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The State of Prevention

Testing, Testing

September 2007

Not long ago, getting an HIV test could be a real pain. Even after setting aside all the accompanying anxieties and fears and stigmas, it was just a hassle.

First, you'd come in for the test -- and unless you went to a private doctor's office, this often meant an uncomfortable and nerve-wracking wait in a lobby full of nervous people. Then you had to sit through a talk with an HIV counselor, who would ask all kinds of personal questions about what you'd done to put yourself at risk for contracting the virus. Then there was the poking and prodding with needles to draw your blood.

But that wasn't the end. There was still the agonizing wait -- as long as two weeks -- while your blood shipped off to a lab to get tested. Then you had to go back to the doctor or clinic and, once more, sit in a waiting-room purgatory before finally getting your test results.

It was a lot to deal with.

And a lot of people never made it through the process: The U.S. Centers for Disease Control and Prevention has long estimated that a third of all people who get tested never claim their results.1

So for years, health departments and testing-technology developers have been working to ease this process. Gradually, new technologies have become available and, in turn, public health officials have adapted guidelines to streamline HIV testing in America. But in 2006, the CDC approved reforms that may represent the most significant overhaul of HIV testing the United States has ever seen.

The agency's move was greeted with a mixture of praise and damnation. Few challenged its overarching goal of making HIV testing an easily accessible, routine part of health care. But many, including the Institute, have questioned whether the CDC's initiative goes too far and, thus, misses a crucial point: testing is not a silver bullet to slay AIDS. Without a similarly robust commitment to the far broader and far more difficult prevention work needed to help individuals and communities make healthy choices, no amount of testing will stop the virus' spread.

How HIV Monitoring Works

In summer 2005, the CDC announced a multi-pronged plan to more closely examine its much-cited estimate of 40,000 new HIV infections each year. As a result, we'll be hearing a lot of new numbers in the coming years, some of which are bound to be controversial. With our minds on that proverbial demon lurking in the details, we give you a brief snapshot of how the CDC's gonna do its math.

How HIV Monitoring WorksWhat they want answered: How'd you get it?

How they'll answer it: The National Behavioral Surveillance System, already up and running, has generated one of the most shocking stats in the epidemic's history: 46 percent of Black men who have sex with men may already be infected, and two thirds of those folks don't know they've got it. The idea is to take a closer look at those who are most statistically at-risk, asking what they are doing and how they are interacting with services.

The system is tracking people who fit three behavioral categories: Men who have sex with men, injection drug users and what the prevention wonks have started calling "high-risk heterosexuals." Yes, the scintillating CDC jargon is distracting, but try to focus -- this is the important part. In alternating 12-month cycles, researchers will focus in on one group and study their behavior, so that they'll get a fresh batch of information on each group every three years.

What they want answered: How many are infected each year and who are they?

How they'll answer it: The HIV Incidence Surveillance System is the agency's tool for getting past its annual 40,000-newly-infected estimate. CDC has chosen 34 sites around the country to focus on each year. In those places, researchers are drilling down on every newly-diagnosed infection to get, among other things, the person's demographics and clinical info on that person's virus. Importantly, they will also run newly-developed tests to determine how recently the person has been infected.

What they want answered: What's the total number of infected?

How they'll answer it: HIV Prevalence Estimates are nothing new. CDC takes data from the 33 states that track HIV by recording names of those infected, runs it through two statistical modeling processes (in order to factor in those who may be positive but have never been tested) and comes up with its total number. In June 2005, CDC updated the current estimate, saying between 1,039,000 and 1,185,000 Americans were living with HIV as of 2003, with anywhere from 24 percent to 27 percent of those folks unaware they're infected. It is the first time CDC has put the positive tally above one million.

The AIDS Case Surveillance system will continue to be a tool for building this sort of big-picture data. This is the original surveillance system, which tallies the number of newly diagnosed AIDS cases and deaths reported by all states each year. As of 2003, around 400,000 of the one million HIV-positive folks had an AIDS diagnosis.

What they want answered: If you're positive, how are you doing in treatment?

How they'll answer it: The Morbidity Monitoring Project will not only tell CDC how people are faring in treatment, it will also figure out what's happening to those who are not in care. Why aren't they getting treated? And are they doing something harmful to themselves -- or others -- in the meantime? Researchers have selected 26 sites in 21 states from which to pull medical records of those in care and ask some questions. They will also interview both people who are in care at those sites and those in the area who are not.

Check Everybody

The federal government maintains a wide range of official public health guidelines that, while not legally binding, offer care providers detailed recommendations on how a given procedure should be handled and carry the weight of the government's approval -- which, in some cases, is needed to access federal funding. There are guidelines for stuff ranging from diagnosing fetal alcohol syndrome to prescribing anti-HIV medicines. And since 1985, there have been guidelines for how HIV tests should be conducted. In September 2006, the CDC completed a rewrite of those guidelines as part of its ongoing campaign to boost the number of people who know their HIV status.2 (See "Standardized Testing Revisited" on page 26.)

The percentage of American adults who have gotten HIV tests in their lifetime has steadily grown since 1987, according to surveys. However, the share of adults who have been tested in the previous 12 months has slowly declined since 1996, when lifesaving drugs hit the market and reports about the epidemic's supposed end became widespread.3 Today, CDC estimates as much as one quarter of the 1.2 million people believed to be HIV positive don't know they are infected.4

Data strongly suggests that these quarter million undiagnosed infections fuel the estimated 40,000 new infections logged in the U.S. each year. The CDC has long cited studies showing once people know their HIV status, they are overwhelmingly likely to take steps to prevent passing it on to their sex or injection drug-using partners.

Research shows more African Americans are getting tested than whites -- 41 percent of Blacks in a Kaiser Family Foundation survey report having been screened in the past 12 months, compared to 16 percent of whites.5 But CDC nonetheless estimates that more than half of all infections among African Americans remain undiagnosed.6

Blacks also appear to be at greater risk for getting tested too late, uncovering the virus only in the final stages of its development towards full-blown AIDS. Forty-two percent of positive Blacks are diagnosed within two months to a year of the infection developing into AIDS.7 Once an infection reaches this endpoint, treatment is far less likely to succeed, a fact which CDC surmises is at least part of the reason for the American epidemic's racial death gap. African Americans who contract HIV are now as much as eight times more likely to die from it than their white counterparts.8

One reason for delayed testing is that people don't think they are at risk. Indeed, mounds of research show just how safe many believe themselves to be, even when they're not. In one CDC study, 60 percent of Black women didn't know whether their male sex partners were positive or negative, yet 70 percent believed themselves to be risk-free.9 This assumed security exists despite the fact that Blacks account for nearly 70 percent of new HIV infections among American women. (See "The Black Epidemic: By the Numbers".)

The perceived lack of risk runs even higher among self-identified Black gay and bisexual men. In one study, nine out of 10 young men who tested positive didn't consider themselves to be at risk for contracting the virus.10

In order to right all of these wrongs, the CDC has set about an aggressive campaign to promote testing over the last several years. The revised guidelines are a major component of that push. "The overarching goal is to maximize opportunities for those persons who are currently unaware of their HIV infection to learn their HIV status earlier," the CDC's Bernard Branson wrote in a March 2006 letter requesting public comment on the new guidelines. He cited studies that show "with current HIV testing practices, many persons with unsuspected HIV infection currently access health care services, but because they are not tested, their infection goes undiagnosed."

That's in part because doctors and patients alike have long engaged in a dizzying and often self-defeating game of trying to determine who should and should not get tested. The CDC's new guidelines dramatically simplify the formula: Anybody between the ages of 13 and 64 who comes into care should be offered an HIV test.11 Period. No more guessing about who is more or less at risk, reading the tea leaves of their sexuality, their race, their neighborhood or job. Just test everyone. Further, the test is to be made a standard part of the bevy of prenatal tests given to pregnant women. These aspects of the new guidelines have received near-universal praise.

Standardized Testing Revisited

In September 2006, the CDC issued its new guidelines for health care providers conducting HIV tests. The new guidelines aim to get more people into testing by streamlining the process, and they mark a dramatic shift in how HIV testing is conducted in America. Here are the big changes:

Everybody gets tested. For years health care providers and patients alike have groped for a reliable formula to determine who needs to get tested when. The old rules urged testing for certain "high-risk individuals" -- injection drug users, people who have anal sex, etc. -- and in geographic areas that have higher HIV prevalence. The new guidelines toss all of these maddening calculations out. Now, the CDC says, everybody aged 13 to 64 who comes in to a health care facility should be given HIV tests as part of their routine medical care.

It's on you to say no. Because of the stigma associated with HIV and the discrimination that was rife when HIV tests first became available in 1985, public health has always gone out of its way to soothe the anxieties of people getting tested. So for years health care providers were urged to obtain explicit, written consent before testing someone for HIV. But providers complained that this process was cumbersome and expensive, particularly in emergency rooms. So now, the CDC says, getting the patient's consent for providing care in general covers HIV testing, too, although, patients should still be informed that they'll be tested in advance, so that they may turn it down if they wish.

Seek counsel elsewhere. HIV testing has always been closely linked with HIV prevention counseling. Whenever someone got tested, he or she first spoke with a counselor about HIV risks and how to reduce them. But, again, providers fretted that this process proved unwieldy for their operations and, moreover, discouraged people from getting tested. So while the new CDC guidelines still stress the import of counseling, they no longer urge that it be part of the testing process.

Making It Too Easy?

But the CDC didn't stop with universal testing. The new guidelines go on to make two far more controversial changes to the testing procedure.

First, the guidelines shift the burden of consent from the doctor to the patient.

Previously, patients had to expressly agree to an HIV test and sign a written waiver declaring their consent. That precaution grew out of real need: After HIV tests were first developed in 1985, patient advocates justifiably feared discrimination. They sought and won a range of protections, including not only strict consent procedures but also limits on how health departments tracked HIV infections.

The new guidelines signal federal officials' belief that we've entered a new era. Now, simply agreeing to overall health care is sufficient consent for an HIV test, and that consent need not be obtained in writing. Patients should be notified they will be tested beforehand, so that they have an opportunity to opt out of it if they chose, but the burden is on them to do so.

Second, and perhaps even more controversial than the consent changes, the CDC's new guidelines break the longstanding marriage between testing and counseling. All of those difficult conversations you once had to sit through before and after getting a test were the result of the old CDC recommendations. They urged that anyone getting an HIV test also be offered HIV-prevention counseling sessions designed to determine the person's risk; to offer prevention information; and to discuss the meaning of the test's outcome, whether it be positive or negative. While the CDC continues to urge that patients have access to such counseling, it no longer recommends that it be linked to the testing process.

The CDC's recommendations are not legally binding upon state and local laws and regulations, but they heavily influence how local officials design their own rules, in part because of the implicit threat of jeopardizing federal funding by failing to comply. Some states have already begun altering their procedures. Most notably, New York is debating many of the same proposals, with health officials from the administration of New York City Mayor Mike Bloomberg aggressively pushing new state laws mirroring the CDC's proposed new guidelines.

But critics argue that consent and counseling requirements are key steps in the testing process because they help counter one of the epidemic's most lasting prevention problems: Stigma.

Battling Stigma

Stigma surrounding HIV remains strong in many Black communities in particular, and those that have opposed streamlining the consent and counseling processes fear it will actually worsen the problem. They argue that by stripping away consent precautions, whether they be needed to protect against discrimination or not, public health risks driving people away from testing altogether. It's not an irrational concern. Particularly in the South, service providers continue to report patients being so fearful of stigma that staff must answer phones without using the word AIDS, hand meds out of clinic back doors, and arrange clandestine off-site rendezvous in order to perform discreet HIV tests.

Moreover, critics argue, weakening the counseling guidelines wastes a chance to battle stigma. That's because counseling serves not only to prepare patients for the test results, but also to educate them about the basics of HIV prevention and treatment. Particularly among African Americans, HIV literacy remains dangerously low -- and that illiteracy both fuels stigma and blocks individuals from taking action to get healthy. The National Association of People With AIDS' Paul Feldman told Housing Works' AIDS Issues Update that changing the guidelines "misses a golden opportunity" to fix that problem.

"HIV continues to be highly stigmatized," says Feldman. "An HIV test is not like a basic blood count or other lab tests. The results can be life changing, and people need to know what they're getting themselves into. A general consent that you sign at the front desk on the way into the hospital or doctor's office does not do the job."

For its part, the CDC counters that "routine" HIV testing is just what's needed to fight stigma. By making the test a regular part of receiving health care rather than ghettoizing it, the agency argues, providers chip away at fears that drive stigma of both testing and the virus itself. (See "Q&A: CDC Explains Its Testing Reforms" on page 30.)

New Challenges

One aspect of the broader testing push that everyone's concerned about is whether we're at all prepared for what will happen if it succeeds. There are real questions about whether the AIDS care safety net can even continue to serve those already in it, let alone absorb tens of thousands of new cases unearthed by more aggressive testing.

"One of the things that this program will do is identify people, but it is not really addressing the shortage of experienced and knowledgeable clinicians to take care of you once you find out you are positive," warned Dallas' Dr. Keith Rawlings, medical director of the Peabody Health Center. "I think that is an issue -- particularly in the Black community -- that we need to be looking at." Additionally, Rawlings notes, "Once you get to an experienced clinician, you need the medication. If you can't get to the medication or can't afford the medication, you are not going to get the particular outcome you want."

The CDC's also not alone in its drive to make HIV testing easier and more accessible. Drug makers and medical device manufacturers are onboard as well, developing and refining their technologies for the brave new world of HIV testing.

Today, oral swabs have largely replaced painful needles for HIV testing. And now, through a technology known as "rapid testing," those swabs can crank out HIV test results right before your eyes, in much the same way as a pregnancy test.

Since the first rapid HIV tests won Food We're the Ones and Drug Administration approval in 2003, they have done their own part to drastically reshape the testing experience.12 Nowadays, when you go for an HIV test you will likely be handed a stick with a cotton swab attached to the end (not unlike a Q-Tip), which you will then be directed to wipe across your gums. The technician places the wiped swab in a solution and waits for results. Twenty minutes later, a color-coded reading indicates whether you've contracted the virus. (If the rapid test indicates you have the virus, a confirmation test must be done the old-fashioned way -- drawing blood and sending it off to the lab.)

Rapid tests are addressing one of the most glaring problems in HIV testing: the once-lengthy wait between taking the test and getting the results. Because an estimated third of those who took the old blood test didn't voluntarily come back to pick up their results, a quarter of all positive test results never got delivered.13

Now, one of the leading makers of rapid test kids, OraSure Technologies, is seeking FDA permission to sell its test, OraQuick, over-the-counter. If ultimately given the go ahead by the FDA, the OraQuick test will be the first HIV test the FDA has approved to be administered entirely without a healthcare provider. According to news reports, Ora-Sure plans to petition the FDA after completing a series of clinical studies scheduled through 2008. Among other things, those studies are examining how to link consumers with mental health services if they test positive.14

Medical device makers have been trying to sell HIV tests over-the-counter since the beginning of the epidemic. The FDA first nixed the idea as far back as 1988. And in 1996, the agency actually approved two home tests, but both products required customers to draw blood and send it in to a lab, waiting a week or more for results.

Critics of take-home tests have always lodged many of the same complaints they have directed at the CDC's new streamlined testing guidelines -- primarily, finding out you're HIV positive, even 25 years into the epidemic, is not the same as discovering you're pregnant or being diagnosed with any other disease.

HIV is still associated with other equally loaded and socially divisive issues -- such as sexual orientation, spousal fidelity and drug use -- and the medical realities of the virus remain widely misunderstood. By allowing people to learn their HIV status alone and without any trained health providers to educate and support them, not to mention connect them with appropriate care, home HIV tests could create as many problems as they solve.

The challenge of today's testing push, then, is how to make it widely accessible without stripping it of meaning. Knowledge is power, but only if you have the tools to use it.


  1. Wright, Kai. 2003. Rapid test time. POZ, February/March.
  2. Branson, Bernard. 2006. Revised Recommendations for HIV Testing of Adults, Adolescents, and Pregnant Women in Health-Care Settings. Morbidity and Mortality Weekly Report, Recommendations and Reports Vol. 55, RR 14.
  3. Centers for Disease Control and Prevention. 2004. Number of Persons Tested for HIV -- United States, 2002. Morbidity and Mortality Weekly Report, Vol. 53, No. 47.
  4. CDC. 2004.
  5. Kaiser Family Foundation. 2006. HIV Testing in the United States. June.
  6. Millet, Greg. 2006. Presentation to Black AIDS Institute physicians' briefing at CDC office in Atlanta, Ga. October 13.
  7. Millet, 2006.
  8. Department of Health and Human Services. Office of Minority Health. Online HIV/AIDS data fact sheet at aspx?ID=3019, accessed September 6, 2007.
  9. Millet, 2006.
  10. CDC. 2001. HIV Incidence among Young Men Who Have Sex with Men -- Seven U.S. Cities, 1994-2000. Morbidity and Mortality Weekly Report, Vol. 50, No. 21. June 1.
  11. Branson, 2006.
  12. Wright, 2003.
  13. Branson, 2006.
  14. 2007. OraSure Preparing To Seek FDA Approval for Nonprescription Sales of OraQuick Oral Rapid HIV Test. Kaiser Daily HIV/ AIDS Report, April 5.

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This article was provided by The Black AIDS Institute. It is a part of the publication We're the Ones We've Been Waiting For. Visit Black AIDS Institute's website to find out more about their activities and publications.