James D. Heffelfinger

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.

Trends in primary and secondary syphilis among men who have sex with men in the United States.

OBJECTIVES We assessed the epidemiology of primary and secondary syphilis in the United States and estimated the percentages of cases occurring among men who have sex with men (MSM). METHODS We reviewed US syphilis surveillance data from 1990 through 2003. We estimated the number of cases occurring among MSM by modeling changes in the ratio of syphilis cases among men to cases among women. RESULTS During 1990 through 2000, the rate of primary and secondary syphilis decreased 90% overall, declining 90% among men and 89% among women. The overall rate increased 19% between 2000 and 2003, reflecting a 62% increase among men and a 53% decrease among women. In 2003, an estimated 62% of reported cases occurred among MSM. CONCLUSIONS Increasing syphilis cases among MSM account for most of the recent overall increase in rates and may be a harbinger of increasing rates of HIV infection among MSM. National efforts are under way to improve monitoring of syphilis trends, better understand factors associated with the observed increases, and improve efforts to prevent syphilis transmission.

The Changing Epidemiology of Syphilis

AFTER DECLINING EVERY YEAR since 1990, and less than 2 years after the launching of the National Plan to Eliminate Syphilis in the United States, rates of primary and secondary syphilis increased slightly in 2001.1 New epidemics involving men who have sex with men (MSM) have since been detected in most major US cities. If we could identify the persons who are most likely to acquire the next syphilis infections and why, we might be able to reach them early and prevent acquisition or reach them soon after they are infected and treat them before they transmit to others. This requires identifying characteristics of persons acquiring infection, how they are meeting partners, and how they are transmitting infection. When this information is known, we can warn the population at risk so they can take precautions to avoid infection or perhaps recognize an infection when they get it. We can also more effectively target screening campaigns and alert health care workers to look for infections among persons at risk. We also want to know how large the current syphilis epidemic will become because it will help with resource allocation decisions. Interventions early in an epidemic may halt transmission that could otherwise eventually become highly magnified. However, effective interventions can be expensive, even early in an epidemic. It is easier to justify extensive interventions for an epidemic that would otherwise grow to millions of cases (e.g., acquired immunodeficiency syndrome [AIDS]) than it is for an epidemic that would ultimately involve a small number of cases (e.g., hantavirus pulmonary syndrome). Finally, we want to know what this epidemic is telling us about other sexually transmitted infections, particularly human immunodeficiency virus (HIV). There has been concern that advances in antiretroviral therapy were leading to disinhibition of the sexual behaviors that were changed due to the AIDS epidemic.2,3 A relaxation of safe-sex practices could lead to resurgence of HIV and AIDS; however, increases in HIV transmission can be very difficult to identify because of the long and variable incubation period. Thus, other indicators have been used to try to identify effectiveness of HIV prevention programs.4 Some studies have suggested there have been increases in unprotected anal sex.3,5,6 Other studies suggest gonorrhea rates have increased among MSM.6,7 Is the current syphilis epidemic another indication that HIV transmission is increasing? We will address these questions by reviewing surveillance data reported to CDC and published epidemiologic research from the United States and elsewhere.

Results of a Rapid HIV Screening and Diagnostic Testing Program in an Urban Emergency Department

STUDY OBJECTIVE We describe outcomes of a rapid HIV testing program integrated into emergency department (ED) services, using existing staff. METHODS From April 2005 through December 2006, triage nurses in an urban ED offered HIV screening to medically stable patients aged 12 years or older. Clinicians could also order diagnostic testing according to presenting signs and symptoms and suspicion of HIV-related illness. Nurses obtained consent, performed rapid testing, and disclosed negative test results. Clinicians disclosed positive test results and arranged follow-up. Outcome measures included number and proportion of visits during which screening was offered, accepted, and completed; number of visits during which diagnostic testing was completed; and number of patients with confirmed new HIV diagnosis and their CD4 counts. RESULTS HIV screening and diagnostic testing were completed in 9,466 (8%) of the 118,324 ED visits (14.2% of the 60,306 unique patients were tested at least once). Screening was offered 45,159 (38.2%) times, accepted 21,626 (18.3%) times, and completed 7,923 (6.7%) times; diagnostic testing was performed 1,543 (1.3%) times. Fifty-five (0.7%) screened patients and 46 (3.0%) of those completing diagnostic testing had confirmed positive HIV test results. Median CD4 count was 356 cells/microL among screened patients and 99 cells/microL among those who received diagnostic testing. CONCLUSION Although existing staff was able to perform HIV screening and diagnostic testing, screening capacity was limited and the HIV prevalence was low in those screened. Diagnostic testing yielded a higher percentage of new HIV diagnoses, but screening identified greater than 50% of those found to be HIV positive, and the median CD4 count was substantially higher among those screened than those completing diagnostic testing.

Implementing Rapid HIV Testing in Outreach and Community Settings: Results from an Advancing HIV Prevention Demonstration Project Conducted in Seven U.S. Cities

Objectives. The goals of this project were to assess the feasibility of conducting rapid human immunodeficiency virus (HIV) testing in outreach and community settings to increase knowledge of HIV serostatus among groups disproportionately affected by HIV and to identify effective nonclinical venues for recruiting people in the targeted populations. Methods. Community-based organizations (CBOs) in seven U.S. cities conducted rapid HIV testing in outreach and community settings, including public parks, homeless shelters, and bars. People with reactive preliminary positive test results received confirmatory testing, and people confirmed to be HIV-positive were referred to health-care and prevention services. Results. A total of 23,900 people received rapid HIV testing. Of the 267 people (1.1%) with newly diagnosed HIV infection, 75% received their confirmatory test results and 64% were referred to care. Seventy-six percent were from racial/ethnic minority groups, and 58% identified themselves as men who have sex with men, 72% of whom reported having multiple sex partners in the past year. Venues with the highest proportion of new HIV diagnoses were bathhouses, social service organizations, and needle-exchange programs. The acceptance rate for testing was 60% among sites collecting this information. Conclusions. Findings from this demonstration project indicate that offering rapid HIV testing in outreach and community settings is a feasible approach for reaching members of minority groups and people at high risk for HIV infection. The project identified venues that would be important to target and offered lessons that could be used by other CBOs to design and implement similar programs in the future.

Rapid HIV Testing in Transgender Communities by Community-Based Organizations in Three Cities

Objectives. This article describes the demographic and behavioral characteristics, human immunodeficiency virus (HIV) testing history, and results of HIV testing of transgender (TG) people recruited for rapid HIV testing by community-based organizations (CBOs) in three cities. Methods. CBOs in Miami Beach, Florida, New York City, and San Francisco offered TG people rapid HIV testing and prevention services, and conducted a brief survey. Participants were recruited in outreach settings using various strategies. The survey collected information on demographic characteristics, HIV risk behaviors, and HIV testing history. Results. Among 559 male-to-female (MTF) TG participants, 12% were newly diagnosed with HIV infection. None of the 42 female-to-male participants were newly diagnosed with HIV. A large proportion of MTF TG participants reported high-risk behaviors in the past year, including 37% who reported unprotected receptive anal intercourse and 44% who reported commercial sex work. Several factors were independently associated with increased likelihood of being newly diagnosed with HIV infection among MTF TG participants, including having a partner of unknown HIV status in the past year; being 20–29 or ≥40 years of age; having last been tested for HIV more than 12 months ago; and having been recruited at the New York City site. Conclusions. Based on the high proportion of undiagnosed HIV infection among those tested, TG people represent an important community for enhanced HIV testing and prevention efforts. MTF TG people should be encouraged to have an HIV test at least annually or more often if indicated, based upon clinical findings or risk behaviors. Efforts should continue for developing novel strategies to overcome barriers and provide HIV testing and prevention services to TG people.

Epidemiology of HIV in the United States.

Background:The United States has a comprehensive system of HIV surveillance, including case reporting and disease staging, estimates of incidence, behavioral, and clinical indicators and monitoring of HIV-related mortality. These data are used to monitor the epidemic and to better design, implement, and evaluate public health programs. Methods:We describe HIV-related surveillance systems and review recent data. Results:There are more than 1.1 million people living with HIV in the United States, and approximately 56,000 new HIV infections annually. Risk behavior data show that 47% of men who have sex with men engaged in unprotected anal intercourse in the past year, and 33% of injection drug users had shared syringes. One third (32%) of people diagnosed with HIV in 2008 were diagnosed with AIDS within 12 months, indicating missed opportunities for care and prevention. An estimated 72% of HIV-diagnosed persons received HIV medical care within 4 months of initial diagnosis. Conclusions:Conducting accurate and comprehensive HIV surveillance is critical for measuring progress toward the goals of the 2010 National HIV/AIDS Strategy: reduced HIV incidence, increased access to care, and improvements in health equity.

Cost-Effectiveness of Pooled Nucleic Acid Amplification Testing for Acute HIV Infection after Third-Generation HIV Antibody Screening and Rapid Testing in the United States: A Comparison of Three Public Health Settings

Angela Hutchinson and colleagues conducted a cost-effectiveness analysis of pooled nucleic acid amplification testing following HIV testing and show that it is not cost-effective at recommended antibody testing intervals for high-risk persons except in very high-incidence settings.

Estimates of primary and secondary syphilis rates in persons with HIV in the United States, 2002.

Background: In the United States, there is a high rate of HIV coinfection in persons with syphilis. Goal: The goal of this study was to estimate the rate of primary and secondary (P&S) syphilis in persons living with HIV in the United States in 2002. Study: We approximated the number of new cases of P&S syphilis in HIV-infected persons and divided this by the estimated number of persons living with HIV. Values for the calculations were obtained from national syphilis and HIV/AIDS surveillance reports and other published sources. Results: We estimated the rate of new cases of P&S syphilis at 186 per 100,000 persons living with HIV in 2002, 25 per 100,000 HIV-infected women, 60 per 100,000 HIV-infected men who have sex with women only, and 336 per 100,000 HIV-infected men who have sex with men. Of the 6862 reported cases of P&S syphilis in 2002, an estimated 1718 (25%) occurred in persons coinfected with HIV. Conclusions: The estimated rate of P&S syphilis in persons with HIV is considerably higher than that of the general population. These findings highlight the importance of providing sexually transmitted disease prevention and control services to HIV-infected persons.

Rapid HIV screening: Missed opportunities for HIV diagnosis and prevention

BACKGROUND Although rapid HIV tests increase the number of persons who are aware of their HIV status, they may fail to detect early HIV infection. OBJECTIVES To evaluate the sensitivity for early HIV infection of several rapid tests and third- and fourth-generation assays compared with nucleic acid amplification testing (NAAT). STUDY DESIGN Sensitivity for early HIV infection was evaluated using 62 NAAT-positive/WB-negative or indeterminate specimens from the CDC Acute HIV Infection study. Specimens underwent third-generation testing with Genetic Systems 1/2+O(®) and rapid testing with Multispot HIV-1/HIV-2. A subset was also tested with four FDA-approved rapid tests and Determine HIV-1 Antigen/Antibody Rapid Test(®) and Architect HIV Antigen/Antibody Combo(®), both fourth-generation tests. RESULTS Of 99,111 specimens screened from April 2006 to March 2008, 62 met the definition for early HIV infection (60 NAAT-positive/seronegative and 2 NAAT-positive/Western blot indeterminate). Third-generation testing correctly detected antibody in 34 specimens (55%; 95% confidence interval (CI): 42-67); Multispot detected antibody in 16 (26%; 95% CI: 16-38). Of the 62 specimens, 33 (53%) had sufficient quantity for further testing. Rapid test sensitivities for early HIV infection ranged from 22-33% compared with 55-57% for the third-generation assay and 76-88% for the fourth-generation tests. CONCLUSIONS Many rapid HIV tests failed to detect half of the early HIV infection cases in whom antibody was present. Programs that screen high-incidence populations with rapid tests should consider supplemental testing with NAAT or other antigen-based tests. These data support the need for more sensitive antigen-based point-of-care screening tests for early HIV infection.