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FDA approves rapid at-home HIV test kit

Will soon bring into homes a screener that clinics have been using since 2004; detects anitbodies to HIV virus in 20 to 40 minutes

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OraSure, OraQuick, HIV, HIV test, gay news, Washington Blade

The FDA has approved for home use the rapid HIV test OraQuick already in use at clinics and testing centers throughout the nation. (Photo courtesy OraSure Technologies Inc)

The U.S. Food and Drug Administration approved Tuesday the rapid OraQuick In-Home HIV Test for over-the-counter sales for the first time.

“The test has the potential to identify large numbers of previously undiagnosed HIV infections, especially if used by those unlikely to use standard screening methods,” the FDA said in a release.

Experts estimate one-fifth of those infected with HIV are unaware of their status. The Centers for Disease Control and Prevention estimates 1.2 million Americans are living with HIV, and that there are 50,000 new HIV infections annually, primarily transmitted from people unaware of their HIV status. As such, increasing access to the HIV screener has become a cornerstone of the fight against the disease.

The newly approved test, which allows users to swab their gums in order to detect the presence of antibodies to HIV in 20 to 40 minutes, will soon bring into homes a tool that clinics have been using since 2004.

“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 in a press release, Tuesday. “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.”

Clinical studies of the test showed a 92 percent sensitivity rate, which means that of every 12 HIV-infected individuals tested with this kit, one negative could be expected, which raised alarm among HIV/AIDS activists.

“Shortly after my first post on this product, I managed to corner an OraSure executive backstage at the NYC AIDS Walk, where I grilled him about the possible abuses of the product by parents and partners and about the potential for self-harm upon a positive result,” wrote AIDS activist and gay blogger Joe Jervis in a blog post on Tuesday. “He told me that the company had considered all of that and had the position that those hopefully rare occurrences were outweighed by the potential for getting many more people on the necessary treatments.”

The FDA release addressed those concerns as well on Tuesday.

“A positive result with this test does not mean that an individual is definitely infected with HIV, but rather that additional testing should be done in a medical setting to confirm the test result,” the release read. “Similarly, a negative test result does not mean that an individual is definitely not infected with HIV, particularly when exposure may have been within the previous three months.”

The OraSure test is the first test that allows users to learn their results at home immediately, without interacting with professionals, which some experts say may not be ideal. The Home Access Health Corporation’s ‘Home Access HIV-1 Test System’ was given FDA approval in 1996, and continues to be available to consumers widely in stores and pharmacies around the nation. The system differs from the approved oral-swab OraSure test, as the test performed is a self-collected fingerstick blood sample that is mailed to the Home Access Health Corporation’s College of American Pathologist accredited laboratory for testing. The results are also given to the consumer via trained HIV professionals, with immediate counseling available.

“We believe that an individual’s access to HIV testing in the privacy of their own home is critical to knowing their HIV status,” said Home Access Health Corporation president Mary Vogt, calling differences in accuracy between the two tests “significant.” “It’s our hope that FDA’s approval of another at-home testing option will add to the body of knowledge surrounding risk factors for HIV, increase overall testing, and reduce the rates of transmission of this dangerous virus.”

Home Access Health Corporation has provided the following side-by-side comparison of the two tests:

Home Access, OraQuick, HIV, HIV/AIDS, gay news, Washington Blade

Home Access provided the above side-by-side comparison of the two tests to media outlets. (Source: Home Access Health Corporation)

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Health

UNAIDS to commemorate Zero Discrimination Day’s 10th anniversary

UN agency urges global action to protect human rights

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A UNAIDS anti-discrimination exhibit at Tocumen International Airport in Panama in 2018. (Washington Blade photo by Michael K. Lavers)

As the world marks the 10th anniversary of Zero Discrimination Day; UNAIDS is sounding the alarm on the increasing threats to human rights, calling for renewed efforts to protect the rights of all individuals as a fundamental step towards ensuring health for everyone.

Established by UNAIDS a decade ago, Zero Discrimination Day aims to promote equality and fairness regardless of gender, age, sexuality, ethnicity or HIV status. The progress achieved over the past years is now in jeopardy, however, due to rising attacks on the rights of women, LGBTQ people and other marginalized communities.

UNAIDS Executive Director Winnie Byanyima emphasized the critical link between protecting human rights and safeguarding public health. 

“The attacks on rights are a threat to freedom and democracy and are harmful to health,” she said in a press release. “Stigma and discrimination obstruct HIV prevention, testing, treatment and care and hold back progress towards ending AIDS by 2030. It is only by protecting everyone’s rights that we can protect everyone’s health.”

Despite challenges, there has been notable progress. 

At the onset of the AIDS pandemic more than 40 years ago, two-thirds of countries criminalized consensual same-sex sexual relations. They are now decriminalized in two-thirds of countries. An additional 38 countries around the world have pledged to end HIV-related stigma and discrimination, contributing to positive changes that include 50 million more girls attending school compared to 2015.

To sustain and enhance these advancements; UNAIDS urges global support for women’s rights movements, LGBTQ rights, racial justice, economic justice, climate justice and peace initiatives. By standing with communities advocating for their rights, the U.N. aims to reinforce the collective effort towards a more inclusive and equitable world.

Zero Discrimination Day is observed on March 1.

Events and activities that will take place around the world throughout the month will serve as reminders of the essential lesson and call to action: Protecting everyone’s health is synonymous with protecting everyone’s rights.

“Through upholding rights for all, we will be able to achieve the Sustainable Development Goals and secure a safer, fairer, kinder and happier world — for everyone,” said Byanyima.

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Health

New CDC report finds transgender women at higher risk for HIV

More than 1,600 people in seven cities surveyed

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The Centers for Disease Control and Prevention in Atlanta (Photo courtesy of the CDC)

The Centers for Disease Control and Prevention issued a new study report this week that revealed that restricted by employment and housing discrimination and lack of access to needed gender-affirming healthcare for transgender women increasing the risk of contracting HIV. 

Researchers reviewed data from a 2019-2020 survey, the National HIV Behavioral Surveillance Among Transgender Women, which found that the demographics of HIV/AIDS have been disproportionally high, especially among Black and Latina trans women, who had experienced employment and housing discrimination coupled with lack of access to gender-affirming healthcare.

The Jan. 25 Morbidity and Mortality Weekly Report was based on data studies of more than 1,600 trans women in seven major urban locales. Participants from Atlanta, Los Angeles, New Orleans, New York, Philadelphia, San Francisco and Seattle were chosen by referrals from people and community-based organizations who knew or were part of the local population of trans women.

The study’s researchers noted: “Employment discrimination occurs at the overlapping nexus of poverty, homelessness, incarceration, health insurance, disability, food insecurity and survival sex work. These issues are interconnected.”

The study stated that trans women’s inability to access quality healthcare, including gender-affirming treatment or access to PrEP, and can expose them to potential incarceration as many turn to “survival sex work” and violence, which increases the risk of contracting HIV. 

The study’s author’s pointed out: “When economically marginalized transgender women are refused employment, this refusal cyclically contributes to economic hardships. This analysis …demonstrates the importance of transgender women working and living with dignity and without fear of unfair treatment.”

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Health

A Whole New Perspective on Well-Being

The Mather’s team recognizes that everyone’s wellness journey is completely unique to their life experiences and influences.

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The Mather is incorporating biophilic design—a design approach to facilitate access to nature or things that replicate natural patterns.

It’s easy to spot the distinctive, elegant silhouette of The Mather, a Life Plan Community for those 62+ opening this spring in Tysons, Virginia. What is not apparent to the naked eye is The Mather’s unique wellness philosophy, which is literally built into the community. 

The Mather’s team recognizes that everyone’s wellness journey is completely unique to their life experiences and influences.

Nature is one of the important factors that contribute to well-being. So The Mather is incorporating biophilic design—a design approach to facilitate access to nature or things that replicate natural patterns. This can include interior spaces with sightlines to a garden, choosing natural wood and stone as interior materials, or incorporating fragrant flowers and plants indoors to spark memories and provide tactile opportunities such as gardening. 

Residents of The Mather will be able to select from plentiful amenities, programs, and other offerings to target their personal wellness goals and preferences.

“Providing biophilic design within interior settings connects residents to the natural world,” says Mary Leary, CEO and President of Mather, the organization behind The Mather. “Research shows that a connection to nature provides positive benefits to mental states and overall well-being. At The Mather, biophilic design is the intersection of buildings and programs with nature in an urban setting.”

“The Mather is attracting a diverse group of older adults,” says Mary. “As a result, we aim to incorporate wellness practices from around the world, including Wyda movement theory of the Celtic Druids, which helps people achieve harmony with nature and contentment through mindfulness.” This holistic regenerative approach is similar to Qi Gong and yoga, while born in a different part of the world. Mather Institute has a special focus on mindfulness to support older adults’ practice of present moment awareness, which can lead to increased overall well-being, compassion, and joy.

A very different example of a wellness offering at The Mather is the Gharieni Welnamis spa wave bed, which uses computer-controlled vibrational therapy and audio frequencies to train the brain to relax. “The bed increases mindfulness, concentration, and creativity—all of which support our mission of creating Ways to Age Well,SM” says Mary.

These and other personalized ways to wellness will ensure that residents of The Mather can choose from seemingly countless ways to focus on their well-being. In other words, the sky’s the limit!

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