Charles Rinaldo poses for a portrait in the lab with a colleague.
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40 years later, the Pitt Men’s Study is still breaking ground in the fight against AIDS

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In 1984, Charles Rinaldo launched a study to learn more about a mysterious illness befalling gay men across the U.S. He was 37 years old, only 6 years into his appointment as an assistant professor in the Pitt School of Medicine and School of Public Health, when he put the University on the map for groundbreaking AIDS research.

With the backing of a $4.2 million, four-year National Institutes of Health (NIH) contract, Rinaldo set out to recruit several thousands of gay men in the Pittsburgh tristate area to donate blood and other clinical specimens. It was the beginning of the Pitt Men’s Study, which aimed to uncover the process by which a virus leads to AIDS and the development of the disease post-diagnosis.

The Pitt Men’s Study recently commemorated 40 years of trailblazing research, including contributions to more than 1,700 scientific articles. The study is behind breakthroughs in understanding the transmission and treatment of HIV and AIDS and continues to impact the lives and careers of study participants and scientists alike.

Bringing the NIH study to Pittsburgh

When he started at Pitt, Rinaldo’s primary research focused on cytomegalovirus, a herpesvirus that can cause serious illness in people with weakened immune systems, but he soon changed course.

“Once the first CDC report on AIDS was published in 1981, I immediately realized how important and potentially central this could be to my virus immunology research,” he said. “I chose that path and never looked back.”

He pitched Pittsburgh as one of five sites for establishing the NIH Multicenter AIDS Cohort Study because the area was considered low-incidence for the disease. The federal agency also chose several high-incidence locations: Los Angeles, Chicago, Baltimore and San Francisco, which exited the cohort after a year. Because the study welcomed both HIV-negative and HIV-positive gay male participants, the cryopreserved specimens have been able to provide valuable insight into how the body changes post-infection.

Participation wanted

Initially, getting the word out about the study was a full-court press.

“I learned in establishing the Pitt Men’s Study that you cannot do it alone. I had to engage and trust in the LGBTQ community that I was not previously a part of,” said Rinaldo.

He formed a dedicated research team that included gay men and lesbians who acted as a bridge to their communities, providing credibility and accessibility in a time of crisis. Study researchers allied themselves with gay bar owners to gain access to patrons, placed ads in local LGBTQ publications and networked with gay churches and sports leagues. The message: We can’t fight AIDS without your help.

Marc Wagner, then 22 years old, answered the call, becoming one of the original study participants.

He was an out gay man who was seeing beloved members of his community fall ill. The decision to volunteer was easy, he said.

When he joined the study, an HIV-positive diagnosis was considered a death sentence; there was no treatment, and stigma in the form of housing, jobs and medical discrimination ran rampant against people who contracted HIV and AIDS.

The study’s requirements for volunteers have changed since its inception. Generally, participants are asked to come in every six months to have copious amounts of blood drawn and to answer questionnaires about their health and habits. At times, study participants also submitted urine, fecal and semen samples, provided throat washings with a salt solution, and had their limbs and torso measured to track sub-dermal fat deposits.

After his second visit to the Pitt Men’s Study, Wagner learned he was HIV-positive. While the news was devastating, it set him on a path of advocacy and a career in research.

“Being a part of the study has been a way of giving back to humanity, giving something to the world,” he said. “It’s important to me to not just live with the condition but do what I can to help.”

To say Wagner is helping is an understatement — along with his volunteer work, he is employed at Pitt as a lab manager for Velpandi Ayyavoo, an expert in HIV-1 virology and faculty member in the School of Public Health who often performs research on samples from the Pitt Men’s Study.

Along with publishing multiple scientific articles on HIV, Wagner is a longtime active member of the International AIDS Society and former chair and co-chair for the National Community Advisory Board for the NIH Multicenter AIDS Cohort Study, which was combined with the agency’s Women’s Interagency HIV Study Combined Cohort Study in 2019. He continues as an active member of the National Community Advisory Board.

“I didn’t know if I was going to live after receiving my diagnosis, so I decided to do as much as I could do towards a cure,” Wagner said

Pitt Men’s Study participant testimonials

“I have been part of this study since the mid ’80s, and I feel as though [attending appointments] is like coming home to visit my family.” — Nick

“My theme song is ‘I Will Survive.’ Thank you to the staff and doctors of the Pitt Men’s Study, my friends, for encouraging me to fight, and to not miss a dose of my medicine no matter how bad the side effects. Thank you for all the hugs, smiles and encouraging words. You all made a difference and are the reason that I am a person ‘LIVING with HIV’ today.” — Richard

“I feel privileged to live in a city that has been continually funded to do AIDS research. I have received wonderful patient care and thousands of dollars’ worth of blood work for donating my time [to the Pitt Men’s Study].” — Doug

 

The commitment of a lifetime

Forty years later, Wagner and Rinaldo continue to contribute — stalwarts of what is now one of the longest-running studies of HIV and AIDS.

It’s unusual for scientific cohort studies to last 40 years or more, said Rinaldo, who remains the principal investigator of the Pitt Men’s Study. To have made it so far, he credits learning from his personal and professional successes with his mistakes. The way forward, he said, is to “keep on truckin’.”

The Pitt Men’s Study is funded by the NIH through 2026. Currently, Rinaldo, in partnership with Yue Chen, a research associate professor of medicine in the School of Medicine, is analyzing oral and fecal microbiome profiles and blood plasma samples the study collected during early years of the study 40 years ago to examine the influence of climate change and antibiotic drug resistance in HIV infection.

A few factors have contributed to the study’s endurance, said Rinaldo: the timeliness of the research, the team’s focused dedication, continuous financial support and the value of the scientific findings.

“But most of all, it’s the dedication of the cohort participants,” he said. “Without them, there is no Pitt Men’s Study.”

Though he set out to include up to 10,000 gay men in the Pitt Men’s Study, so far about 2,000 have participated, with 443 currently enrolled.

The University recently recognized Wagner’s contributions with a Pitt Public Health Practice Established Partner Award.

Said Wagner, “In the early days of the AIDS pandemic, we had leadership that wouldn’t even speak the name of this dreadful disease,” he recalled at the award ceremony. “What they failed to understand is that our lived experiences give people a unique perspective — a perspective that fuels commitment to research, advocacy and education.”

 

Top photo by Tom Altany