Researchers at the University of Maryland School of Medicine have received more than $3 million from the federal government to expand a program that gives Baltimore AIDS patients increased access to experimental drug therapies.
Under the grant this month, the Maryland program, called Baltimore TRIALS, joins 19 other institutions in a clinical research network funded by the National Institutes of Health.
The network was developed five years ago in response to pressure from AIDS activists. Its goal is to offer the chance to receive new treatments to a broad spectrum of people who have the human immunodeficiency virus or people with acquired immune deficiency syndrome.
"The whole impetus behind this approach is to improve the access of minority populations -- women, people of color, IV drug users -- to clinical trials," says Dr. David Wheeler, an associate professor at the University of Maryland School of Medicine.
And the program allows primary care doctors a greater voice in designing some studies undertaken in AIDS clinical research, he says. In 1990, Dr. Wheeler developed a program that allows private physicians and doctors at several Baltimore community health centers --including the Chase-Brexton and Total Health Care clinics -- a chance to take part in experimental drug %J therapies that are being studied at the University of Maryland.
But this is the first year that a Maryland institution has participated in the federal network, known as Community Programs for Clinical Research. Beginning this month, $12 million will be given over five years to participating universities or hospitals, including the University of California at San Francisco and Columbia University in New York City.
The attempt to increase the availability of new therapies is an offshoot of another NIH program called the AIDS Clinical Trial Group, which consists of the Johns Hopkins medical system and 56 other large medical centers that conduct large-scale clinical drug trials.
Historically, the majority of people who participated in AIDS drug trials were white, gay men with links to the medical establishments and access to information about experimental efforts that could potentially slow the progress of their illness, says Dr. Wheeler.
But many AIDS patients are substance abusers, are homeless or are poor -- and don't know how to enroll in the large-scale clinical trials.
Other patients are intimidated by the size of some medical establishments, or by researchers they don't know, says Dr. Joseph Nkwanyuo, a private physician in downtown Baltimore who has been involved with the community research effort for two years.
"Many people say they don't really want to go to a big city clinic," he says. "For certain cultural or social reasons they are very suspicious of big trials. Some people feel they are going to be experimented on with drugs and they are very apprehensive."
One of Dr. Nkwanyuo's patients, who is HIV-positive and is participating in a study that compares the effects of two drugs used to suppress the symptoms of genital herpes, says that he wouldn't go to a large clinic to enroll in a study.
"The program is a good idea: At a big hospital, I feel like I am on
public display. My business is my business," says the 40-year-old, who asked that his name not be used.
In addition to the herpes drug study, the community-based research includes a long-term observational study of about 500 AIDS patients; an investigation into which combinations of anti-viral drugs are most effective in the treatment of HIV; and a study of the best way to administer a drug used to treat a serious eye condition caused by HIV.
In Baltimore, the newly awarded grant money will be used to expand the community-based research program that was developed four years ago by Dr. Wheeler.
"The money will go to hiring outreach workers, study nurses to allow us to be out in the community seeing the patients get care, making sure the data is kept clean and correct, making sure we follow the patients. Up until now, we didn't really have the underlying funding to send nurses to all the sites to support the doctors in the research," he says.
"The whole point is that these people can get treatment at their regular doctors whereas before they wouldn't necessarily go to both their doctors' offices and go to a university for a drug trial."