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COVER STORY: A New Milestone for HIV Prevention

Jonatan Gioia’s research work at UTHealth in Houston helped inform the FDA’s decision to approve the first injectable PrEP treatment.

Jonatan Gioia in the lab at McGovern Medical School at UTHealth Houston (courtesy photos)

When Buenos Aires native Jonatan Gioia moved to Houston for a medical research position in January 2017, he spent most of his time raising awareness for a new HIV-prevention technology that seemed almost unimaginable at the time.

The queer medical professional, who uses he/they pronouns, conducted several weeks of outreach at Houston’s LGBTQ bars and community centers, telling as many people as he could about his new job as a study coordinator for the Houston AIDS Research Team (HART) at McGovern Medical School at UTHealth Houston. His mission was to build trust and recruit cisgender men and transgender women who have sex with men into his research team’s HIV Prevention Trials Network (HPTN) 083 study—an international effort that would test a new Pre-Exposure Prophylaxis (PrEP) treatment that could be injected once every two months. The two HIV-prevention combination drugs, Truvada and Descovy, are currently available as a single pill that must be taken daily. 

The January 2022 edition of OutSmart magazine (photo by Victor Contreras | IG: @closeyoureyesphoto)

Working with researcher Roberto C. Arduino, MD, an infectious-disease professor and the HPTN 083 study’s principal investigator at the local HART Clinical Research Site, Gioia coordinated the logistics for the Houston study. 

Data from the international trials helped the Food and Drug Administration (FDA) inform its decision to approve the first injectable treatment for HIV prevention. On December 20, the U.S. became the first country to authorize the use of this groundbreaking technology that promises to become “the next important tool in the effort to end the HIV epidemic,” according to FDA officials. 

“This injection, given every two months, will be critical to addressing the HIV epidemic in the U.S., including helping high-risk individuals and certain groups where adherence to daily medication has been a major challenge or not a realistic option,” said Debra Birnkrant, MD, director of the Division of Antivirals in the FDA’s Center for Drug Evaluation and Research.

Gioia is excited about the FDA’s approval of this groundbreaking treatment that his study participants have been testing. “It’s a leap of faith when you start research and try to find answers to new questions. The fact that I helped contribute to this huge milestone in HIV-prevention history feels amazing,” he says. “I’m also thankful for all of the volunteers who were there from the get-go. They trusted us and helped recruit other participants. All of their time and effort paid off. This is their success, too.”  

The Only Trial in Texas

HPTN 083 launched in December 2016 with 43 sites in seven countries—Argentina, Brazil, Peru, South Africa, Thailand, the U.S., and Vietnam. Of the 27 study locations in the U.S., UT’s research team had the only site based in Texas, according to the study’s website. 

The study enrolled 4,570 participants across the globe. Sixty of those volunteers were based in Houston, and Gioia played a key role in getting those folks involved. Recruiting volunteers was a busy job that consisted of leaving informational flyers at Houston’s most popular LGBTQ spots, engaging with potential participants in person, and asking community organizations to help spread the word. “It was always so exciting when we’d get a new call from someone saying, ‘Hey, I saw your flyer. How can I get involved?’” he says. 

It’s a leap of faith when you start research and try to find answers to new questions. The fact that I helped contribute to this huge milestone in HIV-prevention history feels amazing.”

—Jonatan Gioia

Gioia explains that all of the communities most impacted by HIV were required to be represented in the clinical trials. In the U.S., those most at risk of acquiring HIV are Black and Latino men who have sex with men, and transgender women of color, according to the Centers for Disease Control and Prevention’s most recent HIV Surveillance Report.  

“In the U.S., 50 percent of participants had to be Black, and 10 percent had to be transgender. We absolutely nailed that target across the nation and in Houston. Our participants really represented Houston’s diversity,” Gioia says. “We also had a lot of monolingual Spanish-speaking people, and all materials are available in Spanish. Undocumented people could also participate. We really wanted to be able to stop all of the barriers to getting to health care, and we’re really happy we were able to achieve that.” 

The HART study began HPTN 083 trials in mid-2017. In the double-blind study, half of the participants received Apretude (cabotegravir extended-release injectable suspension) every two months, along with a placebo regimen of daily oral tablets. The other half received a placebo injection and an actual PrEP prescription of once-daily Truvada tablets.

In May 2020, the independent data and safety monitoring board overseeing HPTN 083 revealed that the new PrEP treatment taken via injection was even more effective than the oral tablets. “According to the CDC, Truvada is already 99 percent effective,” Gioia says, “and the study found that there were even fewer transmissions within the Apretude group.”

Following this news, the Houston HPTN 083 participants were informed which trial group they were in, and were given the option to continue their PrEP treatment through Apretude injections or Truvada oral tablets, or to leave the study. 

A Local Look at HPTN 083

Quentin Jones, a Black gay man who moved to Houston in 2005, is a participant in the local HPTN 083 study. After several of his friends tested positive for HIV, he began to realize he needed to take precautions for his own sexual health. When a friend shared information about receiving free PrEP through HART’s clinical study, Jones filled out a volunteer application form. Learning that he got in “was honestly a relief. It felt like a golden ticket,” he says.

Quentin Jones

Jones says he felt comfortable participating in the study, which was based at Thomas Street Health Center, the first freestanding HIV/AIDS clinic in the country. He went to the clinic every two months to receive PrEP via injections and take-home oral tablets. “The clinic was close to home. I could text my doctor, and even talk to him about Drag Race,” he laughs. “It’s how I’d like all professional medical places to be.”

After a few years of volunteering in the local PrEP study, Jones found out he was in the group receiving the real Truvada pills along with a placebo injection. He decided he wanted to move forward with the study by switching to the Apretude injections. “I love the shot—I can’t say it enough!” Jones says. “It’s so much easier. Instead of remembering something you have to do every day, it’s just once every two months.”

Participating in the study has empowered Jones to help raise awareness about HIV issues. He now uses his Instagram account (@mr.bevicious) to share his experiences during visits with his HPTN 083 doctors. “Just like when I post gym selfies or pictures of food, I want people to see that [promoting sexual health] is normal so others do the same.”

He urges anyone who is hesitant about getting tested for HIV to reach out to him. “As a Black gay male, I know it’s an uneasy feeling to not know your status. But your status doesn’t define you. If you need someone to go with you to get tested, or want information about PrEP, hit me up.” 

The Research Continues

UT Health’s Houston AIDS Research Team has expanded to oversee a variety of other projects. HPTN 091 is an intervention that tries to enhance health care for transgender women by proving that it’s better to provide diverse healthcare services (such as gender-affirming hormone therapy and HIV-prevention medicine) in one place, rather than having those services scattered around the city. The intervention also connects trans women to peer navigators who are also trans women, and who can help them get linked to any resources they might need for employment, housing, and mental health. 

HPTN 094 is a study that aims to help people who inject drugs, and specifically opiates. Gioia’s researchers provide these folks with HIV prevention and treatment services, plus treatment for Opioid Use Disorder, in the setting of a mobile research unit that goes into “hot spots” throughout the city where opiate overdoses are common. The study provides participants with free treatment and linkage to care. 

“We’re not only looking into new medications for PrEP, but we’re also looking for new prevention strategies.” Gioia says. “We need to think about how to reach underserved communities. One of the most important things I’ve learned is that no one is hard to reach—you just have to find creative ways to reach people.” 

In the coming months, Gioia’s team plans to embark on a trial for yet another long-acting PrEP option that only needs to be injected every two months. “Maybe in another five years, you’ll read about another version of PrEP that only needs to be taken twice a year,” Gioia says. “This is how we plan to move forward in the fight to end HIV.”

For more info on UTHealth, visit med.uth.edu. Keep up with Jonatan Gioia on Instagram @jonatangio or email him at [email protected].

This article appears in the January 2022 edition of OutSmart magazine.

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Lourdes Zavaleta

Lourdes Zavaleta is the managing editor of OutSmart magazine.
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