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Spain to test if PrEP can prevent COVID-19 infection in medical workers

Study will examine results over a 12-week period

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HIV epidemic, PrEP usage, HIV status, Pre-exposure prophylaxis, non-daily PrEP, Truvada, domestic violence, AIDS drugs, PrEP, gay news, Washington Blade
Spain is set to test whether PrEP can prevent COVID-19 infection in medical workers.

A new clinical trial is underway in Spain that will assess whether Truvada, a drug commonly used as PrEP for HIV prevention, can stave off COVID-19 infection among medical practitioners seeking to treat patients amid the pandemic.

If successful, the trial may have broader implications for the general public and not just health workers. But the next step would be awaiting the result of the trials before the drug is determined to be effective.

The study, which began April 1 and is expected to run through the summer, is being conducted at Ramón y Cajal University Hospital in Madrid and sponsored by the Spanish National AIDS Plan, an arm of the Spanish government.

An estimated 4,000 participants will participate in the study, each of whom are medical workers age 18 to 65 working in areas of Spain heavily afflicted with the coronavirus.

Dr. Jose Arribas, research director of HIV and infectious diseases at La Paz Hospital in Madrid, said in Spanish via email to the Washington Blade one underlying basis for testing Truvada against COVID-19 is his findings that relatively few HIV-positive people have the disease.

“We are seeing few cases of HIV-positive people with severe COVID-19,” Arribas said. “This is surprising because the immune system of an HIV-positive person has similarities to that of older people who do have severe cases of COVID-19. Furthermore, there is evidence from in vitro studies that supports Truvada can have an immunomodulatory effect.”

Asked whether Truvada could be used for everyone, not just health care workers, if shown to have a positive impact in the study, Arribas replied, “You have to wait for the results of the study before we can answer this question.”

The National Institutes of Health in the United States posted a notice Monday about the test on the agency’s website, which lists ongoing or upcoming clinical trials across the globe.

According to the abstract, the study will seek to assess whether the components of Truvada — as well as hydroxychloroquine, a drug with well publicized potential use against COVID-19 — are effective in preventing coronavirus infection among medical practitioners because “healthcare workers are particularly at risk of SARS-CoV-2.”

“In the absence of a vaccine, other strategies aiming to reduce the development of COVID-19 in the population, more specifically in healthcare workers is being sought,” the abstract says. “Administration of effective drugs to people at risk of developing an infectious disease is well accepted and is part of clinical practice.”

The choice of Truvada for the study, according to the abstract, is the result of anecdotal evidence the medicine may be effective against COVID-19.

“Existing recent and scarce literature shows that RNA synthesis nucleos(t)ide analogue inhibitors, acting as viral RNA chain terminators, like TDF, abacavir or lamivudine, amongst others, could have an effect against SARS-CoV-2 infection,” the abstract says.

Over the course of the 12-week study, administrators will provide daily doses of Tenofovir Disoproxil Fumarate and Emtricitabine, the components of Truvada, Hydroxychloroquine and placebos to study participants.

One group will receive a daily dose of Truvada and a hydroxychloroquine placebo; another will receive hydroxychloroquine and a Truvada placebo; another will receive both drugs; and another will receive a placebo of both drugs.

The trial will assess confirmed infections of COVID-19 as a primary outcome measure, then the severity of disease, including its duration, among confirmed infected participants as a secondary outcome measure.

The initial results of the study are expected to be compiled by June 30, but the study won’t be completed until July 31, the abstract says.

Overseeing the test will be Dr. Rosa Polo of the Spanish National AIDS Plan and Miguel Hernan, an epidemiologist at the Harvard School of Public Health, according to the abstract.

Ramón y Cajal University Hospital in Madrid and the Spanish National AIDS Plan didn’t respond to a request for comment.

Truvada has been brought up as a potential drug to test against COVID-19 among many other medications being assessed for use against the epidemic. Also in the mix is Remdesivir, an antiviral drug the medical experts have said may hold the best chance against COVID-19.

Dr. Sarah Henn, chief health officer of the D.C-based Whitman-Walker Health, welcomed news of the trial in an email responding to the Washington Blade’s request to comment on the study.

“We are happy to see trials focusing on both prevention and treatment of COVID-19 infections and look forward to learning from these results,” Henn said.

Dr. David Hardy, adjunct professor of medicine for the Division of Infectious Diseases at Johns Hopkins University School of Medicine, on expressed skepticism about study because it makes “a big jump” on the use of Truvada for HIV prevention to its use for COVID-19 prevention.

“Truvada for PrEP was created as a new option for trying to prevent
those who aren’t infected with HIV,” Hardy said. “If we can use that analogy with COVID-19, we don’t have a treatment that we can easily extrapolate into prevention yet.”

Based on that, Hardy said he’d be more supportive of a study that strictly tested hydroxychloroquine as a means to prevent COVID-19, and not the combination of the drug with Truvada.

“That’s simply because of the fact that we at least have some laboratory information that says that hydroxychloroquine does in fact have some anti SARS-CoV-2 antiviral activity,” Hardy said. “We know that it works against the virus, at least in a test tube.”

Gilead Sciences, the manufacturer of Truvada, has told the Blade it would conduct an in vitro test of the components of Truvada against the coronavirus, but has low expectations for the drug’s effectiveness. The company hasn’t responded to requests from the Blade for an update.

The Spain study appears strictly to be a project of the Spanish government; U.S. government health officials aren’t involved even though NIH posted an abstract of the study online.

Kathy Stover, a spokesperson for the National Institutes of Health, told the Washington Blade NIH doesn’t have any involvement in the study.

“The study you highlighted is actually not being funded or conducted by the NIH,” Stover said. “It’s being led by the Plan Nacional sobre el Sida (PNS) in Spain.”

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DC residents with HIV eligible for COVID vaccine

Mayor announces expanded eligibility as vaccine supply increases

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COVID-19 vaccine, gay news, Washington Blade

D.C. Mayor Muriel Bowser announced on Feb. 24 that D.C. residents between the ages of 16 to 24 who have one of 19 pre-existing medical conditions, including HIV, will now be eligible to make an appointment to receive the COVID-19 vaccine.

The mayor and D.C. Department of Health Director Dr. LaQuandra Nesbitt said the appointments could be made through the city’s special site, vaccinate.dc.gov, beginning Thursday and Friday, Feb. 25 and 26. The vaccinations themselves for the expanded group of residents, including people with HIV, would begin March 1, the mayor said in an announcement.

Abby Fenton, a spokesperson for Whitman-Walker Health, the D.C. community health center that provides services to the LGBTQ community and people with HIV, said Whitman-Walker has begun contacting its HIV patients about the availability of the COVID vaccine for them.

“We are urging people to try to make an appointment with the city because we have such a limited supply,” Fenton said. She said Whitman-Walker is dispensing the vaccine for those who the city determines are eligible at its medical center locations at 1425 14th Street, N.W., and at its Max Robinson Center at 2301 Martin Luther King Jr. Ave., S.E.

Michael Kharfen, the DOH official in charge of the city’s HIV/AIDS, Hepatitis, STD, and Tuberculosis Administration, said the limited supplies of the COVID vaccine that the city has been receiving from the federal government has prevented the allocation of vaccine supplies to community health centers like Whitman-Walker until a few weeks ago.

He said supplies of the vaccine have increased in recent weeks and the Department of Health was hopeful that it will be able to provide additional supplies of the vaccine to community health centers and other facilities and health care providers.

Kharfen noted that the city has been increasing the availability of the vaccine to different groups of residents in stages as supplies have increased. Front line medical workers and nursing home residents were the first to receive the vaccine. The most recent group to become eligible prior to the mayor’s most recent expansion this week were people 65 years of age and older.

The mayor’s announcement on Feb. 24 listed these pre-existing medical conditions, including HIV, that would make city residents between the ages of 16 and 64 eligible for the COVID vaccine:

Asthma, Chronic Obstructive Pulmonary Disease (COPD), and other Chronic Lung Disease; Bone Marrow and Solid Organ Transplantation; Cancer; Cerebrovascular Disease; Chronic Kidney Disease; Congenital Heart Disease; Diabetes Mellitus; Heart Conditions, such as Heart Failure, Coronary Artery Disease, or Cardiomyopathies; HIV; Hypertension; Immunocompromised State; Inherited Metabolic Disorders; Intellectual and Developmental Disabilities; Liver Disease; Neurologic Conditions; Obesity, BMI ≥ 30 kg/m2; Pregnancy; Severe Genetic Disorders; Sickle Cell Disease; and Thalassemia.

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Coronavirus

D.C. gay bars struggling to stay open in pandemic

Mayor’s new rule banning liquor sales after 10 p.m. called ‘devastating’

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gay bar, gay news, Washington Blade
Nellie’s Sports Bar (Washington Blade photo by Michael Key)

John Guggenmos, co-owner of the D.C. gay bars Number 9 and Trade, says he and his business partners support Mayor Muriel Bowser’s efforts to keep people safe as the number of people testing positive for COVID-19 continues to rise in the city.

But Guggenmos and other gay bar owners say the mayor’s most recent order requiring bars and restaurants to stop serving alcoholic beverages after 10 p.m. has had a devastating impact on what had already been a major decline in business since the COVID restrictions were put in place earlier this year.

“We see hope on the horizon,” Guggenmos said. “But for many places it’s just going to be too late. It is sad because even if I am in a position that we can weather this storm better, if other places in the neighborhood don’t, then we all suffer.”

Exterior of Trade, which is working to serve customers amid new 10 p.m. cutoff for alcohol sales. (Washington Blade photo by Michael Key)

David Perruzza, owner of the Adams Morgan gay sports bar Pitchers and its adjoining lesbian bar A League of Her Own, said gay bar customers traditionally come out to the clubs after 9 p.m. and often remain there several hours later.

Under the mayor’s current Phase II rules for addressing the COVID health emergency all restaurants and bars must close at midnight, two hours earlier than the pre-epidemic closing time of 2 a.m. during the week and three hours sooner than the normal 3 a.m. closing time on weekends. That restriction by itself has resulted in a significant drop in revenue for bars and nightclubs, including LGBTQ clubs, officials with the clubs have said.

The new restriction put in place last month banning liquor sales after 10 p.m. allows bars and restaurants to continue to stay open until midnight. But Guggenmos, Perruzza and other bar owners say few if any customers would likely come in to order non-alcoholic beverages. Thus they and nearly all of the city’s bar and restaurant owners have decided to close at 10 p.m. until the restrictions are lifted, a development that has further curtailed their businesses.

“I’ve had the worst two weekends of my life at the bar,” said Perruzza in referring to the weekends following the ban on liquor sales after 10 p.m. “I can’t sustain a business this way,” he said.

Pitchers (Washington Blade photo by Michael Key)

Dr. LaQuandra Nesbitt, director of the D.C. Department of Health, has said city inspectors have found that more violations of the COVID-related health restrictions at restaurants and bars, such as social distancing and mask wearing, were occurring after 10 p.m. as patrons consumed more alcohol. But nightlife advocates have disputed claims that riskier behavior occurs after 10 p.m. They say there are no studies or data to back up those claims.

Perruzza said he understands that while the mayor’s intention is to curtail the spread of the coronavirus he believes the 10 p.m. cutoff on alcohol service will result in large numbers of bar customers going to private parties in people’s homes where there will be fewer safeguards to curtail the virus.

“By her doing this she is going to push people to have more house parties,” Perruzza said. “At least if they’re in a restaurant or bar they’re in a controlled environment where they take their temperature. They make sure everything is sanitized after people leave,” Perruzza said. “People are not required to wear masks when they go to house parties.”

Prior to the start of the pandemic, D.C. was home to at least 15 gay bars or nightclubs in which the clientele was largely LGBTQ. A number of other D.C. bars and nightclubs are considered LGBTQ friendly, according to gay D.C. nightlife advocate Mark Lee, who said those additional establishments have a significant LGBTQ clientele.

In March, Bowser issued her initial emergency health order requiring all “non-essential” businesses, including bars and restaurants, to temporarily close their indoor operations to customers in an effort to curtail the spread of the coronavirus. Carryout food and drink orders were allowed, and some of the gay clubs joined other bars and restaurants in putting in place a take-out order business.

A short time later, the DC Eagle, the city’s longest continuously operating gay bar, announced it was permanently closing. The Eagle’s majority owner filed for Chapter 7 bankruptcy following longstanding financial problems, but many of the Eagle’s customers believe the pandemic played some role in the permanent shutdown.

At the same time, the popular LGBTQ nightclub Ziegfeld’s-Secrets closed its doors indefinitely after the owner of the building where it was located in the city’s Buzzard’s Point area invoked its longstanding plan to demolish the building to make way for a new condominium and retail development. Ziegfeld’s-Secrets manager Steve Delurba said the club would like to reopen in a new location but efforts to reopen would have to wait until all COVID-19 restrictions on such establishments were lifted.

Among the city’s remaining 13 LGBTQ bars and clubs, all but one has reopened after the mayor put in place the city’s Phase II business reopening plan in June, which allowed bars, restaurants, and other businesses to resume limited indoor operations.

The Fireplace, a gay bar at 2161 P St., N.W. near Dupont Circle, decided to remain closed rather than operate under the COVID restrictions but “definitely” plans to reopen, according Larry Ray, a longtime customer who said he spoke with one of the owners.

Among the other Phase II restrictions for bars, restaurants and nightclubs put in place by Bowser in the spring was the requirement that such establishments must operate at 50 percent of their normal indoor capacity, all patrons must be seated at tables spaced six feet apart, and at least three food items must be served that are prepared on the premises regardless of whether the establishment was exempt from serving food prior to the pandemic. The Phase II order also bans the establishments from offering live entertainment.

Two weeks ago, when the mayor issued her updated order banning the serving of alcoholic beverages after 10 p.m. at bars and restaurants, she also included in the order a reduction in the capacity of customers from 50 percent to 25 percent based on concern that the number of COVID-19 cases was rising in D.C. after the case number had gone down in the spring and summer.

Perruzza told the Blade that due to the Phase II social distancing requirements and the spacing of tables and the ban on allowing customers to stand except to walk in and out and go to the bathroom, Pitchers and his adjoining bar A League of Her Own were never able to reach a 50 percent capacity. At most, he said, he was able to reach a 33 percent capacity, which now must be reduced to 25 percent.

Meanwhile, the D.C. gay bar Dirty Goose at 913 U St., N.W. is among the establishments hit with a fine for allegedly violating the Phase II food serving requirement. According to a report in the Washington City Paper, an inspector from the city’s Alcoholic Beverage Regulation Administration on Nov. 27 cited Dirty Goose for serving only cookies as a food item, saying it failed to provide at least two other types of food such as popcorn or brownies instead of just cookies.

Co-owner Justin Parker told City Paper he plans to contest the citation on grounds that the establishment serves multiple types of cookies that are prepared on the premises and that the different types should be accepted as different food types. He said that ABRA inspectors came to Dirty Goose six or seven times in November prior to citing him for the food violation and found his establishment to be in full compliance with all of the COVID related requirements.

On its Facebook page the Dirty Goose announced on Nov. 10 that it had voluntarily closed its doors after one of its employees tested positive for COVID and out of caution it would remain closed until all remaining employees were tested. On Nov. 15 it announced “we have received all our employees test results and we are ready to reopen,” which happened less than a week later.

In a Nov. 25 Facebook message, Dirty Goose conveyed what appears to be the sentiment shared by the other LGBTQ bar owners and operators.

“First, we would like to thank all of our wonderful family of patrons who have kept us going since May,” the message says. “What a crazy 8 months it’s been!” After announcing the Dirty Goose would be closing at 10 p.m. each day due to the mayor’s order banning alcohol sales after that hour, the message added, “We look forward to continue serving all of you and please know we are continuously following the safety requirements set by the DOH and the safety of our staff and patrons remains our main priority.”

Dirty Goose was recently fined for allegedly violating rules about serving three kinds of food to remain open. (Washington Blade photo by Michael Key)

Lee, the longtime D.C. nightlife advocate who served as director of the D.C. Nightlife Council before being furloughed, said the 10 p.m. cutoff for the sale of liquor at bars and restaurants will be especially harmful coming with all the other restrictions.

“The most maddening aspect of Mayor Bowser suddenly halting all alcohol consumption after 10 p.m. at local bars, restaurants, and nightclubs operating in full compliance with public safety protocols and highly restricted service limitations is that there is no actual data or evidence-based rationale for this financially devastating roll-back curfew,” Lee told the Blade.

“This arbitrary edict jeopardizes the survival of hospitality establishments by causing them to lose the major portion of revenue they had been able to generate,” he said. “We’re getting reports that this decision is costing operators up to 60 percent or more of the little money they were making, leaving most with no choice other than to shut down two hours earlier rather than attempt to now serve only food items and non-alcoholic beverages until midnight,” Lee said.

Lee noted that at a press conference on Dec. 7, Bowser acknowledged that nightlife establishments, including restaurants and bars, have done an exemplary job of complying with health requirements and providing a safe space for patrons and employees.

At that press conference the mayor also said she looks forward to being able to lift all restrictions on businesses once the COVID vaccine becomes widely available. But she said that with a resurgence of COVID cases in D.C. in recent weeks along with the rise in cases in the surrounding suburbs the city could be forced once again to order the complete shutdown of indoor operations of businesses like restaurants and bars if the local COVID situation worsens.

Perruzza, Guggenmos and Doug Schantz, owner of the gay sports bar Nellie’s at 900 U St., N.W., each said their establishments and others like them serve as a place where LGBTQ people can go to be themselves, which many are unable to do at work, school, or even at home in some situations.

“At some point safe human interactions are what people are craving,” said Guggenmos. “You see someone on the street and how they desperately just want that interaction again,” he said. “If we could do that safely, why not?”

D.C.’s LGBTQ Bars/Restaurants

Nellie’s Sports Bar
900 U Street, N.W.
202-332-6355

Uproar
639 Florida Ave., N.W.
202-462-4464

The Dirty Goose
913 U Street, N.W.

JR.’s
1519 17th Street, N.W.
202-328-0090

Windows/DIK Bar
Upper floor at Dupont Italian Kitchen
1637 17th Street, N.W.
202-328-0100

Annie’s Paramount Steakhouse restaurant/bar
1609 17th Street, N.W.
202-232-0395

Larry’s Lounge
1840 18th Street, N.W.
202-483-1483

Pitchers/League of Her Own
2317 18th Street, N.W.
202-733-2558

Duplex Diner
2004 18th Street, N.W.
202-265-7828

The Fireplace
2161 P Street, N.W.
202-293-1293
[Temporarily closed during pandemic]

Number Nine
1435 P Street, N.W.
202-986-0999

Trade
1410 14th Street, N.W.
202-986-1094

Green Lantern
1335 Green Court, N.W.
202-347-4533

D.C. LGBTQ-friendly Bars/Clubs

Dacha Beer Garden
1600 7th Street, N.W.
202-350-9888

9:30 Club
815 V Street, N.W.
202-265-0930

DC 9 Nightclub
1940 9th Street, N.W.
202-483-5000

Dito’s Bar
Lower floor at Floriana Restaurant
1602 17th Street, N.W.
202-667-5937

(Washington Blade photo by Michael Key)
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Global study finds pandemic exacerbates inequities for trans people

More than 77 percent of respondents expect income disruption

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COVID-19 crisis, gay news, Washington Blade

A new global study has found the coronavirus pandemic has had a disproportionate impact on transgender people’s mental health and economic stability.

The study by a team of seven researchers from the Johns Hopkins Bloomberg School of Public Health and the University Center for Public Health and Human Rights found 77 percent of respondents expected a decrease in income. And more than half of them reported losing gender-affirming resources; including surgery delays, inability to purchase beauty products and other factors. 

The study is one of the first of its kind to analyze the intersections of economy, mental health and gender-affirming care for trans people.

The team was also purposeful in making the work community-based with equitably involving queer scientists in the study, said Brooke Jarrett, an author of the study who is a queer woman of color and a doctoral candidate in epidemiology at the university. 

“I think that this topic is something that … is always lit within us,” said Jarrett. “And so whenever I see an area where there’s an opportunity to highlight, to bring out our voices, I think it’s so important to do that.”

LGBT Foundation CEO Sean Howell, who is the founder of Hornet, a global queer dating app, also served as an author of the study.

He disseminated a survey on the app, as well as on the queer dating app Her, from April to August. It received responses from 76 countries that include Turkey, Thailand and Russia. More than 900 users participated in the survey, which was translated into 13 languages.

Howell said the team was purposeful in releasing and analyzing this data during the pandemic in hopes it will point to the need for changes to help trans and non-binary people economically and health-wise. 

The study found positive screens for depression and anxiety are correlated with access to gender-affirming care, and more than 40 percent of respondents reported losing access to mental health counseling. One in six respondents also expected to lose their health insurance.

Access to these resources is essential for trans and non-binary people, said Will Beckham, a study author and a queer trans man who focuses much of his work on trans research. Beckham also serves on Johns Hopkins University’s junior faculty.

He said delays in surgeries are related to symptoms of depression and anxiety. Beckham added losing access to health services or being unable to afford haircuts, binders and other gender-affirming products also have profound negative consequences on mental health.

“It’s not elective, it can be literally life-saving for someone to get a trans-related surgery when they need it,” he said. “Policies need to change, we need to grow the awareness that trans-related surgeries are not elective, but are actually essential medical services.”

Before focusing his research on LGBTQ and trans topics, Beckham focused his work on HIV and was completing research in Tanzania when he realized he was trans. He said he came back to the U.S. to “live fully” and transition. Beckham added limited access to gender-affirming care is a crucial issue that needs to be addressed, and medical and supply chain models need to be reformed to make surgeries deemed as essential.

In addition, a third of respondents reported an inability to live openly in their gender. This could be a result of youth moving back in with unsupportive families as a result of the pandemic, which correlated to positive screens for depression and anxiety.

“They’re having to live less in their affirmed gender, which certainly has an impact on mental health,” Beckham said. “I know very well personally, having been in the closet for a while in Tanzania.”

Jarrett said virtual health interventions, like therapy apps, need to be expanded and explored as a solution to this uptick in depression and anxiety. Beckham said health systems as a whole need to be more inclusive, as well.

Researchers said economic instability is also a notable aspect of the trans experience during the pandemic, with 77 percent of respondents indicating they expected a disruption in their income. More than half of respondents also reported needing and not receiving financial aid.

Jarrett said trans people already dealt with economic instability prior to the pandemic, and “live on the margins of society economically already, especially in places where there’s a lot of stigma and discrimination.” She added those who are employed often have unstable jobs that include casual labor and factory work.

“So when a thing like COVID hits, and there was a lot of job loss, they are the people already on those margins that are the most quickly kicked out of those places and spaces,” said Jarrett. 

Jarrett and Beckham said the amount of community-based assistance popping up during the pandemic for trans people in need is helpful, such as fundraising campaigns for rent payments or giving free haircuts. But they both said there is a need for systemic solutions, such as LGBTQ organizations expanding their advocacy for trans and non-binary people.

Howell said there aren’t government entities or non-profits that have been models in trans inclusion, and this study shows that fact. He said priorities need to be more balanced to better support trans and non-binary people.

“The community has often been put as an afterthought, and I think now we have evidence of a global health crisis that further exacerbated those things,” said Howell. “We’ve known this for quite a long time. But we have to take better action because there’s human factors that are being realized, more and more.”

The research team is currently expanding on this research and beginning new research focused on partner violence, surgery delays and digital mental healthcare during the pandemic.

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