U.S. Weighs Whether to Open an Era of Rapid H.I.V. Detection in the Home
..... panel was not asked to make such a recommendation Thursday but may in a future meeting, and the final decision ultimately rests with the FDA......
By JOHN LELAND
Published: November 5, 2005
At a free clinic in Philadelphia, Jennifer Brown, 26, spent a recent lunch hour talking to a counselor and waiting anxiously for a small white strip to tell her whether she had the AIDS virus.
Ms. Brown said she and her partner had stopped using condoms, and she recently discovered that he had been unfaithful.
"How would you feel if the results come back positive?" the counselor asked.
Ms. Brown exhaled. "I'd have to get on with it," she said. "I have a daughter."
Ms. Brown would get her results in just 20 minutes, thanks to one of two new tests that AIDS workers say have revolutionized testing for H.I.V., the virus that causes AIDS, and become a centerpiece of federal strategy for preventing the spread of the disease.
Before the rapid H.I.V. tests were approved for professional use in 2002 and 2004, most federal programs concentrated on changing the behavior of people who were not infected.
But the availability of the rapid tests moved the Centers for Disease Control and Prevention to direct more efforts at the relatively smaller number of people who are already infected, identifying them before they can infect others, and in time for treatment to be most effective, said Dr. Ronald Valdiserri, acting director at the National Center for H.I.V., S.T.D. and TB Prevention.
On Thursday, the Food and Drug Administration's Blood Products Advisory Committee heard testimony on whether to recommend over-the-counter sales of the rapid test for home use. The agency approved a home testing kit in 1996, but users have to mail a blood sample to a laboratory and wait for results by telephone.
Proponents say rapid testing in the home will reduce the stigma and other obstacles that prevent many people, including one in four of the nearly one million Americans who are infected with H.I.V., from getting tested and starting treatment. Research shows that people who learn they are infected are less likely to infect others.
But many AIDS professionals, including those at the Bebashi clinic in North Philadelphia, have opposed home testing because they believe that people like Ms. Brown need education and counseling along with their results.
"When you eliminate counseling, you eliminate helping the client understand their risky behavior," said Antonio Adophues, a counselor at the Bebashi clinic. "Testing itself is not education."
Mr. Adophues and his supervisor, Sharifah Linton, said clients sometimes became angry, violent and even suicidal after receiving positive results.
"We had one guy who just totally broke down," Ms. Linton said. "You could hear him through the walls. He thought, 'This can't happen to me.' We were able to link him to a medical provider, a case manager, and get him in a support group."
Others, however, just go numb when they hear bad news. "The most emotional responses come from negatives," said Nestor Rocha, the director of counseling, testing and prevention programs at the Whitman-Walker Clinic in Washington.
In the 20 years since federal drug regulators approved the first test for H.I.V., testing and counseling have changed profoundly. The early tests took as long as two weeks, and the counselors helped patients deal with what was essentially a death sentence. Many patients never returned for their results.
Today, the focus is more pragmatic. As H.I.V. has become a treatable illness, counseling has expanded to include a variety of medical advice, help with notifying partners and risk-reduction.
"Now the work is about connecting to a doctor, eating right, reducing stress," said Anthony McWilliams, a counselor at a clinic called AIDS Research Consortium of Atlanta.
Counseling also addresses changing risky behavior, for people who test negative as well as positive, said Ana Oliveira, executive director of the Gay Men's Health Crisis in New York.
"We try to get at what is it in this person's life that they continue to engage in risk behaviors, and what can we help them do differently, beyond the test," Ms. Oliveira said.
In the small, windowless counseling room at Bebashi (originally an acronym for Blacks Educating Blacks About Sexual Health Issues), Ms. Brown said she felt "fine, a little nervous." She usually gets an H.I.V. test with her annual physical, using her health coverage from work, but this time she was really worried. She went to the clinic rather than to her doctor out of fear and embarrassment.
"I've been going to my doctor for years, and I didn't want her to know, because I didn't know what the results would be," Ms. Brown said.
The counselor, Ameenah McCann, asked her frank questions about her sexual life.
"If your results are positive," Ms. McCann asked, "is there anyone you want us to contact?"
Ms. Brown said she dreaded having to tell her former partner, "but I can't let it scare me."
About half of all American adults, and two-thirds of African-American adults, have been tested for H.I.V., reflecting the arc of the epidemic, according to the Kaiser Family Foundation. Though African-Americans made up 13 percent of the American population in 2003, they accounted for 49 percent of new AIDS cases.
Rapid tests have allowed AIDS workers to expand testing to mobile vans or to public events like AIDS walks, and to address high-risk populations, like street prostitutes or addicts who inject drugs, in places where they gather. With rapid tests, people who get a positive result need a second test to confirm.
The federal government distributes guidelines for counseling, but the level and quality of counseling varies by setting, said Dr. David Malebranche, who treats patients at the Infectious Disease/Ponce De Leon Center in Atlanta. When Dr. Malebranche gets tested for H.I.V., he goes to a free clinic rather than to a private doctor.
"When you go to a private doctor, who's seeing twice as many patients as a public facility, do you think they have as much time to do counseling?" Dr. Malebranche said. "In Atlanta, the clinics sit you down for half an hour."
Though clinics often serve low-income or poor populations, he said, he got better care there than he would have at an upscale private office.
At Bebashi, Ms. Brown's counselor stepped out of the room to check her results: one thin line on a white strip. "Your test is negative, but you should come back in six months," the counselor said, because the test might not detect a recent infection.
Ms. Brown gasped with relief.
She said she would not like a home test.
"Even if there was a home test, I'd rather come into a facility," she said. "I would want to be around people. I know in this day and age, it's not a death sentence, so I wouldn't get suicidal, but I'd want people there to discuss options."
Even before Ms. Brown got the results, Ms. McCann, the counselor, asked her what she planned to do differently.
"I guess you can't trust people, so always use condoms, because you never know," Ms. Brown said. "If I ever date anybody again after this, I guess I have to reinforce that."
When it was over, Ms. Brown left with a bag of condoms.
FDA Considers Approving Home HIV Test
By JOHN J. LUMPKIN, Associated Press WriterThu Nov 3, 7:31 PM ET
The Food and Drug Administration's Blood Products Advisory Committee heard opinions Thursday on whether an HIV test should be made available over the counter.
An FDA scientist said the privacy and convenience of the test is a potential boon in that it could lead to more people seeking treatment earlier during the course of the illness, but the agency needs more information before it can be approved for sales directly to the public.
"Anonymous testing potentially leads to more people knowing their HIV status," Elliot P. Cowan, a product review chief at the agency, told the committee.
Still, Cowan raised a number of concerns to the panel, a group of independent experts who can recommend to the FDA whether to approve the product. The panel was not asked to make such a recommendation Thursday but may in a future meeting, and the final decision ultimately rests with the FDA.
The possible availability of the test, which relies on a swab on the inside of the mouth, has raised concerns about the potential psychological impact on people who learn they have the virus with no doctors or counselors present.
A person takes the OraQuick test by taking a mouth swab and then inserting the swab in a vial of fluid that comes with the test. Twenty minutes later, the device indicates whether it detects the presence of HIV-1 or HIV-2 antibodies inside cells picked up by the swab.
The test will not detect the virus if the person only recently acquired HIV because it takes several weeks for the antibodies to appear.
Panelists raised a variety of questions about the test's packaging, instructions and ease of use. Would it include instructions in French, given many immigrants from Africa speak French? (Company officials were open to the idea.) What happens if the cat tips over the test before it has results? (Probably need another test.) Would the test be available in jurisdictions that mandate the reporting of HIV-positive cases? (Company officials said they would address the issue with those jurisdictions).
The company has not decided at what price it would sell the kits to consumers, company officials said. The company sells the kits for between $12 and $17 to clinics and doctors, he said.
One professor flown in by the company to speak to the panel said her studies suggested that many people would find it a burden pay more than $15 for such a test.
The test is accurate more than 99 percent of the time, the company says. Still, a few people will get a positive result when they don't have HIV, and anyone who gets a positive result should be confirm it through an additional test by doctors or public health officials, the company said.
Cowan noted concerns about a person's reaction to learning he or she probably has HIV at a time when no health professional or counselor is immediately accessible.
In that vein, "the biggest issue that has come up repeatedly is suicidal tendencies," Cowan said.
Company officials said they would develop instructions with the kit for someone who receives a positive result that would probably include a telephone number and web site address.
One other home test, made by Home Access Health Corp., is approved for sale in the United States by the FDA. People taking this test must take a sample from themselves and mail it to a lab for results.
About one million people in the United States have HIV. The Centers for Disease Control estimates nearly 300,000 people have the virus but don't know it.