Making HIV Testing Routine: New CDC Guidelines to Diminish Barriers to Diagnosis

Hopkins HIV Report 2006 Jul; 18(4):8

Emily J. Erbelding, M.D., M.P.H.
Johns Hopkins

A draft version of new counseling and testing guidelines was released for public comment in March, 2006, by the Centers for Disease Control and Prevention (CDC). This document, Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health Care Settings, promotes testing procedures that would make HIV testing a routine part of medical care for all teenagers and adults in the United States. Full integration of these recommendations will enhance HIV case finding, but may also represent a major operational shift in the approach to testing in some clinic sites. This article will discuss the history behind some barriers to HIV testing and the rationale for making testing more routine.

Why Promote Expanded Screening for HIV?

Screening for HIV in the general population meets many of the criteria for an effective preventive practice intervention: HIV serologic tests are reliable and inexpensive; untreated infection has serious health consequences; highly effective treatment for HIV is now available; and the average person will gain years of productivity and health if treatment is initiated prior to development of AIDS-related symptoms. Recent cost-effectiveness analyses have demonstrated that HIV screening is as cost-effective as screening interventions for other chronic diseases, even when prevalence rates in the screened population are less than 0.1% [Paltiel AD, et al. N Engl J Med. 2005 Feb 10;352(6):586-95]. If early detection of HIV leads to behavior modification that reduces rate of secondary spread to others, more aggressive screening may have even greater public health benefit not accounted for in these cost effectiveness models.

HIV Testing—The Historical Approach

Serologic testing for HIV first became available in March, 1985, when AIDS/HIV was an untreatable and nearly universally fatal condition. The diagnosis was shrouded in stigma, and the knowledge of an HIV diagnosis could cause an enormous change in one’s life and outlook, even when clinically asymptomatic. Therefore, HIV testing without specific consent procedures represented a violation of an individual’s right to self-determination in a much greater way than other blood tests done for diagnostic purposes. Written informed consent for HIV testing was mandated by statute in most states.

Prevention of HIV spread was also solely linked to changing the behavior of those with HIV infection and those deemed to be at risk for HIV infection: injection drug users, men having sex with other men, and sexual partners of those in these specific groups. Therefore, there was an emphasis on behavioral risk assessment at the time that testing occurred. Organizations that received federal money for HIV counseling and testing were required to collect data on the behavioral risks of those tested. These federally supported counseling and testing sites also had to demonstrate that counselors had competency in “prevention counseling” — training in the assessment of deficits in HIV knowledge and in altering risk behaviors based upon theory-based models of behavior change. Certification was deemed particularly important when counseling and testing centers employed non-professional counselors who were “peers” (i.e., recovering addicts or gay men) in order to make their community outreach more successful. In peer-based models of HIV service delivery, counselors may lack a background in biomedical science or health education but may be more equipped to reach and motivate the targeted community. Thus, unlike other medical diagnostic tests, risk reduction counseling by a certified counselor became tightly linked to HIV testing.

To meet the data collection requirements and requirements of written informed consent, the testing process involved at least 20-30 minutes of time beyond phlebotomy. These practices created barriers in busy practice settings that served patients with a risk of HIV infection who might have presented for other health concerns. For example, given the relatively high prevalence of HIV infection among emergency department (ED) patients, EDs were identified as ideal sites for HIV case finding. However, given other pressing services needs in emergency departments, providing traditional HIV counseling prior to testing (written informed consent and behavior change counseling by a certified counselor) proved operationally difficult, and opportunities for case finding were often missed. Similarly, in STD clinics, where high risk patients presented for STD care and often had blood drawn for routine syphilis testing, HIV testing often required a separate visit with a certified counselor in order to meet standards required for federal funding. Although these additional steps had a valid purpose, they also added operational barriers that led to missed opportunities for diagnosis.

New Considerations

In pregnant women, a streamlined approach to the HIV counseling and consent process, making it a routine part of prenatal care (opt-out), results in a greater proportion of pregnant women getting tested [MMWR Morb Mortal Wkly Rep 2003;51:1013] compared to an opt-in approach. While patients with traditional HIV risk behaviors are most likely to be tested if it is recommended by their medical provider [MMWR Morb Mortal Wkly Rep 2005;54:597], targeted testing in many clinic settings based upon declared behavioral risk factors fails to identify those at highest risk for HIV [Chen Z, Sex Transm Dis. 1998 Nov;25(10):539-43]. Also, although some of the special requirements surrounding HIV testing arose due to its stigma, a series of risk assessment questions leading to the recommendation of HIV testing may paradoxically reinforce stigma and lead to lower rates of testing acceptance. Making HIV serology a routine test, rather than an exceptional one, may actually serve to minimize stigma. The use of the risk assessment to identify those to in need of testing is also problematic because of the changing epidemiology of HIV in the United States: With increasing HIV prevalence among heterosexual men and women and higher cases rates among non-urban populations, it is likely that targeted testing based upon traditional risk factors will become even less effective over time.

The new proposed guidelines from the CDC recommend testing for all adolescents and adults (age 13-64 years) as a routine part of medical care. Those with elevated behavioral risks (drug use, men with same sex contact, etc.) should be tested annually. The CDC guidelines for medical providers also emphasize elimination of regulatory barriers to testing, such as legally mandated requirements for informed written consent and the linkage of testing to prevention counseling. Key changes in the guidelines from the past version released in 2001 are summarized in the Table.

Testing Guidelines for Pregnant Women

Universal HIV screening for pregnant women as early as possible in the pregnancy is unchanged from the last set of CDC guidelines [MMWR Recomm Rep 2001 Nov 9; 50(RR-19):63]. The new draft CDC guidelines reiterate that all pregnant women should be screened for HIV infection as early in the pregnancy as possible, but further emphasize the need to minimize other procedures and documentation that may serve as a barrier to universal testing, such as informed written consent. It is recommended that the discussion of HIV testing should occur after a pregnant woman is informed that HIV testing will be part of the routine prenatal care test package unless she declines it (the “opt-out” approach). To further reduce the risk of perinatal transmission should HIV infection occur during pregnancy, the new guidelines also endorse repeat HIV testing during the third trimester (ideally before 36 weeks) for all women. Re-testing is particularly recommended for those who reside in areas of increased HIV prevalence among women (Table) and in healthcare facilities serving women with an increased HIV prevalence among women of childbearing age. Repeat testing during the third trimester should also be a priority for those with identifiable risk behaviors during pregnancy (Table).

Concerns Over Streamlined Testing

There is now a strong consensus that decreasing the barriers to HIV diagnosis represents a social good. However, getting tested for HIV is not the same as getting a complete blood count or a serum cholesterol test. Most of the barriers to HIV testing were initially conceived as a means to protect vulnerable groups and have, to some extent, served as an important safeguard. Although the “opt-out” approach does not change the voluntary nature of HIV testing in theory, provider communication surrounding the testing event may be less clear in a busy clinic setting when written consent is not a legal requirement. Skipping the basic counseling points on HIV transmission and on individual risk reduction may also serve to perpetuate ignorance in populations with low health literacy.

Summary

The approach to HIV serologic testing in the future will focus on normalizing the HIV test and minimizing barriers to testing. As systems of care move this CDC guideline to full implementation, medical providers should remain committed to ensure that patients know when an HIV test is being ordered and understand that it is voluntary.

2006-07-10
HHR-2006-07-03

Copyright © 2006 - The Johns Hopkins University AIDS Service, Division of Infectious Diseases. Permission to use and reproduce portions of this newsletter is hereby granted provided that author and publication are fully credited and both copyright and permission notice appear with reprinted material. Inquiries may be directed to Sharon McAvinue, Managing Editor. Website: Johns Hopkins AIDS Service.

AEGiS is a 501(c)3, not-for-profit, tax-exempt, educational corporation. AEGiS is made possible through unrestricted funding from Boehringer Ingelheim, Bridgestone/Firestone Charitable Trust, Bristol-Myers Squibb Company, Elton John AIDS Foundation, the National Library of Medicine, Roche and Trimeris, and donations from users like you. Always watch for outdated information. This article first appeared in 2006. This material is designed to support, not replace, the relationship that exists between you and your doctor.

AEGiS presents published material, reprinted with permission and neither endorses nor opposes any material. All information contained on this website, including information relating to health conditions, products, and treatments, is for informational purposes only. It is often presented in summary or aggregate form. It is not meant to be a substitute for the advice provided by your own physician or other medical professionals. Always discuss treatment options with a doctor who specializes in treating HIV.

Copyright ©1980, 2006. AEGiS. All materials appearing on AEGiS are protected by copyright as a collective work or compilation under U.S. copyright and other laws and are the property of AEGiS, or the party credited as the provider of the content.