Category Archives: News

By Susan Lazaruk, The Province May 10, 2012
CLICK HERE to read the article on theprovince.com

 

Safe, supportive housing for marginalized prostitutes that allow them to take clients inside reduces the women’s exposure to violence and HIV infection, according to a Vancouver study.

Researchers interviewed 39 women who reside in housing for poor drug-using sex workers, where they have access to support staff and police. The former street workers, who had seen clients in cars, alleys and the johns’ homes, reported that when they worked indoors they had more control over the sexual transactions, including their right to refuse an act, and an ability to negotiate condom use and avoid violent predators, the study found.

The women-only buildings ensure that guests sign in and there are video cameras, staff on hand to call police if necessary and health and safety resources on-site.

There are three rules at the housing operated by Atira Women’s Resource Society, said spokeswoman Jan-ice Abbott: “No dealing drugs, no violence and no pressuring other women into doing something they don’t want to do.”

The residents aren’t questioned about who they entertain in their rooms but have to escort them in.

The study’s senior author, Kate Shannon of the B.C. Centre for Excellence in HIV/AIDS, said the study shows working indoors reduces the risk to the health and safety of sex workers.

by Tim Horn

CLICK HERE to read the article on AIDSMeds.com

Orasure’s oral swab-based rapid in-home HIV test has been recommended for approval by the U.S. Food and Drug Administration’s Blood Products Advisory Committee. If the FDA follows its advisory committee’s recommendation, the Oraquick In-Home HIV Test will be the first complete home-based screening assay for any infectious disease available for purchase over-the-counter (OTC) from pharmacies and internet retailers.

The advisory committee voted unanimously, 17-0, in favor of the test upon being asked two questions: Do the available clinical trial results provide reasonable assurance that the test is safe and effective? And, importantly, do the benefits of in-home HIV testing outweigh the potential risks, notably false negative and false positive results?

The particulars of the second question were hotly discussed throughout the May 15 meeting in Gaithersburg, Maryland. Of concern to the FDA presenters and advisory committee panelists is the test’s reduced sensitivity—its effectiveness at screening for HIV antibodies in those infected with the virus—compared with the professional oral swab OraQuick assay.

However, even with reduced sensitivity, Elliott Cowan, PhD, of the FDA acknowledged, the in-home HIV test is anticipated to have a net public health benefit. “The OraQuick In-Home HIV Test is expected to be associated with a net increase in the number of HIV infections newly identified each year,” he said, “with evidence of new infections averted with use of the test.”

According to an FDA analysis of available data, in the first year of the test’s commercial availability, the OTC test may potentially identify 45,000 people living with HIV in the U.S..

Only one OTC HIV testing kit has been approved by the FDA. The Home Access HIV test, approved in 1996, requires blood samples to be collected at home, followed by shipment to a laboratory for analysis—results are provided by a Home Access telephone operator. The retail price is between $30 and $40.

The OraQuick In-Home HIV Test allows users to collect samples, conduct the test and interpret the results on their own. The test result is read after 20 minutes, but not longer than 40 minutes, after inserting the oral swab device into the vial of developer solution provided with the OTC kit. The price of the test is not yet known, but the company expects it to retail for under $60.

Major talking points at the advisory committee hearing were the test’s sensitivity and specificity. An assay’s sensitivity reflects its ability to prevent false negatives—an HIV antibody-negative result for someone who is infected with the virus. An assay’s specificity reflects its ability to prevent false positives—an HIV antibody-positive results for someone who is not infected with the virus.

The OraQuick In-Home HIV Test has strong specificity (99.98 percent). Whereas the OTC test will yield one false-positive result for every 3,750 true-negative results among people who aren’t infected with HIV, the professional oral swab Oraquick test yields one false-positive for every 462 true-negative results.

The OTC’s sensitivity, however, averaged only 92.98 percent, compared with the 99 percent sensitivity associated with the professional OraQuick oral swab-based assay. For every 13 “true-positive” results using the In-Home OraQuick test, there may be one false-negative test result—or approximately 3,800 false-negative test results per year—an analysis of the Phase III clinical trial data showed.

Of particular concern to the FDA presenters was the lower end of the estimated sensitivity range in the Phase III clinical trial—the “lower bound of the 95 percent confidence interval” in statistical parlance. Accordingly, the sensitivity may be as low as 86.64 percent, which is significantly lower than the 95 percent that has historically been required by the FDA’s Blood Products Advisory Committee.

Looking solely at the “lower bound” analysis, there could be one false negative for every six true-positive results using the OraQuick In-Home HIV Test—approximately 7,000 false-negative test results per year. By comparison, the “lower bound” sensitivity using the professional OraQuick oral-based HIV test would be expected to yield one false-negative for every 62 true-positive results.

“Understanding the public health implications of approving an over-the-counter test that performs at this level of sensitivity and specificity in the hands of lay users is challenging,” the FDA notes in their pre-advisory committee meeting briefing document. “There is considerable personal and public health value in informing infected, but otherwise untested, persons of their true positive HIV status. However, this benefit is offset in some measure by HIV-positive individuals who receive an incorrect message that they are not infected (false negatives).”

Public testimony at the hearing was overwhelmingly favorable. Roughly 20 agency representatives—including Phill Wilson of the Black AIDS Institute, Cornelius Baker of the Whitman-Walker Clinic in Washington, DC, Dawn Averitt-Bridge of The Well Project, Larry Bryant of Housing Works, C. Virginia Fields of the National Black Leadership Commission on AIDS and Ernest Hopkins of the San Francisco AIDS Foundation—testified that the Oraquick In-Home HIV Test would be a welcome addition to the HIV testing and awareness tool box, particularly for women and people of color living with, and at risk for, HIV who are not being effectively connected to existing testing programs.

“We are concerned by the data indicating that when administered by consumers the accuracy of the rapid HIV tests drops to 93 percent as compared to 99 percent when conducted by professionals,” testified Kimberly Crump, policy officer at the HIV Medicine Association. Yet, Crump noted, “we still believe the rapid test holds great promise as a self-directed tool for individuals to learn their HIV status. We also urge continued research and education in heavily impacted areas and with the low income and minority populations disproportionately affected by HIV infection to determine how the instructions and accompanying support materials can raise the assurance of the test results closer to the level obtained by professionals.”

A particularly crucial issue is the test’s “window period”—the time between possible exposure to HIV and the assay’s ability to detect antibodies to the virus. Study volunteers who used the OTC test during the test’s window period, coupled with human error, likely contributed to the assay’s reduced sensitivity results.

Orasure says it takes approximately two months post-exposure for the test to produce reliable results. In draft test instructions reviewed by the advisory committee, Orasure indicates users should perform the test at least three months, or 90 days, after engaging in behavior associated with HIV transmission.

Amy Lansky, MPH, PhD, of the U.S. Centers for Disease Control noted that professional fourth-generation tests, designed to look for both antibodies and HIV antigens in blood samples, are the most effective at detecting HIV infection in the first few weeks following potential exposure to the virus. These tests become sensitive and specific within 15 days following high-risk behavior.

The advisory committee panelists noted, on several occasions, the need for strong, clear and concise information in the educational materials that will accompany the test to minimize human error and testing during the window period, spell out the risks of false-negative test results and, importantly, to link those who do test positive to licensed health care providers for follow-up testing and care.

“There has been a lot of talk about the false-negative test results,” said Steven Pipe, MD, of the University of Michigan and a member of the panel. “But I still can’t get over the fact that a quarter of a million people living with HIV haven’t been tested. If the in-home test helps to reduce this number, its benefits ultimately outweigh its risks.”

From: GreaterThan.Org

Of the more than 1.2 million people living with HIV in the U.S. today, an estimated one in five, or nearly a quarter of a million people, do not know it. Early diagnosis and treatment saves lives and is known to reduce the spread of HIV.The CDC encourages everyone to know their status.

Together with the National Association of People with HIV/AIDS, the U.S. Centers for Disease Control and Prevention (CDC), and other partners, Greater Than AIDS is pleased to offer FREE community materials to support your testing activities this month and throughout the year. Visit the online store to view all available items, including National HIV Testing Day posters and postcards with space to add information about your activities and other informational resources. Place your order by June 4th to ensure receipt in time for National HIV Testing Day.

With more than 158,000 fans, Greater Than AIDS is a go-to destination on Facebook for those looking to find – and offer – advice and support. Join the community at facebook.com/greaterthanaids. Share updates about your organization’s activities and events leading up to National HIV Testing Day, and show your testing pride by making this year’s National HIV Testing Day logo your organization’s profile picture.

Greater Than AIDS is constantly inspired by the dedicated work of local HIV/AIDS service organizations and activists. Let us know how you are using Greater Than AIDS in your community and you may be profiled in an upcoming newsletter. Share your experiences (and photos!) today.

Original Source: http://www.natap.org/

“I think the information suggests that this test could be very significant in helping to stem the number of new cases of HIV that occur every year,” said Blaine Hollinger, who chairs the panel. Some critics of the test have raised questions about its accuracy, but the benefits outweigh the harm of the occasional misdiagnosis, the panel said……The test, which looks for signs of HIV in oral fluid, is already used at hospitals and doctors’ offices where medical professionals administer it. The FDA first approved its use in 2004.

 healthday: The test, which looks for signs of HIV in oral fluid, is already used at hospitals and doctors’ offices where medical professionals administer it. The FDA first approved its use in 2004. To take the test, known as OraQuick, patients swab their outer gums and put the swab into a vial. After about 20 minutes, the test device will reveal two reddish-purple lines in a small window if there are signs that the body’s immune system has geared up to battle HIV.

The test uses oral fluid, which is not the same as saliva. Its results are considered preliminary, and should be confirmed by a blood test.To take the test, known as OraQuick, patients swab their outer gums and put the swab into a vial. After about 20 minutes, the test device will reveal two reddish-purple lines in a small window if there are signs that the body’s immune system has geared up to battle HIV.

Pant Pai said the oral test’s overall accuracy is similar to that of a blood test, although it’s slightly less accurate. The oral test, in particular, may miss HIV infection in its early stages, she said.

Also, “the sensitivity of the test appears lower when administered in the home setting rather than a medical setting, so some of the people who are HIV-positive will get a test result that they are negative,” said Jane Rotheram-Borus, director of the Center for HIV Identification Prevention and Treatment Services at the University of California, Los Angeles. “However, if they would otherwise not have gotten the test at all, they may also have believed they were negative.”

In addition to talking about its accuracy, the FDA panel may also examine the support that’s available for people who learn at home, possibly alone, that they are probably infected with the virus that causes AIDS.

“The arguments against the at-home test focus on the absence of a counselor who could provide support and link the newly identified HIV-positive individual to medical care,” said Rotheram-Borus, who supports over-the-counter sales of the OraQuick test.

She pointed out that “over-the-counter pregnancy tests are widely used, and pregnant women do find their way into prenatal care.” (from Jules: one person testified in public open mic that pregnancy tests are just as insensitive or inaccurate).

The company that makes the test says it will offer a 24-hour toll-free number that people can call to get support regarding their test results.

 WSJ: It isn’t clear if the home test provided a negative result or if people read the test incorrectly. One measure of accuracy of the OraQuick home test is 93%, but when used by health-care professionals, that level is 99.3%.

There may be other limits to the test. Julie Scofield, executive director of the National Alliance of State and Territorial AIDS Directors, a group that represents state health departments, said in a letter to the FDA that consumers may not be able to detect infections acquired in the previous four to six weeks before testing.

Still, FDA officials said the home-use test would likely encourage more people to get tested. “We believe there would be public-health benefits” of a home-based HIV test, said Richard Forshee, an FDA associate director for research. “But an individual risk remains in the form of an increase in the number of false negatives.”The test uses a swab to collect salvia inside a person’s mouth. After the swab is inserted into a test tube for 20 minutes, the test indicates whether a person is infected with HIV. The company and the FDA said positive tests should be confirmed with a blood test.

MSNBC: U.S. health officials told the panel that home-testing could help get needed healthcare to HIV-positive individuals earlier. At present, only 62 percent of those with HIV are linked to the healthcare services and just 28 percent have access to drugs capable of suppressing the infection.

CNN Blog

Consumers may soon be able to test themselves for HIV and quickly learn the results in the privacy of their own homes following a unanimous approval recommendation from a Food and Drug Administration advisory committee on Tuesday.

The panel said the OraQuick In-Home HIV Test should be made available over-the-counter (OTC) saying the test is safe and effective and that the benefits far outweigh the potential risks.

If approved by the FDA, the test will be the first OTC test to be marketed for HIV or any infectious disease. FDA advisory committee recommendations are not binding, but they are generally followed.

An estimated 1.2 million Americans are living with HIV, according to the Centers For Disease Control and Prevention. One in five of those are unaware of their HIV status. And about 50,000 new cases of HIV are reported each year.

OraSure Technologies, Inc., the manufacturer of this new test, also makes the already approved OraQuick ADVANCE Rapid HIV-1/2 Antibody Test.

That test can only be used in a clinical setting and results are provided in 20 minutes. The In-home test is a modified version where the individual swabs the upper and lower gums with a test pad device. That device is then inserted into a vial of solution. Much like a pregnancy test, one line shows up if the test is negative, two lines means it’s positive.

The kit includes step-by-step instructions on when to test, how to set-up and administer the test, and how to interpret the results. The company also provides information on how to follow-up on the results through OraQuick’s Answer Center for support and local medical referral is also provided. The center is staffed 24 hours a day, 7 days a week.

“The test is designed to be comprehensive across a broad range of literacy levels,” said Stephen Lee, OraSure’s executive vice president and chief science officer. “It enables use in a variety of testing environments.”

According to Lee the test has a high degree of accuracy and 93% sensitivity. In clinical studies the test proved 99.98% effective in determining who did not have the virus. Panelists were concerned about making sure there was comprehensive language in the kit regarding a testing window. Specifically, you must wait 3 months between high risk behaviors before testing. Another major concern was the risk of false positives and false negatives.

But for the 25 or so health care professional and HIV/AIDS advocates that addressed the panel, imploring the committee to vote for approval, those risks did not outweigh the opportunity to expand public access to testing and reduce the number of infections by making sure people know their HIV status. That a test could be done in the privacy of their own homes was seen as an added bonus – and a way to address the stigma surrounding HIV. Nobody requested that the test should not be approved.

“We need to do whatever we need to move the needle of the number of people who don’t know their status,” said Whitney Cordova of the AIDS Healthcare Foundation. “This test helps do that. The perfect cannot be the enemy of the good.”

“It is clear OTC is not the right way to be tested for everyone,” said Tom Donohue, Jr., founder of Who’s Positive. “OTC is another tool. OTC has the potential to reach a far greater number of individuals who want to know their HIV status on their own terms. It’s time for everyone to know their HIV status. It’s time to give people tools without barriers to know their status.”

If the OraQuick In-Home HIV Test gets final FDA approval, hopes are high that this new tool will be instrumental in helping to reduce infection rates in the U.S. and globally.

There are “1.2 million people living with AIDS in the U.S. – and 20% don’t know it. This is a ticking time bomb,” said Frank Oldham, president and CEO of the National Association of People With AIDS. “We need more weapons to reduce HIV infections and we are morally obligated to bring this test to market and reduce the spread HIV.”

Cornelius Baker, technical adviser for the FHI 360 Center on AIDS & Community Health, underscored the value of testing at home with rapid results.

“This is especially important for those who will not seek testing in a public place or who need the convenience because of geography or time to test more frequently with this new method,” Baker said. “If we are to win the battle against the HIV epidemic, we need to employ multiple strategies. While [this is] not a product that every person will use or need, this in-home test is one more contribution to helping every American become part of ending AIDS in the United States.”

FDA presenters clearly felt the test had merit.

“Greater access to testing will potentially lead to more people knowing their HIV status.” said Dr. Elliot Cowan, who spoke on behalf of the FDA. “It appears there is a benefit in increasing the number of HIV positive people who know their status. There is public health impact and personal health impact.”

OraSure Executives seemed confident of approval calling it a momentous day for public health. “We plan to work with the FDA over the coming months to refine product label enhancements,” said Douglas Michaels, the company’s president and CEO. “And as quickly as we can get that done will determine how quickly we can get the product to retailers.”

Michaels says they have not yet finalized their pricing, but will sell the test to retailers at a discount and ultimately retailers will set the price.

———————–

US drug panel “backs over-the-counter HIV tests”

Wednesday, May 16, 2012,15:26

The Food and Drug Administration regulators will decide later this year whether to approve it; it does not have to follow the recommendations of the advisory panel, though it usually does, the `BBC` reported.

The 20-minute test is 93 per cent accurate for positive results and 99.8 per cent for negative, the manufacturer said.

To take the test, the user swabs the outer gum area so the oral fluid, which is not the same as saliva, can be checked for the HIV virus. The test provides results within about 20 minutes, but the experts say the results should be confirmed with a blood test, which is more accurate.

In fact, the experts on the Blood Products Advisory Committee voted 17-0 to back the test, saying it would help people who are HIV-positive get access to healthcare and social services.

The experts urged Pennsylvania-based OraSure, the company that manufactures the product, to include highly visible warnings about false negative results. The panel also advised that the packaging should carry a toll-free phone number offering counselling to those testing positive.

OraSure said the home test could retail for less than US dollars 60 if approved.

Carl Schmid, deputy director of the AIDS Institute, has welcomed the panel`s approval on Tuesday of the home test.

“We are always looking for game changers, and we believe this is one of them. Not only will it help reduce the number of infections but it will bring more people into care and treatment,” he was quoted as saying.

————————-

FDA panel backs first rapid, take home HIV test

Businessweek, Washington The Associated Press May 15, 2012, 6:29PM ET By MATTHEW PERRONE

American consumers may soon be able to test themselves for the virus that causes AIDS in the privacy of their own homes, after a panel of experts on Tuesday recommended approval of the first rapid, over-the-counter HIV test.

The 17 members of the Food and Drug Administration advisory panel voted unanimously that the benefits of the OraQuick HIV test outweigh its potential risks for consumers. While the test, which uses a mouth swab to return a result in 20 minutes, does not appear to be as accurate as professionally-administered diagnostics, panelists said it could provide an important way to expand HIV testing.

The FDA will make its final decision on whether to approve the product later this year, weighing the opinion of the panel.

Government officials estimate one-fifth, or about 240,000 people, of the 1.2 million HIV carriers in the U.S. are not aware they are infected. Testing is one of the chief means of slowing new infections, which have held steady at about 50,000 per year for two decades.

Based in Bethlehem, Pa., Orasure has marketed a version of OraQuick to doctors, nurses and other health care practitioners since 2004. When used by professionals, the test is shown to accurately identify both carriers and non-carriers 99 percent of the time.

But a trial conducted by the company showed the home test only correctly detected HIV in those carrying the virus 93 percent of the time. The FDA estimated the test would miss about 3,800 HIV-positive people per year, while correctly identifying 45,000, if approved for U.S. consumers. The test could prevent 4,000 new transmissions of the virus annually, though the figure could vary depending on how many people purchase the test. While it’s not clear why the test was less accurate in consumer trials, company researchers said they expected the test’s sensitivity to drop when used by consumers versus professionals.

Panelists stressed that the test’s labeling should state that a negative reading does not automatically mean the person does not have HIV, because of imperfect results. Panelists also stressed the importance of a toll-free number to put those who test positive in touch with counseling and medical care.

Despite concerns about less-than-perfect use by the public, the panel overwhelmingly sided with more than two dozen HIV advocates and doctors, who said the test represents a step forward in combating the virus.

“Over-the-counter testing has the potential to reach a far greater number of people who want to know their HIV status on their own terms,” said Tom Donohue, founder of HIV awareness group Who’s Positive.

“We are always looking for game changers, and we believe this is one of them,” said Carl Schmid, deputy director of the AIDS Institute. “Not only will it help reduce the number of infections but it will bring more people into care and treatment.”

Tuesday’s meeting was the second time in less than a week that FDA advisers recommended approval of a novel medical product to slow the spread of HIV. Last Thursday a similar panel of drug experts endorsed the HIV daily pill Truvada for preventive use. If FDA follows the group’s advice, the daily medication will become the first drug approved to prevent healthy people from becoming infected with the virus.

The FDA has already approved other HIV test kits designed to be used at home, although those kits — which require a blood sample — must be sent to a laboratory for development. Orasure executives argue that a test that can be done at home will appeal to a much broader group of people.

FDA officials said it is impossible to predict how widely the test would be used, but it would be most effective in the hands of people at high risk of acquiring the virus, including men who have sex with men.

A recent survey of gay and bisexual men cited by public health officials found that 84 percent would test themselves more frequently if they could buy an over-the-counter HIV test.

Orasure sells its professional version of the test for $17.50, though company executives declined to discuss how they would price the consumer version.

Home HIV test advances

An FDA advisory panel approved the oral swab screening.

By Don Sapatkin

Inquirer Staff Writer

OraQuick’s test gives results in about 20 minutes. About 240,000 Americans do not know they are HIV positive.A federal advisory committee on Tuesday unanimously approved over-the-counter sale of a rapid HIV test, acknowledging the need for new tools against an epidemic that is driven largely by people who don’t know their status and infect others.If the Food and Drug Administration agrees with its advisers, the oral swab screening device made by OraSure Technologies Inc. of Bethlehem, Pa., would become the first infectious disease test approved for home use.The panel overcame considerable unknowns and concerns that the test cannot pick up newly acquired infections.”I still can’t get past the quarter-million people who don’t get tested,” said member Steven W. Pipe, a pediatrics and communicable diseases specialist at the University of Michigan.An estimated 240,000 Americans are unaware that they are HIV positive, and are responsible for 50 percent to 70 percent of the 50,000 new infections each year.The test uses fluid from a swab of the gums. If a single horizontal line appears after 20 minutes, it has not detected antibodies to HIV. Two lines mean it is HIV positive, a preliminary finding that must be confirmed by a laboratory blood test.”We believe we are at a deciding moment in the trajectory of the AIDS epidemic,” Phill Wilson, executive director of the Black AIDS Institute, told the panel, referring to treatments that dramatically reduce transmission of HIV, the virus that causes AIDS. “The key to that begins with getting them tested.”The company has not disclosed a retail price or projected sales, although it estimated the entire market for rapid home HIV tests at $500 million retail. FDA staff projected that the test would be used by 2.8 million people in the first year. It would discover about 45,000 infections that otherwise would have remained unknown, and in turn, prevent HIV from spreading to 4,000 more people, the agency said.But it also would result in several thousand false negatives, either because consumers didn’t use it properly or their infections were too new to trigger the immune system response that produces antibodies picked up by the test. Much of Tuesday’s discussion among the advisory committee was about labeling and other ways to make clear to people at high risk of HIV that a negative test should be repeated three months later or confirmed with a laboratory blood test. Of particular concern was that people not use a negative result as a free pass to engage in risky sex. The company has said that each test kit would include two booklets – one with detailed information about HIV and the other on the meaning of test results – in English and Spanish. It also would refer people to a 24-hour call center. In addition to helping people understand their test results, the bilingual staff would be trained as crisis counselors and could link callers to local counseling and a medical treatment. In a teleconference with reporters after the advisory panel’s 17-0 vote, OraSure officials said they would immediately begin working with the FDA to address labeling issues. “We are extremely pleased with the outcome of today’s meeting,” said Douglas A. Michels, president and CEO of the company, which has 270 employees. The company has sold more than 25 million rapid HIV tests to clinics and testing centers around the world since 2002, when it won approval for the first rapid blood test for HIV. All were manufactured in Bethlehem. The product that was recommended for home use on Tuesday is identical to the oral version of that test, which was approved in 2004, except for the packaging, labeling, and support services. As a result, the company has said it could begin selling the test at pharmacies and online within 60 days of approval by the FDA. The agency typically follows its advisers’ recommendations but is not required to. More than 20 HIV activists, doctors, and public health workers testified at the Blood Products Advisory Committee hearing. They overwhelmingly supported the OraQuick In-Home HIV Test, often in passionate terms. “I envision my parishioners coming to me and saying, ‘Pastor, will you sit 20 minutes with me while I take the test?’ ” said Calvin O. Butts 3d, of the Abyssinian Baptist Church in New York, adding that they might never go to a clinic for a test and so would never know whether they had HIV. Tom Donohue, who grew up in Williamsport, Pa., recalled discovering he was HIV positive while a student at Penn State University. “I know what it’s like to wait for results, I know what it’s like to share my sexual history before a community member who is an HIV tester,” said Donohue, who founded and is executive director of Who’s Positive, an HIV awareness organization.

Grand Prize

The grand prize winner will receive $5,000 USD cash!

2nd Prize

The second prize winner will receive $1,000 USD cash!

Contest Instructions

UCLA IMPACT 2012 is a global competition, open to the general public, which aims to encourage investigators of all disciplines to transform the impact of their research through INNOVATIVE, CREATIVE, and EFFECTIVE HIV/AIDS presentation. The goal is to inspire a new generation of scientists, researchers, and innovators to make fresh scientific discoveries more accessible, useful and relevant to those affected by HIV. Knowledge is the key to the eradication of the HIV/AIDS epidemic. The winners will receive a cash prize and worldwide exposure of their work.

CHIPTS will accept submissions as a video, a written document, or a URL link to an originally designed webpage. The guidelines of presentation are purposely open ended to promote creativity, imagination, and inventiveness.

Participants must be at least 18 years of age.

If you have questions about the contest, please contact Brett Mendenhall at bmendenhall@mednet.ucla.edu.

Contest Starts

May 15, 2012 @ 08:00 am (PDT)

Contest Ends

July 15, 2012 @ 06:00 pm (PDT)

Need more Details?

Read the Official Rules

CLICK HERE TO ENTER

The Banyan Tree Project Launches National Digital Storytelling Initiative to End HIV Stigma for Asians, Pacific Islanders

“Taking Root: Our Stories, Our Community” highlights authentic, emotional stories from the community to fight HIV stigma. The Banyan Tree Project–a CDC-funded community mobilization campaign–uses innovative strategies to engage Asian Americans, Native Hawaiians, and Pacific Islanders in HIV prevention. Watch the stories at http://www.banyantreeproject.org.

May 19th, 2012 is the 8th annual National Asian & Pacific Islander HIV/AIDS Awareness Day. To commemorate the day, the Banyan Tree Project is launching a community-driven initiative to end HIV stigma and discrimination among Asian Americans, Native Hawaiians, and Pacific Islanders (AAs and NHPIs). “Taking Root: Our Stories, Our Community” is an innovative digital storytelling project produced in partnership with the Center for Digital Storytelling.

“We’re all living with HIV, whether we have the virus or not,” says San Francisco Health Commissioner Cecilia Chung, who is also living with HIV. “Real stories told by real people are the only way to get the community to understand how to break the cycle of shame. We can choose to perpetuate shame with our silence and judgment or we can choose to save lives with our love and compassion.”

Taking Root examines the shame, silence, and discrimination isolating AAs and NHPIs affected by HIV from their communities. The stories are rueful, like the one told by Hatsume, a young Japanese-American woman living with HIV. They are also hopeful, like Eric Zheng’s story, which describes his journey from a young medical student recently diagnosed with HIV to his current role as an HIV physician. Taking Root stories are not testimonials or documentary-style interviews. They are short video narratives created by the storytellers themselves. They are honest and real.

As the U.S. implements HIV prevention models like “test and treat”, engaging communities in ending HIV stigma becomes more important than ever. “Test and treat” hopes to drastically reduce the chance of HIV infection by immediately putting patients who test positive on antiretroviral treatment regimens. The success of “test and treat” depends in part on getting more people tested for HIV and into treatment if they are infected. But communities with high levels of HIV stigma will continue to avoid testing unless the shame, fear and discrimination that haunts the disease is addressed.

“We know HIV stigma prevents many AAs and NHPIs from getting tested for HIV or accessing treatment services,” said Barbara Garcia, San Francisco’s Director of Health. “We need community-based and community-driven initiatives like ‘Taking Root’ in order to make an AIDS-free generation a reality.”

AAs and NHPIs are the least likely race or ethnicity to get tested for HIV—over two-thirds of AAs and NHPIs have never been tested for HIV (National Health Interview Survey, 2009). The U.S. Centers for Disease Control and Prevention estimates that one in three AAs and NHPIs living with HIV doesn’t know it. For AAs and NHPIs, the silence and shame that prevents discussions of sex or HIV also prevents them from getting tested or treated for HIV.

“Taking Root: Our Stories, Our Community” can be viewed at http://www.banyantreeproject.org. Taking Root is an ongoing initiative and will include stories from AA and NHPI communities across the U.S. and the six U.S.-affiliated Pacific Island Jurisdictions. Taking Root stories are promoted online and at community events nationwide.

About the Banyan Tree Project

Supported by the U.S. Centers for Disease Control and Prevention, the Banyan Tree Project is a national community mobilization and social marketing campaign to eliminate the shame and silence surrounding HIV/AIDS in Asian American, Native Hawaiian and Pacific Islander communities (AA and NHPI). The Banyan Tree Project produces annual anti-HIV stigma messages and materials, the National Asian & Pacific Islander HIV/AIDS Awareness Day (May 19th), and provides capacity building assistance to community-based organizations serving AAs and NHPIs in the U.S. and six U.S.-affiliated Pacific Island Jurisdictions. The Banyan Tree Project is led by Asian & Pacific Islander Wellness Center in San Francisco. Regional partners include Asian Pacific AIDS Intervention Team (Los Angeles, CA), Life Foundation (Honolulu, HI), and Massachusetts Asian & Pacific Islanders for Health (Boston, MA). For more information visit http://www.banyantreeproject.org.

About the Center for Digital Storytelling

The Center for Digital Storytelling (CDS) surfaces authentic voices around the world through group process and participatory media creation. CDS programs support people in sharing and bearing witness to stories that lead to learning, action, and positive change. Over the past ten years, digital storytelling has emerged as an important participatory media production method used in a variety of community, health, educational, and academic research settings. Since beginning this work in the early 1990s, the Center for Digital Storytelling has drawn from well-established traditions in the fields of popular education, oral history, participatory communications, public health, and, most recently, what has been called “citizen journalism,” to train and work with small groups of people around the world, on the process and production of short, first-person video pieces that document a wide range of culturally and historically embedded stories. For more information please visit http://www.storycenter.org.

 

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Recently Published Article by CHIPTS Researcher, Arleen Leibowitz, Ph.D.

 

Condom Distribution in Jail to Prevent HIV Infection 

by Arleen A. Leibowitz, Nina Harawa, Mary Sylla, Christopher C. Hallstrom and Peter R. Kerndt

 

Download PDF here: [Download not found]

by Mark Mascolini at natap.org

CLICK HERE to read the full article

 
from Jules: as the meeting ended the FDA’s Debra Birnkrant, M.D. Director, Division of Antiviral Products said this was a “landmark” meeting and indeed it was. The meeting started at 8am and ended at 8:30pm. However, this was not the longest meeting. This is the longest FDA Antiviral Ad Board meeting since the FDA hearing for ritonavir & indinavir, a joint hearing for both drugs on back to back days, the ritonavir hearing as I recall was held over night, the FDA & the sponsor had to meet in the hotel overnight & the meeting was resumed the next day, this was under FDA Commissioner Kessler, I was there. Both meeting were landmarks, the IDV/RTV & this one, this one because this is the first hearing to discuss approval for a prevention drug, which will open an unchartered era and will be full of surprises. The discussions today by the panel were controversial & complicated, as lots of concerns were raised including what baseline tests & monitoring tests should be used and how often, including testing for HIV, viral load, HBV, STIs, renal function, bone dexas and more.

By large majorities, the FDA’s Antiviral Drugs Advisory Committee voted to recommend extending Truvada’s license to include pre-exposure prophylaxis (PrEP) for men who have sex with men (MSM) and for HIV-discordant couples (with one partner positive and one negative). The advisory panel also supported Truvada (coformulated tenofovir/emtricitabine) as PrEP for “other individuals at risk for acquiring HIV through sexual activity,” but less enthusiastically than they endorsed the first two indications.

The committee voted 19 to 3 to recommend Truvada PrEP for HIV-negative MSM and 19 to 2 (with 1 abstention) for HIV-negative partners in serodiscordant couples. The vote favoring PrEP for “other individuals at risk for acquiring HIV through sexual activity” was 12 to 8 with 2 abstentions.

Committee members voiced uncertainty about who the “other individuals” are, although completed and ongoing trials offer ample suggestions. In the two placebo-controlled trials Gilead Sciences advanced to support the PrEP indication, participants were MSM in iPrEx [1] and HIV-discordant heterosexual African couples in Partners PrEP [2]. A third trial that found daily Truvada helps protect people from HIV during sex, TDF2, enrolled high-risk Batswana women and men not necessarily in discordant partnerships [3]. Some MSM in iPrEx lived in the US, but most were from South America, South Africa, and Thailand. These trials included no heterosexual US men or women.

A fourth trial, FEM-PrEP, found no protective effect with Truvada taken by high-risk African women [4], while the VOICE PrEP/microbicide trial closed its microbicide arm and its oral tenofovir-only arm because those strategies were not protecting high-risk women from HIV [5]. FEM-PrEP investigators found that only 15% of women who got HIV in the Truvada group had detectable tenofovir levels at two visits. In its briefing document for the Truvada PrEP hearing, the FDA noted that “adherence to prescribed interventions appears to play a key role” in success or failure of PrEP [6].

Both iPrEx and Partners PrEP randomized HIV-negative participants to Truvada or placebo; Partners PrEP also tested tenofovir alone to prevent HIV acquisition by HIV-negative partners with an HIV-positive partner. In their primary analyses, iPrEx documented a 42% lower HIV acquisition risk with Truvada, while Partners PrEP found a 75% lower risk with Truvada and a 67% lower risk with tenofovir alone. An FDA analysis presented at the hearing indicated that iPrEx men with measurable intracellular drug concentrations had an 87.5% lower risk of HIV infection than men taking placebo.

The licensing change formally requested by Gilead is that “Truvada is indicated for pre-exposure prophylaxis (PrEP) to reduce the risk of sexually acquired HIV-1 infection in adults.” Recommendation for an extended indication by the Antiviral Drugs Advisory Committee does not oblige the FDA to follow suit, but it seems likely the FDA will do so. On the way to the committee vote, FDA analysts presented a largely favorable review of Truvada PrEP findings, concluding that “safety and efficacy of [Truvada] for the prevention of HIV-1 infection in high-risk individuals is supported by two large clinical trials” [iPrEx and Partners PrEP].

Data presented by the iPrEx and Partners PrEP principal investigators showed that resistance did not emerge in anyone randomized to Truvada who became infected during the course of the trial. Resistance developed in a few people who took Truvada or tenofovir during early HIV infection that had gone undetected. Neither trial found evidence of risk compensation–the possibility that people using PrEP will ignore other measures that protect them from HIV, such as consistent condom use. In fact, study participants generally practiced safer sex after enrolling in the trials.

The FDA advised that “regular HIV testing, adherence and behavioral counseling on safer sex practices, including condom use, are essential components of healthcare delivery around PrEP.”

FDA officials did raise some safety concerns in their analysis of iPrEx and Partners PrEP. Noting that renal failure or Fanconi syndrome did not occur among Truvada takers in iPrEx, the FDA cautioned that cases of concurrent proteinuria, glycosuria, and hypophosphatemia primarily in the Truvada arm “may be potentially concerning for subclinical proximal renal tubulopathy, although the limited numbers and poor adherence observed in this trial, as assessed by drug level monitoring, preclude reliable interpretation” [6].

In Partners PrEP only 7 people permanently withdrew because of adverse events, and 6 withdrawals were attributed to grade 2 renal toxicity, 3 in people taking tenofovir alone, 2 in people taking Truvada, and 1 in the placebo group [6]. All renal toxicity (creatinine clearance below 50 mL/min) resolved in 5 women when they stopped study drugs. Results are pending on the 1 man who endured renal toxicity.

Analyzing renal toxicity in other ways, the FDA found no evidence linking toxicity to tenofovir or Truvada in Partners PrEP [6]. Treatment-emergent creatinine increases affected 5% taking tenofovir, 7% taking Truvada, and 5% taking placebo. “Drug-related” creatinine toxicity affected only 8 people overall (0.2%), and 5 of those 8 were taking placebo.

Truvada PrEP trials completed so far include few African-American men, who have a higher risk of renal disease than white men. And because HIV incidence has been climbing in African-American MSM, they are likely candidates for Truvada PrEP.

The FDA noted that men enrolled in iPrEx had lower bone mineral density (BMD) when they entered the trial than does the general population. Men randomized to Truvada had small but statistically significant drops in BMD compared with the placebo group throughout the trial. BMD declines of more than 5% from baseline affected 14% of iPrEx participants taking Truvada versus 6% taking placebo. The FDA pointed to similar BMD declines among MSM in a CDC study of tenofovir safety [7].

The FDA mentioned renal toxicity in its overall premeeting briefing conclusion of Truvada PrEP efficacy and safety: “The decision to prescribe [Truvada] for the prevention of sexual acquisition of HIV infection should carefully weigh the individual risks for acquiring HIV, their understanding of the importance of adherence to medication, and their potential for development of renal toxicity” [6].

Before clinicians start Truvada PrEP, the FDA said in its premeeting document, they should (1) test the person for HIV, (2) measure renal function and serum phosphorous, and (3) assess risk factors for renal and bone toxicity [6]. Clinicians might also consider supplementing vitamin D and calcium in someone taking Truvada PrEP, the FDA advised. Everyone using Truvada for PrEP should get tested regularly for HIV and monitored for renal problems. Some Truvada takers may benefit from DEXA bone scans before and during PrEP, the FDA suggested.

The FDA offered this final conclusion in its briefing document: “If physicians prescribe and individuals utilize [Truvada] in the manner described for PrEP, in combination with other strategies to prevent HIV infection, the individual at risk may be spared infection with a serious and life-threatening illness that requires lifelong treatment with a three-drug antiretroviral regimen. That regimen, in line with current treatment guidelines for HIV-infected treatment-naive patients, will almost certainly contain [Truvada]” [6].

On Tuesday, Food and Drug Administration reviewers affirmed clinical trial data suggesting the HIV drug Truvada is safe and effective in cutting HIV infection risk when taken daily. The positive review comes ahead of an FDA advisory panel’s meeting on Thursday to discuss whether to approve Truvada for people at high risk of acquiring HIV sexually. The drug from Gilead Sciences already is approved to treat persons infected with HIV.

The panel will take separate votes on approval to market Truvada as an HIV prevention option among:
*gay and bisexual men,
*people in serodiscordant relationships and
*others at risk for acquiring HIV sexually.

Truvada only worked to prevent HIV when taken every day, reviewers emphasized. Adherence to the once-daily pill was less than perfect in clinical trials, which included condom use and HIV counseling, and adherence may be even less ideal in the real world, reviewers said.

Some researchers note that condoms are still the best prevention against HIV, and that a pill is not the same. Some drugs on the horizon also may prove to be better for HIV prevention than Truvada, which has had mixed results for preventing infection in women, critics say. Nonetheless, many advocates say Truvada should be an option, along with condoms, counseling, and other prevention measures.

Side-effects associated with Truvada include dizziness, diarrhea, nausea, and vomiting. More serious adverse events include liver toxicity, bone thinning, and kidney problems.

FDA does not have to follow the advice of its advisory panels, but usually does so.

By Tim Horn at POZ.com
on May 4, 2012 

Roughly a year ago, I was asked by Jose Zuniga of the International Association of Physicians in AIDS Care (IAPAC) to serve as a writer and member of the first-ever blue-ribbon panel assigned with the task of developing international guidelines for improving engagement in HIV care and treatment adherence. The Guidelines for Improving Entry into and Retention in Care and Antiretroviral Adherence for Persons with HIV were first made available online ahead of print by Annals of Internal Medicine on March 5 and were eventually published in the May 1 issue of the journal.

The experience was eye-opening, to say the least. Working most closely with two of the smartest, dedicated and caring HIV-treating clinicians and researchers I can name–Michael Mugavero, MD, of the University of Alabama, Birmingham, and Melanie Thompson, MD, of the AIDS Research Consortium of Atlanta–I was most heavily involved in the sections focusing on entry into and retention in care. Basically, I was charged with reviewing to what extent people living with HIV are actually receiving regular care–irrespective of whether or not actual HIV treatment is prescribed–and coming up with recommendations to shore up weaknesses. How hard could this possibly be?

Well, it turned out to be much easier than I thought, only because the national portrait of entry into and retention in HIV care has been consistently abysmal and the astounding dearth of data from well-designed studies exploring entry and retention strategies that could be used to construct well-formed recommendations.

In retrospect, I would have liked for my job to have been much, much harder.

Reading through the rest of the IAPAC guidelines, it is abundantly clear that the pharmaceutical industry, along with public and private research networks, have done a bang-up job improving our ability to adhere to HIV treatment. Millions, if not billions, have been spent on transforming fistfuls of relatively toxic pills, taken multiple times a day, into safer coformulations and novel combinations that involve taking no more than one or two tablets or capsules once or twice a day. There have also been several well-designed studies exploring the utility of treatment adherence strategies, such as directly observed therapy, electronic pill bottle caps, text messaging, phone calls, educational programming and a variety of counseling methods.

Synthesizing all of the treatment adherence data for the sake of best-practices guidelines wasn’t easy, for sure, but the end result was a clear set of conclusive recommendations based on strong scientific conclusions.

However, none of this–the ability to prescribe easy, highly effective treatment regimens and a plethora of adherence tools to prolong our health and prevent ongoing transmission of the virus on a massive scale–matters if we can’t first get people living with HIV connected to regular care.

The situation is direr than I, for one, ever imagined. Only in recent years have data emerged, underscoring how far off we are from a central tenet of the National AIDS Strategy: Ensuring that all people living with HIV are well supported in a regular system of care.

Consider the following….