Mark Thrun

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.

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.

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.

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.

Psychosocial Characteristics and Sexual Behaviors of People in Care for HIV Infection: An Examination of Men Who Have Sex with Men, Heterosexual Men and Women

Few studies have examined the psychosocial factors associated with sexual transmission behaviors among HIV-positive men who have sex with men (MSM), heterosexual men (MSW) and women. We enrolled 1,050 sexually active HIV-positive patients at seven HIV clinics in six US cities as part of a clinic-based behavioral intervention. We describe the sexual transmission behaviors and examine demographic, clinical, psychosocial, and clinic prevention variables associated with unprotected anal or vaginal intercourse (UAVI). Twenty-three percent of MSM, 12.3% of MSW and 27.8% of women engaged in UAVI with partners perceived to be HIV-negative or of unknown serostatus. Among MSM and MSW, having multiple partners and lower self-efficacy were associated with increased odds of UAVI. Self-rating one’s health status as excellent/very good was a risk factor for UAVI among MSM. Among women, binge drinking and stressful life events were associated with UAVI. These findings identify variables that warrant attention in targeted interventions.

HIV testing in emergency departments in the United States: a national survey.

OBJECTIVES In 2006, the Centers for Disease Control and Prevention (CDC) published recommendations for HIV testing in health care settings, calling for nontargeted opt-out rapid HIV screening in most settings, including emergency departments (EDs). Although a number of ED-based testing strategies exist, it is unclear to what extent they are used. The objective of this study is to survey academic and community EDs throughout the United States to determine ED-based HIV testing practices. METHODS This was a cross-sectional survey study of all academic EDs and a weighted random sample of all community-based EDs in the United States. A standardized survey instrument was developed and administered with an Internet-based survey platform, followed by direct contact and mail. The survey included domains related to perceived HIV testing barriers, whether HIV testing was performed and methods used, and familiarity with the CDC recommendations and whether they had been adopted. RESULTS Of the 131 total academic sites and the 435 community sites, 99 (76%) and 150 (35%) completed the survey, respectively. A larger proportion of academic sites believed HIV testing was needed (P=.02) and a larger proportion actually provided HIV testing (65% versus 50%; P=.04). Among the academic and community EDs that provided testing, 74% and 62% performed diagnostic testing, 26% and 22% performed targeted screening, and 16% and 6% performed nontargeted screening, respectively. A larger proportion of academic EDs reported receiving external funding to support testing (23% versus 4%; P=.001), whereas a large proportion of community sites considered costs a significant barrier to testing (P=.03). A larger proportion of academic EDs reported being familiar with the 2006 CDC recommendations (64% versus 40%; P<.001), although only 26% and 37% reported having implemented any part of them, respectively. CONCLUSION Academic EDs only make up approximately 3% of all EDs in the United States. Significant differences exist between academic and community EDs as they relate to performing HIV testing. Increased efforts should be made to improve the ability of community EDs to provide this service.

Design and Implementation of a Controlled Clinical Trial to Evaluate the Effectiveness and Efficiency of Routine Opt-out Rapid Human Immunodeficiency Virus Screening in the Emergency Department

In 2006, the Centers for Disease Control and Prevention (CDC) released revised recommendations for performing human immunodeficiency virus (HIV) testing in health care settings, including implementing routine rapid HIV screening, the use of an integrated opt-out consent, and limited prevention counseling. Emergency departments (EDs) have been a primary focus of these efforts. These revised CDC recommendations were primarily based on feasibility studies and have not been evaluated through the application of rigorous research methods. This article describes the design and implementation of a large prospective controlled clinical trial to evaluate the CDCs recommendations in an ED setting. From April 15, 2007, through April 15, 2009, a prospective quasi-experimental equivalent time-samples clinical trial was performed to compare the clinical effectiveness and efficiency of routine (nontargeted) opt-out rapid HIV screening (intervention) to physician-directed diagnostic rapid HIV testing (control) in a high-volume urban ED. In addition, three nested observational studies were performed to evaluate the cost-effectiveness and patient and staff acceptance of the two rapid HIV testing methods. This article describes the rationale, methodologies, and study design features of this program evaluation clinical trial. It also provides details regarding the integration of the principal clinical trial and its nested observational studies. Such ED-based trials are rare, but serve to provide valid comparisons between testing approaches. Investigators should consider similar methodology when performing future ED-based health services research.

Early Linkage to HIV Care and Antiretroviral Treatment among Men Who Have Sex with Men — 20 Cities, United States, 2008 and 2011

Early linkage to care and antiretroviral (ARV) treatment are associated with reduced HIV transmission. Male-to-male sexual contact represents the largest HIV transmission category in the United States; men who have sex with men (MSM) are an important focus of care and treatment efforts. With the release of the National HIV/AIDS Strategy and expanded HIV treatment guidelines, increases in early linkage to care and ARV treatment are expected. We examined differences in prevalence of early linkage to care and ARV treatment among HIV-positive MSM between 2008 and 2011. Data are from the National HIV Behavioral Surveillance System, which monitors behaviors among populations at high risk of HIV infection in 20 U.S. cities with high AIDS burden. MSM were recruited through venue-based, time-space sampling. Prevalence ratios comparing 2011 to 2008 were estimated using linear mixed models. Early linkage was defined as an HIV clinic visit within 3 months of diagnosis. ARV treatment was defined as use at interview. Prevalence of early linkage to care was 79% (187/236) in 2008 and 83% (241/291) in 2011. In multivariable analysis, prevalence of early linkage did not differ significantly between years overall (P = 0.44). Prevalence of ARV treatment was 69% (790/1,142) in 2008 and 79% (1,049/1,336) in 2001. In multivariable analysis, ARV treatment increased overall (P = 0.0003) and among most sub-groups. Black MSM were less likely than white MSM to report ARV treatment (P = 0.01). While early linkage to care did not increase significantly between 2008 and 2011, ARV treatment increased among most sub-groups. Progress is being made in getting MSM on HIV treatment, but more efforts are needed to decrease disparities in ARV coverage.

Implementation and effectiveness of an expedited partner therapy program in an urban clinic.

Background Partner notification of exposure to gonorrhea or chlamydia is traditionally conducted by the index case or a disease intervention specialist. However, a significant proportion of partners remain untreated and thus are at risk for continued transmission. Expedited partner therapy (EPT) obviates the requirement for a health care visit by the partner: the index case delivers medications to the partner. Although shown to be efficacious in randomized control trials, effectiveness studies of delivering EPT in real-world situations are needed. We describe the implementation, patient characteristics, and clinical impact of an EPT program at the Denver Metro Health Clinic (DMHC). Methods We identified 2578 patient visits eligible for EPT (heterosexual men or women diagnosed as having chlamydia or gonorrhea) from November, 2006, to April, 2011. We examined EPT acceptance rates over clinical process improvements. To measure clinical impact, we assessed the association between initial acceptance of EPT and infection status among 351 patients who returned for retesting. Results Requiring complete documentation of EPT in the clinic electronic medical record increased EPT acceptance from 20% to 48%. Expedited partner therapy acceptance was associated with a reduced risk of chlamydial reinfection (odds ratio, 0.7; 95% confidence interval, 0.3–1.6) and a reduced risk of gonorrheal reinfection (odds ratio, 0.5; 95% confidence interval, 0.2–1.4); however, these changes were not statistically significant. Conclusions Expedited partner therapy at the DMHC was substantially enhanced by process changes in the clinic and may be associated with a decreased risk of reinfection.

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