Comparison of HIV Screening Strategies in the Emergency Department: A Randomized Clinical Trial.

Importance: The National HIV Strategic Plan for the US recommends HIV screening in emergency departments (EDs). The most effective approach to ED-based HIV screening remains unknown. Objective: To compare strategies for HIV screening when integrated into usual ED practice. Design, Setting, and Participants: This randomized clinical trial included patients visiting EDs at 4 US urban hospitals between April 2014 and January 2016. Patients included were ages 16 years or older, not critically ill or mentally altered, not known to have an HIV positive status, and with an anticipated length of stay 30 minutes or longer. Data were analyzed through March 2021. Interventions: Consecutive patients underwent concealed randomization to either nontargeted screening, enhanced targeted screening using a quantitative HIV risk prediction tool, or traditional targeted screening as adapted from the Centers for Disease Control and Prevention. Screening was integrated into clinical practice using opt-out consent and fourth-generation antigen-antibody assays. Main Outcomes and Measures: New HIV diagnoses using intention-to-treat analysis, absolute differences, and risk ratios (RRs). Results: A total of 76 561 patient visits were randomized; median (interquartile range) age was 40 (28-54) years, 34 807 patients (51.2%) were women, and 26 776 (39.4%) were Black, 22 131 (32.6%) non-Hispanic White, and 14 542 (21.4%) Hispanic. A total of 25 469 were randomized to nontargeted screening; 25 453, enhanced targeted screening; and 25 639, traditional targeted screening. Of the nontargeted group, 6744 participants (26.5%) completed testing and 10 (0.15%) were newly diagnosed; of the enhanced targeted group, 13 883 participants (54.5%) met risk criteria, 4488 (32.3%) completed testing, and 7 (0.16%) were newly diagnosed; and of the traditional targeted group, 7099 participants (27.7%) met risk criteria, 3173 (44.7%) completed testing, and 7 (0.22%) were newly diagnosed. When compared with nontargeted screening, targeted strategies were not associated with a higher rate of new diagnoses (enhanced targeted and traditional targeted combined: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.7; 95% CI, 0.30 to 1.56; P = .38; and enhanced targeted only: difference, -0.01%; 95% CI, -0.04% to 0.02%; RR, 0.70; 95% CI, 0.27 to 1.84; P = .47). Conclusions and Relevance: Targeted HIV screening was not superior to nontargeted HIV screening in the ED. Nontargeted screening resulted in significantly more tests performed, although all strategies identified relatively low numbers of new HIV diagnoses. Trial Registration: ClinicalTrials.gov Identifier: NCT01781949.

Brief report: Validation of a quantitative HIV risk prediction tool using a national HIV testing cohort.

Routine screening is recommended for HIV detection. HIV risk estimation remains important. Our goal was to validate the Denver HIV Risk Score using a national cohort from the Centers for Disease Control and Prevention. Patients of 13 years and older were included, 4,830,941 HIV tests were performed, and 0.6% newly diagnosed infections were identified. Of all visits, 9% were very low risk (HIV prevalence = 0.20%), 27% low risk (HIV prevalence = 0.17%), 41% moderate risk (HIV prevalence = 0.39%), 17% high risk (HIV prevalence = 1.19%), and 6% very high risk (HIV prevalence = 3.57%). The Denver HIV Risk Score accurately categorized patients into different HIV risk groups.

Opportunity Knocks: HIV Prevention in Primary Care.

Expansions in health care coverage, a comprehensive framework for HIV prevention and care, electronic medical records, and novel HIV prevention modalities create a current opportunity to change the trajectory of the HIV epidemic in the United States. HIV is increasingly disproportionately found in populations historically at higher risk, including gay men and other men who have sex with men, transgender women, injection drug users, and persons of color. This underscores the need for providers to identify persons at higher risk for HIV and assure the provision of screening and prevention services. In turn, universal screening for HIV-testing every adolescent and adult at least once in their lifetime-will increasingly be necessary to find the infrequent cases of HIV in lower risk populations. In both these domains, primary care providers will play a unique role in complementing traditional providers of HIV prevention and care services by increasing the proportion of their patients who have been screened for HIV, opening dialogues around sexual health, including asking about sexual orientation and gender identity, and prescribing antivirals as pre- and postexposure prophylaxis for their non-HIV-infected patients. Primary care providers must understand and embrace their importance along the HIV prevention and care continuum.

Knowledge of pre-exposure prophylaxis (PrEP) for HIV prevention among men who have sex with men in Denver, Colorado.

As part of the National HIV Behavioral Surveillance System among men who have sex with men (MSM) in Denver, Colorado, we assessed knowledge of pre-exposure prophylaxis (PrEP); willingness to use PrEP; and potential changes in risk behaviors among HIV-negative participants reporting sexual activity with a male partner in the preceding 12 months. We examined knowledge of PrEP before (2008) and after (2011) results of the iPrEx trial were available. Of the 425 participants in the 2008 sample, 91 (21 %) were aware of PrEP compared to 131 (28 %) of the 461 participants in the 2011 sample (adjusted prevalence ratio: 1.43, 95 % confidence interval: 1.18, 1.72). Despite the increase in 2011, few MSM in Denver were aware of PrEP. Educating high-risk MSM about the potential utility of PrEP as an adjunct to other effective prevention methods is needed when considering the addition of PrEP to the HIV prevention arsenal.

Initial linkage and subsequent retention in HIV care for a newly diagnosed HIV-infected cohort in Denver, Colorado.

This is a retrospective cohort study of 352 newly diagnosed HIV-infected individuals in Denver, from 2005 to 2007. Utilizing data from 3 health care systems, 2 clinical trials units, and statewide Colorado HIV laboratory reporting databases, we tracked initial linkage to HIV care, retention in care, loss to follow-up, and transitions between HIV care providers. After more than 2.6 years of follow-up, 256 (73%) individuals linked to HIV care within 180 days. Of the 301 individuals who eventually linked to care, 168 (56%) had at least one 180-day gap in care, while 49 (16%) had a 360-day gap. Transitions in care were common, with 131 (37%) individuals accessing care from 2 different providers and 15% having evidence of living outside of Colorado. In this newly diagnosed HIV-infected cohort, linkage to care was slow and long-term retention in care was poor. Transitions between HIV care providers were common and may impair engagement in care over time. Out-of-state migration was frequent and may cause an underestimation of engagement in care.

Comparison of enhanced targeted rapid HIV screening using the Denver HIV risk score to nontargeted rapid HIV screening in the emergency department.

STUDY OBJECTIVE: A clinical prediction tool, the Denver HIV Risk Score, was recently developed to help identify patients with increased probability of undiagnosed HIV infection. Our goal was to compare targeted rapid HIV screening using the Denver HIV Risk Score to nontargeted rapid HIV screening in an urban emergency department (ED) and urgent care. METHODS: We used a prospective, before-after design at an urban medical center with an approximate annual census of 110,000 visits. Patients aged 13 years or older were eligible for screening. Targeted HIV screening of patients identified as high-risk by nurses using the Denver HIV Risk Score during medical screening was compared to nontargeted HIV screening offered by medical screening nurses during 2 separate 4-month time periods. The primary outcome was newly diagnosed HIV-infected patients. RESULTS: 28,506 patients presented during the targeted phase, 1,718 were identified as high-risk, and 551 completed HIV testing. Of these, 7 (1.3%, 95% confidence interval [CI] 0.5% to 2.6%) were newly diagnosed with HIV infection. 29,510 patients presented during the nontargeted phase and 3,591 completed HIV testing. Of these, 7 (0.2%, 95% CI 0.1% to 0.4%) were newly diagnosed with HIV infection. Targeted HIV screening was significantly associated with identification of newly diagnosed HIV infection when compared to nontargeted screening, adjusting for patient demographics and payer status (relative risk [RR] 10.4, 95% CI 3.4 to 32.0). CONCLUSION: Targeted HIV screening using the Denver HIV Risk Score was strongly associated with new HIV diagnoses when compared to nontargeted screening. Although both HIV screening methods identified the same absolute number of newly diagnosed patients, significantly fewer tests were required during the targeted phase to achieve the same effect.

Programmatic cost evaluation of nontargeted opt-out rapid HIV screening in the emergency department.

BACKGROUND: The Centers for Disease Control and Prevention recommends nontargeted opt-out HIV screening in healthcare settings. Cost effectiveness is critical when considering potential screening methods. Our goal was to compare programmatic costs of nontargeted opt-out rapid HIV screening with physician-directed diagnostic rapid HIV testing in an urban emergency department (ED) as part of the Denver ED HIV Opt-Out Trial. METHODS: This was a prospective cohort study nested in a larger quasi-experiment. Over 16 months, nontargeted rapid HIV screening (intervention) and diagnostic rapid HIV testing (control) were alternated in 4-month time blocks. During the intervention phase, patients were offered HIV testing using an opt-out approach during registration; during the control phase, physicians used a diagnostic approach to offer HIV testing to patients. Each method was fully integrated into ED operations. Direct program costs were determined using the perspective of the ED. Time-motion methodology was used to estimate personnel activity costs. Costs per patient newly-diagnosed with HIV infection by intervention phase, and incremental cost effectiveness ratios were calculated. RESULTS: During the intervention phase, 28,043 eligible patients were included, 6,933 (25%) completed testing, and 15 (0.2%, 95% CI: 0.1%-0.4%) were newly-diagnosed with HIV infection. During the control phase, 29,925 eligible patients were included, 243 (0.8%) completed testing, and 4 (1.7%, 95% CI: 0.4%-4.2%) were newly-diagnosed with HIV infection. Total annualized costs for nontargeted screening were $148,997, whereas total annualized costs for diagnostic HIV testing were $31,355. The average costs per HIV diagnosis were $9,932 and $7,839, respectively. Nontargeted HIV screening identified 11 more HIV infections at an incremental cost of $10,693 per additional infection. CONCLUSIONS: Compared to diagnostic testing, nontargeted HIV screening was more costly but identified more HIV infections. More effective and less costly testing strategies may be required to improve the identification of patients with undiagnosed HIV infection in the ED.

Derivation and validation of the Denver Human Immunodeficiency Virus (HIV) risk score for targeted HIV screening.

Targeted screening remains an important approach to human immunodeficiency virus (HIV) testing. The authors aimed to derive and validate an instrument to accurately identify patients at risk for HIV infection, using patient data from a metropolitan sexually transmitted disease clinic in Denver, Colorado (1996-2008). With multivariable logistic regression, they developed a risk score from 48 candidate variables using newly identified HIV infection as the outcome. Validation was performed using an independent population from an urban emergency department in Cincinnati, Ohio. The derivation sample included 92,635 patients; 504 (0.54%) were diagnosed with HIV infection. The validation sample included 22,983 patients; 168 (0.73%) were diagnosed with HIV infection. The final score included age, gender, race/ethnicity, sex with a male, vaginal intercourse, receptive anal intercourse, injection drug use, and past HIV testing, and values ranged from -14 to +81. For persons with scores of <20, 20-29, 30-39, 40-49, and ≥50, HIV prevalences were 0.31% (95% confidence interval (CI): 0.20, 0.45) (n = 27/8,782), 0.41% (95% CI: 0.29, 0.57) (n = 36/8,677), 0.99% (95% CI: 0.63, 1.47) (n = 24/2,431), 1.59% (95% CI: 1.02, 2.36) (n = 24/1,505), and 3.59% (95% CI: 2.73, 4.63) (n = 57/1,588), respectively. The risk score accurately categorizes patients into groups with increasing probabilities of HIV infection.

Routine opt-out rapid HIV screening and detection of HIV infection in emergency department patients.

CONTEXT: The Centers for Disease Control and Prevention (CDC) recommends routine (nontargeted) opt-out HIV screening in health care settings, including emergency departments (EDs), where the prevalence of undiagnosed infection is 0.1% or greater. The utility of this approach in EDs remains unknown. OBJECTIVE: To determine whether nontargeted opt-out rapid HIV screening in the ED was associated with identification of more patients with newly diagnosed HIV infection than physician-directed diagnostic rapid HIV testing. DESIGN, SETTING, AND PATIENTS: Quasi-experimental equivalent time-samples design in an urban public safety-net hospital with an approximate annual ED census of 55,000 patient visits. Patients were 16 years or older and capable of providing consent for rapid HIV testing. INTERVENTIONS: Nontargeted opt-out rapid HIV screening and physician-directed diagnostic rapid HIV testing alternated in sequential 4-month time intervals between April 15, 2007, and April 15, 2009. MAIN OUTCOME MEASURES: Number of patients with newly identified HIV infection and the association between nontargeted opt-out rapid HIV screening and identification of HIV infection. RESULTS: In the opt-out phase, of 28,043 eligible ED patients, 6933 patients (25%) completed HIV testing (6702 patients were screened; 231 patients were diagnostically tested). Ten of 6702 patients (0.15%; 95% CI, 0.07%-0.27%) who did not decline HIV screening in the opt-out phase had new HIV diagnoses, and 5 of 231 patients (2.2%; 95% CI, 0.7%-5.0%) who were diagnostically tested during the opt-out phase had new HIV diagnoses. In the diagnostic phase, of 29,925 eligible patients, 243 (0.8%) completed HIV testing. Of these, 4 patients (1.6%; 95% CI, 0.5%-4.2%) had new diagnoses. The prevalence of new HIV diagnoses in the opt-out phase (including those diagnostically tested) and in the diagnostic phase was 15 in 28,043 (0.05%; 95% CI, 0.03%-0.09%) and 4 in 29,925 (0.01%; 95% CI, 0.004%-0.03%), respectively. Nontargeted opt-out HIV screening was independently associated with new HIV diagnoses (risk ratio, 3.6; 95% CI, 1.2-10.8) when adjusting for patient demographics, insurance status, and whether diagnostic testing was performed in the opt-out phase. The median CD4 cell count for those with new HIV diagnoses in the opt-out phase (including those diagnostically tested) and in the diagnostic phase was 69/microL (IQR, 17-430) and 13/microL (IQR, 11-15) , respectively (P = .02). CONCLUSION: Nontargeted opt-out rapid HIV screening in the ED, vs diagnostic testing, was associated with identification of a modestly increased number of patients with new HIV diagnoses, most of whom were identified late in the course of disease.

Development and implementation of a model to improve identification of patients infected with HIV using diagnostic rapid testing in the emergency department.

OBJECTIVES: Infection with the human immunodeficiency virus (HIV) continues to expand in nontraditional risk groups, and the prevalence of undiagnosed infection remains relatively high in the patient populations of urban emergency departments (EDs). Unfortunately, HIV testing in this setting remains uncommon. The objectives of this study were 1) to develop a physician-based diagnostic rapid HIV testing model, 2) to implement this model in a high-volume urban ED, and 3) to prospectively characterize the patients who were targeted by physicians for testing and determine the proportions who completed rapid HIV counseling, testing, and referral; tested positive for HIV infection; and were successfully linked into medical and preventative care. METHODS: An interdisciplinary group of investigators developed a model for performing physician-based diagnostic rapid HIV testing in the ED. This model was then evaluated using a prospective cohort study design. Emergency physicians identified patients at risk for undiagnosed HIV infection using clinical judgment and consensus guidelines. Testing was performed by the hospital's central laboratory, and clinical social workers performed pretest and posttest counseling and provided appropriate medical and preventative care referrals, as defined by the model. RESULTS: Over the 30-month study period, 105,856 patients were evaluated in the ED. Of these, 681 (0.64%; 95% confidence interval [CI] = 0.60% to 0.69%) were identified by physicians and completed rapid HIV counseling, testing, and referral. Of the 681 patients, 15 (2.2%; 95% CI = 1.2% to 3.6%) patients tested positive for HIV infection and 12 (80%; 95% CI = 52% to 96%) were successfully linked into care. CONCLUSIONS: A physician-based diagnostic HIV testing model was developed, successfully implemented, and sustained in a high-volume, urban ED setting. While the use of this model successfully identified patients with undiagnosed HIV infection in the ED, the overall level of testing remained low. Innovative testing programs, such as nontargeted screening, more specific targeted screening, or alternative hybrid methods, are needed to more effectively identify undiagnosed HIV infection in the ED patient population.

Risk-based human immunodeficiency virus (HIV) testing fails to detect the majority of HIV-infected persons in medical care Settings.

OBJECTIVES: To evaluate opportunities for earlier human immunodeficiency virus (HIV) diagnosis within a comprehensive public health care system. STUDY DESIGN: Retrospective review of newly diagnosed HIV-infected patients between September 2001 and December 2003. RESULTS: One hundred twenty of 348 (34%) newly diagnosed HIV-infected patients had medical care within our system in the 3 years before diagnosis. One hundred five of 120 (88%) patients had at least 1 prior encounter in the emergency department or urgent care center, whereas just 12 (10%) HIV diagnoses were made in these 2 sites. Only 33 (28%) patients previously presented with an HIV clinical indicator condition or sexually transmitted infection. CONCLUSIONS: Although one-third of newly diagnosed HIV-infected patients had clinical visits in the 3 years before diagnosis, few presented with clinical conditions typically associated with HIV infection. Targeted testing based on clinical presentations is not likely to result in substantially earlier HIV diagnosis. Routine screening in high prevalence settings could be more effective.