The Wait is Over
New rapid-results tests for HIV could encourage more patients to be screened and help halt the spread of the virus

By Donna Hemmila
August 25, 2004

Waiting two weeks to find out if you’ve been exposed to HIV is a high-anxiety ordeal, especially for health care workers stuck by a needle or splashed with a patient’s blood.

“There’s nothing like that wait,” said Adele Webb, executive director of the Association of Nurses in AIDS Care, referring to the time it takes for traditional HIV test results to be processed in a lab.

Webb, RN, PhD, ACRN, FAAN, understands personally what that wait feels like: An ED patient who had been raped bit Webb in 1995, and the nurse had to be tested. But that was before the advent of a new HIV test that can deliver results in 20 to 40 minutes.

A newly approved oral quick test not only produces results quickly, but also lowers the health care worker’s risk of occupational HIV exposure by eliminating the need to draw blood.

Public health advocates are hoping the fast and easy tests will move more U.S. adults to get tested, a goal that Susan Shewmaker, RN, MA, thinks nurses need to take a more active role in achieving.

“Nurses are often one of the first caregivers a patient sees,” said Shewmaker, a medical training specialist at the Centers for Disease Control and Prevention’s National Center for HIV, STD and TB Prevention. “They are on the frontlines of care. They spend more time with patients than physicians do.”

Shewmaker believes that nurses can take the lead in persuading patients to undergo HIV testing as regularly as they would screening for other life-threatening diseases. Nurses need to offer the test to all patients in areas with a high prevalence of HIV infections, said Shewmaker, and to all patients who have high-risk behaviors.

“Nurses need to take the time to ask about a person’s sexual history and to offer prevention information and test referrals,” she said.

Convenient and accurate

The CDC’s Advancing HIV Prevention initiative, launched in 2003, has made increased testing a national priority. The initiative calls for testing to be incorporated into routine medical care and to be delivered in more nontraditional settings like community centers and mobile health units.

Less than half of adults aged 18 to 64 have ever had an HIV test, according to the CDC. The agency estimates that one-fourth of the 850,000 to 900,000 HIV-infected people in the United States do not know they are infected. That means they are not receiving the treatment that can prolong their lives, and they may be unknowingly infecting others. About 40,000 new HIV cases are reported each year in the United States, and that number has held steady for the last few years despite massive efforts in prevention education.

Even when people do get tested, many fail to return to the testing site to learn their results. At CDC-funded sites, a startling 31% of people tested for HIV don’t return for their follow-up appointment. But the new one-stop approach to HIV testing may change that pattern.

The OraQuick Rapid HIV-1 Antibody Test, developed by OraSure Technologies of Bethlehem, Pa., was approved in November 2002 to detect the HIV antibody in a blood sample taken with a finger stick.

In March, the Food and Drug Administration approved the same rapid-results test for use with an oral fluid sample. Both uses of the OraQuick test deliver results in as little as 20 minutes with more than 99% accuracy.

The oral fluid test is given by swabbing the outer gums of the person being tested with a device that contains an absorbent pad at the end. After the gums have been swabbed, the tester inserts the device into a vial containing a solution. If HIV antibodies are present, a small window on the device displays two reddish-purple lines.

This preliminary positive result has to be confirmed with a blood test, and if someone tests negative but had recently engaged in high-risk behaviors, such as sharing needles or having unprotected sex, counselors recommend they be tested again in three months.

HIV tests detect antibodies produced by the human immune system when someone has been exposed to HIV. Most people develop antibodies within two to eight weeks, and by three months after being exposed to infection, 97% of the population will develop antibodies. In some people, it takes up to six months to develop detectable antibodies.

The FDA has approved two other rapid-results blood tests: Reveal Rapid HIV-1 Antibody Test by MedMira Laboratories and the Uni-Gold Recombigen HIV Test by Trinity Biotech. Both the OraQuick and the Uni-Gold Recombigen tests have been deemed waived tests under the provisions of the Clinical Laboratory Improvement Amendments, which established quality standards for laboratory testing. CLIA-waived tests are determined easy to use and can be given in clinical and nonclinical settings such as outreach centers and health fairs.

“This really is going to open the way for a lot of people to be tested,” Shewmaker said.

Peace of mind

Nurses who work with the HIV population also hope the advances in safe testing will deliver peace of mind for those who are exposed on the job.

The actual number of health care workers infected with HIV through occupational exposure to the virus is small. As of December 2001, the CDC had documented 57 cases of occupationally acquired HIV infection and another 138 possible infections.

But nurses make up the largest percentage of those cases: 24, or 42%, of the documented cases and 35, or 25%, of the possible cases.

“I believe strongly their numbers only hit the tip of the iceberg,” said Lisa Black, RN, MS, who suffered an occupational HIV exposure in 1997. “I know personally probably 10 nurses who have been occupationally infected.”

Black, now executive director of the Nevada Nurses Association, was working in a hospital acute care unit caring for a man in the advanced stages of AIDS when she became infected through a needlestick. She was clearing the man’s IV line, which was backed up with blood fluid.

As she inserted a syringe into the line’s port, the patient was startled and his movement caused the needle to prick her.

“In my case, it was the highest-risk stick that can happen,” Black said. “A large-bore, hollow needle with a patient in the end stages of AIDS.”

The man died 10 days later, and Black’s injury left her infected with HIV and hepatitis C. Although Black said she’s had some health challenges in the last year, she has not progressed to an AIDS diagnosis. After her injury, she eventually stopped working in hospitals, pursued a master’s degree, and is now in a doctoral program.

When a health care worker is exposed to blood or bodily fluids, a course of postexposure drug treatment is started. One of the advantages of rapid-results tests, Black said, is that some health care workers could avoid taking the drugs unnecessarily.

Many side effects

After her injury, Black immediately started a course of postexposure prophylaxis, and like many who take the drugs, she experienced the overwhelming side effects of diarrhea, nausea, diminished memory, and concentration. Many nurses who take the drugs aren’t able to work, she said.

In her case, the drugs didn’t prevent infection, although she’d been told the chances of seroconversion were slim. The risks for nurses are still there, she said, despite the advances in testing and postexposure prophylaxis.

“Don’t allow that to invite complacency,” she said.

Early intervention

“[The rapid-results test] saves money, side effects, and anxiety,” said Lyn Stevens, MS, NP, ACRN, an HIV training coordinator for the New York State Department of Health AIDS Institute.

Stevens has been training health care professionals to use the OraQuick test, and where centers use quick testing, she’s seen a dramatic increase in the number of people seeking HIV tests.

The rapid-results tests also are being used in labor and delivery settings to lower the risk of transmitting infection from moms to babies. In 2000, the CDC estimates 6,000 to 7,000 HIV-infected women gave birth to 280 to 370 infected infants.

Reduced risk

In cases in which the woman is identified as HIV-positive early in her pregnancy and antiretroviral and obstetrical interventions are used, the risk of the baby contracting the disease is reduced to less than 2%. Without the interventions, the rise jumps to 25%.

“Ideally, a woman should be tested early in her first trimester,” Stevens said. Yet even if the woman is tested at the time she goes into labor, the baby has a lower risk of transmission once nurses and physicians are aware of a woman’s HIV status.

Even with the advancing technology of quick testing, getting patients to consider an HIV test takes extra effort from health practitioners. Not all nurses are comfortable probing into a patient’s sexual practices or broaching the topic of needle sharing.

Stevens said she’s come up with two basic questions nurses can ask patients: “Have you ever had unprotected sex?” “Have you ever shared needles for drugs, tattooing, or body piercing?” These questions open the door for discussion without putting a patient on the defensive because they think they’re being accused of using drugs.

“You can move forward with education and answer questions,” Stevens said. “The more you make this part of routine care, the less patients think you are singling them out.”

Without delay

The South Beach AIDS Project in Miami Beach, Fla., is in a neighborhood the project director describes as ground zero for HIV infection.

The state-funded center, housed discreetly in a space inside a neighborhood pharmacy, provides AIDS prevention education and testing. It was the first outreach center in South Florida to use the OraQuick rapid-results test, said Kevin Garrity, the project’s executive director, and since offering it, the demand for testing has shot up 300%.

“South Beach is sort of an instant gratification place,” Garrity said. “They want their food right away, they want their sun fast, and they want their test results fast.”

The area is a popular vacation destination for gay men and has a large population of gay residents. The typical client, Garrity said, is a gay man in his mid-20s who lives in the area and has seen a newspaper ad about the clinic or talked to one of the outreach workers who regularly visits the bars. About 25% to 35% are first-time testers.

Before the rapid-results test, it took about 10 days to get HIV test results back from a lab. About half of the people tested at the South Beach center never returned for their results, Garrity said.

“We got people who tested anonymously and tested positive, and we had no way to get in touch with them,” he said. “The rapid test eliminates that.”

Now, clients receive counseling before the test and learn their HIV status in 20 to 40 minutes. If someone tests positive, the results must be confirmed with a lab test, but counseling can begin immediately.
Fear and denial are the big reasons why people don’t return for test results, Garrity said. Typically, people are motivated to be tested because someone they are dating asked them to be tested or they panic after engaging in high-risk behavior. When that moment of panic subsides or they are no longer dating the person who asked for the test, people often don’t bother coming back to the center for their results.

When the number of people getting tested at the center increased, so did the number of positive test results, Garrity said. When the center was doing 50 tests a week, it saw a positive rate of about 2%. When the number of tests rose to 150 to 200 a week, the positive rate increased to 4.8% to 5.2%.

“That data alone shows the effectiveness of the test,” Garrity said.

In late August, he hopes to begin using the OraQuick oral swab test, making it even easier to administer and take an HIV test in South Beach.