8. Since 2006, the CDC estimates that the annual HIV incidence has continued at a steady rate of approximately 56,000 new HIV infections per year.

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1 1. Introduction 2. This presentation is intended as an introduction to Routine HIV Testing. The presentation covers: Basic concepts of routine HIV testing HIV epidemiology The rationale for routine testing The CDC recommendations for routine testing Barriers to routine testing; including consent requirements and reimbursement HIV diagnostic tests Communicating test results, and linking to care Further resources on routine testing 3. The Centers for Disease Control and Prevention (CDC) has estimated that at the end of 2006 approximately 1.1 million people were living with HIV in the United States. In September 2006, the CDC issued new recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. o In this landmark document, the CDC recommends routine HIV screening for persons aged in all health care settings. 4. The goal of routine HIV screening in the United States is to diagnose persons with HIV infection and then link them to medical care and HIV prevention services. 5. The desired outcome of Routine HIV screening is twofold 1. improve the survival and quality of life of persons diagnosed with HIV infection, or care; and 2. diminish the likelihood of those diagnosed with HIV transmitting the infection to others, or prevention. 6. HIV Epidemiology Update 7. It is important to understand the distinction between HIV incidence and HIV prevalence. The HIV incidence is the number of people who become newly infected with HIV in a given period. For example, if 50,000 persons become infected with HIV during the year 2003, the HIV incidence for that year is 50,000 new infections per year. The HIV prevalence refers to the total number of people living with HIV in a population at a point in time. The HIV prevalence rate is the percentage of persons infected with HIV in a population. For example, if a city has 100,000 people and 500 of them are infected with HIV, the HIV prevalence in this city is 500 and the prevalence rate is 0.5%. 8. Since 2006, the CDC estimates that the annual HIV incidence has continued at a steady rate of approximately 56,000 new HIV infections per year. 9. The CDC estimates that there are currently around 1.1 million persons infected with HIV in the United States. 10. Among those living with HIV in the United States at the end of 2006, approximately

2 35% were White 46% Black 17% Hispanic 2% Asian/Pacific Islander/American Indian/Alaska Native 11. As you can see, the burden of HIV prevalence in minorities is highly disproportionate to the general population. For example, in 2006, Blacks accounted for 46% of persons infected with HIV despite making up only 12% of the total U.S. population. 12. In 2006, the rate of new HIV infections (per 100,000 persons) was by far highest in Black individuals, with a rate approximately 7 times higher than in Whites. In addition, the rate of new HIV infections among Hispanics was more than twice that of Whites. 13. Data from the CDC have shown that the majority of HIV infected individuals in the United States are male. 14. Male-to-male sexual contact remains the leading risk factor for new HIV infections. The proportion involving high-risk heterosexual contact has also increased substantially and in 2006 accounted for almost one-third of new HIV infections. 15. HIV prevalence is largest among the middle-aged, with the largest two categories being those aged years old and years old, respectively. 16. The CDC estimates that about one-fifth of persons living with HIV are unaware of their HIV infection. 17. The estimated percentages of those unaware of their HIV status, is relatively consistent across ethnicities. 18. However, among young people, the CDC estimates a significantly higher proportion of those unaware of their HIV status, than among all other age groups. 19. In the United States, the rate of death due to HIV disease has consistently been higher among males than among females. However, the rate among black males has been shown to be several times higher than that of all other groups. 20. Since the mid-1990 s, the number of new HIV infections per year has substantially exceeded the number of persons dying from an AIDS-related death. Thus, the number of persons living with HIV in the United States (the HIV prevalence) has steadily increased since the mid 1990 s. In a similar manner, since the mid-1990 s, the annual number of persons newly diagnosed with AIDS in the United States has substantially exceeded the number of persons dying with AIDS. Thus, the number of persons living with AIDS (the AIDS prevalence) has also steadily increased. 21. To Summarize: Approximately 1.1 million people are living with HIV in the U.S. today.

3 21% of those are unaware of their status. Men who have sex with men are the most common transmission category. And, African-Americans and Blacks are disproportionately affected in terms of both infection and morbidity. 22. Now let s discuss the rational behind Routine Screening 23. Between the CDC analyzed data from 16 different US sites, involving 5,980 HIV-infected persons who had known HIV testing data. Individuals were classified as late, intermediate, or early testers based on when they had their HIV test in relation to their AIDS diagnosis. Late Testers: Tested less than 1 Year before AIDS Diagnosis Intermediate Testers: Tested 1-5 Years before AIDS Diagnosis Early Testers: Tested more than 5 Years before AIDS Diagnosis Almost one-half were late testers, meaning they had their first positive HIV test within 1 year of an AIDS diagnosis. 24. Approximately two-thirds of the late testers underwent testing because of a medical illness, whereas most of the early testers had HIV testing because of perceived risk or because they wanted to know their HIV status. 25. A separate report from South Carolina highlighted missed opportunities for earlier HIV diagnosis. Among the late testers, approximately three-fourths had visited a South Carolina health care facility prior to their HIV diagnosis. Of note, most of the reported medical diagnoses at these prior visits would not have indicated a need for HIV testing using only risk-based strategy. 26. This graph shows a typical CD4 cell count decline over time in an HIV-infected individual who is not receiving antiretroviral therapy. Because most HIV-infected persons do not develop AIDS-related manifestations until at least 5 years after their initial HIV infection, routine HIV screening could lead to early diagnosis and treatment before major AIDS-related complications develop. 27. The introduction of HAART (highly active antiretroviral therapy) treatments has dramatically increased the survival rates of patients in some studies. 28. The per-person survival gains from HAART are impressive. Studies show that the survival rate of patients on HAART, increases the earlier the treatment is started. Unfortunately, persons with a late diagnosis of HIV and advanced immunosuppression may obtain less benefit from antiretroviral therapy than those diagnosed earlier in the course of their HIV infection. o For example, a study in Europe involving more than 12,000 adults who received HAART, showed that a low CD4 cell count at the time of starting therapy strongly correlated with a higher probability of progression to AIDS or death. 29. A recent collaborative study with research groups in North America and Canada, compared initiating antiretroviral therapy versus deferring therapy at two different CD4 count thresholds: 350 and 500.

4 Deferring therapy resulted in a 69% increased risk of death for the CD4 count threshold of 350 and a 94% increased risk of death for the CD4 count threshold of Antiviral therapy can also lower the risk of HIV transmission, due to the lowered viral loads of those infected. 31. Transmission models reveal a connection between awareness of HIV infected status, and the sexual transmission of new cases of HIV in the United States. In one case, investigators estimate that the 25% of HIV-infected persons who were unaware of their HIV infection accounted for approximately 54 to 70% of new sexually acquired HIV infections per year. 32. In addition to health benefits of earlier HIV diagnosis, available data suggest HIV-infected persons aware of their HIV status will reduce high-risk behaviors associated with transmission of HIV. 33. A prime example of the potential benefit of routine screening is the reduction of perinatal HIV transmission in the United States. 34. A group of investigators recently addressed the issue of the cost effectiveness of routine HIV screening by conducting a cost-effectiveness analysis of HIV screening in the era of highly active antiretroviral therapy. The study showed if the prevalence of unidentified HIV is 0.5 percent, a one-time HIV screening program has a cost-effective ratio of less than $50,000 per quality-adjusted life-year gained. If the costs and benefits of partners are taken into account, the prevalence of unidentified HIV can be low as 0.05 percent and HIV screening maintains a cost-effectiveness ratio of less than $50,000 per quality-adjusted life-year gained. 35. The cost-effectiveness of routine HIV screening in health care settings, even in relatively lowprevalence populations, is similar to that of commonly accepted interventions, and such programs should be expanded. The authors of this study concluded the cost-effectiveness of screening is well within the range of that of other commonly accepted health care interventions. 36. To Summarize: Early testing yields medical benefits in terms of outcomes for early treatment Early introduction of HAART treatment is more effective than late introduction o Studies have shown a decreased risk of transmission in persons with HIV infection who receive antiretroviral therapy o Studies have shown an overall reduction in high-risk behavior in persons who know their HIV positive status o Routine testing is a cost-effective intervention 37. In 2006, the Centers of Disease Control and Prevention (CDC) released revised recommendations on HIV Testing. The CDC recommended routine HIV testing of all adults, adolescents, and pregnant women aged in all health care settings.

5 38. The CDC Recommendations have been endorsed by a number of physician groups and medical societies, including: American Medical Association American College of Physicians American Academy of HIV Medicine HIV Medicine Association National Association of Community Health Centers National Medical Association 39. The CDC recommends that: Routine screening for HIV should be performed for all persons aged Risk assessment is not a requirement to perform routine HIV screening. Health-care workers should perform routine HIV screening on patient populations unless the prevalence of undiagnosed HIV is less than 0.1% fro the general population. 40. Repeat HIV testing should be performed at least once a year for persons considered at high risk for acquiring HIV. High risk categories include: o injection drug users, o sex workers, o and those with partners who are infected. o Additionally any person who has had a sexual partner since their last test, should be retested. 41. Additionally, patients seeking treatment for STDs or initiating tuberculosis treatment should receive HIV testing. 42. Routine HIV screening among pregnant women has been very successful. Universal screening of pregnant women (with repeat testing in the third trimester under certain circumstances) is recommended. 43. Patients with recent high-risk behavior and with a clinical illness consistent with acute HIV infection should undergo evaluation for acute HIV. Approximately 40-90% of persons recently infected with HIV will develop significant clinical signs and symptoms, but these signs and symptoms are non-specific. Soon after a person becomes infected with HIV, high levels of HIV RNA typically develop and this precedes the production of detectable HIV antibodies. Patients who present with symptomatic acute HIV infection generally have high-level viremia and absence of detectable HIV antibodies. 44. Some clinical manifestations of HIV/AIDS include oral candidiasis, Kaposi s Sarcoma, Oral Hairy Leukoplakia, and pneumocystis pneumonia. 45. Other patients with acute HIV manifest symptoms of fever, lethargy, myalgias, rash, headache, and pharyngitis. 46. Now let s talk about some of the barriers to implementation of routine testing.

6 47. Medical providers commonly express a number of concerns regarding HIV testing in the clinical setting. Such as: I don t have time to do test all my patients for HIV. It s not my job to screen for HIV. The patients I see aren t at risk for HIV. Why should I do routine HIV screening when I can just screen high-risk people? o Will our clinic get reimbursed for HIV testing? o The clients I see don t want to be screened.i might offend them by asking them to be tested. Do I need to get written consent? I don t even know the laws in our state. I don t have the skills to give a client their HIV-positive test result. 48. A recent study examined three distinct health care settings to address the issue of why US physicians do not routinely offer HIV testing. 49. The three most common barriers identified in a recent study related to logistical issues: insufficient time burdensome consent process the perception that clients had low HIV risk. Additionally, some providers may have concerns about reimbursement for HIV testing. 50. The CDC 2006 recommendations for HIV screening address each of these major barriers by: Eliminating the requirement for written consent; Eliminating the requirement for prevention counseling in conjunction with screening, and; Changing from a risk assessment HIV screening process to uniform screening of all persons aged These CDC-recommended changes were intended to transform the time-consuming and cumbersome HIV testing procedure into a simple, uniform testing process similar to the process used by clinicians for ordering many routine medical tests. 51. HIV testing must be considered voluntary and free from coercion. The patient should be informed orally or in writing that HIV testing will be performed unless the patient declines to undergo HIV testing. This process is referred to as opt-out screening. Separate written consent for HIV testing should not be required. The general consent for medical care should be considered sufficient to encompass consent for HIV testing. 52. Many physicians are also unaware of the laws in their state regarding HIV testing. A majority of states now have laws that allow for routine HIV testing. o However, some states still have barriers to routine testing in their state laws, such as written consent or counseling requirements. However, providers should check their state s laws on counseling and consent requirements for HIV testing.

7 53. In a study conducted by the San Francisco Department of Public Health, investigators found that eliminating the requirement for written consent for HIV testing was associated with a significant and sustained increase in HIV testing rates and HIV case detection. Another study from New York reported a streamlined HIV consent procedure introduced in 2005 led to a 31% increase in the state s HIV testing rate. 54. Now, let s talk about reimbursement for HIV testing. 55. The American Medical Association (AMA) and the American Academy of HIV Medicine (AAHIVM), in partnership with the Centers for Disease Control and Prevention (CDC), have developed a guide to reimbursement coding for HIV testing. 56. In the guide, are listed all the necessary CPT codes and ICD codes to submit for reimbursement of testing services, along with patient examples, and a review of the CDC recommendations. Contact the American Academy of HIV Medicine for a free copy of the guide. 57. The Centers for Medicare Services (CMS) recently announced that Medicare now covers HIV testing services. Additionally, most private insurance coverage also covers and reimburses for HIV testing. 58. Let s talk about some forms of HIV tests. 59. The different HIV diagnostic tests are used as either initial or supplemental tests. The enzyme immunoassay (EIA) remains the most common initial test used in the United States to diagnose persons with established HIV. More recently, some laboratories have begun using the chemiluminescent assay (CIA) for initial testing. Initial tests should be confirmed with a supplemental test, either a Western blot test, an indirect immunofluorescent assay (IFA), or a qualitative HIV-1 RNA test (also referred to as nucleic acid amplification technique [NAAT]). 60. The HIV EIA tests have undergone significant modifications and four generations of tests have been developed. The basic principle of the first generation EIA screening test involves: 1. Use of HIV antigens (obtained from a crude viral lysate) coated on a well; 2. Binding of human IgG antibodies (from patient plasma or serum) to the HIV antigens; 3. Binding of anti-human IgG immunoglobulin (coupled with an enzyme detector) to the human HIV antibodies; and 4. Use of a color reagent to activate the enzyme detector substrate and generate a color change. The second generation HIV EIA is similar to the first generation, except the HIV antigens consist of recombinant HIV proteins or synthetic peptides, instead of a viral lysate. The third generation assay, which is now the predominant EIA test used by laboratories in the US, differs from earlier generation EIAs in two ways: 1. IgM and IgG antibodies (not just IgG) can be detected; and 2. HIV antigens (not anti-human immunoglobulin) are linked to the enzyme detector and bind to human HIV antibodies.

8 o The third generation assay is referred to as a sandwich assay since the HIV IgM and IgG antibodies are sandwiched between the HIV antigens. 61. With all three generation of tests, a color change in the well occurs if HIV antibodies are present. Based on a color change or degree of fluorescence compared with a standardized cut-off, the EIA provides an overall result of positive or negative, but it does not provide information regarding antibody reactions to specific HIV antigens. As shown here with a traditional 96-well plate, multiple samples can be run simultaneously. Newer random-access EIAs run specimens one at a time, and therefore, do not require batching of samples. 62. The HIV Western blot assay is the most commonly used supplemental test. In the first step of the Western blot, HIV proteins and glycoproteins from a lysate of HIV are separated according to their molecular weight by gel electrophoresis. o The p stands for protein and gp for glycoprotein. o The number following either the p or gp designates the molecular weight of the viral protein or glycoprotein (given in kilodaltons). The separated HIV proteins and glycoproteins are then transferred from the gel to a nitrocellulose membrane. The membrane is then cut into individual Western blot strips. 63. To perform the Western blot test for a patient, serum from the patient is added to the nitrocellulose membrane. If HIV antibodies are present in serum, they will bind to the HIV antigens on the membrane. In this example, the HIV-infected patient s serum contains antibodies that bind to the HIV envelope glycoproteins (gp120) and capsid proteins (p24) on the Western blot strip. Next, antihuman IgG antibodies linked to an enzyme detector are added. The antihuman IgG antibodies bind to the HIV antibodies on the Western blot strip. Last, a color reagent is then added that reacts with the enzyme detector substrate to generate a colored reaction. o This reaction forms a band on the Western blot strip that correlates with the region of bound HIV antibodies. The HIV Western blot assay is a very accurate test since it identifies specific anti-hiv antibodies in a patient s serum that react to individual HIV antigens on the Western blot strip. 64. The general approach to HIV diagnostic testing in the United States consists of a two-stage process: initial testing and supplemental testing. The initial HIV test is optimized for sensitivity, with the goal of detecting all HIV antibody positive specimens. o A negative initial test should generate confidence the person does not have HIV infection. The supplemental HIV test is optimized for specificity and a positive supplemental test should generate confidence the person truly has HIV infection. In the original 1989 CDC and Association of Public Health Laboratories algorithm, initial screening was conducted with an EIA and repeatedly reactive specimens underwent supplemental testing with a Western blot test or IFA. 65. Let s discuss how to communicate test results after HIV testing.

9 66. Communicating HIV test results is an essential component of the overall HIV testing process. 67. For clients who have a negative HIV test result, the health care provider may communicate the result to the client without direct personal contact, in the same manner as when giving results of other commonly performed screening and diagnostic tests. For example, a health care provider could provide a negative HIV test result to a client over the phone. Persons with known high risk for acquiring HIV should be advised to have periodic retesting, and they should receive counseling on HIV prevention measures, or referred for prevention services. 68. Clients who have a positive initial and supplemental HIV test are considered HIV infected and the test result should be provided to them by direct personal contact. A positive HIV test result should be disclosed confidentially. When discussing a positive test result, the health care provider should make sure the client clearly understands the test result. 69. Clients who undergo point-of-care (rapid) HIV testing and have a reactive test should have the result provided to them by direct personal contact. The client should understand the reactive test is a preliminary positive and that HIV infection has not been confirmed. The health care provider should order a supplemental HIV test and discus the importance of follow-up for the supplemental test results. 70. Clients who have undergone initial and supplemental testing and have an indeterminate HIV test result should be counseled that additional follow-up testing is necessary. In addition, until this has been further evaluated, clients should be instructed to use the same prevention measures recommended for persons with known HIV infection. 71. Clients who are newly diagnosed with HIV infection should receive basic introductory counseling about HIV and AIDS, including information regarding the effectiveness of medical treatment for persons with HIV infection. The health care worker should also discuss HIV transmission and the steps the client can take to reduce their risk of transmitting HIV to others. 72. As when communicating a diagnostic test result of any serious medical condition, health care providers should promptly link the newly diagnosed person to appropriate clinical care and support services. In addition, because HIV is communicable, the client should be referred to HIV prevention services. 73. Health care providers should make certain they document the HIV test result and the HIV risk factors for transmission in the patient s confidential chart. All states require health care workers to report persons with a new diagnosis of HIV infection to their state or local health department. Health care workers should strongly encourage newly diagnosed HIV-infected persons to disclose their HIV status to their current and past sex partners.

10 o If needed, health departments can provide assistance in partner notification. 74. The CDC has recently updated its recommendations regarding services provided to partners of persons with HIV and other STDs. The recommendations provided by the CDC are intended for health department program managers who are responsible for overseeing and managing programs for partner services. The overall goal of the partner services program is to ensure that potentially infected partners are notified of their exposure to HIV or other STDs. 75. In a 2003 study that involved persons in New York City newly diagnosed with HIV, investigators used routine surveillance data to determine time to initiation of care for their HIV. Among the 1928 persons with a new positive Western blot, 64% initiated care within 3 months of diagnosis, 19% initiated care later than 3 months, and 17% never initiated care. Overall, more than one-third of the patients were not promptly linked to medical care for their HIV. 76. Outlined here is a four-step sequential pathway for HIV testing: 1. The health care professional recommends the HIV test 2. The client agrees to undergo HIV testing 3. The client receives the test results, and 4. If the client is infected with HIV, they are successfully linked to an appropriate medical care site. It is important to note that connecting persons newly diagnosed with HIV to an appropriate clinical care site is a critical element in making routine HIV screening cost-effective and in obtaining the desired health benefits. 77. Many organizations can provide information regarding referrals for newly diagnosed HIV-infected individuals to care and services, including: The American Academy of HIV Medicine AIDS Education and Training Centers The HIV Medicine Association Additionally, the Ryan White HIV/AIDS Program provides direct care services for HIV. Health care providers should be aware of the Ryan White HIV/AIDS programs and clinics in your area. For more information on the Ryan White program, contact the Health Resources Services Administration (HRSA). Visit to locate a Ryan White clinic in your region. 78. Here are some further resources on routine HIV testing. 79. Additional resources and training materials regarding the CDC recommendations for routine HIV screening and other aspects of HIV testing are available through: The Centers for Disease Control and Prevention (CDC) The AIDS Education and Training Centers (AETC) The Society of General Internal Medicine (SGIM) o The Health Research and Education Trust (HRET) o The American Academy of HIV Medicine (AAHIVM) o The American Medical Association (AMA)

11 80. The National Clinicians Consultation Center (NCCC) maintains updated information on state-specific HIV testing laws, that is available on their website. In addition, expert consultation regarding any aspect of HIV testing, including interpretation of HIV test results, is available for clinicians through the National HIV/AIDS Clinicians Consultation Center Warmline at For more information on Routine HIV testing, contact any of the following organizations. 82. Thank you for participating on this presentation.