Implementation of Rapid HIV Test Off to Slow Start

Nearly a year after the Food and Drug Administration approved a highly anticipated rapid HIV test, fewer than a dozen sites in California are offering the screening exam, which offers results in 20 minutes.

AIDS advocacy groups and health officials, who had hoped to have many more test locations running by now, say strict state testing guidelines and confusion about how to implement the test have limited its introduction in California.

The test’s slow arrival is frustrating doctors and patients. A major concern is that up to a third of people who undergo traditional HIV tests, which can take up to two weeks to process, never come back for their results and may go on and infect others. The rapid test allows people to learn their HIV status in the same visit and receive counseling and treatment quickly, if needed.

“I think many people had hoped this would go a bit more smoothly, especially considering how long we’ve waited for this to arrive,” Karen Mall, director of prevention services for the AIDS Healthcare Foundation in Los Angeles, said of the new test.

In several instances, officials aren’t advertising what sites are conducting the new test for fear of being overrun with patients.

At the heart of the problem, state health officials say, is the fact that California has some of the most stringent regulatory testing guidelines in the country.

Federal regulations require that any site offering blood tests outside of traditional laboratory settings apply for a waiver to U.S. rules. In addition to those federal rules, California requires test givers to have at least a high school diploma and go through more extensive training than the federal government requires.

Many of the people expected to administer the rapid test are now HIV counselors who often have little or no experience administering blood tests. Most of them have worked with tests that use only an oral swab instead of blood, and haven’t had to deal with many of these state and federal rules before.

“It’s been a little confusing figuring out how this test fits in with our current system and all the rules that surround it,” said Deanna Sykes, who has overseen implementation for the state’s Office of AIDS.

The new test, conducted with a relatively easy finger prick, is expected to be available eventually at many local social service organizations, as well as on mobile vans and at sites such as bathhouses frequented by people considered at high risk for contracting HIV.

However, a pilot program the state planned to introduce at 11 sites in late May began at only four locations because the testing sites weren’t prepared in time. Officials said the sites that did not make it into the pilot program did not have enough measures in place to guarantee the test’s safety and accuracy.

Recently, Los Angeles County’s separate proposal for 26 testing sites was held up for several weeks because officials at the state Department of Health Services, which must approve all waivers, said they were unsure if the county’s application was technically valid since it lumped together all 26 on one application. After checking with federal officials, the state health department decided it was all right. But it still could be months before counselors at all the Los Angeles-area sites are trained to administer the tests.

State health officials say they are working to ease the initial logjams facing new testing sites. By processing waivers more quickly and offering training seminars, they hope that the rapid test could be available at as many as 700 sites statewide by next summer.

“In the big picture, we’re dealing with this as quickly and efficiently as we can,” said Paul Kimsey, assistant director of the state health department’s laboratory field services office.

Nationally, although California once led the country in the push for the rapid HIV test, state and federal health officials now estimate it is somewhere in the middle of the pack in relation to other states’ implementation schedules. New York, for example, began rapid testing in April, and now has it at more than 50 sites throughout the state. Wisconsin has roughly the same number of rapid testing sites up as California, although it has just a seventh the population.

(Some private doctors’ offices in many states may be using the rapid test already but health officials are not tracking them.)

Even before the recent delays in California, the rapid HIV test clocked a glacial pace before finally hitting the market last fall.

AIDS advocacy groups protested for years that the federal government was dragging its feet on approving the test. They suggested that was because traditional laboratories are expected to lose significant revenues once rapid tests are more widely available. Several AIDS groups in California have suggested that resistance by labs influenced the state -- and its scientists who review test waivers -- to go slowly. The department denies that charge.

The rapid HIV test is a cornerstone of the federal government’s new AIDS prevention strategy announced by the Centers for Disease Control last spring. The agency estimates that up to a quarter of the nearly 1 million people in the U.S. living with HIV don’t know they have the disease.

In California, questions remain about the potentially large costs to train test givers. Those expenses could be especially hard on small community-based organizations already under budget constraints.

The state Legislature is expected to consider a bill early next year that would condense some of the training into one session as a way to alleviate some of the costs.