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Improving Access to Rapid HIV Testing: An Update

NOTE:  This report represents information on this subject as of November 2006.

Resolution 511 (A-05), introduced by the Medical Student Section and adopted as amended, calls for  the American Medical Association (AMA) to work with any and all local and state medical societies, and other interested US and international organizations, to increase access to and utilization of Food and Drug Administration (FDA)-approved rapid human immunodeficiency virus (HIV) testing in accordance with the quality assurance guidelines for rapid HIV testing developed by the Centers for Disease Control and Prevention (CDC). Additionally, the resolution encourages that pre- and post-test counseling be performed in accordance with guidelines established by the CDC. Finally, the resolution asked for a progress report at the 2006 Interim Meeting on efforts to increase access to FDA-approved rapid HIV testing.

This Council report describes current AMA efforts on HIV testing, particularly with respect to rapid HIV testing.  It also briefly updates national efforts to increase utilization of this testing.

Data Sources

• The CDC’s November 1-2, 2005, national stakeholders’ consultation on HIV screening recommendations for adults, adolescents and pregnant women.
• The CDC’s revised recommendations for HIV testing of adults, adolescents and pregnant women in health care settings.¹

Introduction

Following adoption of amended Resolution 511 (A-05), the AMA participated in a national stakeholders’ consultation on revising the CDC’s existing guidelines for HIV testing in adults, adolescents and pregnant women. It became clear that with these revised recommendations, the use of rapid HIV testing would likely increase dramatically.  Accordingly, the AMA has been working with the CDC on the revised recommendations; this collaboration serves as the basis for part of this report.

Update on HIV Testing

At the end of 2003, approximately one-fourth of the estimated one million HIV-positive people living in the United States were believed to be unaware of their HIV status.²  These individuals may unknowingly transmit their infections to others, thus contributing to the incidence of new HIV infections in the United States (currently 40,000 new cases annually), ² and they also do not receive the benefits of treatment to reduce morbidity and mortality.³  As a result of these and other factors, the CDC has revised its recommendations on HIV testing of adults, adolescents, and pregnant women in health care settings, moving from a risk-based screening methodology to recommendations for routine testing. These recommendations advocate that screening for HIV infection be routinely performed for all persons aged 13 to 64 years who present to a health care setting.¹  The availability and use of rapid HIV tests is expected to be a critical component in ensuring successful implementation of the new recommendations.

There are now six FDA-approved rapid HIV tests, utilizing either whole blood/serum obtained from a blood draw or a fingerstick, or fluids obtained from the oral cavity. These tests provide a result within 15 to 20 minutes.  Demonstration projects have shown that 99.7% of patients subjected to a rapid HIV test receive their results and undergo post-test counseling.³ This success rate is explained by the fact that the average time between sampling and receiving the test result is 28 minutes, instead of the two weeks typically associated with conventional HIV tests.  As with the enzyme-linked immunosorbent assays, it is important to note that confirmatory testing of positive results from rapid HIV tests is essential because of the potential for false-positives, combined with higher testing rates. Also, rapid HIV tests using oral fluids may have a higher rate of false-positives.⁴

The CDC’s Rapid HIV Test Distribution Program

In 2003, the CDC implemented a new initiative, “Advancing HIV Prevention,”  which was intended to reduce the prevalence of undiagnosed HIV infection by expanding HIV testing and by taking advantage of rapid HIV tests, enabling individuals to receive results within 30 minutes.⁵  From  September 2003 through December 2005, within a project called the Rapid HIV-Test Distribution Program (RTDP), the CDC purchased and distributed rapid HIV tests in order to expand testing and to assess the feasibility of using these tests in new environments, such as emergency departments.⁶  Data from this program will provide valuable insight into the role of rapid HIV testing in implementation of the revised recommendations discussed above.

During the RTDP period, 790,310 rapid HIV tests were distributed to 107 coordinators representing 230 organizations in 37 states, the District of Columbia, Puerto Rico, and the Virgin Islands.  Of these, 372,960 were administered for diagnostic purposes, 60,294 were used for external quality control, and 25,378 were used for training. The remainder either had not yet been used or were returned to the CDC.  Among tests administered, results from 5,385 samples were preliminarily positive for HIV infection, and 4,650 were confirmed as HIV positive.

These results indicate that HIV testing can be successfully increased by the use of rapid HIV testing, and that the RTDP enabled the diagnosis of HIV infection in persons who otherwise may not have known their status. ⁶  Previous research has shown that the majority of persons who learn their HIV status take steps to prevent transmission of infection to others and also to obtain health care that will improve the quality and duration of their lives.^7,8 Significantly, many of the participating organizations continue to offer rapid HIV testing even after the RTDP concluded. ⁶

Current AMA Efforts

The AMA participated in all consultations for the revision of the HIV testing recommendations for adults, adolescents, and pregnant women; submitted comments in response to the final draft; and continues to work with the CDC to address implementation issues associated with the new recommendations.  The AMA has supported these revised testing recommendations publicly.⁹

The AMA and the CDC have agreed to collaborate on the best ways to promote the use of rapid HIV testing in primary care physicians’ offices. One option under consideration is the creation of a toolkit for the primary care setting to help implement the revised CDC recommendations for HIV testing, as well as provide information on the different rapid HIV tests, details on appropriate quality assurance, and guidance on obtaining reimbursement following administration of the test.

Recently, the AMA helped the CDC clarify Current Procedural Technology (CPT) coding issues with respect to the different specimen sources that are used for the different rapid HIV tests.  While CPT code 86701 refers to HIV-1 antibody testing, it does not distinguish the source of the specimen (oral fluids versus blood/serum). Thus, an additional code (S3645) was created for an HIV-1 antibody test  performed on an oral fluid specimen. However, this has created some confusion because CPT code 86701 can still also be used for coding an HIV-1 test performed on an oral fluid specimen.  The AMA has offered to work with the CDC to create two separate CPT codes for HIV-1 antibody testing (one for blood/serum and the other for oral fluids) to simplify reporting for rapid HIV testing and is currently awaiting a CPT application from the CDC

Recommendations (Adopted AMA Policy and Directives)

The following statements, recommended by the Council on Science and Public Health, were adopted by the AMA House of Delegates at the 2006 AMA Interim meeting:

1. The AMA supports the Centers for Disease Control and Prevention’s (CDC) 2006 Revised Recommendations for HIV Testing of Adults, Adolescents and Pregnant Women in Health Care Settings. (Policy)
2. The AMA will continue to work with the CDC to implement the revised recommendations for HIV testing of adults, adolescents, and pregnant women in health care settings, including exploring the publication of a guide on the use of rapid HIV testing in primary care settings. (Directive)
3. The AMA will identify legal and funding barriers to the implementation of the CDC's HIV testing recommendations and develop strategies to overcome these barriers. (Directive)

References

1. Centers for Disease Control and Prevention. Revised Recommendations for HIV Testing of Adults, Adolescents and Pregnant Women in Health Care Settings.  MMWR. In press.
2. Centers for Disease Control and Prevention. HIV/AIDS Surveillance Report, 2004 - Vol. 16. Atlanta, Georgia: US Department of Health and Human Services, Centers for Disease Control and Prevention; 2005. Available at: http://www.cdc.gov/hiv/stats/hasrlink.htm. Accessed: August 1, 2006.
3. Branson BM. Rapid HIV Testing: 2005 Update. Available at: http://www.cdc.gov. (PDF, 1.2MB, requires Adobe® Reader®). Accessed: November 2006.
4. Centers for Disease Control and Prevention. Supplemental testing for confirmation of reactive oral fluid rapid HIV antibody tests. MMWR. 2005;54(Dispatch):1. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm54d1216a1.htm. Accessed: August 2006.
5. Centers for Disease Control and Prevention.  Advancing HIV prevention: new strategies for a changing epidemic – United States, 2003. MMWR. 2003;52:329-332. Available at: http://www.cdc.gov/mmwr/preview/mmwrhtml/mm5215a1.htm. Accessed: August 1, 2006.
6. Centers for Disease Control and Prevention.  Rapid HIV test distribution – United States, 2003-2005. MMWR. 2006;55:673-676.
7. Marks G, Crepaz N, Senterfitt JW, Janssen RS. Meta-analysis of high-risk sexual activity in persons aware and unaware they are infected with HIV in the United States: implications for HIV prevention programs. J Acquir Immune Defic Syndr. 2005;39:446-453.
8. Kendrick SR, Kroc KA, Withum D, Rydman RJ, Branson BM, Weinstein RA. Outcomes of offering rapid point-of-care HIV testing in a sexually transmitted disease clinic. J Acquir Immune Defic Syndr. 2005;38:142-146.
9. Stobbe M. CDC wants AIDS virus testing to be part of routine physical. New York: Associated Press; May 8, 2006. Available at: http://pqasb.pqarchiver.com.
Accessed: August 1, 2006.

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