Health regulators on Tuesday said they approved OraSure Technologies Inc’s in-home test for HIV, making it the first over-the-counter, self-administered test for the virus that causes AIDS.

The Food and Drug Administration gave its green light to the OraQuick In-Home HIV Test, which within 20 to 40 minutes provides results from an oral fluid sample taken by swabbing the upper and lower gums inside the mouth.

The company said the test — already approved for use by trained technicians — will be available starting in October at more than 30,000 retailers and online. The price will be set closer to the launch date, it said.

The FDA cautioned that a positive result does not mean an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the result.

About 1.2 million people in the United States are living with HIV infection, but one in five are not aware of it, according to estimates from the Centers for Disease Control and Prevention. About 50,000 new people are infected with HIV each year, often from people who may not know they have the virus, the FDA said.

“Knowing your status is an important factor in the effort to prevent the spread of HIV,” said Dr. Karen Midthun, director of the FDA’s Center for Biologics Evaluation and Research. “The availability of a home-use HIV test kit provides another option for individuals to get tested so that they can seek medical care, if appropriate.”

An FDA advisory committee of outside experts voted unanimously in favor of the test in May, saying its ability to prevent new HIV infections and link people to medical care and social services outweighed the risk of false results.

Clinical trials for the test showed it was accurate 92 percent of the time in diagnosing people who had HIV — meaning one out of every 12 test results would be a false negative.

False negatives are of particular concern because they could lead HIV-positive individuals to take fewer precautions, raising the danger that they will engage in unprotected sex.

The test accurately gave a negative result for those without HIV in 99.98 percent of cases, meaning there would be only one false positive result out of every 5,000 tests.

“We set out with a clear purpose – to dramatically impact the number of people getting tested for HIV nationwide,” Douglas Michels, OraSure’s chief executive, said in a statement.

“Today’s FDA approval of OraQuick brings us much closer to accomplishing that goal.”

(Reuters) – (By Bill Berkrot and Anna Yukhananov; Reporting by Bill Berkrot in New York and Anna Yukhananov in Washington; Editing by Maureen Bavdek, Jim Marshall and John Wallace)

ATLANTA (AP) _ Getting an AIDS test at the drugstore could become as  common as a flu shot or blood pressure check, if a new pilot program takes off.

The $1.2 million program will offer the free rapid HIV tests at pharmacies and in-store clinics in 24 cities and rural communities, the Centers for Disease Control and Prevention announced Tuesday.

“We believe we can reach more people by making testing more accessible and reduce the stigma associated with HIV,” Dr. Kevin Fenton, who oversees the agency’s HIV prevention programs, said in a statement.

The tests are already available at seven places, including Washington, D.C., Oakland, California, and an Indian health service clinic in Montana. The CDC will soon pick 17 more locations.

The HIV test is a swab inside the mouth; it takes about 20 minutes for a preliminary result. The test maker says it’s correct 99  percent of the time. If the test is positive for the AIDS virus, pharmacy employees will refer customers to a local health department or other health care providers for a lab blood test to confirm the results, counseling and treatment. The workers are expected to deliver the news face-to-face and give customers privacy, the CDC said.

An estimated 1.1 million Americans are infected with HIV, but as many as 20 percent of them don’t know they carry the virus, according to the CDC. It can take a decade or more for an infection to cause symptoms and illness.

Since 2006, the CDC has recommended that all Americans ages 13 to 64  get tested at least once, not just those considered at highest risk: gay men and intravenous drug users. But fewer than half of adults   younger than 65 have been tested, according to the agency’s most recent statistics.

It’s important to know about infection not only for treating the condition but also to take steps to prevent spreading it to others. An HIV diagnosis used to be a death sentence, but medications now allow those infected to live longer and healthier lives.

On special occasions, health organizations have sent workers to some  drugstores to offer HIV testing. This week, Walgreens, the  nation’s  largest chain of pharmacies, is teaming with health departments and AIDS groups to offer free tests in 20 cities.

But in that program, health professionals conduct the tests and deliver the news. The CDC program aims to train pharmacy staff to test and deliver the results themselves.

“I’m excited. It’s such a new and novel thing for us,” said  Sarah  Freedman, who manages a Walgreens in Washington, D.C., that is participating in the pilot program.

At her pharmacy, prominent signs advertise the test, which is then done in a private room. The pharmacy has also taken steps to let a   customer discreetly request the test, putting out stacks of special test request cards (they look like business cards) at George Washington University and nearby businesses. Anyone seeking a test can simply hand the card to the clerk, she said.

Only three or four customers have gone through with a test in the first few weeks.

“We get a lot of questions,” she said. “Usually they get the information and they go and sit on it and think about it.”

The drugstores are expected to keep the test confidential.  Pharmacy workers are to refer customers with positive tests to counseling and other services.

When the project ends next summer, CDC officials will analyze what worked well and what didn’t, said Paul Weidle, the epidemiologist who is heading up the project.

The program carries both promise and potential pitfalls, said Julie Davids, a longtime advocate who now works for the AIDS Foundation of Chicago.

More testing is a plus, she said. And even if they don’t get a free test, signs in the drugstores may prompt people to get tested at a doctor’s office or clinic where they feel more comfortable, said Davids.

But Davids said pharmacies more used to handling cholesterol screenings might have difficulty responding to patients who learn in a drugstore they’re HIV-positive.

“A person may freeze up and fall apart later,” or get emotional on the spot and even talk about suicide, she said.

In addition to Freedman’s store, a second Walgreens in Washington is  offering the test, as well as branches in Chicago and Lithonia, Georgia. The other sites are East Pines Pharmacy in Riverdale, Maryland, Mike’s Pharmacy in Oakland, California and a federal Indian Health Service location in Billings, Montana.

Each location will get enough tests to check 200 to 300 people.  Made  by OraSure Technologies Inc., the $17.50 test is the only government-approved rapid HIV test that uses saliva. Other rapid tests on the market analyze a finger-prick blood sample. The tests are used   routinely in doctor’s offices, hospitals and clinics.

The OraSure swab test’s stick-like testing device is used to wipe the inside of the mouth, then it is put in a solution, said company spokesman Ron Ticho. If two lines appear, that indicates a positive test.

The company is seeking government approval to sell it over-the-counter for home testing. A decision is expected later this year.

The test is sold in about 40 countries, including Mexico, Italy, South Korea and South Africa. Ticho said he is not aware of another country where pharmacies routinely offer the testing.

From the CDC Website:

Hepatitis B and Hepatitis C can become chronic, life-long infections which can lead to liver cancer. Millions of Americans are living with chronic viral hepatitis, and many do not know they are infected. CDC’s Division of Viral Hepatitis is leading a  national education initiative called Know More: Hepatitis.  The initiative aims to decrease the burden of  chronic viral hepatitis by increasing awareness about this hidden epidemic and  encouraging people who may be chronically infected to get tested.

Online Hepatitis  Risk Assessment

Know More Hepatitis is being featured in May as part of Hepatitis  Awareness Month.  This year, May 19th  will serve as the first ever Hepatitis Testing Day in the United States. Since chronic  hepatitis often does not cause any symptoms until serious liver damage has been  done, testing for hepatitis is crucial. Find out if you should be tested by taking a 5 minute  online Hepatitis  Risk Assessment.

The  online assessment is designed to determine an individual’s risk for viral  hepatitis and asks questions based upon CDC’s guidelines for testing and  vaccination.  The Hepatitis Risk  Assessment allows individuals to answer questions privately, either in their  home or in a health care setting, and print their recommendations to discuss  with their doctor.

Go to the Centers for Disease Control and Prevention Website for the full story.

From the LA Times:

The Food and Drug Administration said Tuesday that Gilead Sciences’ Truvada appears to be safe and effective for HIV prevention. It concluded that taking the pill daily could spare users “infection with a serious and life-threatening illness that requires lifelong treatment.”

On Thursday, a panel of FDA advisors will vote on whether Truvada should be approved as a preventive treatment for people who are at high risk of contracting the human immunodeficiency virus through sexual intercourse. The FDA is not required to follow the advice of its panels, but usually does.

An estimated 1.2 million Americans have HIV, which attacks the immune system and, unless treated with antiviral drugs, develops into AIDS, a fatal condition in which the body cannot fight off infections. If Truvada is approved, it would be a major breakthrough in the 30-year campaign against the AIDS epidemic. No other drugs have been proven to prevent HIV and a vaccine is believed to be decades away.

Gilead Sciences Inc., based in Foster City, Calif., has marketed Truvada since 2004 as a treatment for people who are infected with the virus. The medication is a combination of two older HIV drugs, Emtriva and Viread. Doctors usually prescribe the medications as part of a drug cocktail that makes it harder for the virus to reproduce. Patients with low viral levels have reduced symptoms and are far less likely to develop AIDS.

Researchers first reported in 2010 that Truvada could prevent people from contracting HIV. A three-year study found that daily doses cut the risk of infection in healthy gay and bisexual men by 44%, when accompanied by condoms and counseling. Another study found that Truvada reduced infection by 75% in heterosexual couples in which one partner was infected with HIV and the other was not.

Read the full article on the LA Times Website.

From Thinkprogress.com:

Medical progress now ensures that HIV/AIDS is no longer a death sentence, but only for those who can access good medical care. The Centers for Disease Control and Prevention reports that almost three out of four Americans with HIV are not receiving enough medicine or regular health care “to stay healthy or prevent themselves from transmitting the virus to others.” Out of the 1.2 million people in the U.S. have HIV, 850,000 aren’t receiving regular treatment to keep the virus at a low enough level to prevent transmission or hurt their own health and 240,000 Americansdon’t even know they’re infected with HIV.

For some, medical treatment is  hard to come by. A Williams Institute study found that 5 percent of dentists in Los Angeles refused services to those with HIV/AIDs, a rate that is “lower than that of other health care providers. Over the past decade, “55% of obstetricians, 46% of skilled nursing facilities, and 25% of plastic surgeons” in L.A. “had policies that specifically discriminated against people living with HIV or AIDS.” Successful treatment rates “were lowest in blacks and women,” according to CDC director Dr. Thomas Frieden.

Read the full article on Thinkprogress.com.

A new field guide from the Joint Commission urges US hospitals to create a more welcoming, safe, and inclusive environment that contributes to improved health care quality for lesbian, gay, bisexual, and transgender (LGBT) patients and their families.

The field guide features a compilation of strategies, practice examples, resources, and testimonials designed to help hospitals in their efforts to improve communication and provide more patient-centered care to their LGBT patients.  The guide, Advancing Effective Communication, Cultural Competence, and Patient- and Family Centered Care for the Lesbian, Gay, Bisexual, and Transgender (LGBT) Community, was developed with support from the California Endowment and is available for free download below.

An independent, not-for-profit organization, The Joint Commission accredits and certifies more than 19,000 health care organizations and programs in the United States. Joint Commission accreditation and certification is recognized nationwide as a symbol of quality that reflects an organization’s commitment to meeting certain performance standards.

You can get the Field Guide on the Joint Commission website.