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Press Release Date: May 1, 2002
A nationwide study sponsored by the Agency for Healthcare Research and Quality (AHRQ), shows that black and Hispanic HIV patients are only about half as likely as non-Hispanic whites to participate in clinical trials of new medications designed to slow the progression of the disease. Together, blacks and Hispanics comprise roughly 48 percent of the HIV patient population—33 percent and 15 percent, respectively. The study also found that women, regardless of race or ethnicity, are no less likely than men to participate in HIV drug studies.
By periodically interviewing a nationally representative sample of HIV patients between 1996 and 1998, a team of researchers led by Allen L. Gifford, M.D., of the VA Healthcare System and the University of California, San Diego, found that, overall, 14 percent of the patients participated in an HIV medication trial. In addition, 24 percent of the patients overall received experimental treatment at some time through a trial or approved investigational drug mechanisms that allow doctors and patients to obtain promising experimental HIV drugs. During the study period, several potent new anti-retroviral medications were being tested.
About 10 percent of black patients and 11 percent of Hispanic patients participated in a clinical trial, compared with 18 percent of non-Hispanic white patients. Black patient participation in trials did not increase during the study period, and these patients were more likely to drop out of the research.
"These findings underscore the need to increase the diversity of patients in research," said Carolyn Clancy, M.D., AHRQ's acting director. "It is a priority for AHRQ and the Department of Health and Human Services (HHS) to include a broader range of patients in studies of treatment effectiveness."
According to Dr. Gifford, black and Hispanic patients' limited attempts to obtain experimental HIV medications may reflect lack of awareness of clinical trials in minority communities, as well as suspicion and distrust of trials and researchers. Black patients were less than half as likely as white non-Hispanic patients to try to obtain an experimental HIV medication.
"Our findings suggest that to boost minority participation in trials, we must look critically at structural barriers such as research-entry criteria, enrollment and tracking procedures, and study center operations, as well as clinical researchers' attitudes and practices," said Dr. Gifford.
Other factors contributing to a reduced likelihood of participation in a clinical trial were having less than a high school education, being in a commercial HMO, and receiving primary care eight miles or more from where the clinical trial was held.
The analysis was conducted as part of the RAND-led HIV Cost and Services Utilization Study Consortium (HCSUS) under the direction of Martin F. Shapiro, M.D., Ph.D., and Samuel A. Bozzette, M.D., Ph.D., the co-principal investigator. HCSUS is sponsored by AHRQ and other components of HHS.
Details of the study are in "Research and Access to Experimental Treatments for HIV-Infected Patients," published in the May 2, 2002, issue of The New England Journal of Medicine.
Note to Editors: For interviews of Dr. Gifford, contact Cynthia Butler, VA San Diego public affairs officer, at (858) 552-8585, ext. 7821, or by E-mail at Cynthia.Butler@med.va.gov.
For more information, please contact Bob Isquith, (301) 427-1539 (RIsquith@ahrq.gov).