About once a month, James Swire, venue outreach worker at NO/AIDS Task Force in New Orleans, runs a rolling laboratory, alternating between a trio of bars clustered on and around Bourbon Street, the neon-lit, brassy entertainment strip of topless bars, music clubs, restaurants, souvenir shops and T-shirt stalls that cuts through the fabled French Quarter.
Swire brings to the block the latest in HIV-testing technology: a finger-prick test called OraQuick that delivers on-the-spot results in 20 minutes with 99.6 percent accuracy. "I make up fliers and posters that I cover the whole building with," he says.
The building might be the Bourbon Pub Parade, the Good Friends Bar or Cafe Lafitte in Exile, where Tennessee Williams used to drink. Some of the bar managers even allow him a promo speech, something like "'Hey, we're upstairs doing the HIV rapid testing. Know your results in 20 to 25 minutes.' And they'll come up and get tested," Swire says. And sometimes "they're lined up before we get there, knowing what's going on that day."
At the Bourbon Pub Parade, in the hours before disco and laser and smoke shows take over the second floor, Swire assembles the OraQuick kits on the back bar, where a technician gives the test. Swire counsels at the front bar, ready to meet anyone who climbs the stairs, hanging a shower curtain for privacy.
"I don't pressure anyone to come up," he says. But as word of the rapid testing spreads to revelers downstairs in the video bar, "more people come up. A lot of them will say, 'I've been meaning to get tested and didn't know where.' Or 'I didn't know how to go about it.'" Others may just want to ensure a safe hookup for the night. "They'll say, 'I just met this person, and we want to get tested together.'" But their security is a gamble; as with any test for HIV, a negative result may not show recent infection. Explaining such issues is part of what the counseling's for.
Not that a couple mid-date will necessarily get the message.
Approved by the Food and Drug Administration almost two years ago and granted a round of waivers that have extended its reach from hospitals to sex clubs, OraQuick has wrought a cultural and psychological sea change in HIV testing. With its 20-minute turnaround time, the rapid test obliterates the nerve-racking wait between test and results, and removes a tremendous barrier to getting tested for many people, health experts say.
But the ease, speed and portability of the technology pose new dilemmas for clinicians, counselors and test takers. For one, how do you deliver the news that someone's HIV positive, or even preliminary positive (positive results require confirmation with a follow-up, nonrapid test) in a club bar?
"We've had this ethical debate," says Jean Redmann, director of education and prevention at NO/AIDS Task Force, who works with Swire in New Orleans. "Should we be doing this here? We talk to people about it in pre-test counseling: 'How are you going to feel if this comes back positive?' My attitude is, these people are adults. They can choose how they want to test. We shouldn't be the ones saying, well, this probably isn't going to be good for you, so we're not going to let you have the test."
For now, the rush to rapid testing seems unstoppable. Given the choice, people prefer to know, right away, whether they're positive or negative. And rapid testing could eventually take the next logical step -- people testing themselves and receiving their results within minutes -- at home. But are people really ready to get up in the morning, brush their teeth, and test themselves for HIV?
Rapid testing is undeniably popular. Lately, Swire says, he's getting a lot of out-of-towners, from other parts of the state and country, especially the South, where the epidemic has hit hard.
"Either they just see it here, or they don't have rapid testing where they are. Different states have different laws. I get a lot of people from Mississippi," perhaps, although Swire doesn't say, because it's one of 10 states that doesn't offer anonymous testing. "From what I understand from the clientele, they feel outed [if they test] there."
Swire has also used OraQuick at Latino soccer league events, bathhouses and black churches. "In one, even the pastor asked me to test him in front of the whole congregation," he says. "So we did that inside the church, and the congregation just started coming up to get tested."
He says he's reaching people who might be at high risk but who wouldn't necessarily seek out an organization to get tested or who might not return for their results if he used a lab-based test that required a one- or two-week wait for results. He knows, because he used to test that way in these same bars.
"People were not interested in getting their results whatsoever," he says. "This is a party town, and people are here for one thing -- to party. They don't care after they take the test. And they're ready to just party and possibly find somebody else to go home with. It's like, 'I'm not coming back, I know I'm negative.'" But Swire has found otherwise. "I'm finding more, I hate to say it, positives out in the community."
Other testing professionals back up Swire's perception that the short time period before getting one's results is contributing to OraQuick's popularity. "HIV testing technology, HIV counseling and testing change all the time, probably in very small ways," says Barbara Adler, program manager at the AIDS Health Project at the University of California at San Francisco, where the first HIV test debuted almost 20 years ago. "But capturing people in one session is a huge change. So many people have said, 'I won't test. The idea of waiting for my results is just too difficult.'"
Charles (a pseudonym), a 44-year-old gay man in New York, is one such person. "When this came out, I was freaking out because I hadn't tested in a while. I had started to see somebody, and I said, I can't wait for the test. I had friends I didn't even know were positive getting sick around me. I thought, well, if they're positive, everybody is. It really does get at you, especially when you start thinking back on everything you've done. It drives you insane. I had put off testing for so long. It gnawed at me. But I wouldn't go ... Finally, I get to the point where I can't deal with this any longer. So I put it in my head that I was going to go for the 20-minute test. If I'd had to go somewhere and have a two-week wait, I would have postponed it even longer. Boom, I went in and I went out."
In the pre-rapid test days, others would test but skip the outcome -- either out of fear, stigma, denial, depression, worry over loss of privacy, inconvenience or any number of reasons not fully understood. In what has become a mantra of oft-repeated statistics, the Centers for Disease Control and Prevention estimates that 33 percent of those who test positive each year at publicly funded testing sites -- where most people test anonymously and so can't be found later -- never return for their results; that a fourth of the 850,000 to 950,000 people living with HIV in the United States don't even know they're infected; and that 41 percent first learn they're infected rather late in the game -- less than a year before an AIDS diagnosis.
Faced with these stats -- as well as an annual infection rate that hasn't budged below 40,000 in almost 15 years and telltale signs that HIV is on the rise -- the CDC has seized on the rapid test and made it the tool behind a new prevention initiative that's tied tightly to technology, redirecting prevention efforts and dollars toward identifying and serving people already infected with the virus to prevent them from spreading it. "I think the rapid test is going to help reduce the number of infections," says Dr. Bernard Branson, chief of laboratory determinants and diagnostics at the CDC's AIDS/HIV prevention division. "More people will get tested and get tested earlier, and receive their results. At least that's our hope."
But while the test removes a barrier -- that week or two of anxious waiting -- for some test takers, it also jettisons a buffer. "It's a delicate balance," says Nicolas Sheon, a medical anthropologist at UCSF's Center for AIDS Prevention Studies. The rapid test eliminates the torturous waiting period, but it also wipes out a "sort of safety where people could just choose not to come back." No-return rates have been particularly high in outreach settings, explains Sheon, who's planning a study of rapid testing in a Berkeley bathhouse. Sometimes that's because the location changes, he says, but "maybe they were talked into getting tested through some incentive ... and they're not quite ready." But with rapid testing, there's no turning back.
"Sometimes we get a client who realizes 10 or 15 minutes into it that they're about to get their results," says Joe Mendoza, program manager for prevention and testing at the AIDS Healthcare Foundation in Los Angeles. Since April, the foundation has been rapid testing out of mobile vans parked alongside bars and cruising areas in Long Beach, Echo Park, Silverlake, Sunset Junction and West Hollywood. "Maybe they didn't realize what high risk they were until the counseling session. Then they realize that we're about to give them that result, and they could very well come back positive. People are like, maybe this wasn't that great an idea."
Counselors, too, have to brace themselves for more psychologically challenging sessions. "In the past, they'd have a little time to prepare themselves for meeting with the client. That's not the case anymore. They go in, they see the result and there's the client ready for the result," says Patricia Kummel, director of the David Geffen Center for HIV Prevention and Health Education at Gay Men's Health Crisis in New York. "You get the entire arc of the story," says Redmann, of the NO/AIDS Task force. "In the old days they'd come back two weeks later. You might not even have been in the building. These days there's a little less distance."
When a rapid test does come back positive, says Redmann, "we'll spend anywhere from 45 minutes to a couple of hours with that person," no matter where they're testing. "We really try to get them into follow-up care."
The trend line that the new rapid tests already established seems destined to continue. OraQuick is expected to forge further into outreach when a much-anticipated oral version of the test, which the FDA approved last March, hits the market. (OraSure Technologies, of Bethlehem, Penn., the maker of OraQuick, has delayed the launch as it scrambles to figure out why one isolated clinical trial produced an unusually high rate of false positives.)
When the oral version does arrive at testing sites, though, "it will be a wonderful advance in HIV testing," says Mick Ellis, the former director of HIV counseling and testing at the Whitman-Walker Clinic in Washington. "You won't need all the medical supplies -- the lancets, gauze, bandages, alcohol wipes. There'll be less risk to the counselor, because they won't be dealing with blood anymore." And it might prove less unnerving for test takers. "People are very phobic about blood," says Kummel. "Even a finger stick, which is better than a blood draw, gets people upset."
And once the test goes oral, can home tests sold over-the-counter be far behind?
With its plastic dipstick device, OraQuick looks and works a lot like a home pregnancy test. At its core is a strip of synthetic peptides -- bits of protein that mimic the structure of the AIDS virus. If HIV antibodies are present in a finger prick of blood or a dab of saliva, they bind to these viral proteins, triggering two purple-pink lines for a positive result, while one line signals a negative result.
"The antibody is specific to the virus it's fighting off," says Mike Formica, executive vice president of operations at OraSure. "Think of it as a lock-and-key arrangement."
When Drew De Los Reyes, assistant director of the Geffen Center at GMHC, dons gloves and demonstrates the concept a few days later, the second line emerges, faint, almost spectral, within five minutes. "We still wait the full 20 minutes," says De Los Reyes. "Sometimes the line is faint, sometimes it's bright. Its intensity is irrelevant. That it's there is all that's important."
So far, the government has been OraQuick's biggest customer. The CDC has bought 500,000 test kits for $4 million, distributing them free to state, county and city health departments, and to some community-based organizations. The New York City Department of Health divvied up its 25,000 free tests among its sexually transmitted disease clinics, its public hospitals and 10 jails on Rikers Island. "We've been rolling in one place at a time," says Susan Blank, assistant commissioner of the Bureau of STD Control. "Many of our inmates are gone within 72 hours," says Robert Berding, deputy executive director for policy and planning for the city's jails. "In the past, those who tested might not be around for the results later on. That's the importance for us." New York has just started offering the HIV rapid test to single adult men living in shelters.
In August OraSure scored another government deal, a $4 million sale to the Substance Abuse and Mental Health Services Administration (SAMHSA) for tests destined for 22,000 substance-abuse and treatment sites.
The quick test is the one people want. At GMHC, 95 percent of the clients choose it, says Kummel. "That's been consistent since the day we started offering it more than a year ago. Kummel says she has seen a 35 percent jump in people under 24 coming in to test, as well as more people of color. "I don't know what the reasoning is for that, but a lot of people have said this test drops their anxiety level considerably."
Redmann saw the numbers at NO/AIDS Task Force almost double during the first four months of the year. "People want the rapid test. It's a one-shot deal." In New York City's STD clinics, about 80 percent of the people choose the rapid test. "The allure of it brings people to the clinic," says assistant commissioner Blank. In New York State, 34 percent of clients in a CDC survey said they would have skipped testing altogether if not for the rapid test.
"A lot of people do have severe anxiety while they're waiting," says Dr. Ewald Horwath, a psychiatrist who works with AIDS patients. The rapid test helps them get over it. Charles, the 44-year-old New Yorker, has now taken the OraQuick test three times in the past year and a half, even though for years he couldn't bring himself to test at all. "I can't deal with the wait," he says.
Brad Shipp, 27, hasn't taken the rapid test but has experienced the conventional test. "I've tested knowing that I was likely OK, but it's still like two weeks or so of hell. Imagine a pregnancy test that took two weeks."
In the waiting room of one of New York's STD clinics, where the rapidity of the test is somewhat diminished by a four-hour wait -- the cost of a free, anonymous test, apparently -- a 37-year-old gay designer calling himself Mike says he hadn't tested for two years. In between the nonstop videos on genital warts, herpes, chlamydia and the president's pet prevention strategy -- abstinence -- Mike smiles as he recalls the relief he felt when he showed up here a few months ago and learned about the rapid HIV test for the first time. "I'd always try to distract myself during that waiting period." He's back now because his last test wouldn't have covered "what I did on vacation," he says, referring to the "window period," or three-month lag between possible exposure to the virus and developing detectable antibodies to it. "I'm safe about things, and am doing it more to be sure. I'll probably test again in three months to assure my new boyfriend."
OraQuick is no longer the only rapid test in a U.S. market that's growing increasingly cutthroat. In the past year, the FDA has approved two other rapid tests to detect the AIDS virus. Reveal, from MedMira in Canada, delivers results in three minutes but, unlike OraQuick, requires lab analysis and so is restricted to settings equipped to handle more complex tests. Uni-Gold Recombigen, from Trinity Biotech in Ireland, delivers results in 10 minutes, and since it does not require a laboratory, has emerged as OraQuick's closest contender in a competition that will only intensify now that the FDA has approved it for use on finger-stick blood samples. Other rapid tests, from U.S. companies such as Calypte and Chembio Diagnostics, are also in the pipeline. "It's a market that is exceptionally price sensitive and competitive," says Rod Katzer, president of RAK Associates, which analyzes medical markets.
"We were hoping to see several rapid HIV tests on the U.S. market," says the CDC's Branson. "Having different tests available and having some competition out there will, we hope, have a positive impact on price."
Competition could also lead speedily to the development of a new market, one that's even more challenging to counselors. Quick, simple, accurate HIV tests with easy-to-read results that require neither a lab nor special equipment have resurrected the debate over do-it-yourself home test kits sold online or over-the-counter in drugstores and retail chains such as Walgreens, Rite-Aid and CVS. If testing maximum numbers of people is the goal, what could beat the convenience of a home test sold right alongside the glucose monitoring systems, Cholesterol Trackers, ovulation and pregnancy kits? And soon, HeartStart, which allows you to shock your heart at home during cardiac arrest. And for those who'd prefer not to share with a stranger the number of sex partners they've had in the last three months, what could better protect privacy?
"It's an important development," says Dr. James Versalovic, director of the microbiology labs at Texas Children's Hospital in Houston, and an assistant professor of pathology at Baylor College of Medicine. "For the first time, one can conveniently do the collection and testing separately from the laboratory. As far as the actual test goes, OraQuick and other tests that might be similarly developed really do pave the way for something like an early home pregnancy test that anyone can do. We have effective treatment for HIV, so it's not like a genetic test. The big issues are over counseling and support."
Home Access Health Corp., located outside Chicago, has sold its Home Access HIV test online and in big chain stores since 1997, a year after the FDA approved it, after rejecting the home approach for years. But the Home Access test goes only halfway: A person pricks a finger with a spring-loaded lancet, collects a blood sample about the size of a dime on a test card, and sends it off to a laboratory. Three to seven days later, using a unique 11-digit code to guard anonymity regardless of state laws, the customer phones a toll-free number for results, counseling and local medical referrals. About 50,000 people a year opt for this home-collection kit, paying between $45 and $63 for it.
The idea of a home rapid test that goes the whole route and delivers results right in the home is not that preposterous. The CDC recently floated the idea in recently concluded focus groups. "I'm notoriously bad at looking at the crystal ball and saying when," says Branson, "but the focus groups with consumers are the first step in seeing what people think about it." Participants saw privacy and convenience as major advantages. "One person talked about a situation where he had not made his family aware of his risk for HIV, and would be uncomfortable going to the family doctor, especially in his small rural community where it would be difficult to get confidentiality."
"The home test would be absolutely fine with me," says Charles, "as long as I don't have to prick myself. For me that's worse than testing positive. I'm at the point in my life where I would do it just for convenience and to ensure that I'm not promiscuous. I'd rather do that than walk over to Washington Square to the clinic." And would he need counseling if he turned up positive? "God, no. Not from that clinic doctor. We've read books on it. I've been down the road so many times with so many friends. For a 44-year-old gay man, it's like breast cancer. If I were a 19-year-old, hopefully there'd be some form of counseling."
Mike offers a similarly mixed response about rapid results delivered at home. "I'd feel OK. I'm educated about this stuff. I don't need a diagram for the condom, but there's always something new. I know HIV is not necessarily a death knell. The devastation of a positive result is not as harsh as it used to be." And would he need a counselor standing by if he tested positive? "Not necessarily," he says as he's called for his test.
A home rapid test "would be an interesting experiment," says Sheon, the medical anthropologist. Despite the difficulties surrounding it, "we're a culture that just loves tests and taking control of your health and all that stuff."
OraSure Technologies has at least entertained the possibility of OraQuick going the home route. "Certainly, as a company, we want to be cooperative and will do what we believe is the right thing to do for society in conjunction with the CDC," says Ron Spair, OraSure's executive vice president and CFO, hesitating palpably over a speakerphone. "I would not believe this is something that is imminent, though."
Setting aside for a minute the "right thing to do for society," a home test would be, to put it mildly, a "growth opportunity" for a small, young company like OraSure that has yet to sustain profitability. "It would provide a rapid way to drive sales," says Aaron Lindberg, an analyst with Denver-based William Smith & Co. "It would be extremely positive, although it's a little hard to predict what the market would look like."
But the idea of taking the test over-the-counter raises psychological and social issues that go beyond the performance of the test, says Elliot Cowan, a senior regulatory scientist at the FDA, the agency that has the final say on whether OraQuick or any other potential home HIV rapid test appears on store shelves. "We would have to see some additional studies. Counseling remains a very big part of it, but there are studies that show there are ways around that that could make for more consideration for over-the-counter, but we're not there yet."
While the CDC is not saying do away with counseling entirely, says Branson, "we're looking at alternative models. There are many routine-care situations where providing information, in a pamphlet or video, is sufficient."
But fears persist that people testing themselves alone at home over the bathroom sink would bungle or misread the results. Or would not grasp the window period. Or would receive a positive result and not understand it's preliminary. Or would become suicidal or have another type of catastrophic reaction. And, says Charles, "if you make it too easy, people might gamble with it ... test negative, go out and have unsafe sex, see if you test positive."
Many AIDS advocates and service providers believe that counseling is the most important part of the test. "Many of our clients would be happy if we dispensed with the counseling session altogether," says GMHC's Kummel. "But counseling is a big piece of the session we do. It's an opportunity for them to think about their behavior, and if they want to change it. Speaking personally, I'm not sure I would want to get a positive result, or a preliminary positive result, alone in my bathroom. What do you do with that?"
No doubt many would agree with her. "There are a lot of things that people are unaware of, that they don't take seriously enough," says Shipp, a potential home-tester. "That's the part you're going to miss with the at-home test."
"It's not only about am I positive or negative," says Mike, "but what constitutes safe or unsafe sex."
But such state-mandated probing about practices and partners is also what keeps some people from ever entering a testing site. "At the same time that we've said people should have 'client-centered' counseling, they've also said we need to collect all this data about people and their sexual habits -- did you have sex with a condom this time and that time," says Sheon, "which doesn't help the counseling relationship." The recounting becomes a kind of "ritual recording of one's transgressions ... experienced as an unpleasant ... requirement for getting the test," a dynamic more akin to a confession or police interrogation than a counseling session, Sheon writes in a chapter on HIVInSite.
"We always feel it's like a carrot we're dangling," says Adler, of San Francisco's AIDS Health Project. "I'm sure quite a few people would love to not have the counseling."
For some, the debate over home HIV testing parallels a struggle that took place 25 years ago over home-pregnancy tests. "Finding out you're pregnant and finding out you have HIV infection is a very different story. Nevertheless, it seems to me that the opposition to home-access testing kind of overplays the fragility of people who have to make a decision about their own bodies," says Ronald Bayer, a professor of sociomedical sciences at the Mailman School of Public Health at Columbia University, and coauthor of the recently published "Mortal Secrets: Truth and Lies in the Age of AIDS." "I think it's important not to sell people short. The opposition to home testing is playing off yesterday's script. It's sort of a legacy of a kind of paternalism that I would have thought at this stage had lost its capacity to persuade."
It might be only a question of rethinking what we've come to accept as standard: the bundling of testing and counseling. "Sometimes I think we get used to certain things and think they can't be different," says Adler. "We used to [give out positive results] and not even have referrals to give anybody. I remember when Home Access came out. At first, we were just appalled. How would people get their counseling, and if they got their results, what would happen? Would they go into crisis? I'm sure there are a lot of people who should not be at home getting their HIV test result without someone around. For some people, though, it might be the best thing in the world. I kind of can't imagine it coming, and yet we need to not assume that we know what's best for every person. I've delivered enough positive results where it's so unpredictable. I've given negative results that were more intense than positive results. It all depends on what's going on for the person."