I think that the other problems are part provider-sided and part patient-sided. At this conference, there was a poster showing that a lot of patients still seem to think that you need to be "eligible" for an HIV test -- that you have to have some risk factor.2 Even though they're infected, they refuse or decline the test because they think that they're not at risk for HIV infection.
I think that over the last 25 years, we've created a culture that says you have to basically do something socially undesirable in order to get HIV infection. People don't really want to acknowledge that -- or they don't perceive that -- they have any reason to have encountered HIV. Therefore, they still don't accept an HIV test, even when it's more routine.
I saw that study. I thought, perhaps, it's also that some people think they're at great risk, but when offered a test without warning -- a test that'll change their life forever -- they're just not ready for that kind of information at that moment. They came for something else entirely: an injury, for instance. They may have thought about getting tested, but it's still such a dramatic thing to test positive for HIV. Many people who suspect they are positive have been harboring fears about being positive for years and have repeatedly put off the testing.
There is that, which I think influences a proportion of people. But to be honest with you, I think that is much more in the provider's mind than it is in patients' minds.
If you look at -- this was three years ago -- the Kaiser survey about HIV testing, two thirds of people said they didn't think they needed to do anything special to consent for an HIV test.3 Providers still harbor this feeling that HIV is very different, very life changing. Especially in emergency department situations: a car accident, a heart attack. It's like finding out that you have cancer when you went in because you had a cough, and you didn't think it was going to be any big deal.
I don't think HIV is that different from those other circumstances. Dr. Holson [David Holson, M.D., M.P.H., of the Queens Hospital Center] has one of the best responses with respect to this issue. He says, "Everybody who comes in with a laceration, we give them a tetanus shot. In Queens, what do you think are your chances of getting tetanus compared to your chances of getting HIV?"
We do certain preventive things in those circumstances that people just accept as a matter of course. In those environments, perhaps finding out you have HIV would be much more significant, or not finding out that you have HIV would be much more significant.
What I was getting at was the drama associated with HIV, both in the minds of practitioners and the minds of patients. If you go where people don't know very much about HIV, they still think it's a disease that will kill you immediately.
That, I think, is the most important misimpression that we need to correct. People have done life expectancy studies, and they have looked at the relative benefits of several different medical interventions that we do. What you can accomplish with effective antiretroviral therapy is quite remarkable compared to even the comprehensive care after a myocardial infarction, after a heart attack. Antiretroviral therapy has so much more significant per-person survival benefit. So that is the message I think people need to understand, that HIV is not like it used to be.
How do we make people understand that?
I think it's going to take a period of time. I think it's going to take more general awareness of not only how effective treatment is, but how simplified it's become. For a period of time, when people had to take multiple medications every four hours or every six hours, and eat with some meds and not eat with others, it was complicated. Now, with combination medications, in many circumstances you're talking about taking one pill a day that has long-term benefit. In many cases now, people are talking about starting treatment earlier.
The other concept that is gaining traction is what's called "test and treat," where you would potentially start people on HIV treatment as soon as you find out that they're infected, in order to help reduce their chances of spreading it to other people.
So, we've got two things that are going on. One is the personal benefit to an individual from a longer life expectancy. The second is the benefit to the people they care about by reducing the chances that they might pass the infection on.
New Technologies in HIV Testing
Let's discuss some of the technologies that are already being used now in HIV testing. For instance, a lot of people still may not know that they can get orally tested for HIV.
Yes. There has been an oral test to collect the specimen for conventional testing since the mid-1990s. And of the rapid HIV tests, there have now been six approved since 2002. The first of them to be approved, the OraQuick test, can work either on a finger-stick blood specimen or on an oral fluid specimen that you get just by swabbing the gums. It still needs to be confirmed [e.g., with a Western blot test], but the oral fluid test has made it a lot easier for people to do testing in settings where it's not feasible to collect blood specimens. That, I think, has made a large difference in the acceptability of testing.
And people can get results within 20 minutes.
The definition is that in less than half an hour you can get results. Some are as few as 10 minutes, some 20 minutes. But yes, all of them are nearly immediate.
I've heard that some of them have reliability issues.
There are two sides to that. One is the problem of a false-positive test, which had been the major concern in HIV testing since 1989, when recommendations first came out. Originally, rapid tests weren't available in the United States because you could not give a person a result unless it was doubly confirmed afterwards. We don't do that in any other circumstance: If you get a Pap smear and it is positive, that's just a screening test -- it may turn out to be negative.
If you look at the same issues with false positives in mammograms, we're not afraid of getting mammograms simply because they may not be correct. That's the nature of screening tests. You want them to pick up everybody who's infected, even though the tests might be wrong sometimes. We've applied a very different standard to HIV testing. They have to be perfect compared to other things.
The other concern that had been raised with respect to the oral fluid test was that there had been these episodes where there were little clusters of excess numbers of false positives. The company making that test reformulated it earlier this year, and though there haven't been any subsequent reports of an excess number of false positives, that's not to say they'll never occur. But it is really a very, very low proportion -- much lower than with any other diagnostic test.
I heard that one of the issues was the expiration date on the test -- that a lot of clinics never got around to using all of them before they had expired, and then ended up using the expired tests.
Certainly, if you use anything that's expired, it's not going to work as well as something that's in date. I wouldn't eat expired food either. So obviously the consequences are unpredictable in that circumstance.
Can you review some of the new technologies in HIV testing?
One technology that has been employed in a number of places around the country is using a test for RNA. Most of the tests up until now had been tests for antibodies, which look for the body's reaction to the virus. Depending on the test that you use, it may take anywhere between two weeks and six weeks for a person to develop enough antibodies to the virus to be detected.
You mean after exposure?
Yes, after a person's been exposed to HIV. The RNA test, which tests for the actual viral RNA itself, will detect infection starting at 10 days after a person has been exposed to HIV.
Nothing is perfect. There's no morning-after test that you can take. But the RNA test will pick up infection earlier than the antibody test. In some groups of people, it's important to pick up infection early -- men who have sex with men [MSM] in particular, because infection is spreading so quickly among them.
From Revised Recommendations for HIV Testing in Healthcare Settings in the U.S. Courtesy of the U.S. Centers for Disease Control and Prevention. Click here
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In the CDC's National HIV Behavioral Surveillance System, 92% of men who have sex with men said that they had been tested for HIV before and three quarters say they've been tested in the past year. Yet when they tested people who were HIV infected -- they tested people during the surveillance -- half of the people who were infected didn't know it. So, despite testing and despite relatively recent testing, people end up being infected and not being aware of it.
When they did these tests for RNA in people who come in for antibody testing, anywhere between 10% and 20% of the people who were infected with HIV weren't positive for antibodies yet. Picking them up with these earlier tests, these RNA tests, ended up not giving a person a false sense of reassurance that they were uninfected.
The problem with the RNA tests is that they're expensive. To make it less expensive, what people have tended to do, is what's called pooling, in which you combine anywhere between 10 and 100 specimens together in order to test them at one time, which saves money.
Outside the U.S., for several years tests have been available that will look for both HIV antigen and HIV antibody at the same time. Several companies have indicated their intention to introduce those in the United States -- both the conventional test, where you send it off to the laboratory, plus one that's a rapid test: It looks like they'll report an infection within four days of the time that the RNA test picks up infection. That will very likely help to identify people earlier in this stage of infection and miss fewer people who have been infected but haven't yet developed the antibodies. This is the "window period."
We have talked about the window period for a long time. Each test has a different length of the window period. The idea is to make it as short as possible. As I mentioned, there's no way to close the window period. For about the first 10 days after exposure, there's no test that will determine that a person has been infected. But certainly, shortening it as much as possible is important.
On the other hand, for people who have been recently exposed to HIV, if they should have a test that's negative, it still is important that they get retested in between two and four weeks in order to make sure, if they've had a risky exposure, that they haven't acquired HIV.
When will these new tests be rolled out?
I think that really depends on the manufacturers. They have to do the clinical trials and take that information to the FDA [U.S. Food and Drug Administration]. I would love to be able to look into a crystal ball and say what's going to happen for sure. I think we're optimistic that we'll see them during 2010. But that depends entirely on the nature of the manufacturers and when they complete their clinical trials and get FDA approval.
Whatever happened with the home test -- the idea that you could test yourself for HIV without going to a testing facility?
There is a home collection system, where you obtain the specimen and you send it off to a laboratory. The idea of doing home tests is still a consideration. I think that several companies had approached the FDA about seeking approval for home tests, and at the meeting of the FDA's blood products advisory committee, the committee was positive. It saw that there would be a potential role for that.
However, what we need to do is make sure that people can do it right at home -- and if they get an answer, they understand what the answer means at home. I think that's the phase that we're at right now, where the companies are conducting clinical trials to see to it that somebody can just read the directions, do the test and get the right answer.
Women across the country are taking pregnancy tests, and they're reading it pretty correctly and figuring out what to do with the results.
The situation with the pregnancy test is: You see this all the time in the movies, where a woman goes out and buys six pregnancy tests and keeps doing it until she feels comfortable about what the right answer is. The significance of an HIV test result, negative or positive, and the correct answer from an HIV test result is, I think, in a different dimension than a pregnancy test.
When you look at some of the early data when pregnancy tests were first introduced, probably people got the right answer only about 60% of the time. Now that they're more common and people are more acquainted with it, I think there is a higher degree of accuracy.
And a pregnancy test, in general, is done on urine. It's pretty easy. With HIV, you have to obtain a specimen, either an oral fluid specimen or a blood specimen. Some mistakes are going to come from that part as opposed to just reading the test: making sure that you got enough of a specimen, and a correct specimen, in order to get the right answer.
In 2010, it looks like there's going to be a lot of really interesting things for people who are worried about whether they have HIV.
Yes, I think that we're going to see continuing developments and evolution. The CDC works with manufacturers to try to bring things to the market that are going to be beneficial for screening.
In addition to the fourth-generation test -- the antigen/antibody combination test -- there are several other, more sensitive tests that may be able to be done on oral fluid and that might detect antibodies when the levels are lower, meaning it'll detect infections sooner.
I think the other very interesting development is that people are starting to create combinations of tests. For example, you would test for hepatitis C and HIV together at the same time with the same specimen, because people who are susceptible to one condition may be susceptible to several. If you could test for all of them at the same time, I think it'd be a huge advantage.
HIV Testing Requirements: Opt-In, Opt-Out and Counseling
Let's talk a little bit more about some of the issues that have been raised since the new HIV testing recommendations came out in 2006. For instance, is there a state-by-state issue? Does each state have to start deciding whether it should do opt-in or opt-out testing?
Opt-in and opt-out are perhaps unfortunate terms because they lead to a whole lot of misunderstanding.
What the CDC's recommendation has been since 2003 is that testing for HIV ought to be pretty much the same as any other routine diagnostic or screening test that you would get. Usually, when you go to the doctor and he says, "I think you need a blood count. I think you need a cholesterol test. I think you need whatever," you don't sign for each of them separately, or make up your mind and say, "Yes, this I want. No, this I don't want." That's uncommon.
In many places, that was the case with HIV. At the time that the CDC's recommendations came out in 2006, there were 20 states that explicitly required by law that you had to sign a separate consent form and receive pre-test counseling.
Right now, there are only seven states that still have those [laws]. Thirteen states had changed [their laws] to be consistent with making it easier both for providers and for patients to get their test results.