The prevalence of trichomoniasis in the population was 16.7% (502 of 3,009 women) using the reference standard. PCR with urine combined with agarose gel-based detection was 66.9% sensitive and 98.3% specific compared to the reference standard. Detection of PCR products using an unlabeled enzyme-linked immunosorbent assay (ELISA) improved the sensitivity to 86.4%, but specificity fell to 86.1%. Using a digoxigenin-labeled ELISA for detection of amplified T. vaginalis DNA from urine, the sensitivity and specificity of the PCR improved to 90.8 and 93.4%, respectively, compared to wet mount or culture from vaginal swabs. For clinical research settings in which vaginal specimens are not available and culture conditions are not feasible, urine-based PCR-ELISA may be useful for the detection of trichomoniasis in women.