HIV screening: How we can do better

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Applied Evidence

HIV screening: How we can do better

J Fam Pract. 2014 July;63(7):383-387

By

Jeffrey T. Kirchner, DO, FAAFP

Aahivs

The CDC and USPSTF recommend routine HIV screening of adults. This review of the tests at your disposal, and a new diagnostic algorithm from the CDC, provide guidance.

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References

1. amFAR. Thirty years of HIV/AIDS: Snapshots of an epidemic. amfAR, The Foundation for AIDS Research Web site. Available at: http://www.amfar.org/thirty-years-of-hiv/aids-snapshots-of-anepidemic. Accessed May 9, 2014.

2. Centers for Disease Control and Prevention. HIV Surveillance Report, 2011. Vol. 23. Centers for Disease Control and Prevention Web site. Available at: http://www.cdc.gov/hiv/pdf/statistics_2011_HIV_Surveillance_Report_vol_23.pdf. Published February 2013. Accessed October 19, 2013.

3. Centers for Disease Control and Prevention. HIV in the United States: At a glance. Centers for Disease Control and Prevention Web site. Available at: http://www.cdc.gov/hiv/statistics/basics/ataglance.html. Accessed May 9, 2014.

4. The White House Office of National AIDS Policy. National HIV/ AIDS Strategy for the United States. AIDS.gov Web site. Available at: http://aids.gov/federal-resources/national-hiv-aids-strategy/nhas.pdf. Accessed October 25, 2013.

5. Branson BM, Handsfield HH, Lampe MA, et al; Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. MMWR Recomm Rep. 2006;55(RR-14):1-17;quiz CE1-CE4.

6. Centers for Disease Control and Prevention (CDC). Vital signs: HIV testing and diagnosis among adults-- United States, 2001-2009. MMWR Morb Mortal Wkly Rep. 2010;59:1550-1555.

7. Moyer VA; U.S. Preventive Services Task Force. Screening for HIV: U.S. Preventive Services Task Force recommendation statement. Ann Intern Med. 2013;159:51-60.

8. Brown M. AAFP, USPSTF recommend routine HIV screening but differ on age to begin. Available at: http://www.aafp.org/news/health-of-the-public/20130429hivscreenrecs.html. Accessed August 17, 2013.

9. Bayer R, Oppenheimer GM. Routine HIV testing, public health, and the USPSTF--an end to the debate. N Engl J Med. 2013;368:881-884

10. Cornett JK, Kirn TJ. Laboratory diagnosis of HIV in adults: a review of current methods. Clin Infect Dis. 2013;57:712-718.

11. Baron EJ, Miller MJ, Weinstein MP, et al. A guide to the utilization of the microbiology laboratory for diagnosis of infectious diseases: 2013 recommendations by the Infectious Diseases Society of America (IDSA) and the American Society for Microbiology (ASM)(a). Clin Infect Dis. 2013;57:e22-e121.

12. Delaney KP, Branson BM, Uniyal A, et al. Evaluation of the performance characteristics of 6 rapid HIV antibody tests. Clin Infect Dis. 2011;52:257-263.

13. FDA. FDA approves first rapid diagnostic test to detect both HIV-1 antigen and HIV-1/2 antibodies [press release]. US Food and Drug Administration Web site. Available at: http://www.fda.gov/newsevents/newsroom/pressannouncements/ucm364480.htm. Silver Spring, MD: US Food and Drug Administration; August 8, 2013. Accessed October 26, 2013.

14. Chavez P, Wesolowski L, Patel P, et al. Evaluation of the performance of the Abbott ARCHITECT HIV Ag/Ab Combo Assay. J Clin Virol. 2011;52:S51-S55.

15. Centers for Disease Control and Prevention (CDC). Rapid HIV testing in emergency departments—three U.S. sites, January 2005-March 2006. MMWR Morb Mortal Wkly Rep. 2007;56:597-601.

16. Napierala Mavedzenge S, Baggaley R, Corbett EL. A review of self-testing for HIV: research and policy priorities in a new era of HIV prevention. Clin Infect Dis. 2013;57:126-138.

17. Centers for Disease Control and Prevention (CDC). Detection of acute HIV infection in two evaluations of a new HIV diagnostic testing algorithm - United States, 2011-2013. MMWR Morb Mortal Wkly Rep. 2013;62:489-494.

18. Nasrullah M, Wesolowski LG, Meyer WA 3rd, et al. Performance of a fourth-generation HIV screening assay and an alternative HIV diagnostic testing algorithm. AIDS. 2013;27:731-737.

PRACTICE RECOMMENDATIONS

› Screen all adolescents and adults ages 15 to 65 years for human immunodeficiency virus (HIV) infection. A
› Screen younger adolescents and older adults who are at increased risk for HIV infection on an annual basis. A
› Screen all pregnant women for HIV infection, including those who are in labor and who are untested or whose HIV status is unknown. A

Strength of recommendation (SOR)

A Good-quality patient-oriented evidence
B Inconsistent or limited-quality patient-oriented evidence
C Consensus, usual practice, opinion, disease-oriented evidence, case series

For the first 15 years of the epidemic, human immunodeficiency virus and acquired immunodeficiency syndrome (HIV/AIDs) was uniformly fatal. Between 1981 and 1996, approximately 362,000 people in the United States succumbed to the disease.¹ That began to change in the mid 1990s, though, when highly active antiretroviral therapy (HAART) came into routine use. From that point forward, HIV became a chronic, manageable disease for most patients; an estimated 1.2 million people in the United States are now living with HIV infection.²

Unfortunately, the number of new infections continues to grow. There are more than 50,000 new infections in the United States each year,² and an estimated approximately 200,000 people have it but are undiagnosed, leading to further spread of the disease.³ The Office of National AIDS Policy has issued a National HIV/AIDS Strategy that seeks to reduce new infections by 25% in 2015, in part by identifying people with the disease who do not know their HIV status.⁴

But screening still has not gotten the uptake by clinicians that health officials would like.

Lack of awareness by physicians? Or an unwillingness of patients?

In 2006, the Centers for Disease Control and Prevention (CDC) began recommending routine HIV screening for individuals between the ages of 13 and 64, with patients given the ability to opt out of such testing.⁵ That same year, the CDC also removed some prior barriers to testing, such as requiring written consent and pretest counseling. But as of 2009, fewer than 50% of US adults had ever been tested for HIV⁶—possibly the result of physicians being unaware of the guidelines, patients being unwilling to be tested, and/or reimbursement issues.

Conflicting recommendations may have played a role. When the CDC released its 2006 recommendations, the United States Preventive Services Task Force (USPSTF) felt there was insufficient evidence to support routine HIV screening and issued a grade C recommendation. At that time, the USPSTF recommended that only high-risk individuals and pregnant women be tested (A recommendation, meaning there was high certainty that the net benefit was substantial).

However, in April 2013, based on new evidence regarding the clinical and public health benefits of early identification of HIV infection and subsequent treatment, the USPSTF updated its recommendations. The USPSTF now encourages clinicians to screen all adolescents and adults age 15 to 65 years for HIV (A recommendation).⁷ Shortly thereafter, the American Academy of Family Physicians (AAFP) also endorsed routine HIV screening, although the AAFP calls for such screening to begin at age 18.⁸

Insurance now covers it… A USPSTF A recommendation carries significant health policy implications because the Affordable Care Act requires private and public health insurance plans to cover preventive services recommended by USPSTF.⁹

Integrating screening into your practice

Serologic tests have come a long way. The first HIV antibody test was an enzyme immunoassay (EIA) that was introduced in 1985 and used mainly to screen the blood supply. This first-generation EIA identified only immunoglobulin G (IgG) antibodies to HIV type 1 (HIV-1). More sensitive and specific second- and third-generation EIAs have since been developed to detect both IgG and IgM antibodies, as well as antibodies to HIV-2. The third-generation assays also can detect antibodies as soon as 3 weeks after infection.

Fourth-generation assays allow for reliable detection of HIV infection within about 2 weeks of infection.The fourth-generation EIAs were approved by the US Food and Drug Administration (FDA) in 2010¹⁰ and are the first step in the CDC’s current HIV diagnostic testing algorithm. These tests can detect HIV-1/HIV-2 IgG and IgM antibodies and also p24 antigen, which is present within 7 days of the appearance of HIV RNA.¹¹ The fourth-generation assay allows for reliable detection within about 2 weeks of infection (FIGURE 1).¹⁰

Rapid HIV tests are also an option.¹² These tests can detect IgG and IgM antibodies in samples of saliva, whole blood, serum, and plasma. Results of rapid tests usually are available in 20 to 30 minutes and allow physicians to give patients the results while they are still in the office. In 2013 the FDA approved a combination p24 antigen/antibody rapid HIV assay that according to the manufacturer can detect infection earlier than other currently available rapid tests.¹³