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November 6, 2008

Pitt Men's Study marks 25th year

When the Pitt Men’s Study began 25 years ago, researchers “had a strong vision for the need to respond to the approaching storm,” in spite of the fact that men in Pittsburgh were not dying in significant numbers from AIDS, recalls Philip Parr, who at the time directed the Pittsburgh Free Clinic.

“I did not realize at the time I was witnessing a very remarkable and powerful occurrence that would last to this day: The building of a public health research initiative that would place the collecting and analyzing of data on equal footing with the dignity of the research subjects and their needs for education, support and services,” said Parr, who also is a former president of the Pittsburgh AIDS Task Force.

As the Pitt Men’s Study marks its 25th year, it continues to provide new data on the progression and transmission of HIV infections and AIDS. In a symposium commemorating the anniversary, public health researchers and advocates reflected last week on the study’s impact on science as well as on the local gay community.

When Pitt researcher Charles R. Rinaldo Jr. began recruiting local gay men for a pilot study in 1982, reports were circulating about a mysterious “gay plague,” before the term AIDS came into use and before HIV was identified as the cause.

In response to a National Institutes of Health request for proposals, in 1983 Rinaldo submitted a plan for a study that sought to recruit 7,000-10,000 men ages 18-55 for a “prospective study of AIDS in homosexual men in Pittsburgh.”

Based on Alfred Kinsey’s research on human sexual behavior, Rinaldo estimated a population of 35,000 gay men in the tri-state area, “and we were going to recruit 10,000 of them,” he noted wryly at the Nov. 3 event.

By using the offer of free testing for hepatitis, syphilis and gonorrhea as well as “shoeleather epidemiology” that included recruiting in gay bars, the discreetly named “Pitt Men’s Study” initially recruited a cohort of approximately 1,200 men.

The Pitt Men’s Study became one of four locations in the NIH-funded Multicenter AIDS Cohort Study (MACS), along with sites in Chicago, Los Angeles and Baltimore. Rinaldo, professor and chair of Pitt’s Department of Infectious Diseases and Microbiology, continues as the principal investigator for the Pittsburgh site.

Science Magazine in July recognized MACS, with an annual budget of $14.4 million, as among NIH’s most cost-effective research investments. The project involves some 150 investigators following about 3,000 men in a long-term study on the transmission and progression of AIDS.

Of the subjects, approximately 1,600 are infected with HIV; of those, 90 percent take antiviral drugs.

Some 1,000 HIV/AIDS research papers have sprung from MACS data to which the Pitt Men’s Study has contributed. Early data showed AIDS is not spread by casual contact. Later research found that certain genetic mutations impact the development of AIDS infections and associated high levels of HIV in the blood with increased risk of developing AIDS.

Researchers were able to use samples stored from the early days of the Pitt Men’s Study more than a decade later to determine how much HIV they contained. Along with information gained by tracking participants — some of whom developed AIDS in the ensuing decade — Rinaldo said researchers found they could predict who would develop AIDS based on the amount of the virus in the blood during the first year of infection. “It was a profound finding at the time,” Rinaldo said.

Hundreds of papers addressing virology, neuropsychology and therapeutics have been published in the interim. The MACS study also continues to gather information on “elite controllers” — HIV-positive men who are receiving no treatment, yet do not progress to AIDS.

Vanderbilt University epidemiologist Sten Vermund, a former NIH project officer responsible for MACS from 1988 to 1994, noted, “Maybe we can derive some insights from Mother Nature on how certain people control their HIV infection that can be terribly helpful in vaccine development.”

Today, as Pitt Men’s Study participants age, researchers can study how the virus affects such conditions as heart or liver disease, cancer and other conditions associated with aging. The data also enable researchers to assess the long-term toxicity of treatments for HIV — a logical progression of the research, “taking advantage of the fact that you have a total knowledge base for 25 years of medical history for your participants. Some of these people are in their 50s and 60s; a couple of them will be 70,” Vermund said. “They have the natural problems of aging, but there are also the side effects of the antiretroviral drugs and the primary effects of HIV. Who’s going to tease that out better than MACS?”

He added, “There’s been a volume of work that has not escaped a single aspect in what’s important about HIV that’s come out of MACS,” adding that Pitt researchers were ahead of the curve in studying the disease. “It didn’t take them having a hundred or a thousand reported cases to CDC for them to recognize how important this was,” he said.

“It may be the Pitt Men’s Study helped reduce the magnitude of the epidemic in Pittsburgh with its educational efforts, with its outreach with its frank talk about AIDS at a time when it wasn’t deemed proper to talk about AIDS, when it wasn’t even deemed proper to do research about AIDS,” he said.

Rinaldo noted that he insisted on building prevention education into the Pitt Men’s Study even though it wasn’t a required component.

Parr commended Pitt’s researchers for their concern for the gay community and their emphasis on prevention education as well as their vision for enlisting community involvement in the study through the formation of a community advisory board.

In addition to prevention education, the study began conducting HIV screening as soon as it was available. That forced the researchers to deliver the grim news that some 400 of the men had tested positive, Rinaldo recalled.

Researchers also organized group sessions and therapy, with a “tremendous impact on the men who volunteered for the study,” Parr said.

The community responded with cooperation.

“Pittsburgh was one of the first cities to mobilize as quickly and as strongly as it did. Bar owners put signs up, bartenders went to trainings. … The community rallied to put out as much info as possible and to support the study,” Parr said.

“It gives me great pleasure to document in some small measure the extraordinary initial, prescient and dogged ongoing work in Pittsburgh of the key people who established the collaborative scaffolding for the ongoing success of the Pitt Men’s Study. Together, these compassionate people launched research, service and support initiatives that have saved lives and have helped people live more healthy lives in vast numbers that cannot be completely known,” he concluded.

In spite of the contributions of the Pitt Men’s Study to the better understanding of HIV and AIDS, Rinaldo is not without his regrets regarding early approaches to the epidemic.

He said his research team walked a fine line between wanting to grab people by the shoulders and shake them to alert them to the danger, and the desire not to intimidate, insult or disrespect their choices in life. “Maybe if we had been more fear-inducing … maybe we would have saved more from infections, more lives.”

Likewise, Parr said much was done to get the message out through peers, but he wished the community earlier had “really honed in on that strategy much more powerfully — to actually have gay men go out and talk to men who have sex with men — friends, friends of friends. It’s a very powerful way to get the messages out because it’s coming directly from someone in the community.”

Parr said he also regrets that the initial work focused mainly on the community of white men who have sex with men. Although infection rates have remained stable in the U.S. for the past two decades, with about 35,000-55,000 new HIV cases each year, the demographics of the disease are changing.

Hidden within those numbers, Vermund said, is a rise in the number of women and a substantial rise in the numbers of black homosexual men infected.

Advances in antiretroviral treatments have contributed to a decline in mortality for people infected with HIV, but the rate of decline has been slower for blacks and Hispanics than for whites, Vermund said.

The AIDS crisis, particularly in the gay community, is not over, Vermund said. “Gay men still represent a majority of cases,” he said citing CDC statistics that show 53 percent of the transmission of HIV is from male-male sexual contact.

—Kimberly K. Barlow

Filed under: Feature,Volume 41 Issue 6

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