August 21, 2013
Pharmacies Should Play Crucial Role in HIV Testing of Hard-to-Reach Individuals

Bronx, NY—Community pharmacies can play a critical role in providing rapid HIV testing and diagnosis, as well as making sure those who test positive are quickly connected with medical care.

That’s according to a new report in the journal AIDS Patient Care and STDs based on a study by researchers from Albert Einstein College of Medicine of Yeshiva University. The study was undertaken because, while nearly one in five Americans with HIV are unaware they are infected, the number of new HIV infections diagnosed each year has remained at 50,000 for a decade.

“There are many reasons why these numbers have not improved, but access to testing likely plays a large role,” said Yvette Calderon, MD, lead author for the study and an emergency medicine physician at Einstein. “Access to healthcare remains particularly poor among low-income and minority populations—groups that shoulder the highest HIV burden. We have been looking for new ways to reach out and offer testing to individuals in these groups and bring them into care if they need it.”

To make HIV testing available to hard-to-reach, high-risk individuals, researchers formed partnerships with five community-based pharmacies in the Bronx, where the medical school is located, and in the Chelsea and Hell's Kitchen areas of Manhattan. The authors said they chose their home turf, the Bronx, because it is ethnically diverse and has one of the highest HIV rates in the country. They pointed out that diversity was important because some groups are at much higher risk for HIV infection than others: The national rate of new infections among African-Americans—68.9 per 100,000—is nearly eight times greater than that of whites, 8.7, with Hispanics having the second-highest rate at 29.3.

Public Health Advocates (PHAs) were trained to administer the rapid HIV test to people inside the pharmacies and on the sidewalks outside. Once agreement was obtained and the test, which only requires a swab of saliva, was administered, results were available in about 20 minutes. During that time, participants were asked to fill out an HIV-risk factor and test satisfaction questionnaire and counseled about HIV-risk reduction behavior based on their answers.

If the HIV test result was positive, PHAs offered an escort to either the clinic at Jacobi Medical Center or a collaborating HIV clinic near the testing site, and patients with positive results were usually seen in less than an hour after being diagnosed.

Over the 294-day study period, 2,030 individuals agreed to HIV testing, with six of those testing positive, and five of those agreeing to accompany the PHA to an HIV clinic. Of those tested, 41% were male and 59% were Hispanic; 77% had been previously tested for HIV, and 34% were uninsured. With a median CD4 count of 622 white blood cells/mL, the patients—who represented an HIV incidence of 0.3%—were diagnosed at a relatively early stage of infection.

“In many urban areas, community pharmacies play an important role,” Calderon said. She noted that pharmacies in New York are not yet allowed to provide blood tests or medical care but do administer vaccines and provide wellness advice, adding, “Many area residents view the pharmacists as trustworthy and more accessible than doctors and go to them for advice.”

She concluded that the study results “demonstrate that pharmacies can effectively supplement the current health care system for HIV testing, especially in some of our lower-income communities. They could become an important component of an extended network for informing more people to their HIV status and bringing them into care.”

The study report was especially timely, published just 2 weeks before the FDA approved the first rapid HIV test for the simultaneous detection of HIV-1 p24 antigen as well as antibodies to both HIV-1 and HIV-2 in human serum, plasma, and venous whole blood specimens.

The FDA said the Alere Determine HIV-1/2 Ag/Ab Combo test was approved for use as an aid in the diagnosis of HIV-1 and HIV-2 infection and also is the first FDA-approved test that independently distinguishes results for HIV-1 p24 antigen and HIV antibodies in a single test. The test is manufactured by Orgenics, Ltd. (an Alere, Inc. company) of Yavne, Israel.

“This test helps diagnose HIV infection at an earlier time in outreach settings, allowing individuals to seek medical care sooner,” said Karen Midthun, MD, director of the FDA’s Center for Biologics Evaluation and Research. “Earlier diagnosis may also help to reduce additional HIV transmission.”

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