The Pitt Men's Study

PMS Matters

_____________________________

Oral HPV Testing

Founding Member of the CAB Dies

Testing Microbicides to Combat HIV

25th Anniversary Speech by Philip Parr

Research With A Heart

Syphilis Testing Now Available

Oral History Project and PMS 25th Anniversary

PMS Medical Director Creates Anal Dysplasia Clinic

Randal G. Forrester, Dec. 13, 1947 - April 23, 2008

Envelope of LIFE

Oral HPV Testing

As a Pitt Men’s Study volunteer, you may have been asked to provide us with a saline oral rinse sample at your most recent visit. This is part of a sub-study that we are asking some of our men to participate in. Oral human papillomavirus (HPV or wart virus) infection has been recently identified as a cause of oropharyngeal cancer. Researchers are aiming to compare the persistence and prevalence of oral HPV infection among HIV infected and uninfected men in the Multicenter AIDS Cohort Study (MACS), of which the Pitt Men’s Study is a part. In addition, researchers are attempting to identify and evaluate biological and behavioral risk factors for oral HPV infection. This research is needed to better understand both who is at risk of HPV-associated oral cancers and the magnitude of these risks. If you are a Pitt Men’s Study volunteer and need more information, contact the clinic at 412-624-2008 or 1-800-987-1963.

Founding Member of the CAB Dies

Albert Pasquarelli, one of the founding members of the Pitt Men’s Study Community Advisory Board, died Wednesday September 23, 2009. Pasquarelli was a Democratic committeeman—having worked with Congressman Coyne to get federal proclamations thanking the Men’s Study volunteers for their tireless efforts. As a computer whiz in the early days of computers, he worked with the Study’s staff to update and maintain equipment. He was also a former Commissioner of the gay softball league.

Dr. Anthony Silvestre, co-investigator with the Study noted: "Al and I were close friends. He was a rock of support for many people in the community. He enjoyed helping people and working to organize them whether for softball games or fundraisers. He was an important asset to our community and will be sorely missed."

Dr. Charles Rinaldo, the Men’s Study principle investigator, remembers all of the contributions that Pasquarelli made to the study: "Al was an early and strong supporter. As a native Pittsburgher, he knew many leaders in the community and worked to get their support for the study."

You can find Albert Pasquarelli’s obituary in the Post Gazette by clicking here.

Testing Microbicides to Combat HIV

The development of safe and effective prevention strategies against HIV infection is a critical component of the HIV research agenda and, in recent years, the University of Pittsburgh School of Medicine has emerged as a global leader in microbicide development. Ongoing microbicide research is based both in Pittsburgh and at international sites in Africa and India.

A microbicide is a substance designed to prevent transmission of HIV and other sexually transmitted diseases in men and women. It can come in the form of a gel, cream, suppository, film, sponge or ring that releases an active ingredient over time.

The Microbicide Trials Network (MTN) is led by Dr. Sharon Hillier and headquartered at Magee-Womens Research Institute & Foundation in Pittsburgh. The MTN is funded by the National Institute of Allergy and Infectious Diseases of the National Institutes of Health specifically to conduct clinical trials to evaluate the safety and effectiveness of topical microbicides. Several microbicides are being tested in clinical trials and the present network includes a total of 17 sites located in seven countries.

The concept for a microbicide-like product was developed more than 15 years ago by reproductive health specialists and advocates who recognized the need for female-controlled HIV prevention methods. Beyond being effective, microbicides for HIV prevention must be safe and easy to use.

Microbicides first undergo rigorous testing in the laboratory before testing in humans can occur. Phase I trials evaluate safety in a small number of people exposed to study products for brief periods such as one to two weeks. If those study results suggest the product is safe, investigation then progresses to a Phase II trial. Researchers then track safety of the product over greater periods of time.

Finally, Phase III trials are performed to establish the product’s effectiveness. This type of study is conducted in a large number of participants, and usually involves multiple centers. Studies may be designed to compare one product’s effectiveness with another’s and/or with an inactive agent, or placebo. The data resulting from a Phase III trial are often used by regulatory agencies to determine if a product should be approved for widespread use.

Public health experts estimate microbicides that are even 60 percent effective against HIV could prevent upwards of 2.5 million infections over a three-year period. More research is focusing on the development of rectal microbicides. One current trial involves assessment of rectal safety of microbicide products originally formulated for the vagina, as it is assumed that once vaginal microbicides are licensed they will also be used in the rectum. In addition, a team lead by Dr. Ian McGowan are developing microbicide products formulated specifically for rectal use.

For information about microbicides, the following websites offer a variety of views and news including research and advocacy efforts. They are: www.mtnstopshiv.org; www.ipm-microbicides.org; www.global-campaign.org; and www.microbicide.org.

Persons interested in participating in upcoming local microbicide research studies at the University of Pittsburgh are encouraged to call Anne Davis at 412-641-3381.

Pitt Men’s Study

25th Anniversary Speech

Philip B. Parr

Research With A Heart

It was a scary time. I remember in late 1981, one Sunday morning reading a New York Times’ article about doctors in New York and Los Angeles who were attempting to treat young gay men who were dying of pneumocysits carinii. The doctors did not know what was causing the disease in these young men. I remember looking up from the newspaper to say to my then partner: “I think the causative agent could be something that is transmitted sexually since the common denominator seems to be gay men.”

At that time I worked as the Executive Director of the Pittsburgh Free Clinic, an alternative primary community health care center for adolescents and young adults. I went to work the next day and met with all of the clinic counselors and told them of my conviction that the disease spreading in young gay men on the coasts was most probably caused by an agent transmitted sexually. I said we should strongly urge the gay and bisexual men coming to the Free Clinic to use condoms as a precaution in case the causative agent could be foiled by a condom. The counselors looked at me in disbelief and reported back that the gay and bisexual men coming to the clinic received this information with incredulity and told them to get real.

It was an ominous time. One had the feeling of being alone, of thinking that a time-bomb was planted under the surface and few knew it and nothing could be done about it. In 1982 Sharon Karger (now Sharon Sutton), then the director of the Gay and Lesbian Community Center, had contacted the University of Pittsburgh after she received a call from a person in New York City who heard there was somebody in Pittsburgh doing research on GRID, the Gay Related Immunodeficiency. She called the University to inquire and was eventually connected with Dr. Rinaldo at the Graduate School of Public Health.

When she met Dr. Rinaldo, he expressed gratitude that she had sought him out because he was looking for contacts beyond the “Ivory Tower” of the research setting. Dr. Rinaldo was also working at that time with Dr. David Lyter, then a medical student, to find contacts so that he could learn more about and make contact with the gay community. Through Sharon and David, Dr. Rinaldo was introduced to key people such as Randy Forrester and Jim Huggins of Persad Center; Master Boots of the Pittsburgh Leathermen; Frank Borrelli, Donny Thinnis, Chuch Honse, Bill Kaelin, and Chuck Locey, members of the Tavern Guild, a group of gay bar owners; the Reverend Roberta Dunne of The Metropolitan Community Church of Pittsburgh; members of Dignity, the gay Roman Catholic group, and to others as well.

Sharon was impressed that this researcher from the University reached out to learn about gay and bisexual people and she was amazed from the start by his dedication to the entire community at a time when it was struggling to receive basic respect. Sharon sums it up by stating that: “There are not words to capture his heart. He was told by other professional colleagues that he should not get involved with gay research because it would not help his career, but that did not matter. He worked diligently on getting to know people in the community. He was not a clinical researcher behind the scenes; rather he was a man who was passionate and spiritual. He lived the word “public” in public health. He cared about and sought to know the people he was serving long before he and Dr. David Lyter drew the first tube of blood to begin their early, pre-PMS research.”

So it was that Dr. Rinaldo entered the gay community to talk at the Gay and Lesbian Community Center, at Town Meetings, at gay bars and at other venues about his concern that the cause of pneumocystis might be viral and could well be sexually transmitted and he talked of possible avenues of prevention, including condoms. Having been engaged in the early 80s in cytomegalovirus research he read that gay men who were contracting the deadly pneumocystis tended to have cytomegalovirus infection and that perhaps the cause could be viral and even transmitted through seminal fluid. He became concerned not only about doing research to learn more about this phenomenon, but also about the health and welfare of the gay and bisexual community in Pittsburgh.

I and many of us in and serving the gay community were extremely impressed with Dr. Rinaldo’s work and encouraged gay and bisexual men to hear what he had to say at the various community venues at which he spoke. I made sure that the counselors at the Free Clinic were transmitting his message to our gay and bisexual clients. I did not realize at the time that I was witnessing the beginning of a truly remarkable and powerful occurence 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.

The next thing I heard about Dr. Rinaldo was his work to write a proposal to the National Institutes of Health in competition to bring one of four AIDS research studies into Pittsburgh to establish the Pitt Men’s Study. I was not surprised to hear that he was including considerable input from the gay community in the proposal.

For an example, although it was not a requirement for the initial NIH proposal, a Community Advisory Board (CAB) was written into Pittsburgh’s application. Vital leaders in the community such as Kerry Stoner, Lou Kavar, Frank Lackner, August Pusateri, Sharon (Karger) Sutton, and Herman McClain were appointed to be among its first members. The CAB was designed to be independent with its own ability to create operating procedures (this innovative feature later became a requirement for the other three NIH funded AIDS research projects). The application also had a high degree of community outreach built into it, and affirmed the need to not only recruit research volunteers, but also to serve their health needs. The proposal clearly demonstrated research with a heart.

In fact, one of the key differences between the proposals from Pittsburgh and those of Los Angeles, Chicago, and Baltimore, the other cities that were subsequently NIH funded, was in 1983 our city was not yet realizing the very personal threat of AIDS with men dying in significant numbers. Despite this, Pittsburgh had a strong vision, driven by both the GSPH and the community, of the need to respond to the approaching storm. We were already organizing to learn more about AIDS and to move forward as quickly as possible with prevention education. This was remarkably unique and peculiar for a city of Pittsburgh’s size and position.

My next exposure to the study was in 1984, after it was funded. Dr. Rinaldo, in a move that demonstrated his deep concern to get community outreach right, engaged the study’s Community Advisory Board to form a search committee to find the most highly qualified Director of Community Relations for the research study. I was asked to serve as a member of that committee and was impressed with the commitment to find a person with the required knowledge who would have a passion for and an understanding of this role and would be able to strongly resonate with the community to be served. Our work ended with the hiring of Dr. Anthony Silvestre, and those of you in this audience who know him, know we did our job well.

It is not surprising that the Pittsburgh study has had a remarkable track record not only in its research findings but also in developing community as well as hospital resources and University research. The concern about community education and prevention that was in place before the study originated, has permeated its culture form the beginning until this day. Consider the following:

The PMS through its CAB, was the catalyst that began the Pittsburgh AIDS Task Force.
The CAB was instrumental in organizing the Pittsburgh Inter-organizational Council on AIDS and the South-West Pennsylvania AIDS Planning Coalition.
Although it was not part of the study, the PMS began doing HIV screening as soon as it was available and does so until this day.
Recognizing the need, the PMS in its infancy also quickly organized group sessions with therapy, another service feature that was not part of the original study design.
In the late 80s, the CAB started and maintains to this day, a World AIDS Day inter-faith religious service to create a space where people can mourn, grieve, and remember those who have died.
PMS staff organized additional projects to educate health care professionals in the state about HIV, which became a model for other states to emulate.
The PMS sought and received funding to establish the Pitt Testing and Evaluation Unit and the Pittsburgh AIDS Center for Treatment.
Concerned about the challenges young gay and bisexual men face including the risk of greater HIV infection, suicide, and alcohol and drug abuse, the PMS staff wrote a proposal to obtain grant funding for the Youth Empowerment Project, in collaboration with the Mentoring Partnership of Southwestern Pennsylvania, and initially operated it until it was turned over to Persad a couple of years ago.
Through PMS, thousands of referrals have been made not only for the effective treatment of HIV, but also for counseling and support groups.
And, PMS is now engaged in work to get prevention information out into gay chat rooms on the internet.

The study’s culture of compassion, education and service has resonated with the staff and has had a tremendous impact on the men who have volunteered for research. Here are some examples of each:

Early on in the study two staff, Drs. Lawrence Kingsley and Anthony Silvestre spent considerable time in Harrisburg successfully lobbying for increased funds for HIV/AIDS related services. In Dr. Kingsley’s words: “Our immediate task now is to educate people and prevent spread of disease.”
Another staff person, Ric Witt, the head nurse, said in the early days of the study: “I have come to realize that many gay men do not identify or deal with the fears and anxieties about AIDS. By not facing their fears, they live with a great burden of stress. My job is a constant one. When I am out socially, it is not unusual for people to come up and ask me questions about AIDS. I am pleased that the Pittsburgh AIDS Task Force is beginning an educational campaign. It is a great need in the community.”
A study volunteer recalled in a recent confidential interview that once, after his partner and he had broken up, a study clinician noticed his sadness and would not let it go. In her kindness she helped him to think through how he could take better care of himself during that period of separation and loss. She referred him to counseling and he made steady progress toward well-being. He concluded: “The staff is so humane. They care about you as a whole person.”
A volunteer who joined the study in its first year said: “What the study did for me was give me a chance to do something about a deadly health phenomenon we knew nothing about during a very dark time. This gave me great relief. The study also gave me information on my overall health as well and very expert counseling about how to stay healthy and how to speak about safe sex to men I was thinking of dating. This helped me to get through a lot of fear.”
Recently, a staff person noticed that all of a sudden a volunteer, after repeated visits to the study, had engaged in risky sexual behavior multiple times. The staff member took the time to have meaningful conversations about what was causing the change to risky behavior. These conversations resulted in a referral to a counselor and an abatement of the behavior.

The early work in Pittsburgh that laid the foundation for the ongoing success of the Pitt Men’s Study was uncommon. Dr. Silvestre sums it up best in words written on the occasion of the study’s 20th Anniversary when he wrote: “If you read And the Band Played On, you get the impression that the gay community was not responsive until the mid ‘80s or late ‘80s, but in Pittsburgh that wasn’t the case. 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, and so on and so on. The community rallied to put out as much info as possible and to support the study.”

It is a distinct honor to have been asked by Drs. Rinaldo and Silvestre to speak here today to represent the community on the occasion of the 25th anniversary of the study. 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 and the ongoing success of the Pitt Men’s Study. Together, these compassionate people launched research, service and support initiatives that have saved lives and helped people live more healthy lives in vast numbers that cannot be completely known, both here and across the country. On behalf of the community, I extend sincere and heart felt thanks.

Syphilis Testing Now Available for Study Participants

In April of this year, the Pitt Men’s Study sent out a Health Alert message to gay and bisexual men across Pennsylvania, warning some 4000 individuals that syphilis infections among gay and bisexual men are on the rise. The information in the alert was based on Pennsylvania State Department of Health statistics and a recent study by Dr. James Heffelfinger, et. al., of the HIV Prevention Division at the Centers for Disease Control and Prevention.

Most importantly to the Pitt Men’s Study, Heffelfinger’s research showed that the on-going increase in infections was being driven primarily by men who have sex with men (MSM). In an article published in 2007, Heffelfinger and his colleagues concluded: “Mobilizing the MSM community to take an active role in these [prevention] efforts is crucial for their success. Training providers to improve their skills in diagnosing and treating syphilis, to screen sexually active MSM routinely for syphilis and other STDs, and to screen for STDs in conjunction with HIV counseling and testing is also critical for controlling syphilis among MSM.”

In regards to the local statistics, Pennsylvania State Department of Health records show a particularly sharp increase of cases in Allegheny County and the greater Philadelphia area. As a result, the Pitt Men’s Study, in conjunction with the Allegheny County Health Department, has begun offering free syphilis testing as part of volunteers’ clinic visits.

“We’re excited about our collaboration with the Allegheny County Health Department,” noted Marcie Holloway, a physician assistant and long-time employee of the Pitt Men’s Study. “We’re always looking for new ways to help our guys stay healthy. Having this kind of screening, free of charge, is a valuable and much-needed resource.”

In its early stages, syphilis is easily cured with a simple injection of penicillin. If it goes untreated, however, it can lead to serious health conditions. Syphilis usually begins with a sore, called a chancre. It is usually firm, round, small and painless. The chancre will heal on its own but the infection remains. As the disease progresses, it can include a rash, sore throat, swollen lymph glands, fever, headaches, patchy hair loss, weight loss, muscle aches and fatigue. These symptoms may also pass, but the disease does not go away. In fact, it progresses to a latent stage that involves more serious health consequences such as damage to internal organs, the brain, nerves, eyes, heart, blood vessels, bones and joints. If left untreated, syphilis can even cause death.

For more information about syphilis or the research discussed in this article, please check out these sites:

The Centers for Disease Control and Prevention http://www.cdc.gov/std/syphilis/STDFact-MSM&Syphilis.htm

Dr. Heffelfinger’s findings regarding syphilis rates and MSM at

http://www.ajph.org/cgi/reprint/97/6/1076

To sign up for the Pitt Men’s Study Health Alerts, click on the Health Alerts link on this page.

Oral History Project and PMS 25th Anniversary

The things that unite us as a community are often the memories we share. Memories help us through hard times by touching on universal emotions. Some times we cry and other times we laugh. But no matter what our reaction is to life’s twists and turns, it is the sharing of our history that helps to unite us as a community.

Over the past 25 years, those of us involved with the Pitt Men’s Study have seen our fair share of history. We’ve experienced the twists and turns of the AIDS epidemic first hand. In commemoration of our extraordinary efforts—particularly among the study’s volunteers—the staff of the Pitt Men’s Study would like you to share your memories with us by putting them in writing.

Your letters will be kept on file, as part of the Study’s Oral History Project, and may be published on the Study’s website in commemoration of our 25th anniversary.

Memories can pertain to clinic visits, reactions to the AIDS crisis, or about the loss of a friend or family member. Whatever your memories are, we’d like to make them part of our community’s history.

You can send your letters electronically to pms@stophiv.pitt.edu, or by mail to the Pitt Men’s Study, P.O. Box 7319, Pittsburgh, PA15213. In order to maintain the Study’s strict confidentiality, your letter should contain only your first name, last initial and your study identification number. If you don’t know your study number, you can include your date of birth. All materials sent to the Pitt Men’s Study will become the property of the Study and cannot be returned.

New PMS Medical Director Creates Anal Dysplasia Clinic

Dr. Ross Cranston was recruited to Pittsburgh in 2007 to create an Anal Dysplasia Clinic at the Pittsburgh AIDS Center for Treatment (PACT). The focus of the clinic, which is also open to non-PACT patients, is to address the high incidence of human papillomavirus (HPV or wart virus). HPV has been associated with anal cancer in gay men - particularly those living with HIV.

“As gay men, we run the risk of serious health issues because we don’t pay enough attention to our butts.” Dr. Cranston states. “So, one of my goals is to promote an ‘anal agenda’ that increases awareness of the medical conditions gay men are more likely to experience.” Putting the issue into perspective, he adds: “Anal health has yet to emerge as an area to which it is deemed appropriate to direct our attention. As a result, gay men in particular are unaware of their increased risk of many anal diagnoses including those related to sex or sexually transmitted infections, such as the development of anal cancer.”

Patients with an abnormal anal cytology (a test of anal cells that is used to detect abnormalities) are referred to Dr. Cranston for high-resolution anoscopy (HRA). This office procedure involves examining the anal canal using magnification. If there is evidence of high-grade dysplasia – the precursor to anal cancer – a biopsy may be performed. If high-grade dysplasia is confirmed, Dr. Cranston can then remove the lesion in order to prevent its potential progression to cancer.

“We are currently diagnosing about one case of anal cancer every 2 weeks,” says Dr. Cranston, “which is why I suggest that gay men who are HIV-positive talk to their clinician about anal dysplasia screening and have an annual anal Pap smear.” Although there are no national screening guidelines, Dr. Cranston notes, it is also suggested that HIV-negative men over 40 get tested every two to three years.

Dr. Cranston is an Assistant Professor in the Division of Infectious Disease and the Medical Director of the Pitt Men’s Study. He began his studies at the University of Edinburgh before moving to London, where he completed a fellowship in HIV and Sexually Transmitted Infection. He moved to the U.S. to conduct doctoral research at the University of California—San Francisco and then spent five years working at the UCLA Center for AIDS Research and Education in Los Angeles, where he established and ran the UCLA Anal Dysplasia Clinic.

For many years, Dr. Cranston has used his knowledge of anal dysplasia, HPV, and HIV to help countless HIV-positive men. He moved to Pittsburgh in September 2007 with his partner of 11 years, Ian McGowan, who is also employed by the University as a Professor in the School of Medicine, and is Co-Principal Investigator of the Pittsburgh-based Microbicide Trials Network.

For more information about the anal dysplasia clinic, you can call 412-647-0996.

In Remembrance of Long-Time Civil Rights Activist

and Friend to the PMS

Randal G. Forrester

Dec. 13, 1947 - April 23, 2008

Most of us in the community knew him simply as Randy. His name carried a fair amount of notoriety. The local media turned to him for an interview whenever LGBT

civil rights were an issue. He co-founded Persad Center in the early 1970’s with his long time partner, Jim Huggins—one of only a few counseling centers for

sexual minorities. He founded the Lambda Foundation in the early 1980’s, which has been responsible for funding endless LGBT organizations, HIV/AIDS services, and individuals in and around Pittsburgh.

The Pitt Men’s Study turned to Randy in 1984, when it came time to organize the gay community around recruitment for the study. After getting the ball rolling, Randy then recommended Dr. Silvestre for the position—Randy had too much on his own plate to take up the task full-time. Randy recounted the early days of the PMS as part of an oral history project (click here to read the oral history article that includes Randy’s interview). In those early days of the epidemic, it was Randy who insisted participants in the study remain anonymous, and that the person who would eventually handle the recruiting should also be gay.

Randy’s obituary in the April 25th edition of the local Post Gazette sums up his long list of accomplishments, and gives credit to his dedication to community activism and civil rights (click here for the full article). But on a more personal note, Dr. Mark Friedman, a researcher at the University of Pittsburgh, studying LGBT youth, had this to say: “I remember when a representative of Bishop Donald Wuerl requested a meeting with Randy. I was there, as Persad’s Director of Development. The representative wanted to build a relationship with Persad. Randy told him, politely but firmly, that the Bishop’s and the Church’s positions on condoms lead to the transmission of HIV and to death, that their position on homosexuals lead to personal anguish among so many; that these positions were incompatible with the mission of Persad Center and, as a result, a relationship between the two would not be possible. Randy was that direct,” Friedman concluded, “And of course, so on-target.”

When asked about their personal relationship, Friedman went on to say: “Randy was a mentor to me, in addition to being a good friend. He helped teach me the importance of community activism. He was a tireless advocate for gay civil rights when the general population considered homosexuality on par with criminal behavior. Randy helped change that. We may have a long way to go in terms of civil rights, but it was Randy who laid the ground work in southwestern Pennsylvania.”

Envelope of LIFE

City of Pittsburgh residents are being urged to take advantage of the Envelope of LIFE program offered by the city’s Emergency Medical Services. The Envelope of LIFE is a standardized form that provides vital health-related information to emergency personnel in the event that you are incapacitated or unconscious during a medical emergency.

The Pittsburgh Emergency Medical Services websites notes: “By taking just a few minutes to fill out an Envelope of LIFE form, you will be giving yourself the advantage in an emergency and will also help in making a difficult time much easier for your family.”

Marcy Holloway, a Physician Assistant here at the Pitt Men’s Study, brought the city’s Envelope of LIFE program to the attention of the PMS staff and volunteers. “The study values the health and wellness of our participants,” she said, “and this program is an excellent mechanism that can essentially save lives.”

Click on the picture above, or follow this link to the Envelope of LIFE document:

http://www.city.pittsburgh.pa.us/ems/assets/07_envelope_life.pdf

For more detailed information, you can go to the Pittsburgh Emergency Medical Services website at: http://www.city.pittsburgh.pa.us/ems/html/envelope_of_life.html#overview

Questions or comments about the site?
Send to: webmaster