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A nationwide study sponsored by the Agency for Healthcare Research and Quality 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 account for 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. Several potent new antiretroviral medications were being tested during the study period.
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. Participation of black patients in trials did not increase during the study period, and these patients were more likely to drop out of the research.
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.
These findings suggest that to boost minority participation in trials, it will be necessary to 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, concludes 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 8 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 (HCSUS) consortium under the direction of co-principal investigators Martin F. Shapiro, M.D., Ph.D., and Samuel A. Bozzette, M.D., Ph.D. HCSUS is sponsored by AHRQ and other components of HHS.
For more information, see "Participation in research and access to experimental treatments for HIV-infected patients," by Dr. Gifford, William E. Cunningham, M.D., M.P.H., Kevin C. Heslin, and others, in the May 2, 2002 New England Journal of Medicine 346(18), pp. 1373-1382.
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